chrisvoncsefalvay/vaers-outcomes huggingface dataset:
he "was achy like I had the flu"; I have sores in my mouth; no energy; angry; This spontaneous report was received from a 69-year-old male patient, referring to himself. The patient's historical conditions included low thyroid issue, atrial fibrillation, heart problems (unspecified), blood pressure a little high, tinnitus and incontinence (unspecified). The patient's concurrent condition included kidney issue "on edge of kidney disease stage 3". The patient was allergic to rifampicin (MYCINS), sulfacetamide sodium (+) sulfadiazine (+) sulfadimidine (+) sulfamerazine (SULFAS), penicillin and tetracyclines. The patient's concomitant medications included levothyroxine, apixaban (ELIQUIS), losartan, pravastatin or maybe something else now (unspecified), citalopram, oxybutynin, pyridoxine hydrochloride (VITAMINE) and what not" (unspecified) and influenza vaccine (FLU).     On an unknown date in November 2020 (also reported as last year), the patient was vaccinated with first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) or pneumococcal vaccine conj 7v (crm197) (PREVNAR) (reported as PREVNAR 23, it was unsure which products he has received) (strength, dose detail, lot# and expiration date not reported; route reported as injection) for prophylaxis due to the patient was told by the doctor that he needed to receive it if he have not had it yet. It was reported that the patient did not have any side effects.  On an unknown date in 2021 (also reported as "past few days" and "recently"), the patient received pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) or pneumococcal vaccine conj 7v (crm197) (PREVNAR) (it was unsure which products he has received) again along with the influenza vaccine (FLU) shot (unspecified) in the same arm.  On unknown dates in 2021 (reported as "in the last few days"), the patient was achy like he had the flu, he had sores in mouth (reported as less today than yesterday) and no energy. The patient wanted to know if the sores were going to go away. He was taking ibuprofen (ADVIL) for the reported effects noted above and "felt a bit better", 4 hours later, he took a second dose of ibuprofen (ADVIL) and "feels better" but "left with sores in his mouth". The patient became angry. On an unknown date (reported as recently), the patient had kidney labs without results provided. Therapy was reported as not discontinued. The outcome of the events was reported as not recovered. The causality assessment was not reported.
Felt like death; Body aches; Headaches; Fever 100.7; Loss appetite; Fatigue; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Dec2021 12:00 (Lot number: FL3197) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing), notes: other medical history: Anxiety MItral valve prolapse; "MItral valve prolapse" (unspecified if ongoing), notes: other medical history: Anxiety MItral valve prolapse. Concomitant medication(s) included: SERTRALINE; INDERAL. Past drug history included: Vancomycin, reaction(s): "known allergies: Vancomycin", notes: known allergies: Vancomycin. Vaccination history included: Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose brand unknown=False,, prev dose lot number=EP6198,, prev dose lot unknown=False,, prev dose administration date= 25Mar2021,, prev dose administration time=01:00 PM, prev dose number=2, prev dose vaccine location=Left arm), administration date: 25Mar2021, for COVID-19 immunization; Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose brand unknown=False,, prev dose lot number=EP8730,, prev dose lot unknown=False,, prev dose administration date= 04Mar2021,, prev dose administration time=01:00 PM, prev dose number=1,, prev dose vaccine location=Left arm), administration date: 04Mar2021, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 29Dec2021 12:00, outcome "unknown", described as "Booster"; ANXIETY (non-serious) with onset 29Dec2021 19:00, outcome "unknown", described as "Felt like death"; PAIN (non-serious) with onset 29Dec2021 19:00, outcome "unknown", described as "Body aches"; HEADACHE (non-serious) with onset 29Dec2021 19:00, outcome "unknown", described as "Headaches"; PYREXIA (non-serious) with onset 29Dec2021 19:00, outcome "unknown", described as "Fever 100.7"; DECREASED APPETITE (non-serious) with onset 29Dec2021 19:00, outcome "unknown", described as "Loss appetite"; FATIGUE (non-serious) with onset 29Dec2021 19:00, outcome "unknown", described as "Fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of anxiety, pain, headache, pyrexia, decreased appetite, fatigue. No follow-up attempts are possible. No further information is expected.  Additional information: Patient was not received any treatment for adverse event. Covid prior vaccination was reported as no. Covid tested post vaccination was reported as no.   No follow-up attempts are possible. No further information is expected.
Arm hurts; Feels like arm is going numb; Injection site warmth; Lump in the injection site; Injectiion site itching; Injection site red; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurts), HYPOAESTHESIA (Feels like arm is going numb), VACCINATION SITE WARMTH (Injection site warmth), VACCINATION SITE MASS (Lump in the injection site) and VACCINATION SITE PRURITUS (Injectiion site itching) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Injection site warmth), VACCINATION SITE MASS (Lump in the injection site), VACCINATION SITE PRURITUS (Injectiion site itching) and VACCINATION SITE ERYTHEMA (Injection site red). On 15-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm hurts) and HYPOAESTHESIA (Feels like arm is going numb). On 14-Feb-2021, VACCINATION SITE WARMTH (Injection site warmth), VACCINATION SITE PRURITUS (Injectiion site itching) and VACCINATION SITE ERYTHEMA (Injection site red) had resolved, VACCINATION SITE MASS (Lump in the injection site) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (Arm hurts) and HYPOAESTHESIA (Feels like arm is going numb) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.
She got her vaccine, by the evening of that day her arm had a square red mark, and it was warm and it was swollen. It felt a little bruises.  She went to sleep, not hindering her.  When she woke up it was very red, warm, and still having the same reaction.  It is going away now.  It was noticeable so she did not take off her sweater last night as it was obviously swollen and red.  She was told to only get one vaccine at a time so that if she had a reaction they would know which one.
Prior to bedtime on March 27, after undressing my shirt, I noticed some red spots around my neckline, skin rash underneath left arm, red spot on left armpit, light skin rash underneath right arm and red spot on right armpit.  There was no itching noted.  No Swelling of Lymph Nodes was detected.  I took Chlortrimeton (Antihistamine), 1-tab every 6 hours since time of discovery and will continue to take this until the allergy signs are gone.  Applied a thin layer of OTC Calamine Lotion on reddish spots and rash on the skin.  The areas affected did not change on Mar. 28 and today Mar. 29.  The rash and red spots remained in the areas as first reported.
This spontaneous report was received from a License Practitional Nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and drug reaction/allergies were not provided. On 28-JUL-2016, the patient was vaccinated with an expired dose of ROTATEQ Lot # K022993 with expiration date: 20-JUL-2016, (route of administration, strength and dose were not reported). Concomitant medication was not reported. No adverse effects were reported. No Product Quality Complain (PQC) was involved. Additional information has been requested.
[MODERNA] COVID-19 Vaccine EUA Friday, January 8 (~9:10 am): received vaccine Saturday, January 9, ~8pm (after shower): Husband noticed netlike pattern on back of both of my legs. Appeared to be reddish/blueish in color and swollen blood vessels. Did not notice them b/c usually do not look at the back of my legs. Sunday, January 10: Symptoms did not go away. Monday, January 11: Primary Care Virtual Visit. Sent photos. Referral to Dermatology. Tuesday, January 12: Dermatology Virtual Visit. Recommend to come into clinic for biopsy. Wednesday, January 13: Dermatology Clinic Visit. Biopsy and bloodwork taken. Awaiting Results. Possible Livedo Reticularis. Possible COVID-19 vaccine related due to timing of symptoms and no other/obvious triggers.
Pt had witnessed arrest by wife. Pt wife started CPR and called EMS. CPR started at 15:12. Continued by EMS. Pt arrived to medical center asystole with CRP in progress and ventilated via igel device.  He was in refractory ventricular fibrillation and continued CPR for a total of 1 hour.  At that point, we checked a bedside ultrasound which showed his heart at a standstill.  He was unresponsive to verbal and tactile stimulus and had fixed unreactive pupils.  He was pronounced at 16:13.
I received the first dose of the Moderna  COVID vaccine in my right arm on on Wednesday, February 3, 2021.  Eight days post-vaccination, my arm began itching at the injection site.  It felt hot with a ?cyst-like? structure beneath the skin.  The area around the injection was red and raised in about a four inch diameter circle.  Today, the itching continues, there is still a hard area beneath the skin, and the red , raised area is now ten inches in diameter.  There are no other symptoms.
Received Moderna shot at 2PM on January 12,2021.  On January 21 around 10AM my upper left arm was itching.  upon further investigation of the area I noticed a good size red oval patch on my upper left arm located approximately 1 inch above the site of my Moderna injection site.  It was slightly itchy and was hot to the touch.  I had no fever and felt perfectly fine.  The area was not sore.  I applied an anti-itch cream and placed an inquiry with my personal doctor.  His office sent a response this morning advising me to notify the provider.  There was no information on my COVID-19 Vaccination Record Card of who to notify and I could not get through to them on their phone which is constantly busy with people calling for appointments.  I did see info saying to report adverse reactions on line at vaers.hhs.gov which is what I am doing.  My concern is whether or not I should get the second shot.
Case was admitted to hospital 03/23/2023 in preparation to go to facility. Case tested positive for COVID-19 on 04/05/2023, 24 hours before being discharged to the facility.  Case had family visiting him  in hospital on 04/05/2023 and all members have since tested positive for COVID. His wife is currently hospitalized admitted on 04/06/2023, 24 hours after being exposed to case.
There has been so much long term affects from cardiac to neurology contacting my primary care doctor would be best. I've seen every specialist there is in the medical field
pt recv vax 2JUN95 & 24-36 hrs p/vax devel rash which covered entire body;8JUN95 pt was seen by MD & was noted to have bulls eye lesions over body which were pruritic;dx erythema multiforme;also had puffiness of ankles & knees w/pain
Pt died 05/27/2021- not a covid related death  Vaccine #2 Moderna 03/05/2021 Lot # 032M20A
received 2nd shot of influenza before the correct time with no reported adverse event; Initial information was received on 28-Nov-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves 9 months old male patient who received 2nd shot of influenza quadrival a-b vaccine [Fluzone QIV] before the correct time with no reported adverse event.  The patient had no medical history, concomitant disease or risk factor.   On 03-Nov-2022, the patient received a total dose of suspect influenza quadrival a-b vaccine suspension for injection (lot UT7744NA) via intramuscular route in unknown administration site for influenza before the correct time with no reported adverse event (inappropriate schedule of product administration) (latency- same day). The patient did not experience any side effects or symptoms per his mother.   There were no lab data/results available.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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 the guidelines. 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.
Having a lot muscle pain in the leg, in the hip, and it has not gone away; Having a lot muscle pain in the leg, in the hip, and it has not gone away; This is a spontaneous report from a contactable consumer (Patient's wife). A 72-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection and batch no/lot number: not reported), dose 1 via an unspecified route of administration on an unspecified date (at the age of 72-years-old) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was stated that her husband has just got the Pfizer vaccine and it's been 3 and half weeks so he was good to go for the second one. He had been having a lot muscle pain in the leg, in the hip, and it has not gone away. Outcome of the event was not recovered.  Follow-up attempts completed. No further information expected. Information on the lot batch number has been requested.
Same day post vax, the pt experienced fever, chills, and a rash that was all over his body. The pt was bedridden for five days. It was also reported that the pt was seen by a dermatologist and was treated with Prednisone. No other information was available.
Information was rec'd concerning a pt with allergies to grass, mold, dust mites, and dairy who on 2/5/02 was vaccinated with the 1st dose of hepatitis B, in the L deltoid/IM. On 2/8/02 the pt experienced swelling of the L arm and red band like papules in clusters on the R arm. The bands measured 6 1/2cm X 1cm and 7cm X 1 1/2cm. The reaction was local and treated with 1% hydrocortisone cream and chlorpheniramine tablets. The pt recovered on 2/13/02. The pt sought medical attention. No further info is expected.
Slight fever that lasted about 4-6 hours.  Congestion and slight cough for about 6 hours Arm and shoulder felt fine for several hours. Suddenly my arm felt extremely sore and heavy. The pain was severe for about 8-10 hours before subsiding.
Hives and unbearable itching on hands and forearms a day after first injection. Second injection - full body rash with hives and unbearable itching and prickly (Painful) needle sensations over entire body.. Primary car physician prescribed steroids and antihistamine tablets. recommended following up with dermatologist and allergy  doctor. Dermatologist prescribed 2 - types of ointment (steroid) and 2 - types of lotions , second visit dermatologist prescribe steroids and antihistamine. Allergist doctor prescribed antihistamines and creams and lotions for the itching. The inching was almost none stop since a day after first injection . The date is June 2, 2021 and itching is still very severe.
Pfizer Covid-19 vaccine administered on 04/07/2022 date has been determined to be outside of the recommended stability guidelines by Pfizer and the CDC and a repeat dose is recommended.
22MAY95 pt recv vax by late morning 22MAY pt was irritable & unable to be easily consoled, cried alot, leg where immunization given was warm, swollen & indurated @ site of immunization; APAP given t101.4;
Redness, swelling, warmth of right upper extremity.  Started on Keflex 250mg TID for 10 days 1/20/06.
Vomited profusely; This is a spontaneous report from a non-contactable consumer. A 12-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 08Aug2021 (at the age of 12-years-old), as a single dose for COVID-19 immunization. The patient had no medical history. The patient 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. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 21Jul2021, as a single dose for COVID-19 immunization. On 08Aug2021, the patient vomited profusely within 3 hours of receiving the vaccine. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the event which included rest and treatment with unspecified fluids. The clinical outcome of the event vomited profusely was recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
4 hours after injection pt complaints of diffuse body aches, pain soreness in joints, myalgia, arthralgia, ED visit  Nov 9 and Nov 16 w hospital admission w Leukocytosis, elevated crp.
Patient is currently 33 weeks pregnant - was given PCV 13 instead of FLU Vaccine
Pt recvd vax & 5 hrs p/vax exp itching @ inject site & redness from inject site to top of shoulder; pt was seen by MD;
Patient was erroneously given their 2nd dose too early.  That patient's first dose was on 11/29/21.  The patient did sit for 15 minutes after the vaccine was administered and experienced no adverse reaction.  The patient was alerted and told that per Pfizer's Medical Information regarding invalid dosing, she should return for a 3rd dose 21 days after today's invalid dose, 12/10/21.
following vax pt devel a fever of 106 the next morning; fever subsided w/use of APAP; day #3 p/vax pt was examined by MD who recommended that pertusis be elimanted in future vax;
Swollen and very sore lymph node(s) underneath arm and  towards the front of arm ( above breast). Also hard and swollen hot itchy lump at injection site.
Developed immediate rash, itchiness 3 min after injection. Lungs clear with wheezing.  No respiratory distress, no oral swelling. Gave Zyrtec 10mg per mouth, instructed mom on symptoms to watch for that would required immediate attention. Rash noted on torso only.
This is in follow-up to report(s) previously submitted on 6/13/2008. Information has been received from a nurse practitioner concerning a 25 year old female, with a family history of sickle cell anemia (Father), lupus (mother) and stroke due to lupus (mother), who on 02-APR-2007 was vaccinated intramuscularly in the left deltoid with her first dose of GARDASIL (Lot # not reported). On 12-JUN-2007, the patient was vaccinated intramuscularly in the right deltoid with her second dose of GARDASIL (Lot # reported as "0089O"). On 14-DEC-2007, the patient was vaccinated intramuscularly in the left deltoid with her third dose of GARDASIL (Lot # 655324/0089U). The nurse practitioner reported that the three GARDASIL doses were given at another office. Concomitant therapy included hormonal contraceptives (unspecified). The reporter stated "birth control started on 26-MAR-2007 (Patient was on birth control prior to this date but stopped at an unspecified time due to family reasons)". On 23-APR-2008 the patient had a thin prep PAP smear "(a high risk HPV test gets done goes along with thin prep PAP)." On 01-MAY-2008, the results of the PAP smear and HPV test were reported and the HPV test plus low grade squamous intraepithelial lesion (LGSIL) and cervical intraepithelial neoplasia I (CIN1) were positive. The patient was referred to gynaecologist for coloscopy and treatment. Previous pap smears performed on 09-JUN-2006 and 26-MAR-2007 were negative for lesions and malignancy. On an unspecified date, the patient was found to be positive for sickle cell anemia and will be going to a specialist. The patient will be going for a colposcopy for the abnormal PAP results. No further information was provided. Additional information is not expected.
As the day progressed he realized he couldn't smell as much, he still can smell but not very well; Taste diminished; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient). This male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was feeling fine earlier today and as the day progressed he realized he couldn't smell as much, he said he still can smell but not very well and his taste has been diminished as well and he wanted to know if these were possible side effects of vaccine. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sudden onset stiffening while sitting in chair. Eyes back in head, unresponsive, no cyanosis. Taken to hospital via ambulance.
Delayed reaction; This spontaneous case was reported by a physician and describes the occurrence of SKIN REACTION (Delayed reaction) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced SKIN REACTION (Delayed reaction). At the time of the report, SKIN REACTION (Delayed reaction) had not 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 provided No treatment information provided
Weird, indescribable taste in mouth initially and resolved after 10 minutes, feeling hot, facial flushing, scratchy tingling throat, BP 205/98, HR 70, R 20.
Pt recvd 1st dose of Engerix-B 9COT91 & 2 hrs p/dose vax pt exp stuffy nose, 3 hrs p/dose exp sinus, h/a, 3 1/2 hrs p/dose chest congestion, 5 hrs p/dose nausea, exhaustion that led to deep sleep;
Fatigue, chills, hot flashes/sweats, body aches, difficulty concentrating/thinking, dizzy,  nausea, flu like symptoms without fever, sore arm.
Sleep paralysis the morning after receiving the vaccine. patient has been having sleep paralysis symptoms almost once a week.