chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tingling in upper arm that radiates to lower arm.  Also cold feeling in upper arm.  Also tingling in leg.  Unsure if related but started after second shot was received and no history of this before.
Vomited x1, 2 loose stools, temp 101.6. Onset 36 hours post vaccination.  6/20/08 Reviewed hospital medical records of 5/15-5/16/2008. FINAL DX: gastroenteritis Records reveal patient had markedly decreased oral intake, vomiting, diarhea, fever x approx 12 hrs.  Tx w/IVF.  No further vomiting, diarrhea or fever & improved oral intake.  D/C to home.
Rash on body, arms, and legs Mast Cell Activation Syndrome symptoms: electrical sensation and itchiness all over the body, nausea when eating, chest pain, heart palpitations, dizziness
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 01-JUL-2013 at 07:40, ZOSTAVAX lot # J001005 was exposed to an exact T not recorded but noted as equal to or > 12C for an estimated total time out of range of 44.5 hours. On 11-JUL-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX  (dose and route administration were not provided) (Lot number J001005, Exp. Date: 24-APR-2014). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
Patient received lower dose than what is recommended for dose 1 of the primary COVID vaccine series for his age.  He received the Moderna Bivalent Booster vaccine for 6mon-5yrs.  It is recommended that he receive the Moderna Bivalent vaccine for 6mon and older (Primary series).  Therefore, the patient received a lower dose than recommended.
Patient was given incorrect dose of moderna booster shot. patient should have received 0.25 milliliters but received 0.05 milliliters in error.
Patient admitted as inpatient on 8/29 due to COVID-19. Patient was tested for COVID-19 and was positive on 8/29.  Since Friday (8/27)patient states she has been having low blood pressures while at home.  With this she has been having a cough seizing feeling congested having a decreased appetite.  She states that she has been stumbling a little bit as well.
I had COVID in late January 2021. I received my first two doses of the Pfizer vaccine in April 2021. The day after I received my Moderna booster, I woke up with painful, large and puffy lips, which has never happened to me before. Benadryl eased the symptoms. For the past 5 weeks, I have had incidences of severe and itchy hives about 4 times a week all over my body but mostly on my torso (sometimes on my hands and face), painful puffy lips about 4 times a week (sometimes on the same days, sometimes not), extremely painful chest tightness twice (once on 11/17 and once on 12/5), extremely painful knuckle joint tightness in my hands (for about a week, the week of 11/29), and occasionally a swollen tongue. Benadryl eases the symptoms and Claritin and Allegra do not have any noticeable effects. I have not found a way to ease the symptoms. I saw my primary care physician who referred me to an allergist and provided no treatment. I also lost my smell the day I received the vaccine (11/1) and it has mostly returned by about 11/22.
extreme swelling of lymph node; swelling on in the injection arm/swelling on left arm; swelling of neck; swelling on the face; pain; pain inside of left ear; swelling on in the injection arm/swelling on left arm; rash on lower extremity of both leg more towards upper calf and lower thigh side; lost sense of taste; dehydrate; lack of appetite; fatigue for 4 days; A spontaneous report was received from a consumer concerning herself, who is a 65-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events extreme swelling of lymph node, swelling on in the injection arm, swelling on left arm, swelling on the face, pain, pain inside of left ear, soreness on the injection arm, rash on lower extremity of both leg more towards upper calf and lower thigh side, lost sense of taste, dehydrate, lack of appetite, fatigue for 4 days.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 8 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) Intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 5 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 012M20A) Intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 5 Feb 2021, the patient experienced the events in evening with extreme swelling of lymph node, swelling of neck, swelling on in the injection arm as well as swelling on left arm, swelling on the face, pain, pain inside of left ear, soreness on the injection arm, rash on lower extremity of both leg more towards upper calf and lower thigh side, lost sense of taste, dehydrate, lack of appetite, and fatigue for 4 days.  Treatment details included diphenhydramine: for 2 days, acetaminophen, dextromethorphan, and phenylephrine 1/ 2 recommended dose listed on the bottle for 3 days.  Patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event was not applicable  On 9 Feb 2021 the outcome of event pain inside of left ear, fatigue for 4 days was resolved. The outcome of events extreme swelling of lymph node, swelling of neck, swelling on in the injection arm, swelling on left arm, swelling on the face, pain, soreness on the injection arm, rash on lower extremity of both leg more towards upper calf and lower thigh side, lost sense of taste, dehydrate, lack of appetite was resolving.
1st dose of HEP A gave pt. "severe stomach cramps and diarrhea".  Symptoms lasted 2 days per mother.  2nd dose gave patient the same stomach cramps without the diarrhea.
have had liquid diarrhea for the last 3 days; tired/feeling weak; Headache; flu like; nausea; This is a spontaneous report from a contactable consumer or other non hcp. A 62-years-old female patient (who was not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8730), first dose via an unspecified route of administration in Arm Left on 22Mar2021 10:15 as 1ST DOSE, SINGLE at pharmacy store for covid-19 immunisation. Medical history included hypertension, sleep apnoea syndrome, and drug hypersensitivity with penicillin. Concomitant medications included benazepril taken for an unspecified indication, start and stop date were not reported. Post vaccination patient was not diagnosed or tested for COVID-19 at the time of vaccination. Patient did not receive any other vaccinations with in 4 weeks time of vaccination. Patient received benazepril in two weeks of vaccination. Vaccine Facility ,Ethnicity and Race information was available.The event had not resulted in for death, life-threatening, prolonged hospitalisation, disabling/incapacitating or congenital anomaly/birth defect. On 22Mar2021 the patient experienced headache, flu like, nausea, tired, feeling weak. On 25Mar2021 the patient had liquid diarrhoea lasting three days. No treatment was received for the events. The outcome of the events were not recovered.  No follow-up attempts are needed. No further information is expected.
Post vax, arm aching and sore to touch and on movement. Unable to hold baby with left arm due to pain where received vax, numbing in entire arm for two days. MD told her to take Tylenol, it did relieve symptoms in two days. Noted that physician saw her on 05/05.
No adverse event; expired dose given; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose given) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 082B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Sep-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose given). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose given) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (expired dose given).    No Concomitant medication were reported. It was found out later that the vial Expired on. 04-Sep-2022 (From the time out of freezer to use). No treatment drug were reported.
I got the Phizer 2nd shot this past Wednesday. 24 hrs later I had the normal symptoms, headaches, fatigue. Through the weekend things were fairly normal till Sunday night. I had a hard time sleeping and a low grade temperature 99.4. Over night I hoped it would get better but in the morning it got a little worse 100.0. Didn't sleep till 2am. A little bit ago I took my temp again and it's 100.2. I don't have flu type symptoms, just tired and fever. I've been taking Tylenol every 8 hrs or so. Drinking water and resting.
Left arm and shoulder feels crampy; Stiffnes in arm; Soreness in arm / Left arm and shoulder where vaccine was administered hurts; Mobility is limited; Left arm and shoulder where vaccine was administered hurts; Expired vaccine used; This is a spontaneous case, reported by other health professional to Company (case ID: SEQ19-07051) and initially received on 26-Nov-2019, concernig a 44-year-old female patient.  The patient's medical history and concomitant medications were not provided.  On 25-Oct-2019, the patient was administered Afluria Quadrivalent [Influenza vaccine, dose: 0.5ml, anatomical location: left arm, batch number: P100118559, expiration date: 30-Jun-2019, route of administration: not reported] (explicitly coded as 'Expired vaccine used') for influenza prophylaxis.  On the same day, after vaccination the patient experienced stiffness and soreness in the arm. Left arm and shoulder where vaccine was administered started hurting, feeling crampy and the patient's mobility was limited.  On an unspecific date, the patient's shoulder was iced to relieve the pain.  On an unspecific date, one month later, left arm and shoulder where vaccine was administered still hurt, felt crampy and the patient's mobility was limited.  At the time of initial reporting the outcome of the events was not recovered.  The reporter did not provide causality and seriousness criteria.  This case is linked with companion case 201906333 due to the same reporter.  Company Comment: The patient experienced muscle spasms, musculoskeletal stiffness, pain in extremity, mobility decreased and musculoskeletal pain after administration of expired product Afluria Quadrivalent. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Expired product administered is assessed as not related per company's conventions.  Considering all the above mentioned, causality between suspect product and all other events is assessed as possibly related.; Sender's Comments: The patient experienced muscle spasms, musculoskeletal stiffness, pain in extremity, mobility decreased and musculoskeletal pain after administration of expired product Afluria Quadrivalent. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Expired product administered is assessed as not related per company's conventions.  Considering all the above mentioned, causality between suspect product and all other events is assessed as possibly related.
Patient experience severe muscle pain, fatigue, and body ache. Followed by muscle spasms and strain (charlie horses) all over her body. Patient describes as "frozen muscle". No fever. No cough. No sore throat. Some nausea.
This non-serious medically confirmed report (initial receipt 11-SEP-2014) concerns a 59-year-old female patient. The patient tolerated AFLURIA in the past. on 11-SEP-2014, the patient received subcutaneus AFLURIA (batch number T58006, expiry date 06-JUN-2015) 0.5 ml. On 11-SEP-2014, after receiving the vaccine, the patient noted that the vaccine was administered with 5/8 inch needle. The patient suspected that she received a subcutaneous dose of the vaccine. No adverse reaction was experienced since the administration of vaccine. The outcome was recovered on 11-SEP-2014. Reporter's comments: The reporter assessed the events as medication error, non-serious and unrelated to the influenza vaccine.  Batch record review for lot T580096 noted: Batch records and QA batch review checklists for the seed lot, MPH, formulated bulk vaccine and filling and inspection were inspected to determine if there were any issues or atypical events during processing which could be considered to be related to the adverse events reported. No events or results were identified which could be considered to be related to the adverse events reported. All deviations relating to the seed lot, MPH, formulated bulk vaccine and finished product lot T58006 were reviewed and none were considered to have contributed to the adverse events reported. All QC test results for the seed lot, MPH, formulated bulk vaccine and finished product process stages associated with lot T58006 were reviewed, and all results were satisfactory with no out of specification results reported. Trend analysis of the product attributes which were the focus of this investigation (HA content, TDOC, ovalbumin, endotoxin and protein by nitrogen) was performed, and all of these attributes were within statistically derived process control limits. In conclusion, there were no batch related issues identified that may have caused the adverse events reported.
Flu like symptom for 3-4 days, fever, sore, throat, body aches, nausea, headache, eye pressure. Back of arm and lower arm was bruised and sore for approx 7-10 days. All resolved except for eye pressure, headache, and unbalanced, muscle weakness. This continues, neurologist consulted.
Initial unsolicited case received from literature on 21-Oct-2015. Abstract: OBJECTIVES: In the Safety Monitoring Program, we examined risk of febrile seizures (FS) after trivalent inactivated influenza vaccine (TIV) and pneumococcal conjugate vaccine (PCV13) during the 2010-2-11 influenza season, adjusted for concomitant DTaP. Assuming children would receive both vaccines, we examined whether same-day TIV and PCV13 vaccination was associated with greater FS risk when compared with separate-day vaccination. METHODS: We used a self-controlled risk interval design, comparing the FS rate in a risk interval (0-1 days) versus control interval (14-20 days). Vaccinations were identified in claims and immunization registry data. FS were confirmed with medical records. RESULTS: No statistically significant TIV-FS associations were found in unadjusted or adjusted models (incidence rate ratio [IRR] adjusted for age, seasonality, and concomitant PCV13 and DTaP: 1.36, 95 percent confidence interval [CI] 0.78 to 2.39). Adjusted for age and seasonality, PCV13 was significantly associated with FS (IRR 1.74, 95 percent CI 1.06 to 2.86), but not when further adjusting for concomitant TIV and DTaP (IRR 1.61, 95 percent CI 0.91 to 2.82). Same-day TIV and PCV13 vaccination was not associated with excess risk of FS when compared with separate-day vaccination (1.08 fewer FS per 100,000 with same day administration, 95 percent  CI 25.68 to 6.09). CONCLUSIONS: No statistically significant increased risk of FS was found for 2010-2011 TIV or PCV13, when adjusting for concomitant vaccines. Same-day TIV and PCV13 vaccination was not associated with more FS compared with separate-day vaccination. This case involves one hundred forty two people (aged 6 to 59 months) had received a dose of DTaP (manufacturer: unknown, batch number, dose in series, route and site of administration were not reported), a dose of influenza vaccine (manufacturer: unknown, batch number, dose in series, route and site of administration were not reported) and a dose of Pneumococcal conjugate vaccine (PVVD 13) (manufacturer: other, batch number, dose in series, route and site of administration were not reported) on unspecified dates. Medical history and concomitant medications were not reported. On unspecified dates after 2010-2011, patients experienced seizure and fever (i.e., a measured temperature of about 38 Degree Celsius or tactile fever within 24 hours of a seizure or a physician's diagnosis of a concomitant febrile illness or a physician's diagnosis of a Febrile Seizure). On unspecified date, study, IRRs, another study used a design with chart confirmation of FS were performed. Other tests were not reported. Corrective treatments were not reported. At the time of report, outcome of the event was not reported. Upon internal review, the case was considered as serious due to important medical event: febrile seizure. List of Documents held by Sender: none.
Myalgia, Fever & NauseaVomiting Narrative: fever tmaz 102.7, chills, fatigue, muscle/body aches, severe arm pain, nausea
Vaccine given 8 days early at a vaccination event; first dose was on 3/18 and second dose 3/31
A report was received from a health care professional on 10/10/2003 concerning 5 vaccinees of unknown demography who inadvertently received expired Fluvirin vaccine on 10/03/2003. No adverse reactions were reported. There was insufficient information to determine the reporter's causality assessement. Follow up pending.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2021, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: anti viral details included COVID 19 Treatment from 15Apr2021. No known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
pt recv vax; devel less than 50 varicella-like lesions on legs & on trunk;
Noted tongue parathesias and sensation of tongue swelling after vaccination.  Denies SOB, dizziness, C/P, pruritis or rash.  BPMHx, no current meds, allergy sulfa.
On 9/30/17 patient received two vaccines: FLUZONE HD in her right arm and PREVNAR 13 in her left arm. Patient is a regular of ours and hasn't complained of arm pain. When RPh went to give her flu shot on 10/10/17 patient stated that she was having pain in her right arm (where she received the FLUZONE HD last year). She stated that she has been having pain in that arm since last year when she got the flu shot. Pharmacist noticed that she had a stitches scar in the area she was stating she had pain and she said within the last year she had surgery to have a cyst removed from there. So perhaps the pain was caused from the cyst and the surgery. Pharmacist recommended her to follow up with her PCP about the pain. I tried to call the patient to get the information from her but there was no answer on both 10/11/17 or 10/12/17 on either house or cell phone. As far as I know from pharmacist, she has not gone to the doctor in regards to this.
Around the beginning of May I notices some lumps under both of my armpits and went to see my Gynecologist, on May 19 to have her check them out.  She wanted me to have a mammogram and ultra sound, which I had on May 25.  They did not think it was cancer, but were not sure what the lumps were, so wanted me to return again in 3 months, for another ultra sound, which I am scheduled to have on August 26.
rash in the arm of the shot/Rash is red blotchy; Rash is red blotchy and hurts to touch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 12 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Jan2022 20:00 (Batch/Lot number: unknown) at the age of 12 years as dose 1 (tris), single for covid-19 immunisation. Relevant medical history included: "Allergy to trees" (unspecified if ongoing); "sports induced asthma" (unspecified if ongoing); "Known Allergy: Peaches and Mangos" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; FLONASE [FLUTICASONE PROPIONATE]. The following information was reported: RASH MACULAR (non-serious) with onset 15Jan2022 19:00, outcome "recovering", described as "rash in the arm of the shot/Rash is red blotchy"; PAIN (non-serious) with onset 15Jan2022 19:00, outcome "recovering", described as "Rash is red blotchy and hurts to touch". Therapeutic measures were taken as a result of rash macular, pain.  Additional information: Facility type vaccine was Pharmacy or Drug Store. No other vaccine in four weeks. No Covid prior vaccination and no covid tested post vaccination. Other medications in two weeks was Multi Vitamin Zyrtec Flonase. On 15Jan2022, night at 7pm he was complaining of a rash in the arm of the shot. Shot was given at to left arm. Rash was at bottom of arm. Rash was red blotchy and hurted to touch. AE treatment: Benadryl.  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 Licensed Practical Nurse refers to a 80 years old female patient who had a medical condition of bronchiectasis. Patient had received her second dose of PNEUMOVAX 23 and developed an injection site reaction. Patient received her first dose of PNEUMOVAX 23 (Lot #, dose, route unspecified) on 18-OCT-2007, and she received a second dose of PNEUMOVAX 23 (in her left arm, Lot # reported as H018441, exp 28-FEB-2014, dose, route unspecified) on 19-DEC-2012. Patient called the practice on 21-DEC-2012 to state that she had some swelling in her left arm, but "it is getting better and I do not need to be seen." The reporting nurse would like to request a lot check for this lot of PNEUMOVAX 23, lot # H018441, exp 28-FEB-2014. This was one of several reports that received from the same source. Additional information has been requested.
Pt began complaining of dizziness after receiving Pfizer vaccine, while sitting in recovery area.  Pt was pale and clammy to touch.  Pt's father stated that Pt did not eat anything today prior to coming in for vaccination.  Pt was evaluated by staff, and given a bottle of water and a granola bar.  Pt ate and drank what was provided, stated he felt better, and left clinic in care of his parents without further incident.
1 day post vax, pt experienced full seizure. Hospitalized overnight for observation. Saw pediatrician. Placed on anti-seizure medication.  Follow-up: 7/26/00 Hosp. and MD's f/u office notes rec'd. EEG was NL and no further seizure activity noted. Has hx of breath holding spells since 6/99. MD believes these may have been seizures all along. So maintained on TEGRETOL. Case is now complete.
Headache Neck muscle pain Dizziness "Foggy" right eye vision Numbness and tingling in both hands  Visits to ER, primary care,employee health,neurology,allergy and immunology, cardiology, opthalmologist,pain management