chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash on injection Site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (Rash on injection Site) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided.).    On 21-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE RASH (Rash on injection Site). At the time of the report, INJECTION SITE RASH (Rash on injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
PATIENT SAYS THE VACCINE CAUSED A FLARE-UP OF HER GRAVES DISEASE
Headache and fever (99.2) after receiving vaccination, lasted about one day. Also experienced a sensation of having a swollen throat. All symptoms resolved.
Myalgia & Fever Narrative: Fever 100 advised to stay home if febrile.
The day after taking first dose of oral typhoid vaccine, developed severe nausea, vomiting, diarrhea.  He did not complete the vaccination, and later received the injectable form of the vaccine.
Occurrence Date: 03/22/2021. Following Covid-19 vaccine administration, patient reported feeling dizzy. V/S: BP: 172/91, P: 76, and o2 sat: 99%. Patient stated that she has a history of HTN. A bottle of water was given, and emotional support was provided. Second set of vitals: BP: 161/98, P: 72, RR: 18, and o2 sat: 98%. At that point, patient stated that her dizziness had lessened. At 15:20, Patient stated that she wanted to go home. Patient walked to the bathroom, and back. Patient then stated that she was not feeling well. V/S: BP: 172/101, and P: 96. Patient was taken to the ED.
irritability, feverish, dec appetite throughout noc & AM p/vax;PE unremarkable;tx reassure, dec fluids, APAP, PRN;
Effective 03/16/2022, could not breath laying flat on my back.  Determined to be paralyzed Diaphragm, right side of body.
tested positive; tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 05May2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 06Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (14May2022) Negative, notes: Tested negative twice on final day of Paxlovid course (14May); (16May2022) Negative; (20May2022) Positive; (23May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient received vaccine. The patient did not receive other medication in 2 weeks. Anti viral details: Product: COVID 19 Treatment, brand: Paxlovid, treatment start date was 09May2022 and stop date was 14May2022. Adverse event: Tested negative twice on final day of Paxlovid course (Sat 14May), and then again on the following Monday (16May). I then experienced new symptoms starting evening of 18May, and tested positive again on 20May, with new anosmia. Continued to test positive through today, 23May. Adverse event start date was 18May2022 and the patient was recovering without ae treatment. The patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
The second Pfizer shot caused me to have a second period in the month of April. The period occurred around the time of ovulation for me (4/17/21).  We were trying to conceive at the time. We managed to become pregnant that month despite the confusion with two periods and not knowing  if my ovulation schedule would change. I had a positive pregnancy test on 5/7/21. By 5/20/21 I started bleeding.  I had a hospital removal procedure (MVA) completed on 6/11/21 due to a miscarriage during this pregnancy.
dizziness/dizzy spells; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Nov2021 (Lot number: 32030BD) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetic" (unspecified if ongoing), notes: Illness/AE: Diabetic on Metformin and not insulin. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus. Vaccination history included: Bnt162b2 (1st dose ,  Lot EN5318, Expiration unknown. , Injected in right arm in the muscle.), administration date: 13Feb2021, when the patient was 41 years old, for COVID-19 immunization; Bnt162b2 (2nd dose , Lot EN5318, expiration is unknown., injected in left arm in the muscle.), administration date: 08Mar2021, when the patient was 41 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 15Nov2021, outcome "unknown", described as "Booster"; DIZZINESS (non-serious) with onset 18Nov2021, outcome "not recovered", described as "dizziness/dizzy spells".  Additional Information: It was reported that, received call from consumer regarding the Pfizer COVID vaccine booster. She got the booster on 15Nov2021, and 3 days later started having dizzy spells.  If she sits down or up or lays down too fast, she gets really, really dizzy. She got vaccinated with booster on 15Nov2021, and about 18Nov2021, is when she started having dizzy spells and lasted until now. Caller also added that she was on a diet pill that she was taking for a month now and she was not sure if this is associated to her reaction that she was experiencing. They was still here.  It seemed like today is worse. She wanted to know if there are others who have reported these symptoms.  She called the pharmacy. and they suggested she call Pfizer. Vaccination Facility Type: Pharmacy. Time the Vaccination was Given: 12:45-13:00. Additional vaccines administered on same date of the Pfizer suspect: None. Dizzy Spells - third night around 12:30-01:00 and noticed she was dizzy when she sat up. The patient did not require visit to Emergency Room/ Physician Office for adverse events. Prior Vaccinations, the patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. AE(s) following prior vaccinations: None. Patient's Medical History included: Diabetic on Metformin and not insulin. Onset Date: She was pre-diabetic but diagnosed as being full diabetic for a year or year and a half. Family Medical History Relevant to AE(s): None. Relevant Tests: None   Follow-up attempts are completed. No further information is expected.
Ten days after shot: Transient global amnesia  Seven weeks after the shot: Heart palpitations, tightness in breathing, slight burning in chest, tightness in back of neck, lightheaded
Flu vax 0.5 mg given left deltoid, 15 min later, pt c/o pain left shoulder, Red rash noted on back & shoulder, Emergency protocol followed. Benadryl 75 mg po per MD orders, Ice applied. Denied any Resp symptoms
Joints pain, diarrhea, muscular weakness, insomnia, Skin rash back pain.
Chill, headache Saturday and Sunday the 1 /24/21 and 1/25/21. Coughing began on Sat the 24 along with terrible aches through out my whole body. Very weak and tired. Today is Tuesday, 1/26/21 and my symptoms are the same.  My 95 year old mother had a bad cold and I thought I had gotten a cold from her. Now I believe it is a reaction from my first covid shot. No symptoms til 3 days after injection. My aches throughout my whole body have only been this bad when I was diagnosed in 1994 with derma-polymiostis.  An arthritis that attaches the skeletal muscles in your whole body.  A question is: What should I possibly expect when I get my 2nd covid injection? How long are these current symptoms going to last?
TEN MINUTES AFTER VACCINATION, PERSON BECAME LIGHTHEADED, PALE, NAUSEATED AND C/O HEADACHE. SHE ALSO C/O OF BEING HOT AND COLD. HR AND BP ELEVATED AT 157/100 AND 130 BPM. PERSON SITTING WITH LOWER EXTREMITIES ELEVATED, ICE PACK GIVEN TO POSTERIOR NECK, JUICE AND ICE WATER GIVEN TO PT TO DRINK. RAPID RESPONSE TEAM ACTIVATED. PERSON RESTED AND MONITORED AT VACCINE SITE FOR ONE HOUR WITH IMPROVEMENT IN SYMPTOMS. PERSON STABLE AFTER THIS TIME AND ABLE TO GO HOME.
Got 1st dose on 04/03/21 On Friday, 04/09/21 I started to notice some itching and redness in my scalp and neck. By Saturday afternoon on 04/10/21,I have considerable redness and inflammation, rash on my neck, scalp and pretty much all over my body but to a lesser extent. Most noticeable in the neck and scalp.
Information has been received from a medical assistant (also reported as a nurse) referring to unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (lot# M025865, expiration date 24-MAY-2018; dose and route unknown) for prophylaxis. No adverse effect was reported. This is one of several reports received from the same reporter. Telephone call attempt on 16-MAY-2016 to obtain follow-up information was unsuccessful. Additional information has been requested.; Sender's Comments:  US-009507513-1610USA011727:, MERCK 1610USA011945:Mfr number.
Nurse or PA said take Tylenol for pain. Tylenol did not work; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2020, the patient received the 1st dose of Shingrix. In December 2020, less than a week after receiving Shingrix, the patient experienced pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of patient was not reported but was captured as an adult as per vaccine indication. The reporter stated that the nurse or PA told patient to take Tylenol for pain and do not  take Advil. The patient stated Tylenol did not help and asked if the patient could take Advil.
After I received the bivalent booster on 4/22/23, I experienced the normal side effects I had gotten from the four previous Covid vaccines (low-grade fever, body aches, and chills for 48 hours). Then on day 3 following the vaccine, I experienced burning in my nose, congestion, coughing, sneezing until day 8. Those symptoms resolved on their own. But since receiving the bivalent vaccine, I have expeienced a worsening of my Sjogren's symptoms - my dry eyes have gotten much worse, and my mouth dryness has gotten much worse. It has continued over the past two months (to the present). I made an appointment with the rheumatologist and opthamologist. The rheumatologist had me complete blood work and urinalysis.
She coerced another Registered Nurse into giving her a 3rd dose of the Moderna COVID-19 vaccine. Event occurred around 12:50 on 9/24/2021. Moderna was given in the deltoid of the left arm. Patient reported no adverse effects and was monitored for 30 minutes following the event, no medical changes or signs of anaphylaxis.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; 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: Unknown) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced Suspected COVID-19 infection and Suspected clinical vaccination failure. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the Suspected COVID-19 infection and Suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210423108. This report was associated with product quality complaint: 90000176123; Sender's Comments: V0: 20210423095-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.
14OCT2020, 1800 - patient noted golf ball sized reddened, sore, swollen area on her left deltoid at the injection site. 15OCT2020, 1400 - Physician Assistant's evaluation: 7cm by 9 cm erythema, slightly swollen, warm to the touch and described by the patient as remaining sore.   B/P 142/67, Pulse 63, Temp: 96.7 F.   Rx for Prednisone 20mg #10, Two QD for 5 days.
Injection site swelling and redness; increased warmth at injected site; Injection site swelling and redness; increased warmth at injected site; Injection site swelling and redness; increased warmth at injected site; This is a spontaneous report from a contactable consumer (patient husband). A female 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 medical history and concomitant medications were not reported. The reporter stated he know it's one of the possible mild side effect is injection site swelling and redness and what about increased warmth at injected site. He asked if it is normal to have. He know it says injection site swelling and also Injection site redness but what about like warmth like increase warmth, heat at injection site. The action taken in response to the events for bnt162b2 was not applicable. The outcome of events was unknown.  Pfizer is a marketing authorization holder of [BNT162B2] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [BNT162B2] has submitted the same report to the regulatory authorities.    Lot/batch number has been requested in follow-up.
Pt presented with swelling and redness at the injection site approximately 2" wide. Pt said it was hot and itchy. She noticed it was red right away but was full blown this AM. Advised pt to take BENADRYL and let MD know if it gets worse or doesn't improve.
A physician reported that a 32 year old male patient received FluMist vaccine from a military clinic on 10/28/05. On 10/31/05, he noted flea-bite like rashes on his ankles, pruritic and had a burning pain sensation. He was seen by a medic at the military facility, who initially thought it was scabies and treated the rash with Permethrin cream. Over the next ten days, the rash progressed up to his legs, groin, abdomen, chest, back, neck, head, and scalp. Edema of the forearms, legs, and hands were also noted. A skin biopsy was done on 11/10/05, the result of which is unknown. On 11/12/05, he was admitted to a hospital. He was treated with oral prednisone, Zyrtec, loratadine, and ranitidine. No improvement was noted. On 11/14/05, the patient was transferred to a hospital. Upon admission, diffuse erythematous rash was noted. The reporter's description was that the patient's whole body looked like it was sunburnt. Micropustules were noted on the knuckles of the hands, arms, and thighs. Labs done at this hospital on 11/14/05 included: CBC which was within normal except for white blood cell count which was elevated (24,000); urine analysis was within normal and Basic Metabolic Profile (BMP), also within normal limits. A skin biopsy was done on admission and which confirmed diagnosis of Acute Generalized Exanthematous Pustulosis. Vital signs were within normal. A Triamcinolone whole body wrap was started as part of the treatment. Currently the patient is taking oral cetirizine, loratadine, and diphenhydramine for the rash and morphine for the burning pain sensation. On 11/15/05, some improvement was noted one day after the whole body wrap was administered. The micropustules were noted to be desquamating and the edema was less. Per the reporter, the patient did not have any past medical history, no known drug or egg/egg product allergies and was not taking any medications prior to receipt of FluMist. The patient received FluMist vaccine during the 2005-2006 flu season. The reporter assessed the adverse events as possibly related to FluMist vaccine, but also considered the possibility of drug reaction to the earlier treatments received for the rash. The patient was not yet recovered and remains admitted to the hospital.
PATIENT GIVEN VACCINE BEFORE AGE IT WAS APPROVED (PATIENT AGE 56 AND VACCINE INDICATED FOR 60+). NO REACTIONS REPORTED
Pt c/o itching of neck approximately 5 hours post Hep immunization.  On the morning of 12/8/99, pt had swelling of hands, feet, face and knees.  Pt seen by primary MD and given Rx of Zyrtec.
Was given PNEUMOVAX on 2/22/18 in upper left arm. Was very sore & swollen for a few days, on 2/27/18 started to notice rash ~ 8 x 20 cm patch of erythema and warmth centered on left deltoid. No streak or fluctuance. Patient treated with doxycycline hyclate 100 mg tablet - for 10 days to cover possible infection.
Rashes throughout the entire body, Feaver, Headache, Body Aches.
Covid-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Aug2021 as dose 3 (booster), single (Lot number: FC3181), in left arm, on 22Jan2022 as dose 4 (booster), single (Lot number: 33130BA), in left arm and on 22May2022 as dose 5 (booster), single (Lot number: FJ4989) at the age of 59 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "RA" (unspecified if ongoing), notes: other medical history: RA. Concomitant medication(s) included: TYLENOL, start date: 07Aug2022, stop date: 11Aug2022. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered", described as "Covid-19"; COVID-19 (medically significant), outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Covid treatment from 08Aug2022 to 12Aug2022. No known allergies. The patient received vaccine and other medication in two weeks.  No follow-up attempts are possible. No further information is expected.
I am the grandfather making out this report, not a medical doctor. Patient was born a month premature (36 weeks) and vaccinated two days after birth with Hep B Vaccine. I noticed she began turning yellow that afternoon while driving her home from the hospital (4 hours after being vaccinated). She was returned to the hospital for three days of light treatments the following day. On 12/15/03 she quit breathing, turned blue, was ressusicated with CPR, and then flown to hospital  where she has been ever since.  I hope I filled out the reports correctly from the medical records that I have gotten from the birth hospital. I have yet to get the medical records from the hospital. The hospital record received on 1/15/04 states GERD. The discharge summary received on 3/30/04 states reflux, UTI and improved tracheomalecia. Per annual follow up report She is having a very difficult time. She is currently taking occupational therapy because she has so many problems.
Only diluent portion given; Only diluent portion given; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA749A, expiry date 30th November 2023) for prophylaxis.   On 1st February 2023, the patient received Menveo. On 1st February 2023, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 01-Feb-2023 Reporter's comment: The exact patient was unknown, no patient demographics were available at the time of call. The reporter consented to follow-up. Additional supportive information: The patient received only diluent portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Myalgia, Arthralgia, Chills, fatigue, pain at the injection site Narrative:
About 1 year, post vax of the 1st dose, the joints in 2 of my fingers became painful and swollen. My back began to pain me. As time went on, several more joints in my other fingers became swollen and painful. I am afraid the skin will break around those joints. My knees are affected but less. I never had anything like this prior to receiving Lymerix and have no family history.
Redness, itchiness, pain, and red blotches on the site of injection (left arm)
HE BEGAN TO HAVE SEIZURES AN HOUR AFTER THE VACCINATIONS. I TOOK HIM TO THE EMERGENCY ROOM. WHERE THEY SAID THAT HE WAS HAVING SEIZURES. LATER THAT NIGHT HE BEGAN TO RUN A FEVER OF 103-105. HE CONTINUED TO HAVE THIS FEVER AND ON SUNDAY FEB 8TH HE STOPPED BREATHING AND HAD ANOTHER SEIZURE AND WAS VERY LETHARGIC FOR HOURS. WE TOOK HIM BACK INTO THE ER WHERE THE INFORMED US THAT THEY WANTED US TO TAKE HIM TO SEE THE NEUROLOGIST. WE TOOK HIM HOME WITH THIS HIGH FEVER AND MADE AN APPOINTMENT WITH THE NEUROLOGIST. BY THE NEXT SATURDAY FEB 14TH HE HAD BROKEN OUT INTO A RASH. WE TOOK HIM BACK INTO THE ER AND THEY TOLD US HE WAS HAVING AN ALLERGIC REACTION TO SOMETHING. SO WE WAITED IT OUT AND CALLED DR. ON SUNDAY WHEN HE CONTINUED TO GET WORSE AND HE MET US AT THE OFFICE. HE TOLD US TO KEEP A VERY CLOSE EYE ON THE RASH AND TO BRING HIM BACK THE NEXT DAY IF HE CONTINUED TO GET WORSE. THAT MONDAY I TOOK HIM BACK INTO DR. AND HE PUT HIM ON A STEROID HOPING THE RASH WOULD GET BETTER. IT DID NOT AND ON TUESDAY WE WENT BACK TO SEE HIM AND HE SENT US TO THE DERMATOLOGIST WHOM SUSPECTED THAT HE HAD 5TH'S DISEASE OR THE MEASLES. SO I CALLED DR. AND TOLD HIM WHAT HE SAID. HE ASKED THAT WE GO AND HAVE A BLOOD TEST DONE TO SEE IF IT WAS ACTUALLY THE MEASLES.  THE TEST CAME BACK POSITIVE FOR MEASLES. WITH THIS HE RAN A FEVER OF 103-105 FOR TWO WEEKS.
left arm weakness and numbness. Unable to hold anything in left hand. Slight  drooping in left side of face.