chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PSORIASIS FLARES/PSORIASIS OUTBREAKS ON THE RIGHT PALM OF THE HAND; Appetite suppression; Weakness; HALF-DOLLAR-SIZED LOCAL REACTION WITH HUMIRA INJECTIONS; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), PSORIASIS (PSORIASIS FLARES/PSORIASIS OUTBREAKS ON THE RIGHT PALM OF THE HAND), DECREASED APPETITE (Appetite suppression), ASTHENIA (Weakness) and INJECTION SITE REACTION (HALF-DOLLAR-SIZED LOCAL REACTION WITH HUMIRA INJECTIONS) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In 2020, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced PSORIASIS (PSORIASIS FLARES/PSORIASIS OUTBREAKS ON THE RIGHT PALM OF THE HAND), DECREASED APPETITE (Appetite suppression), ASTHENIA (Weakness) and INJECTION SITE REACTION (HALF-DOLLAR-SIZED LOCAL REACTION WITH HUMIRA INJECTIONS). At the time of the report, COVID-19 (COVID-19) and INJECTION SITE REACTION (HALF-DOLLAR-SIZED LOCAL REACTION WITH HUMIRA INJECTIONS) had resolved, PSORIASIS (PSORIASIS FLARES/PSORIASIS OUTBREAKS ON THE RIGHT PALM OF THE HAND) was resolving, DECREASED APPETITE (Appetite suppression) had not resolved and ASTHENIA (Weakness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, Weight: lost 5 pound.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant and treatment information was provided.  The reporter's causality with humira (adalimumab) for the events of appetite suppression and half-dollar-sized local reaction was a reasonable possibility, not provided for event weakness and was no reasonable possibility for events psoriasis flares/psoriasis outbreaks on the right palm of the hand and covid.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2022: Follow-up information included patient age, moderna covid-19 vaccine dosage regimen updated, event outcome updated and reporter causality updated.
Arm was swollen, red and very hot.  arm was numb on left side and had fever.
Pfizer Covid 19 vaccine vial was mixed with 1.4 instead of 1.8 ml of diluent and a dose was administered to patient. Spoke to patient 04/11/2021 and he reported having a sore arm. Provided counseling.
some soreness in the arm; was exhausted; and sleep after the shot; This is a spontaneous report from a contactable consumer (patient).    This 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included slow growing blood cancer. Concomitant medications were not reported. On an unspecified date, the patient experienced some soreness in the arm, was exhausted and sleep after the shot with outcome of unknown.    Follow-up attempts completed, information on batch number can not be obtained. No further information expected.
Received vaccine at 11:30am.  At 1:30p didn't feel well, noted that my left hand was swelling and felt tight.  The injection site looked OK. I was sweating and face was flushed.  I was given Benadryl 50mg PO and lay down for an hour at work.  I went home at 2:30p.  The following day I went to work but at 12:00noon I was feverish (100.0F), dizzy, SOB, all-over sore muscles and my blood pressure was 200/100 taken twice by nurses at the facility.  I was taken to the ER by car and had labs and work up in the ER.  They were unable to determine if symptoms were vaccine related or not.  I had taken first dose of hypothyroid medication on 1/14/21.  They diagnosed hypertension and wrote me a script for Lisinopril 5mg PO daily.  I continue to have high BP readings.  My left arm at injection site is sore.  The edema in my hand resolved the first day after the Benadryl dose.
Fever up to 104.0. Vomiting. Shakey tremors. Fussy. Not eating well. Onset the next day.
Pfizer BioNTech Vaccine administered(patient also took paxlovid for covid-19 treatment after received BNT162b2).; Pfizer BioNTech Vaccine administered(patient also took paxlovid for covid-19 treatment after received BNT162b2).; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation; coviD-19 vaccine nrvv ad (chadox1 ncov-19) (COVID-19 VACCINE ASTRAZENECA), on 14Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 31May2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 04May2022, outcome "unknown", COVID-19 (medically significant) with onset 04May2022, outcome "recovering" and all described as "PAXAES report with Pfizer BioNTech Vaccine administered(patient also took paxlovid for covid-19 treatment after received BNT162b2).". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04May2022) Positive, notes: Testing positive for Covid again. Therapeutic measures were not taken as a result of covid-19.Clinical course :other medication in 2weeks was reported as no. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a medical assistant refers to a 12 year old patient of unknown gender. On an unknown date in April 2014, between 12-APR-2014 and 24-APR-2014, the patient was vaccinated with a dose of VARIVAX (Merck) lot # J012210, expiry 28-SEP-2015 ("VFC" stock), 0.5 ml, once, intramuscular. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX (Merck) doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX (Merck) was exposed to 46F for 1 hour, at worst. There were no prior excursions. There was a site visit from local health department on an unspecified date. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient  (employee)received 1st dose Moderna vaccine on 12/30/2020.  According to patient on Thursday morning, 1/7/2021, she noted redness  and  at injection site warm to touch she did not report it at the time.  On 1/8/2021 she had a routine appointment with her allergist who assessed the injection site  and he stated that this was  a normal injection site side effect.  On Monday, 1/11/2021 patient presented and injection site mild erythema.  No itching.
22SEp93 t103 fever for 48 hrs used APAP did not bring fever down; also very irritable the 48 hrs;
Moderna first dose administered at a clinic on Feb. 12th, 2021 and patient lost vaccination card. Told healthcare workers he received Pfizer. Pfizer was given as Boost dose.
Gastrointestinal hemorrhage with hematemesis; Procedures:  EGD with banding of gastric varices. He was on octreotide for 72 hours.  He has been stable with his Hgb holding around 8.2.  He has resumed his lactulose and rifaximin and his ammonia level decreased to 37 by the time of discharge. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Pt was given shot @ clinic 8MAY92 & approx 2-3 hrs p/shot spiked a t103 & began vomiting; mom took pt to ER & was observed w/no further s&s;
This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (lost appetite/absolute lack of appetite no interest of eating at all), WEIGHT DECREASED (lost 20% of his body wake for starvation), FEEDING DISORDER (he had to force feed himself, look like he was  in a concertation camp for loosing so much weight.) and ILLNESS (The vaccine made him sick) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     Concurrent medical conditions included Bladder infection (Antibiotics for bladder infection, furosemide,). Concomitant products included FUROSEMIDE for Bladder infection, FINASTERIDE, TAMSULOSIN and CALCIUM for an unknown indication.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced DECREASED APPETITE (lost appetite/absolute lack of appetite no interest of eating at all). On an unknown date, the patient experienced WEIGHT DECREASED (lost 20% of his body wake for starvation), FEEDING DISORDER (he had to force feed himself, look like he was  in a concertation camp for loosing so much weight.) and ILLNESS (The vaccine made him sick). On 27-May-2021, DECREASED APPETITE (lost appetite/absolute lack of appetite no interest of eating at all) had resolved. At the time of the report, WEIGHT DECREASED (lost 20% of his body wake for starvation), FEEDING DISORDER (he had to force feed himself, look like he was  in a concertation camp for loosing so much weight.) and ILLNESS (The vaccine made him sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The treatment medication was nitriofur mono on the 24nov2021.   This case was linked to MOD-2021-409301 (Patient Link).
Moderna vial opened on 1/24 at 09:20 am. dose from same vial was inadvertently given on 1/25/22 at 13:30 pm. Vial had been stored at refrigerated temps since first puncture and had not experienced any excursions. Moderna was contacted for stability info.
This spontaneous report as received from a Nurse refers to an unspecified number of patients of unknown age and gender. On an unkonwn date the patients were vaccinated with PROQUAD (Merck), 0.5 ml, subcutaneous, which was improperly stored, temperature excursison. No addverse effects were reportd. No product quality complaint was involved. No additional information provided. Additional information has been requested.
Patient reports left sided tongue numbness approximately 2 hours after receiving vaccine. Numbness continued, and facial drooping approximately 4 days later. Pt seen by primary provider at this time.
Acute Urticarial reaction developed 1 day after receiving her 3rd prophalactic dose of Rabies Vaccine.
tachycardia, hypertension within 1 hour of receiving COVID vaccine, sent to ER where treated with Benadryl.  Released from ER with no admit.  Follow up reveals no further incident other than occasional flare-ups of anxiety symptoms
aches; sore arm after dose 1 and 2; fever; chills; vaccine breakthrough infection; COVID; This spontaneous case was reported by a consumer and describes the occurrence of VACCINE BREAKTHROUGH INFECTION (vaccine breakthrough infection) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jul-2021, the patient experienced COVID-19 (COVID). On an unknown date, the patient experienced VACCINE BREAKTHROUGH INFECTION (vaccine breakthrough infection) (seriousness criterion medically significant), PAIN (aches), VACCINATION SITE PAIN (sore arm after dose 1 and 2), PYREXIA (fever) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL A) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINE BREAKTHROUGH INFECTION (vaccine breakthrough infection) outcome was unknown and COVID-19 (COVID), PAIN (aches), VACCINATION SITE PAIN (sore arm after dose 1 and 2), PYREXIA (fever) and CHILLS (chills) had resolved.            Patient is taking concomitant for blood pressure , pill from having breast cancer  No concomitant medication was provided by reporter.  This is a spontaneous case concerning a 68 years old, female patient with no clinical history who experienced the unexpected event of COVID-19 (AESI), PAIN, VACCINATION SITE PAIN, PYREXIA, CHILLS and VACCINE BREAKTHROUGH INFECTION The event occurred 120 days after the second dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about the second dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-392113 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 68 years old, female patient with no clinical history who experienced the unexpected event of COVID-19 (AESI), PAIN, VACCINATION SITE PAIN, PYREXIA, CHILLS and VACCINE BREAKTHROUGH INFECTION The event occurred 120 days after the second dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about the second dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Within 2 hours of receiving the COVID 19 shot (Pfizer) is immediately experience muscle cramping.      With the 2nd shot, I immediately began to experience pain in all of my major joints, shoulders, neck, hands, knees and feet.     This pain was so bad there were days I could barely walk.     I continue today having these joint problems in my hands, neck and feet (almost 7 months after my last vaccine)      I paid $2000 for therapy over the course of 3 months which relieved it somewhat, but I have not felt the same since being forced to get this vaccine.    My joint pain and inflammation in my body has exacerbated by this vaccine and it continues to this day.
Patient's actual birthday is date but his mom lied to us and intentionally provided incorrect birth date in vaccine consent form to make patient's age 12  just to get a vaccine for her son. When I asked for if he has insurance, she again lied and said no he does not have an insurance. I also overheard them that they were leaving town soon to visit may be location. So his mom had an intentional plan to provide wrong birthday and do not disclose insurance just to get vaccine. Patient will be 12 years soon. I called thrice to patient's mom to verify DOB when found real DOB different with central patient search . First call she hung up on me, second call she did not answer and with third call, she said she was under impression of age limit is 9 for Pfizer vaccine, then why she need to provide wrong DOB in vaccine consent form? Also she asked me to make correction in a system of DOB and let it go. I refused it and told her I will use birthday you provided in vaccine consent form which is date
Pt fainted after vaccine given . C/o of not eating prior to arrival. PT ambulate to stretcher w/o assistance. Water and crackers given. No c/o dizziness or S.O.B.  Pt released at 8:18am.
Site: Pain at Injection Site-Mild, Systemic: After the second dose pt has had som arm pain from top of arm to elbow-Medium
Been taking amoxicillin to treat a tooth infection after he had received the primary series of the COVID vaccine; This is a spontaneous report received from a contactable consumer (patient's wife) via a Pfizer-sponsored program.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection) dose 1 via an unspecified route of administration on an unspecified date (Lot number was not reported) as DOSE 1, SINGLE, and dose 2 via an unspecified route of administration on an unspecified date (Lot number was not reported) as DOSE 2,SINGLE both for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced tooth infection after he had received the primary series of the COVID vaccine. Consumer reported that her husband has been taking amoxicillin to treat a tooth infection after he had received the primary series of the COVID vaccine, and she was wondering if her husband can take the booster dose after being on amoxicillin. Therapeutic measures were taken as a result of event. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The day after my vaccination I started having loose bowel movements. They continued until the morning after my second shot a month to the day afterwards. The moving after the 2nd dose, everything was back to normal.
Patient presented to Clinic on 2/1/22 to report she had very enlarged lymph nodes (left axillary, groin, cervical) with pain after vaccine administration. Also reports left persistent shoulder pain and weakness with nerve pain since administration. Patient states she has been receiving treatment from her primary care provider and is now requiring physical therapy treatment.
10/12/2019 THE PATIENT CAME INTO THE PHARMACY. HE NOTICED HIS ARM HAS DRY SKIN. THE SKIN WAS NOT RED BUT THERE WAS VISIBLE DRY, SCALY, AND PEELING SKIN (NOT INFLAMMED) THE PATINET DID NOT NOTICE IT, THERE WAS NO PAIN, HIS WIFE NOTICED IT.
Extreme pain in left underarm upper part. Pain radiating Halfway down under the forearm. Painful to touch on arm skin with burning sensation. Worsening each day.
RECEIVED A DOSE OF VACCINE DRAWN FROM A VIAL THAT WAS HELD IN THE FRIDGE FOR NEARLY 24 HOURS; PUNCTURED VIAL STORED IN FRIDGE FOR 24 HOURS; This spontaneous report received from a pharmacist concerned a 36 year old male. 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 not reported, batch number: 204A21A, and expiry: 07-AUG-2021) dose was not reported, administered on 29-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 29-JUL-2021, the subject experienced received a dose of vaccine drawn from a vial that was held in the fridge for nearly 24 hours. On 29-JUL-2021, the subject experienced punctured vial stored in fridge for 24 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received a dose of vaccine drawn from a vial that was held in the fridge for nearly 24 hours and punctured vial stored in fridge for 24 hours was not reported. This report was non-serious. This case, from the same reporter is linked to 20210804917 and 20210805634.
Fever starting later that night that resolved by morning, headache, dizziness, loss of appetite continuing for the next day
Very bad headache about 3 hours after vaccine on 9/5 Chills, sore arm, headache & palpitations 1am 9/6  Fever. 101.9, headache, sore arm, palpitations most of the day 9/6 Headache & rash at injection site 9/7 Fluids & ibuprofen not helping
About 1am after I got the dose I get a fever. My thermometer was broke but I got the chills and felt like I had the flu. Around 8am I then got diarrhea but no nausea. I continued to have diarrhea the whole day went to the bathroom about 5 times on Tuesday. Continued to feel really bad (felt worse than I did with the second shot).  I took some Tylenol in the afternoon about 500 mg. Slept most of the day Tuesday. Left arm hurt worse than it did with my second booster. I am afraid if we have to do a 4th shot it might send me to the hospital the next time I get one. No nausea mostly diarrhea and fever. I took 1000 mg of Tylenol around 10 pm and my fever broke and I woke up drenched in sweat. I still feel a little exhausted today and I have a low grade fever of 99 F. Did have a small headache yesterday as well. Just reporting because the side effects this time for me were much worse than the 2nd shot.
Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Warm Transferred from Moderna Customer Care Case No.00135704. HCP reported on 02Apr2021 that they had power outage on 02Apr2021 and vials were in Freezer and Refrigerator where Temperature dropped to : Frozen Vaccine 47Minutes -13.79 C Refrigerator 59 Minutes 12 C and effected vials are: Lot no 003B21A, 100 doses Lot no 027B21A 100 doses Lot no 030B21A 100 doses Lot No 02B21A 140 doses HCP said that 63 doses were administered to 63 Patients. She provided all requested information of patients who received the effected Vaccine.  No concomitant medications were provided.; Sender's Comments: This report refers to a case of Product Storage Error for mRNA-1273 (Lot #: 003B21A)  with no associated AEs.
(A few of the same symptoms when hospitalized 05/01/2020) *Low energy  *slur speach *forgetting basics(daughter phone number and passwords) * bell palsey- more noticable
Experienced severe rigors. I was sitting in my college class and I started to feel very cold. I put on my sweatshirt, but it didn't help. I started intermittently shivering. By the end of class I couldn't stop shivering, my hands were white and numb, I was very nauseous, and my legs were aching. I thought going outside in the warm weather would resolve the issue, but it didn't my symptoms continued.  When I got to my car I turned on the heat to warm my hands because for no reason I felt so cold and was tremulous. At this point I started to develop a severe throbbing headache, which was generalized at the top of my forehead. I sat in the parking lot for a long time because I was worried I was going to pass out. I drove home cautiously and got home around 7:50 pm.  When I got home I checked my temperature, which was 102.3 degrees Fahrenheit. I immediately took 1000 mg of tylenol, drank 32 ounces of water, and attempted to nap. After 2 hours my symptoms were nearly gone, my temperature was 99.5 degrees Fahrenheit and the only thing left was my throbbing headache. Once it got to 11:30 pm the process restarted. I got chills, severe body aches, and a horrible throbbing headache. I took 30 ml of Nyquil and 400 mg of ibuprofen. I eventually fell asleep and woke up today feeling much better. My headache and body aches are now mild. I'm also afebrile at this time.
pt recv vax;lab tests done & results were most consistent w/ an active lesion;another MRI performed which showed no evidence of progression of white matter lesions over prior to studies in 1992;