chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nausea; Vomiting; Swelling under armpit of injected arm; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), VOMITING (Vomiting) and VACCINATION SITE LYMPHADENOPATHY (Swelling under armpit of injected arm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (Allergic to Sulfa Medications).   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced NAUSEA (Nausea), VOMITING (Vomiting) and VACCINATION SITE LYMPHADENOPATHY (Swelling under armpit of injected arm). At the time of the report, NAUSEA (Nausea), VOMITING (Vomiting) and VACCINATION SITE LYMPHADENOPATHY (Swelling under armpit of injected arm) outcome was unknown.            No concomitant medications were reported.
pt recv vax;c/o fever of 101 po;cold sx & achy feelings;pt felt rxn from rabies vax;given anti inflammatory & or antihistamine to relieve sx;
Tolerated immunizations fine Given four on 4/14/2009. Next day 4/15 some tenderness and on 4/16/09 noted sweling left deltoid down to elbow with redness. Went to Urgent Care in evening.  Per Dr. noted some pain, warm to touch, erythema and swelling but has excellant range of motion. No evidence of abscess.  Dr felt a "normal immune reaction"  but gave a RX for Keflex. Mom states later the redness went down to the hand, but with antibiotics improved.
Pt pain describes gradually increasing pain 2-3 hrs after PNEUMOVAX to injection site.
I started having migraines and dizziness when standing and ringing in my right ear. I also was very fatigued.
Pin Stroke; A spontaneous report was received from a consumer concerning a 66-year-old,  female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event  pin stroke.  The patients medical history was not provided. Products known to have been used by patient with in last two weeks included montelukast  , alendronate and varenicline tartrate.  On  04-Mar-2021, prior to the onset of the events, the patient received their first  of two planned doses of mRNA (Lot number: 010A21A ) through intramuscular route of administration in the left deltoid for prophylaxis of COVID-19 infection.  On 06-Mar-2021, patient experienced pin stroke and was hospitalized for four days. Laboratory tests performed included magnetic resonance imaging and electro cardiogram and the results was not provided. No treatment information was provided..  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event pin stroke was considered unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
What I have noticed since taking the Pfizer vaccine is that when I now get a bug bite, I am getting severe reactions, such as large areas of redness and itching.  This has never happened before being vaccinated. I would only get a mild reaction to a bug bite. It appears to be an overaggressive immune response from the vaccine.  In fact, I've been using over-the-counter cortisone cream to calm the areas down, which I've never had to use before getting vaccinated.  It makes me wonder if the vaccine is changing my immune response.  This needs to be monitored.
Onset commenced approximately one week after flu shot was given.  Reported headaches (crown, occiput - Frontal); runny nose; however, no fever.  No treatment provided and no OTC medicines taken.
Information has been received from a nurse practitioner referring to a patient of unknown age and gender. The patient's concurrent and historical conditions were not reported. On 11-JUN-2015, the patient was vaccinated with one dose of improperly stored GARDASIL (dose, route and site of administration were not reported), lot # K008931, expiration date 04-MAR-2017). No adverse symptoms were provided. This is one of several reports from the same reporter. Additional information has been requested.
Patient received dose 1 12/4/2022, dose 2 on 1/12/2022. Mother had COVID end of December, child not tested. Admitted2/18 with change in mental state and pancytopenia requiring blood transfusion, all attributed to worsened liver function, ke[atic encephalopathy and vitamin K deficiency. Re-admitted 2/24/22 with altered mental status, disorientation, unusual behavior and aphasia. Found to have CNS white matter demyelination. Aso found to have possible endocarditis (bacterial cultures negative). Virus testing so far negative.
Left upper arm swollen, red and warm to touch. Dr. prescribed Benadryl 1.75 tsp q 6 hours and Keflex 250 mg/ 5 ml,
Abrupt onset erythema, swelling, warmth, and local pain severe enough to limit movement and daily activities.
No additional AE; Hcp called to report expired PROQUAD inadvertently administered to a patient.; This spontaneous report was received from a medical assistant referring to a 4-year-old female patient. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 23-SEP-2023, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (rHA) injection (0.5 ml x1, lot#: W007743, expiration date: 04-SEP-2023; route of administration was not provided) for prophylaxis (expired product administered). No additional adverse events (AE) were reported (no adverse event).
STIFFNESS; PAIN; FEELING UNWELL; This spontaneous report received from a patient concerned an elderly female. The patient's height, and weight were not reported. The patient's past medical history included: stiff, and hurting, and concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported.  On an unspecified date, the patient experienced stiffness, pain, and feeling unwell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable and action taken with adalimumab was not reported. The patient recovered from stiffness, pain, and feeling unwell. This report was non-serious. This case, involving the same patient is linked to 20220307647.
Headache & NauseaVomiting Narrative: out of work following second dose due to post vaccination side effects
BODY ACHES; BODY CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 22 year old male. The patient's weight was 180 pounds, and height was 182 centimeters. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 29-JUL-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021, the subject experienced body aches. On 30-JUL-2021, the subject experienced body chills. On 30-JUL-2021, the subject experienced headache. On 30-JUL-2021, the subject experienced fever. Laboratory data included Body temperature (NR: not provided) 100.7, and Heart rate (NR: not provided) 101bpm. Treatment medications (dates unspecified) included naproxen sodium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body chills on 30-JUL-2021, and had not recovered from body aches, headache, and fever. This report was non-serious.
Patient was given an injection of ZOSTAVAX into the (R) arm (upper). 24-48 hours later a 2.1cm x 1.8cm raised, erythemic area was noted at the location site of injection. Patient stated that it was warm, not painful, but itching.
Patient experienced tachycadia to 180s, back pain, dizziness within 1 hour of receiving vaccination
bump to L arm the swelling runs all the way from the upper arm all the way to the elbow, yesterday pt had some vaccines apply the vaccine apply on the L upper arm was the mcv, ibuprofen was given today in the morning and the medication help, but the arm continues to be swollen .Aunt feels a bump and its really hard and the arm feels really hot .
This spontaneous report was received from a certified medical assistant referring to an unspecified patients of unknown age and gender. The concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot #: L030865, expiration date on 07-JUN-2018 and lot #: L030867, expiration date on 09-JUN-2018 (route, dose and anatomical location were not reported). Concomitant therapies were not provided. The medical assistant reported that the doses of PEDVAXHIB lot #: L030865 with expiration date on 07-JUN-2018, underwent a temperature of 32F during 2 hours and 15 minutes and that the doses of PEDVAXHIB lot #: L030867 with expiration date on 09-JUN-2018 underwent a temperature of 30.7F during 20 hours. No adverse events were reported. No product quality issue was involved. This is one of several reports coming from the same source. Additional information has been requested.
Red, swollen, warm to touch, 7" x 3". Noticed 8/17/05 PM.
she tested positive to COVID-19; Drug ineffective; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 42-years-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on 09Mar2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient got tested positive for Sars-CoV-2 and the patient is scheduled to have second dose and is just completing her isolation. The patient's doctor has recommended her to wait 2 weeks before getting the second dose, but she also heard opposite recommendations. The outcome of the events was reported as unknown at the time of report.  No follow-up attempts are possible. No information about lot/batch number cannot be obtained.
red rash at injection area; red rash at injection area; This case was reported by a consumer via interactive digital media and described the occurrence of injection site rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site rash and injection site erythema. On an unknown date, the outcome of the injection site rash and injection site erythema were not recovered/not resolved.   It was unknown if the reporter considered the injection site rash and injection site erythema to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-OCT-2022 Reporter's Comment: This case was reported by a patient via (Shingrix GSK) interactive digital media. The patient received dose of Shingles vaccine and asked how long would he/she had red rash at injection area. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Patient started on 10 day course of bactrim for UTI on 5/3/21, got covid vaccine 4:30 pm 5/10/21, started to develop pruritic rash on torso 4:00 pm on 5/11/21 - 24 hours from vaccine, spread to face, upper/lower extremities, very itchy.  Seen in clinic today 5/13/21.  Instructed patient to stop bactrim, put on sulfa on her allergy list.  Due to timing of rash with covid vaccine, entering into VAERS.
pt recv vax;same day devel d & v;exp n & abd pain;lasted 1 mo;noted that pregnancy tests fr blood & urine were both neg;
strong headaches; fever around 99.8 - 100 degree F; This is a spontaneous report from a non-contactable consumer.  A female patient (reporter's wife) of an unspecified age receive BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 24Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that since Sunday morning, 24Jan2021, the patient has been suffering of strong headaches and fever. The patient experienced fever around 99.8 - 100 degree F and a very strong headache that cannot be controlled with medication. The outcome of the events was unknown. The events were reported as non-serious.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient was shopping in the store after receiving the vaccine and passed out. Patient's spouse lowered him to the ground. Upon arrival to the scene, patient was talking "saying i'm fine). I helped patient to sit up and eventually helped him to sit in a chair. Patient said he could taste the vaccine while receiving the shot and he told the immunizing technician about it. Patient left after 20 minutes without any treatment.
01/27/22 presents to ED for "SBO (small bowel obstruction)". PMHx of "breast cancer, HTN, HLD"
Patient reported immediately noticing a radiating pain down his arm and burning feeling (injection site feels hot). This pain has lasted since the date of the vaccination and has been particularly bothersome and painful at night time.
ACHALASIA; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was in perfect health prior to vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced achalasia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of achalasia was not reported. This report was non-serious. This case, from the same reporter is linked to 20230636371 and 20230636250.
Case number PHEH2014US004544 is an initial spontaneous report from a physician on  04 MAR 2014. This report refers to a patient under 18 years old who was inadvertently vaccinated with FLUCELVAX (batch number: unknown) on an unknown date. No adverse event was reported following the maladministration (inappropriate age at vaccine administration). Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 04 MAR 2014: The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indications as "adult product administered to child".
There has been no adverse event.  This was a vaccine administration error.  Patient's first vaccine was Pfizer.  Moderna was given as the second vaccine.  the error was caught when inputting into the vaccination system.  Patient has been called.  Patient is having no adverse reactions.  Patient will be monitored or asked to call clinic if adverse reactions are detected.
Wheezing within a few minutes of delivery, wheezing continues as of 9-28. Sore throat, nasal congestion, nausea, vomiting, sore joints and muscles, fatigue, fevers (intermittent 100.5 to 101.5). Chills, headache, cough, Heavy chest  to take a deep breath.
This 31 yo patient advised he has recurrent worsening of commonly reported side effects to Influenza vaccine. Between 2010-2014 each annual flu shot, IIV or mist, resulted in headaches, sensation of fever, body aches, stomachaches/nausea wo vomiting, which could last 1-3 days. Vaccines were typically given prior to a 4 day weekend so he would spend the weekend in bed and was back to normal self by day 4. Symptoms were worse with the nasal flu. However following 2015 flu shot he had a syncopal episode about 12 hours post vaccination. He had been there for several months, had no current illness, no exposures to chemicals/gas, has no PMH, has an allergy to avocadoes; no true seasonal allergy (if pollen high has issues otherwise okay) and is on no medications. He advised he received annual flu about 1600 hr, went and ate dinner (same items prior to and after vaccine has no reaction), about 3-4 hours after vaccination he began to experience a diffuse headache, body aches, stomach ache and feverish similar to past reactions, but faster in onset and severity. He went to bed believing these were expected side effects he had before with every flu shot. About 2-230am he left home walked about 100 feet to a port a john to urinate. While urinating, he advised his head was throbbing 10/10, his nausea worsened to point he knew he was going to vomit, felt dizzy and then recalls nothing - he passed out. He was found by buddies about 3am outside of toilet against a barrier wall support, pants unzipped, no visible injuries from falling out of toilet. He had to be shaken for him to arouse. He was taken to medical center where he reported a severe headache and flu like symptoms. He was treated with ZOFRAN which relieved nausea within 5 minutes; however when he sat up to drink water as he was thirsty, he again wanted to pass out feeling lightheadedness/nauseated which resolved lying down. Providers then treated with PHENERGAN and 1 liter of D5NS. Medical records document BS of 69, BP 93-67 unknown heart rate, but BP reported as normal after 1 lither of fluid. CBC, CMP, UA, EKG all normal. He has not had any similar reaction since. He does admit to head injuries in past causing him to be dizzy, but nothing like this has ever happened. He questions relationship/allergy to flu vaccine. Vaccine site had no reported reaction.
Arm pain radiating to fingers at times;progressing to decreased range of motion of arm. pain at times brings pt to knees and wakes her up.
There was a very small amount of leakage from the injection site.; This is a spontaneous report from a contactable Pharmacist. A 18-year old female patient received BNT162b2 (COMIRNATY, Formulation: solution for injection, Batch/lot number: not reported, Expiry date: Not reported), via an unspecified route of administration as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient had no known allergies. Reporter stated that patient took her first dose of vaccine and was waited for 15 minutes and came back to pharmacist and showed that there was a very small amount of leakage from the injection site. The outcome of the event was unknown.  Follow up attempts are completed. No further information is expected.
Real sick; Upset stomach; Didn't feel well; Fever; Chills; Headache; Felt like the patient had COVID again; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Dec-2021 and was forwarded to Moderna on 10-Dec-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (Real sick), ABDOMINAL DISCOMFORT (Upset stomach), MALAISE (Didn't feel well), PYREXIA (Fever) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced ILLNESS (Real sick), ABDOMINAL DISCOMFORT (Upset stomach), MALAISE (Didn't feel well), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and SUSPECTED COVID-19 (Felt like the patient had COVID again). At the time of the report, ILLNESS (Real sick), ABDOMINAL DISCOMFORT (Upset stomach), MALAISE (Didn't feel well), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and SUSPECTED COVID-19 (Felt like the patient had COVID again) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. The patient decided not to get the second shot of the vaccine due to the adverse reactions.  The reporter asked if the patient had to take the second dose as of now, then how would it work, whether the patient would be getting the second or booster dose or not.  Company Comment: This case concerns a male patient of unknown age with a history of COVID-19 in November 2020 who experienced the unexpected adverse event of special interest of suspected COVID-19 which occurred on an unknown date relative to vaccination with mRNA-1273 vaccine. The medical history of COVID-19 remains a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed as per Regulatory Authority reporting.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 10-Dec-2021: Significant Follow up : reporter email address updated, reporter occupation updated and new event of missed dose was added; Sender's Comments: This case concerns a male patient of unknown age with a history of COVID-19 in November 2020 who experienced the unexpected adverse event of special interest of suspected COVID-19 which occurred on an unknown date relative to vaccination with mRNA-1273 vaccine. The medical history of COVID-19 remains a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed as per Regulatory Authority reporting.
Initial information received on 25-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a five years old female patient who received QUADRACEL (lot C5325BA and Exp. Date 14-Nov-2019) as her fourth IPOL dose and in addition got a separate vaccination of IPOL (lot N1K931M and Exp. Date 18-Nov-2019)via unknown route in the right deltoid on 23-Jan-2019. Patient also received IPOL previously on 28 Feb 2014, 28 April 2014 and on 28 Jul 2015. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE for Immunisation; and MMR for Immunisation. It was an actual medication error case due extra dose administered. It was reported that that a patient received QUADRACEL on 23Jan2019 which was her fourth IPOL dose. In addition she got a separate vaccination of IPOL making that her fifth dose. It was unknown whether the patient had any adverse reactions. 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 and Module VI of the 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. List of documents held by sender: none.