chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash on the body , arms and legs ,that goes away but returns on other places of the body; Skipped the second dose; Tongue swelling; Lips are swelling; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (Tongue swelling), LIP SWELLING (Lips are swelling), RASH (Rash on the body , arms and legs ,that goes away but returns on other places of the body) and INCOMPLETE COURSE OF VACCINATION (Skipped the second dose) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWOLLEN TONGUE (Tongue swelling), LIP SWELLING (Lips are swelling), RASH (Rash on the body , arms and legs ,that goes away but returns on other places of the body) and INCOMPLETE COURSE OF VACCINATION (Skipped the second dose). At the time of the report, SWOLLEN TONGUE (Tongue swelling), LIP SWELLING (Lips are swelling) and INCOMPLETE COURSE OF VACCINATION (Skipped the second dose) outcome was unknown and RASH (Rash on the body , arms and legs ,that goes away but returns on other places of the body) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Headache onset each time after shot. Last for about a month or so; did not seek treatment. I filled out the VSAFE questionnaire and someone called suggested I fill out this form.
itching; "a rash for the whole body"; Headache; This spontaneous case was reported by a health care professional and describes the occurrence of HEADACHE (Headache), PRURITUS (itching) and RASH ("a rash for the whole body") in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced HEADACHE (Headache). On 08-Mar-2021, the patient experienced PRURITUS (itching) and RASH ("a rash for the whole body"). On 05-Mar-2021, HEADACHE (Headache) had resolved. At the time of the report, PRURITUS (itching) and RASH ("a rash for the whole body") outcome was unknown.        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.
Pt. received first dose of COVID-19 vaccine on 05/10/2021 (JANSSEN Lot # 205A21A Exp-06/23/2021) at Pharmacy according to vaccination records.   Received second dose of COVID-19 vaccine on 06/18/21 (Moderna Lot #047A21A Exp-09/01/2021).  Received two doses of different vaccines. No know adverse reactions.
I had vomitting and that was moderate. The following day I was nauseous. My arm was pretty swollen and pain in the arm for two day. I had a headache that was pretty severe for two days. The third day I felt a little bit of arm soreness but I could use my arm a little better.  I started having a little bit of a rash at the point of where I received the vaccine.
My face drops and returns. My face goes numb; my toes and feet sometimes go numb. I have pain in my neck and shoulders.
Shooting pains like needle jabs in my neck proximal to skull attachment sites, along SCMs and in ligaments. Lasted for a week. Was intermittent during the daytime.
redness, rash the size of 1.5 square inch developed 7 days after the first covid shot(moderna) where the injection occured.
should have given DTaP-IPV-HIB (Pentacel), but instead grabbed QUADRACEL/mistakenly gave a wrong injection with no reported adverse event; Initial information received on 28-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 months old female patient and it was reported that patient should have given DTap-Ipv-Hib (Pentacel), but instead grabbed DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (Quadracel) /mistakenly gave a wrong injection with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE); ROTAVIRUS VACCINE (ROTAVIRUS VACCINE); and PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE).  On 28-Oct-2022, the patient received a dose 1 of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE , at dose of 0.5 ml , once, (lot: U7526AA ; expiry date: not reported) via unknown route in unknown administration site for immunization.  It was reported that patient should have given Dtap-ipv-hib (Pentacel), but instead grabbed quadracel/mistakenly gave a wrong injection with no reported adverse event (wrong product administered) following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  Action taken : not applicable.  Outcome: 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 the 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.
Right after my vaccine I felt like I was having a heart attack. My heart was racing. I was afraid to go to sleep. I took an aspirin. The aspirin did help and I was fine by the next day.
Mild injection site muscle soreness with onset 4 hours after dose, spontaneous resolution within 40 hours.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 26-year-old male. Neither medical history nor concomitant medications were reported. On 24-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.
pt recv vax 20DEC95 & c/o tenderness on the lt shoulder & lt side of the neck;the tenderness devel into swollen lymph nodes w/a pea sized,palpable knot;sx persist,& the know has gotten larger
Red, raised rash under injection site on left arm.   Very warm and sore to the touch.  Noticed 7/18 (2 days after 2nd covid vaccine).  Applied cool compress.
The night after vaccine mild pain and soreness in elbow area. Reported pain resolved, but mild edema in arm. Slowly resolving. No redness, pain, or heat in skin as of 10/15/2018. Routine MD visit scheduled this week. Pt. instructed to discuss with MD.
I received my booster shot a few days after finishing my period and my next period was 7-10 days late.
bil inner/outer ear infect; generalized muscle aches sensitive skin & needles & pins; throat infect/throat constriction, h/a's;
Approximately 5 days after administration at 6 weeks pregnant, I began bleeding. The following day (6 days after administration) miscarriage was confirmed via ultrasound
Patient came to get a Moderna booster and was inadvertently given Pfizer pediatric. We had used a vial of pediatric Pfizer Saturday and had left in fridge should another patient come that day for a shot. This was given to patient instead of Moderna (0.25ml given). No known adverse effects to patient. We have attempted to contact him to inform of error and ask him to return for appropriate shot, but had to leave a message pending return call.
Diplopia (vertical), followed by muscle weakeness in throat, arm, and leg muscles.  Eventually diagnosed with seronegative (no antibodies to AChR or MuSK) Myasthenia Gravis.  Started on corticosterioids in March 2013.  Thymectomy performed on February 2014.  Received flu shot again on 10/16/2014, 10:00 AM.  Myasthenia Gravis symptoms worsened within hours or receiving shot.
Patient complained of pain in bottom and started acting like she was having difficulty breathing. Symptoms progressed to redness, facial swelling, hives, decreased oxygen saturation and wheezing. Symptoms responded to Epinephrine and BENADRYL. Patient monitored in office for one hour. Patient's oxygen increased, swelling decreased and mild hives on cheeks.
A non-serious spontaneous report of "administration of expired product" and "vaccine given to a patient" was received from a non healthcare professional concerning a 52-year-old female out of 18 patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 15-Jan-2010. O 20-Jan-2010, the patient received expired H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Client called 5 days after vaccinating to indicate she experienced local rx within 1 hr of getting vaccinated - red itchy lump -> progressed to size of 1/2 dollar hot to touch - lasted few days. Also within hrs of vaccine developed wheeze/cough. Persisted x 5 days. Unsure if correlates with vaccinating as has sick grandchildren exposure. PCP notified.
Myalgia, Fever, NauseaVomiting, fatigue Narrative:
iNJECTION SITE REACTION - REDNESS, SWELLING - REPORTED INFECTION NEAR/AROUND SITE OF INFECTION
Approximately a week after I was administered influenza vaccine, I experienced frequent bowel movements, frequent bloody stools, frequent abdominal pains, etc.
1. Throat pain  2. Constant cough - triggered after second dose as well  3. Chest pain
After 20-30 minutes post vaccine dose #1, I experienced headache and dizziness. 1.5 hrs later body aches began. The same for the next day. Sore arm the 3rd day. Fatigue, headache and body aches and joint pains have persisted for the last 10 days.
Concern for new onset type 1 DM in a 52 year old with well-controlled type 2 DM.  When labs were done by our office on 4/5/21 the patient had signs of DKA and reported sx consistent with this.  The sx began insidiously and last labs had been done 9/2020 (at which time A1c was 5.9) so it is difficult to say if this is truly a side effect of the vaccine, but pt reports that she began feeling sick after the first dose of the Covid vaccine.  She did receive a subsequent dose on 3/6/21.
16 year, 6month old male presented to vaccine site accompanied by two parents. All three received Moderna vaccine.  Minor should have received Pfizer vaccine and received Moderna in error.
R57.9 SHOCK, UNSPECIFIED 1/21/2023 GI HEMORRHAGE
Loss of consciousness, cardiopulmonary arrest aprox. 6 to 7 hours after vaccine administration Could not be resuscitated and ultimately expired
Patient states that 10 minutes after getting her 2nd Covid vaccine, she started to feel her tongue swelling. Denies any difficulty swallowing , denies chest pain, denies palpitations. No observation of redness, swelling o face hnds or feet. Vitals signs obtained 0930 BP 117/72 HR 52bpm Sp02 100% , and 1006 BP 103/63 HR 52bpm Sp02 100%.  No RRT called. Pt left clinic by herself 1010
Crohns disease aggravated; Weight loss; Depression; output of feces was more than what was input for food; This is a solicited report from a non-Pfizer sponsored marketing program (FACILITATED COLLECT) based on information received by Pfizer from AbbVie (manufacturer control number: 21K-163-4146567-00.   A contactable 79-year-old female consumer (patient) reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 13Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE , dose 2 intramuscular on 13Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE, for covid-19 immunization at age of 79 years old; adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for moderate to severe adult crohn's disease. The patient medical history and concomitant medications were not reported. In 2021, the patient experienced crohns disease aggravated, weight loss, depression, output of feces was more than what was input for food, and adalimumab was not working. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient underwent lab tests and procedures which included weight: 105 pounds on an unspecified date.  The action taken in response to the events for adalimumab was unknown. The outcome of events crohns disease aggravated, weight loss, depression was not resolved, for other events was unknown.   The reporter's causality for the events of weight loss, crohn's disease symptoms worsened, humira was not working and output of feces was more than what was input for food with adalimumab was not provided, the reporter's causality for the event of depression with adalimumab was a reasonable possibility.   The reporter's assessment of the causal relationship of the events with the suspect product bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the current available information and a possible contributory role of the suspect product BNT162B2 to the development of events crohn's disease aggravation, weight loss, depression and abnormal faeces cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
DEVELOPED OCULAR NEURITIS IN LEFT EYE. PATIENT NOTED THAT SHE DOES HAVE MULTIPLE SCLEROSIS (MS). SHE IS FOLLOWING UP WITH HER PROVIDER.
This spontaneous report was received from a 62 year old male consumer referring on himself. The patient stated that his good cholesterol was low. On 14-NOV-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number not reported). Concomitant therapies included an unspecified tetanus shot. Within 12 hours after received ZOSTAVAX the patient developed a tingling on skin, sharp pain on lower back; over the next few days he noticed lumps and spots. On 20-NOV-2013 he went to healthcare professional and was diagnosed with shingles. He was prescribed valacyclovir and lidocaine patch, and the next day after, presumably after taking the valacyclovir, a rash grew around his side and back. In addition, patient said that "statins" give him a heat rash. The outcome of shingles was unknown. This is one of two reports from the same reporter source. Additional information has been requested.
Severe headache, high fever (101-102), whole-body aches, chills and began ovulating for the first time in two years (my breastfeeding daughter was 16 months old at this time, and 11 months past being solely breast-fed).
Attendee received dose at 4:04pm, reported symptoms of nausea, chest heaviness, dizziness, anxiety at 4:24pm, received benadryl for symptoms at 4:30pm with her daughter present for comfort, reported feeling better at 5pm
Pt vax'd w/3rd dose of Hep B vax 10mcg instead of 40mcg.
This case was reported by a consumer via Merck and described the occurrence of arm soreness in a male subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. In 2013, the subject received unspecified dose of FLUARIX (unknown route and injection site: lot number not provided). At an unspecified time after vaccination with FLUARIX, the subject experienced arm soreness. At the time of reporting the event was unresolved. No further information was provided.
Missed her second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed her second dose) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Lung cancer (Currently cancer free from lung cancer.) and Pacemaker insertion (cardiac) (Pacemaker for bradycardia.). Concurrent medical conditions included Hypothyroidism, Blind left eye and COPD (Having COPD and is on oxygen.). Concomitant products included ATENOLOL, CLOPIDOGREL, LEVOTHYROXINE and FUROSEMIDE (LASIX [FUROSEMIDE]) for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed her second dose). On 06-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Missed her second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products used included atenolol 40 mg once a day, Lasix 40 mg daily, eyedrops orbolamide twice a day, levothyroxine 50 mg once a day, clopidogrel 75 mg once a day, on oxygen.  Treatment medication was not provided by the reporter.  This report refers to a case of Product dose omission issue for mRNA-1273, lot # unkonwn with no associated AEs.; Sender's Comments: This report refers to a case of Product dose omission issue for mRNA-1273, lot # unkonwn with no associated AEs.
noc p/vax recvd pt had t102 orally & exp body jerking w/head held back x 10 seconds, pt already recvd APAP;
ADMINISTERED 2ND PFIZER VACCINE BEFORE 90 WAITING PERIOD AFTER PATIENT RECIEVED TOCILZUMAB ON 12/9/2021- NO ADVERSE OUTCOME TO RECORD AT THIS TIME.
A report has been received from a PSS via physician concerning a two child and this report was for second patient. No information regarding medical history and concomitant medicines was provided. The reporter called to report adverse event that was reported to her by Pediatrician HCP. HCP reported that he had two patients who received FLUMIST quadrivalent, 0.2 milliliters and developed severe nose bleed later that same day. One of the patients was seen the following day and the reporter reported that the childs mucosal tissue in the nares was inflamed and irritated. No specified date for FLUMIST for either child was given but a time frame of a week or two was given. The reporter reported that one patient got a severe nose bleed that night she got the FLUMIST and the other patient got a severe nose bleed five days later after getting the FLUMIST. The action taken to suspect drug was unknown. The outcome of the events of developed severe nose bleed and mucosal tissue in the nares was inflamed and irritated was unknown. The report was considered to be non-serious by company physician.
pt recv vax 30JUN95 & subsequently pt was exposed to chicken pox @ school;16MAY96 pt presented to MD ofc w/an outbreak of chickenpox described as extensive maculopapular vesicular lesions on trunk legs, arms, scalp & perineal area;
Developed swelling of my cheeks and under my chin; This is a spontaneous report from a contactable consumer (patient) received via program.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 05Mar2021 as dose 2, single for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number unknown, via an unspecified route of administration on 12Feb2021, as single dose for COVID-19 immunization. On an unspecified date, patient had developed swelling of cheeks and under the chin, looks like, chip monk cheeks. The patient saw her family doctor.  The patien underwent lab tests and procedures which included on an unspecified date, chest x-ray and x-ray, both were negative. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
About 8 hours post vaccination she reports muscle spasms radiating from her shoulders to her chest, 12 hours after vaccine developed severe headache, and hives along the right side of her chest. Thirty six hours after vaccine she claims she had hallucinations during the night.  About 48 hours post vaccination states she had reports ringing in her ears. Six days post vaccination she claims she had tingling along the sides of her mouth.
8-10 Days I got a huge red mark on my arm, hot to the touch, it was sore, itchy. It kept growing in size. 3 days later it started to go down.
A non-serious spontaneous report of given expired FLUMIST was received from a health professional concerning a five-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 22-Jan-2012. On 25-Jan-2012, expired FLUMIST was administered to the patient. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
The next day I had a fever of 109, tiredness and achy and it lasted for 34 hours. Two days later from the vaccination I had a pulsing in my right ear and I noticed it when I was in bed. That lasted for a long time and it gotten less for a while. I went to doctor on May 7 and the doctor said I had ear wax in my ear and then they irrigated the ear and got the wax out and then two weeks later I developed dizziness and it was really bad. Then I contacted the ENT and then the dizziness went away and according to them everything was fine.
I have many tachycardias and palpitations (still lingers), Bronchitis (still lingers), Headache (still lingers) pain in the body and chest very strong, ear pain and throat. Agitation and shortness of breath, weakness, fatigue (still lingers) feels like I have bugs all over my body and I do not have any bugs on me. I am worried and I cried for 3 days but I do not understand why.
Headache starting mid afternoon or evening - ongoing Sore arm starting ~ 1 week following injection. still sore if rubbed Right hand cramping intermittently- started 1 week ago , ongoing Didn?t feel ?my usual self? - ongoing