chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a consumer refers to herself: a 73 year old female patient. No details on pertinent medical history provided; the patient had no known drug reactions or allergies. Diazepam, VALTREX was reported as a concomitant drug. On an unspecified date in 2008 the patient was vaccinated with ZOSTAVAX; no lot number, dose or route of administratio was provided. The consumer stated that she "still has episodes of shingles a few years later", usually occurring once a year; the adverse event onset date was reported as "two to three years". On an unknown date in 2014 (reported as "a few weeks ago") the patient suffered with rash and the itching sensation around her body. The patient sought medical attention; unspecified treatment was given to her. No lab diagnostics studies were performed. The outcome of episodes of shingles and the recent rash and itching was unknown. The relatedness between adverse events and the vaccination with ZOSTAVAX was not reported. Additional information is not expected.
Woke up at 3:00am feeling nauseous and vomited shortly after. For the next 12 hours, I had fever, chills, headaches, neck and shoulder pain, felt sore all over, and was dizzy when standing up.
Patient stated she did not feel good, the color drained from her face and she almost passed out. She also had a local reaction at injection site.
2.5cm x 3cm raise, circular induration on (R) deltoid. Red and purple in color. Antibiotics Rx per provider, home care instructions given: warm soaks 3 times per day.
That morning I felt jittery and my legs felt like rubber like I had to focus to walk. My vision was blurred a little. This lasted a few hours. From then on for about 4- 6 weeks I would bouts of weakness and like I was having mucsle spasm and these symptoms went from my feet and progressed to my head over this 4-6 week period. It was very strange but I was still able to function and it wasn't constant it came and went. Still have feelings of heaviness evey now and again for the past year.
Patient fainted due to an anxiety attack after receiving her 1st covid immunization. An ambulance was called and she was taken to the hospital.
UNRESPONSIVE FOR 30 SECONDS; HIT HEAD ON THE CONCRETE WALL; FELL TO THE SIDE, FELL OFF THE CHAIR; PALE; DIAPHORETIC; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. 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: 201A21A and expiry: UNKNOWN) dose was not reported, once total administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported The reporter stated that, the patient while sitting in the observation area, fell to the side, fell off the chair and hit head on the concrete wall on 07-APR-2021. On the same day, the patient was unresponsive for 30 seconds, pale and diaphoretic. Transported and evaluated by emergency medical services (EMS). Patient refused transport to hospital.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the unresponsive for 30 seconds, pale, diaphoretic, fell to the side, fell off the chair and hit head on the concrete wall was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210417256, 20210417209, 20210417456 and 20210417122.; Sender's Comments: V0:20210417469- covid-19 vaccine ad26.cov2.s-unresponsive for 30 seconds. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
pt recv vax & devel a dermatographic rxn; pt is being treated w/Hismanal, Pepcid, Hydorxyzine
High temperatures; This is a spontaneous report from a Pfizer sponsored program. A non-contactable consumer(patient) reported that, a patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced high temperatures (Misplaced comment, as reported) on an unspecified date. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
rash on right foot; both hands itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (both hands itching) and RASH (rash on right foot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced PRURITUS (both hands itching). On 18-Feb-2021, the patient experienced RASH (rash on right foot). At the time of the report, PRURITUS (both hands itching) and RASH (rash on right foot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Upon in internal review on 21 May 2021, the age was corrected to unknown age.  No concomitant medication was provided.  No treatment details were provided.    Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: updated reporter details
Rashes / hives after 9 days of getting booster shot Itchiness all over Ghost like rashes that disappear after a while Extremely sensitive and red skin Knee and elbow swelling one day after hives started and lasted for only a day
Shortly after the vaccine my right arm was red, swollen, hard and painful.  I had shivers and chills, nausea and extreme back and leg pain all which lasted about 36 hours with the pain level easing up throughout that time. But to date the fatigue is still hanging on but all other symptoms has subsided
Chills, fever, headache, nausea, sweats. Arm sore and red at injection site.
Patient reported light headedness and cough  45 min after injection.  with rest and oral fluids. resolved. over the next few days. patient reported increased fatigue and SOB.  advised patient to seek medical attention for symptoms which she did today.  reports she has now left sided chest discomfort. and left arm pain.
2/1 vaccination Headache was pretty immediate 4 hours later; chills went to bed at 8pm. Woke up to hot flashes, joint pain, temp 99.7, nausea, and rash. Symptoms lasted for 36 hours. Took Ibuprofen  Rash lasted for 3 days
This spontaneous report was received from a physician referring to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a first dose series of GARDASIL 9 (strength, dose, route, anatomical location, lot # and expiration date were not provided), for prophylaxis. On an unknown date, the patient almost fainted after receiving the first dose in vaccination series (presyncope). At the time of reporting, the outcome of presyncope was unknown. The causal relationship between the event and the GARDASIL 9 was not reported.
Headache, soreness and weakness in legs and hypertension. Sign of issue hypertension consistent headache full skull and neck. Started day after vaccine  6 days after vaccine taken to Er blood pressure 200 over 121 and taken to Er 7 day after and 8 days later  still trying to bring it down today.
Patient arrived at the pharmacy today, 7/17/2021, stated she received the second dose of Moderna yesterday morning, and this afternoon, has noticed red-spots/hives on arms and torso. Patient advised to take Benadryl and follow up with a  Physician if worsens or continues.
I evaluated pt on 12/14 at which time mom reported that she noted erythema to (R) thigh at injection site 2 days after immunization given. Area increased in size to approx 8cm, was warm to touch & very tender. No oozing, no fever, mom did not bring him to medical attention during acute erythema bc no fever. On my exam on 12/14 -> small nodular area palpable (R) anterior thigh (needle site per mom); no erythema, warmth or fluctuance.
Information has been received from a physician concerning a 4 weeks old patient who on 21-MAY-2010 was vaccinated PO with a first dose of ROTATEQ (Lot number not provided). The physician reported that the patient was vaccinated with ROTATEQ at 4 weeks of age which was two weeks earlier than what is suggested by the prescribing information. No adverse event reported. The patient received unspecified medical attention. Additional information has been requested.
nurse gave Adacel instead of the 4th Daptacel dose, NO AE; nurse gave Adacel instead of the 4th Daptacel dose, NO AE; Initial information received on 22-Jan-2020 regarding an unsolicited valid non-serious case received from a pharmacist.   This case involves a 15 months 9 days old male patient who was vaccinated with 0.5 ml dose DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] Prefilled syringe instead of the fourth dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] On 21-Jan-2020 for prophylactic vaccination.  It was actual medication error due to Wrong vaccine administered and Inappropriate age at vaccine administration.   At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.  Information on the batch number was requested.
Gen multiple, pink, raised, pruritic wheals accompanied by nausea (no vomiting) & mild facial & digital (fingers) edema which devel 1 day following administration of the 1st HBV; edema lasted 2 days, rash lasted 7 days w/no peeling;
Per parent - "water blisters" on (L) arm about 2 hrs. after receiving the vaccine. Tdap was given in (L) arm. Patient then broke out in hives and blisters from her shoulders down to her feet. Patient was vomiting "violently" for about a half a hour. Patient was complaining of joint pain, especially in her legs. Mom gave patient 2 teaspoons of Children's BENADRYL and took pt to the ER.
Swelling of the mouth; Swelling of the salivary glands; Swelling of the lips; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of MOUTH SWELLING (Swelling of the mouth), SALIVARY GLAND ENLARGEMENT (Swelling of the salivary glands), LIP SWELLING (Swelling of the lips) and MYALGIA (Body aches) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to plants (Allergies with trees of unknown kind.), Allergy to plants (Allergy to citrus.) and Penicillin allergy. Concomitant products included IBANDRONATE SODIUM (IBANDRONATE) for Osteoporosis.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced MYALGIA (Body aches). On 26-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MOUTH SWELLING (Swelling of the mouth), SALIVARY GLAND ENLARGEMENT (Swelling of the salivary glands) and LIP SWELLING (Swelling of the lips). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at an unspecified dose and frequency. On 03-Apr-2021, MYALGIA (Body aches) had resolved. At the time of the report, MOUTH SWELLING (Swelling of the mouth), SALIVARY GLAND ENLARGEMENT (Swelling of the salivary glands) and LIP SWELLING (Swelling of the lips) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy salivary gland: negative (Negative) Negative for Sjorgren's syndrome.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication was not reported.  Lab data included blood works and series of diagnostics. It was reported that patient did not experience any event after first dose of vaccination.   This case was linked to MOD-2021-385897 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Event added, reporter type updated
Fever after Shingrix; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The patient experienced fever after Shingrix.
Elevated temperature with left deltoid inflammation, pain and redness hospital admit; IV antibiotics; CAT scan and lumbar puncture - 3 days stay.
pt recv vax SEP95&devel a hard lump @ inj site;pt eval by NP&no tx was ordered;hx of allergies&takes Beconase spray&Seldane;
Chest pain, hives, vomiting, diarrhea, nauseous, egg burps.
Vaccine administered after temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no treatment medication provided. no concomitant medication provided. 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.
15 vesicular lesions over abdomen, back, hairline.  1 lesion in left eye.  Lesions appeared within 4 days of vaccination.
A report was received from a health professional on 10/30/2002, concerning approximately 10 vaccinees who inadvertently received last year's Fluvirin.  From 10/28/2002 to 10/30/2002, approximately 10 vaccinees were inadvertently vaccinated with expired Fluvirin. There was insufficient information to determine the reporter's causality assessment. Update 1, 01/27/2003. A report was received from a healthcare professional concerning a 50 year old female vaccinee who received expired influenza vaccine (brand unspecified) on an unspecified date.  The vaccinee was subsequently re-vaccinated with this years influenza vaccination and experienced no adverse reaction.
Pt. reported to office w/blisters on both legs, arms and few on the back. Provider diagnosed with varicella without complication.
Around 2:00 am, around 7 hours after receiving vaccinations, I started having severe muscle spasms and twitching. I felt extremely uneasy and weak. Even though my head felt extremely heavy and tired, I could not fall back asleep. My body felt the complete opposite as if it was full of energy. This lasted until about 5 am when I was finally able to go back to sleep. No other reactions occurred until today 12/09 around 7 am when I woke up my whole body felt numb and I felt a tingling sensation all over. It got worse the more I moved. It would travel up to my head and make me feel unsteady where my hearing would start to fade. I felt like I was going to faint multiple times. A few times my head would shake as if I was trying to mimic getting a bad taste out of my mouth. It is now 4:00 pm on the same day and I am still experiencing these side effects. The slightest movement makes my head feel uneasy.
client one week later complained of arm itching with red swollen area resolving by 1/21/21
Patient had his first asthma attack on this date, he did have a fever after vaccination, and his eczema flared up. I didn't think much of the fever as his Dr reassured me that this was a normal reaction. Patient was diagnosed with a cat dander allergy after an allergy panel was completed. Patient showed no symptoms of allergy prior to his initial vaccination at 2 months of age. We had a cat all throughout my pregnancy and Josiah was in our home with our cat for 2 months with no symptoms or signs of an allergy, it wasn't until after his first vaccination on 8/7/2012 that his cheeks began to turn red and irritated.
pt devel swelling & induration within 12 hr after inject; tender, warm, itchy, progressively warmer, more itchy @ lt leg; 6/2 much improved.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 30-NOV-2016, the patient received an improperly stored dose of M-M-R II (therapy type: recombinant human albumin, RHA) injection (lot # M015931 with expiration date at 30-MAR-2018; dose, route of administration and anatomical location were not reported). The administered dose of vaccine was exposed to a temperature of -14.4 degrees Celsius (C) for 54 minutes. Digital data logger was used to track the temperature. There was no previous temperature excursion reported. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information is not expected as all scheduled correspondence was received. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113.
About 10 mins after vaccination was given, patient called pharmacist over to report tachycardia (pt reported HR from watch was over 100), and shaky hands. Patient BP was taken and was 156/107, and HR was in the 80s. Patient reported being on flecainide and metoprolol for high BP and history of tachycardia. Patient denied history of anxiety attacks, chest pain, dizziness, lightheadedness and shortness of breath. Patient reports normal BP around 111 DBP. Pharmacist instructed patient to relax, focus on breathing and BP would be taken again in 10 min. It seemed that patient was not able to calm down and was looking at her watch repeatedly monitoring HR over the 10 mins. BP was taken again after 10 mins and was 170/105. It was agreed with pt that 911 would be called to evaluate patient for rising BP. EMTs showed up about 10 mins later and took over monitoring patient. Upon evaluation, it was decided that pt would go to ER for further evaluation given pt history.
No other adverse effects were reported; a patient received a dose of VAQTA (lot S007770 Exp Date 7/24/2020) on 7/27/2020; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.      On 27-JUL-2020, the patient received a dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5, 0.5 milliliter, lot # S007770, expiration date 24-JUL-2020,  via unknown route for prophylaxis (Expired vaccine used). No other adverse effects were reported. No product quality complaint (PQC). The outcome of the events was unknown. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S007770; expirationdate: 24-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Patient experienced soreness on the right upper arm approximately 4 hours after administration. Patient also noticed the next day that the swelling moved towards the lower part of her arm (towards the elbow).
Full body hives 10 days after booster; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Full body hives 10 days after booster) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 002B21A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (Full body hives 10 days after booster). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Hives and Itching, at a dose of UNK, qd. At the time of the report, URTICARIA (Full body hives 10 days after booster) had not resolved.  No concomitant medication was reported. The patient's gave antihistamine, and Zyrtec, once a day. On 08-Dec-2021, he still had the hives and itching all over the body.
cold sweat, ear ringing, chest tightness, nausea, cold extremities, light headed, severe headache, upset stomach, fatigued