chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe pain on March 9, 2011; foul taste in mouth. Visited ER 3 times over 3 days. Admitted to hospital March 13, 2011 with loss of sensation from head to calves, severe facial paralysis, blurred vision inability to walk without support. Diagnosed with Guillain Barre Syndrome & treated with 5 day course of IVIG. Still recovering 1 year later - continue to have facial paralysis.
she is dying; She got sarcoidosis all over her body; sarcoidosis all in her lungs; She got sarcoidosis on her heart; D-dimer went to the roofs/My D-dimer went to 980. So did my wife's; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEAR DEATH EXPERIENCE (medically significant), outcome "unknown", described as "she is dying"; SARCOIDOSIS (medically significant), outcome "unknown", described as "She got sarcoidosis all over her body"; PULMONARY SARCOIDOSIS (medically significant), outcome "unknown", described as "sarcoidosis all in her lungs"; CARDIAC SARCOIDOSIS (medically significant), outcome "unknown", described as "She got sarcoidosis on her heart"; FIBRIN D DIMER INCREASED (medically significant), outcome "unknown", described as "D-dimer went to the roofs/My D-dimer went to 980. So did my wife's". The patient underwent the following laboratory tests and procedures: Fibrin D dimer: 980, notes: D-dimer went to the roofs. Clinical course: Reporter stated, his wife was dying because of Pfizer Vaccine (Pfizer COVID-19 Vaccine), her D-dimer went to the roofs, his wife had sarcoidosis all in her lungs, it was on her heart, in her kidneys it was all the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300250154 same reporter/ drug, different patient/ events;
Approximately 7 hours after receiving vaccine, patient developed flu-like symptoms of body aching, fatigue and low grade fever for 2 days.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown ages and genders. The patients' medical history was not reported. On unknown dates the patients were vaccinated with improperly stored doses of MMR II albumin status rHA (route and dosage unknown; lot # M004899, EXP 27-JAN-2018). No adverse event was reported. This is one of several reports from the same reporter. Additional information has been requested.
The day after I received my vaccine, I had extreme fatigue, chills, body aches, and felt feverish. I also had severely painful swollen axillary lymph nodes on the same side that I received my injection. I was not able to work or do any of my daily activities for almost three days. Then on day 7 after receiving my first vaccine dose, I developed a itchy, painful, red rash and hives surrounding the injection site (about a two to three inch radius around the injection site. I also got hives and red itchy painful skin on my face. I went to an urgent care and was prescribed prednisone and a week of pepside and zyrtec. After a week I stopped taking the allergy meds and then the hives came back, so I kept taking the allergy meds until my second vaccine dose.
Information has been received from a nurse concerning a female patient (age not reported) who in March 2007 "within the last several weeks," was vaccinated with Gardasil. Concomitant medication was not reported. Subsequently in March "within the last several weeks", the patient experienced shortness of breath after receiving Gardasil. The patient was sent to the emergency room, however it was unknown if the patient was admitted to the hospital. The outcome and causality of the event was not reported. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 4/13/2007. Additional information is not expected.
Fever, chills, body aches, headache, sore arm, lasted about 2 days.
Information has been received from a physician and an office manager concerning an 8 year old female patient who on 15-AUG-2007 or 16-AUG-2007 was vaccinated with a dose of Zostavax (Oka/Merck) (Lot#656394/0162U) instead of Varivax (Oka/Merck) (MSD).  No adverse symptoms were noted.  No further information was provided.  There was no product quality complaint involved.  The patient's twin sister had a similar experience.  (WAES#0708USA04533)  This is one of several reports from the same source. Additional information is not expected.
her arm started feeling funny and she checked it and it was red; itchy; This is a spontaneous report from a contactable consumer (patient) reporting for herself.  A 94-year-old female patient (94 years age at vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9267; Expiration Date: 31May2021), via an unspecified route of administration in right arm on 20Feb2021 (Saturday) at 09:30 as single dose for COVID-19 immunisation. The patient did not have any other prior vaccinations (within 4 weeks) except the COVID-19 vaccine first dose. The patient had been vaccinated with his first dose of COVID-19 vaccine (Batch/Lot Number: EL3248; Expiration Date: 30Apr2021), via an unspecified route of administration in right arm on 30Jan2021. The first shot was fine. She got a little reaction. Other medical history included ongoing blood pressure and cholesterol level (unspecified -high/low) abnormality. The patient's concomitant medications included unspecified cholesterol and a blood pressure medication since unspecified years. She had been on cholesterol medication unspecified years ago and it kept her study. She was on both blood pressure and cholesterol medications when she got the vaccine. She had been visiting the doctor once a year. Two days after vaccination (on 22Feb2021, Monday), the patient experienced her arm started feeling funny and she checked it and it was red. At the time of report, the redness was getting bigger all the time. It was itchy and red. The outcome of events was not recovered.
Due to traveling with family that were diagnosed with COVID, she had a COVID test completed that was positive and she received monoclonal antibodies.  She had minor respiratory symptoms including a three day nonproductive cough.  No fevers or chills.
Injection site turned red with hive. 1/2 tsp. Benadryl given po. Pt waited 20 minutes and hive was gone.
Severe side effects began at midnight (after the 2nd dose was received at 3:45 in the afternoon) that included headache,  fever, chills, fatigue, nausea, joint pain, and muscle  pain  that lasted over 6 hours. Phoned triage nurse who set me up with an alternating regimen of  ibuprofen and acetaminophen.   Muscle & joint pain subsided quickly.   Fever & chills  left were next to go .  Headache, fatigue  & nausea stuck around until the afternoon (almost 24 hours after the vaccination) .
This spontaneous report was received from a healthcare worker and refers to approximately 60 year old male patient. No pertinent medical history or concurrent conditions were reported. On an unknown date, the patient was vaccinated with M-M-R II. Concomitant medications were not known. Antibody titre's were drawn and it was found that the patient failed to seroconvert (seroconversion test negative). Patient sought medical attention. Outcome of the event was unknown. Causality assessment was not provided. Additional information is not expected as the reporter did not wish to be contacted further.
Two weeks after 2nd Pfizer shot I cut my finger and had a hard time controlling the bleeding. I arranged to get a blood test to measure my platelets and I had dropped 50% from the previous test a month before. (From 444 to 200). I have another appointment on 05/10/2021 to test my platelet levels again. This is very unusual for me because I take medication to lower my platelet numbers since I make too many.
Info has been received from a health professional concerning a 59 year old "frail" female who on an unspecified date was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Subsequently, the pt developed a sterile abscess at the injection site. It is unknown if medical attention was sought or if intervention was required. Additional info has been requested.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 2:18 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 2:18 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 26.32 for dose administered on 15-APR-2021.  No concomitant medications were reported.  Batch number 044B21A underwent temperature excursion 15-APR-2021 with temperature 34 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 06-APR-2021 and beyond use date for the vial was reported 09-MAY-2021. Product moved to clinic 15-APR-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.
Coughing; severe muscle pain; Severe Joint pain; This spontaneous case was reported by a patient and describes the occurrence of COUGH (Coughing), MYALGIA (severe muscle pain) and ARTHRALGIA (Severe Joint pain) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis and Parkinson's disease.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced COUGH (Coughing), MYALGIA (severe muscle pain) and ARTHRALGIA (Severe Joint pain). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at a dose of 1 dosage form. At the time of the report, COUGH (Coughing), MYALGIA (severe muscle pain) and ARTHRALGIA (Severe Joint pain) outcome was unknown.            On 01-AUG-2021 patient received a negative result for lime disease also he had experienced two cerebral aneurisms and post traumatic stress disorder. No concomitant information were reported by the reporter
Severe all over pain in joints and muscles. Severe diarrhea. Overall tiredness.
patient received 4th booster dose with Moderna vaccine which he should have received Bivalent vaccine for booster dose.
This spontaneous report received from a patient concerned a 39 year old female. 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: 043A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the subject experienced thrown up. On 09-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.9 F. On 12-APR-2021, Laboratory data included: Body temperature (NR: not provided) 100.9 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, thrown up and fever was not reported. This report was non-serious.
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; SORE ARM; This spontaneous report received from a patient concerned a 61 year old female of an unspecified race and ethnicity. The patient's weight was 265 pounds, and height was 69 inches. The patient's concurrent conditions included seasonal allergies, non-smoker, and non-alcoholic, and other pre-existing medical conditions included no drug abuse or illicit drug usage. The patient was not pregnant at time of report. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: 25-MAY-2021) dose was not reported, 1 total administered on 06-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 06-MAR-2021, the patient experienced sore arm.  On an unspecified date patient underwent through laboratory test included: Antibody test revealed negative (suspected immunological vaccine failure) was reported. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 08-MAR-2021, and the outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210637750. This report was associated with product quality complaint: 90000183360.; Sender's Comments: V0 ; 20210637986- COVID-19 VACCINE AD26.COV2.S-SUSPECTED IMMUNOLOGICAL VACCINE FAILURE . This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
My temperature started to rise rapidly. I could feel my heart racing and noticed that my skin appeared to be breaking out in a heat rash; looked like a severe sunburn that came on suddenly on my face neck and arms. My stomach and back had red splotchy areas.
patient received vaccine that was compromised due to the temperature excursion, No AE; Initial information received on 20-Nov-2019 regarding an unsolicited valid non-serious case received from other health care professional.  This case is linked with case 2019SA291040 (same reporter).  This case involves a 26 months old female patient who received a dose of vaccine IPV (VERO) [IPOL] (lot P1E701M and expiry date 09-Nov-2020) via unknown route in the left thigh on 13-Sep-2019, which was compromised in the temperature excursion, vial was opened at the time of the temperature excursion.  Medical history and concomitant medication were not provided.  It was a case of actual medication error due to incorrect product storage.   At the time of reporting, 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.
HERPES INFECTION; This spontaneous report received from a consumer concerned a 71 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no significant medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982 expiry: 23-JUN-2021) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAY-2021, the subject experienced herpes infection. On 02-JUN-2021, treatment medications included: valaciclovir hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from herpes infection. This report was non-serious. This case, from the same reporter is linked to 20210612299.
Client to health center today for first dose of COVID.  Nurse mistakenly administered Pfizer 5-11 dose and patient is 4 years old.  Error was not noticed until patient and family had left center.  Nurse contacted Pfizer and was advised to inform the recipient, complete adverse event form, and to not repeat dose.  Nurse contacted Pfizer a second time for further counsel of dosing due to child's age and incorrect dose received and advised to wait three weeks and then administer one dose of Pfizer 6mos-4years and return 8 weeks following dose for second dose of appropriate age.  Nurse contacted patient's father, and advised of medication error.  Father states that patient is doing well with no adverse symptoms at this time.  Nurse informed patient's father of instruction received from Pfizer.  Patient's father wants to speak to spouse and will contact the Agency or Health Center for future appointment if desired.  Patient's father was understanding of information with no concerns at this time.
It was reported, "A physician reported that a 2 month old male pt received his 1st dose of Rota Shield, as well as, DTAP, Hib, IPV and Hep-B vaccines on 6/4/99. Three days later, the infant developed recurrent episodes of fever every 4 hours; his temperature went as high as 102F." It was reported that the pt recovered from this experience. From follow up #1 correspondence received on 05/25/01, it was reported, "No further information at this time". -(05/19/01). This case is closed
Initial report received on 31 January 2013 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a nine-month-old male subject (initial not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; dose 1 received on 03 February 2012 (lot number not reported), dose 2 received on 04 April 2012 (lot number C4156AB) and dose 3 received on 14 June 2012 lot number C4277AC (routes and site of administration not reported). The subject developed cold-like symptoms and a cough on 26 September 2012, approximately three months after the last dose. On 27 September 2012, the subject developed a paroxysmal cough with a whoop. Laboratory testing included negative PCR on 28 September 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 28 September 2012 for five days. The subject was not hospitalized. At the time of final contact on 12 October 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 16 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
36 y/o patient EDC 16Nov2018 was seen for routine OB appointment the day of her immunizations. At that time her only concern was anxiety. The week before she had been prescribed ZOLOFT for this but had not started taking it. She was also offered counseling. The week before her fetus was breech. At this appointment, the fetus was noted to now be in cephalic presentation, a visually adequate appearing amount of amniotic fluid was present, and movements observed. The day following immunization, Oct 6th, she presented for evaluation due to no longer feeling fetal movement. An intrauterine fetal demise was subsequently diagnosed.
per mother, couldn't see for about 5 minutes and felt nauseous    went away on own
Patient was seen on 4/4/17. She received BEXSERO 1st dose and also was put on BACTRIM for abscess. Noticed blotchy rashes on Rt. upper arm on Friday 4/7/17. Has one large circular erythematous lesion 1.5 x 1.5 cm with central induration seen on Rt. forearm. No other rashes in the body.
At first I got Hepatitis B shot in the left arm, and as soon as I received the Tdap on the same arm I felt pain. I mean Just Tdap was painful when the needle went into the arm. Itching and skin rash and red skin both in the place of injection and other body parts like on the ankles and wrists. I also had pain in heart and bruise on the injection location. Followed by headache and feeling cold in whole body and chill. Extreme fatigue. After one week I went to see my doctor. She prescribed DiphenHydramine capsule 25 mg every 8 hours one capsule. After 3 days just itch is getting better but still I have some itching and headache.
Patient received the flu shot at our pharmacy. The day after administration, the patient stated she had swelling, redness, and a lump under her skin at the injection site. This lasted for several days and then went away.
Fever, headache, chills, feeling worn down, tiredness, dizziness. Took Tylenol and slept and felt better within 14 hours.
The day of the vaccination 5 hours after receiving the vaccine I started to get bruises the size of my hand on my left leg then I kept getting more on the upper part in the leg and in the buttock I take photos to have the record then I started to feel dizzy that I couldn't walk and I was going to faint, I had to call the rescue to come to my house because I felt very bad I could not move then I went to the emergency room to the hospital with the same symptoms I couldn't move it seemed that if I get up I was going to faint, I was under observation the bruises did not continue to appear, but I have been left with nervous tic symptoms in the left eye and in the left arm I have involuntary reflexes in the muscles of the left arm
Vaccine administration on 1-28-12. 12 noon at Pharmacy at 9 PM I felt a sharp pain to my lower Rt side of head. Same at 9:15. On Sunday, sharp pain became horrific pain to same area of my head. It was constant all day long. Horrific pain lasted from 6 AM to 10 PM on Sunday. On Monday it was gone.
Driving home after waiting period, shaking uncontrollable until arriving at destination. Patient was shaking for over an hour but less than an hour and a half, after felt lethargic/cold. Hard time thinking and felt ill. Headache and pain in head.
Rash at injection site with tingling/numbness/burning that turned into onset of shingles.
Headache - treated with Tylenol  Severe ringing in ears  - Motrin, chewing gum, drinking water