chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 53 year old male. Initial information was processed along with the additional information received on 28-JUL-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180525 expiry: UNKNOWN) dose was not reported, 1 total administered to right arm on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 16-APR-2021, the patient experienced COVID-19 which was suspected vaccination failure and suspected covid-19 infection. On 26-JUL-2021 the patient experienced tickle in his throat. On 27-JUL-2021 the patient experienced cold like symptoms (no fever or tiredness), cough, raspy voice and stuffy nose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a Product Quality Complaint: 90000187393.; Sender's Comments: V0: 20210757719-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS
Within 2 days of 2 month immunizations, baby developed poor sucking resulting in decreased intake of fluids and subsequent dehydration. He was hospitalized and treated with IV fluids. At that time, the episode was thought to be of viral etiology but had similar response after 4 month vaccines, not requiring treatment.
NIGHT PHARMACIST WAS CALLED AT APPROXIMATELY 9:04PM BY PATIENT STATING "SEVERE NUMBNESS, FINGERS WERE BLACK AND PURPLE AND SWOLLEN".  Pharmacist advised patient to go to ER to seek medical attention right away and to call pharmacy at their earliest convenience.  Pharmacist left message for patient 6/19/21 as follow up, patient did not call back. At time of this report, have not heard from patient.
Heart rate range from 178-200 all night.  Ended up in ER.  Referral to cardiologist.
Strep throat; she went to emergency, had a swollen lymph node "right glands, throat/Very swollen glands; This is a spontaneous report from a contactable consumer. A 59-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 27Apr2021 (Batch/Lot Number: EW0171) as DOSE 1, SINGLE (at the age of 59 years) for covid-19 immunisation. Medical history included blood pressure, bipolar disorder and anxiety, all from an unknown date and unknown if ongoing. Concomitant medications included aripiprazole (ABILIFY); lamotrigine (LAMOTRIGINE); amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); benazepril (BENAZEPRIL); temazepam (TEMAZEPAM); diphenhydramine hydrochloride (BENADRYL); nifedipine (NIFEDIPINE); magnesium (MAGNESIUM), all taken for an unspecified indication, start and stop date were not reported.   The patient went to emergency, had a swollen lymph node "right glands, throat/very swollen glands on 07May2021 and strep throat on 16May2021 with outcome of unknown. It was further stated that when the patienr was about to get the second dose of the vaccine she stated that started experiencing the side effect on 07May2021, and it was on 08May2021 that she went to emergency, had a swollen lymph node "right glands, throat", her first COVID test was negative and she is waiting for the result of the second COVID test. She had her tooth pulled, it was the pain in her chin and her jaw and she was diagnosed with strep throat on 16May2021. Patient ended up getting results of an a strep throat and a very very swollen glands. Therapeutic measures were taken as a result of the events. Treatment included  Amoxicillin that did not work. Dosage for Amoxicillin was 500mg, 3 times a day for 7 days. Then next one she tried was Clindamycin 200mg, 4 times a day. She didn't feel better when she took, I've been on I've been on this since last Friday and she didn't start feeling better till yesterday. The patient underwent lab tests and procedures which included pap smear gynecological test with unknown result.   Follow-up attempts are completed. No further information is expected. Information about batch/lot number already obtained.
Patient received Moderna COVID vaccine on 4/2/21 (lot 026B21A) and 4/30/21 (lot 017C21A), and Pfizer COVID vaccine on 12/27/21 (lot 33026BD). On 1/4/22, patient was tested positive for COVID and admitted to our facility for neutropenic fever (after recent administration of R-CHOP for diffuse large B-cell lymphoma), sepsis, and COVID-19 infection.  Patient has infiltrates on her chest x-ray though it may be bacterial pneumonia in the setting of neutropenia. As of today (1/5/22), patient is still admitted in our med/surg unit.
INJECTION SITE, HEADACHE TIRED, CHILLS,FEVER,NAUSES,MODERATE COUGH
Pt received vaccine 2/27/16. Pt called 3/1/17 the injection site looked red and was itchy. BENADRYL was recommended. Follow up on 3/6/17. Pt was doing better.
I got the vaccine and chills, fever, nausea, diarrhea and dizziness. I was kind of our of breath and fatigue, I wasn't able to life anything and constantly out of breathe. It was hard for me to do anything, I had to rest all the time and take off of work. I was driving to work and had to keep pulling over because I felt dizzy. I ended up going to the Dr. and had test ran and they said I was extremely dehydrated and I didn't understand because I drink a lot of water. they hooked me up an IV and gave me fluids. They said I was Healthy just extremely dehydrated it.  My injection site was kind of tender but nothing more. I'm still having issues. I'm just always thirsty no matter how much water I drink.
12/19. 7th day hx of left arm rash, redness, swelling and pain.
Patient developed swelling on bottom right side of lip with a small blister located in the middle of it. Pt got vaccine on Monday and started with lip swelling on Wednesday
Patient describing pain in arm where flu injection was given. Pain started 3 hours after injection. Minor improvement seen over a period of 2 weeks but still complaining of pain. The pain is up and down arm.
I got really sick with the Moderna; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (I got really sick with the Moderna) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Iron deficiency. Concomitant products included IRON for Iron deficiency, FISH OIL for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (I got really sick with the Moderna). At the time of the report, ILLNESS (I got really sick with the Moderna) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient's ethnicity was reported as white.  Patient got Pfizer booster instead of Moderna because she got really sick with the Moderna.  No treatment medications were reported.
Got 3rd moderna vaccine on 10/30/21 around 4pm.  Had headache, body aches, chills, sore arm at injection site most of the night. I got up to pump around 5am (I have a 5mo daughter) and while pumping I stared to feel nauseous, walked to the bathroom to vomit, tunnel vision started and I passed out. Unsure how long unconscious. Woke up with numbness in arms, face which did not improve with lying down and feet propped up. Called paramedics? vital signs were WNL, EKG showed right bundle branch block, numbness decreased so I told paramedics I would take myself to the ER. Arrived at ER around 6:30am; had urine/blood work, chest X-ray, another EKG. Per ER doctor, all is normal. No treatment, was discharged around 8:45am
He woke up at midnight throwing up and having chills. He went back to bed and ate breakfast in the morning. At 9:30 am he threw up again.  Claimed he hurt all over. Has a fever of 101.8 and his cheeks are red and flush. He has no energy, tried to get up and ended up laying on the ground. His lower lip is red and swollen. His tounge he said feels normal.
From the very day after after receiving my JNJ/Janssen Covid-19 vaccine I have had persistent and worsening tinnitus, primarily in my left ear. It is present 24/7 and has been constant since vaccination. Saw an Otolaryngologist and mechanical brain/inner ear issues were ruled out via use of MRI.
Muscle aches, headache, fever (up to 100.8), nausea, vomiting, chills, and fatigue.  Lasted 48 hours.  Called physician, who prescribed Promethazine to control symptoms.  Tylenol, also recommended by physician, was used to address symptoms.
extreme fatigue, muscle weakness, dizziness, possible visual blurring, intermittant fever,
Patient called the next day complaining of a high 3 inch in diameter knot on her arm at the site of injection, low grade fever, joint pain in her knees and elbows. I spoke with her later that evening and she said she still had all of those symptoms. She said she had called her primary care Doctor and she said to take some Ibuprofen and she should be fine, it was normal in her opinion.
Information has been received from a female consumer and registered nurse who on 23-OCT-2006 was cut by a vial of Recombivax HB (lot # 653391/0186F). It was reported that two doses of the vaccine 0.5 ml were broken when received. While trying to clean up the broken vials the nurse cut her finger. She described it as a minor poke. There was no additional information regarding the extent of severity of the cut. The patients outcome was not reported. Medical attention was sought. There was a product quality complaint involved. Additional information has been requested.
SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no problems from injection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 19-MAY-2021 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On MAY-2022, the patient experienced suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection. This report was non-serious. This report was associated with a product quality complaint: 90000262391.
Bacterial infection of smallpox vaccination site: low grade fever, axillary lymphadenopathy, pain and cellulitis of arm, foul-smelling drainage at vaccination site after vaccination scab came off. All per patient report. Treated with cephalexin 1000 mg BID beginning 3/15/03. Patient has history of frequent infections at different sites in past two years (reported after this event occurred).
Beginning at 6:30 am on 1/8, two days following vaccination, the individual was driving to work and began to experience nausea while at a traffic light. He pulled over and threw up. Once he got to work he vomited again. He drove to another facility for work and then threw up 3 or 4 more times. He began experiencing hot flashes at this time. He went to the hospital and was seen in the emergency room. He threw up several more times in the ER and stated that his heart was racing and that he had diarrhea. The emergency room gave him medications for the nausea and he stayed there for 2 or 3 hours. He began to feel better and was discharged to home.
He just stopped being normal. no fever, but reverted to a baby, not walking normal, always falling down, very clumbsy. stopped all speech.
very uncomfortable; severe constipation; rash around illness area in her vagina and anal area; This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (severe constipation), VULVOVAGINAL RASH (rash around illness area in her vagina and anal area) and MALAISE (very uncomfortable) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D30L2DA-030L20A not sure) for COVID-19 vaccination.     Concurrent medical conditions included Lichen sclerosus and Blood pressure (Takes "12mg blood pressure pills"). Concomitant products included DENOSUMAB (PROLIA), ESTRADIOL, CALCIUM CARBONATE (CALCIUM AL) and VITAMINS NOS for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced CONSTIPATION (severe constipation) and VULVOVAGINAL RASH (rash around illness area in her vagina and anal area). On an unknown date, the patient experienced MALAISE (very uncomfortable). The patient was treated with PLANTAGO OVATA (METAMUCIL CITRON) for Constipation, at an unspecified dose and frequency. At the time of the report, CONSTIPATION (severe constipation), VULVOVAGINAL RASH (rash around illness area in her vagina and anal area) and MALAISE (very uncomfortable) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment of these events included steroid cream, Hot water.
Received vaccine on 4/9/21 and had arm pain for 24-48 hours.  This morning 4/30/21 started having severe arm pain in left arm constant dull ache and stabbing sensations severe that comes and goes.  No redness or swelling today at the site.   Reports received first dose on 3/10/21 and 5 days later had bruise for 2 weeks. Spoke with Dr and advised to follow up with PCP.
Patient fully vaccinated and boosted with Moderna 12/30/20, 1/27/21, and 10/19/21. Patient admitted to the hospital for hypoxia on 10/22/21. CTA chest was negative for PE. Patient was admitted for workup of early acute CHF exacerbation and monitoring of hypoxia. Patient was discharged on 10/24/21.
Caller stated that she received her first vaccine on 04/12/2021 and developed a headache and fever of 101.1. Denies other symptoms.
On 2/28 I developed an itchy rash, redness, hot to the touch with a lump under the skin.
tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from product quality group, Program ID. The reporter is the patient.  A 60-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Oct2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 59 years for COVID-19 immunization; BNT162b2 (BNT162B2), on 20May2021 as dose 1, single (Lot number: EW0169), on 10Jun2021 as dose 2, single (Lot number: ER8731) and on 10Dec2021 as dose 3 (booster), single (Lot number: 330308D) for COVID-19 immunization. The patient's relevant medical history included: "COVID-19", start date: Feb2021 (unspecified if ongoing), notes: patient, his wife, and one of his twin boys; "monoclonal antibody infusion", start date: 2021, stop date: 2021. The family, (patient, his wife, and one of his twin boys) all got COVID-19 at the same time in Feb2021. Patient and his wife had the monoclonal antibody infusion. They had to wait 90 days before receiving a COVID-19 Vaccine. Patient clarified that when they had COVID-19 in Feb2021, none of them had received any COVID-19 Vaccines yet, it was prior to being vaccinated. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Dec2022, outcome "unknown" and all described as "tested positive for COVID-19". The patient and his wife both just got over COVID-19. Both tested positive for COVID-19, he thought on 29Dec2022. The patient underwent the following laboratory tests and procedures: COVID-19: (29Dec2022) Positive; (08Jan2023) Positive, notes: around 1pm. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received PAXLOVID from 29Dec2022 to 02Jan2023 as treatment for COVID-19.
First night, I had terrible anxiety, could not fall asleep and had heart palpitations, I have heart disease. Called my PCP right away. Then the anxiety went away still felt really tired and could not do anything. Heart palpitations got worse and got shingles within one week after on the same side of injection. Hurt under my arm and side. Pain, fever and sensitive skin, I do not get blisters. Next went see cardiologist and he put heart monitor for 2 weeks. There was changes but could not confirm if it was caused by the vaccine. Still have muscle aches and have now recovered from heart issue but still really tired. Saw cardiologist on 09/03/2021 and then on 11/12/2021.
None reported by mother on 10/9/2009 at 2:30 PM.
Vaccines were given 8/28/14 at 10:17AM. Mom reported 3 min seizure occurring at about 12:10 PM. Mom took pt to ER.
I had trouble with my left knee and I went to see an Orthopedic Doctor to see why. I was told it was the IT band and PT was recommended to stretch the IT band area.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 22-SEP-2015, the patient was vaccinated with an improperly stored doses of ROTATEQ lot # L008053 with expiration date on 30-NOV-2016, oral, (dose was not provided) and RECOMBIVAX HB (dose, route, lot # and expiration date were not provided). The vaccines were exposed to temperature excursion of 34F during that month. No symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.
COVID-19 Vaccine EUA; Side effects began less than 15 minutes following vaccine injection, lasted for approximately one hour, and occurred sequentially; Within the first hour: Nerve pain down to fingers on right arm :Nerve pain down to toes on right leg: Stabbing pain on bottom of right foot: Cold and achy back of neck and crick in the neck: Lips swelled: Off and on headache: Nausea: Slightly blurred vision: Dizzy: Loopy: Off balance: Tight throat After 2:00am on 04/23/2021: Body aches and chills until around 2:00pm 04/24/2021
Mother phone clinic 4 days after vaccinations given stating babe was sleepy, eating well however. Instructed to watch and follow-up if no change 1-2 days. Returned to clinic at 6 days - sent for lab work. Was evaluated later that night in emergency department. Returned to clinic 7 day and referred to Primary children's medical center.
Within hours of first dose, low grade headache that never went away. 2 1/2 weeks after first injection a severe migraine headache that lasted 24 hours. I rarely have regular headaches. And never had a migraine headache in my life. Headaches continued. 2nd Dose within hours severe headache and fever of 100 + degrees, chills aches & pains. Daily headaches continued. 2 1/2 weeks after 2nd dose, another severe migraine lasting 24 hours.  Headaches & intermittent incapacitating migraines have continued to present. Loss of appetite and nausea from pain has resulted in a loss of 5 pounds from 115 to 105 in last 3 weeks.
Site: Pain at Injection Site-Mild, Systemic: PAIN DOWN ADMINISTRATION ARM-Mild, Systemic: Lymph Node Swelling-Mild, Additional Details: Pt reported lymph node under armpit started swelling starting about 4 days after date of administration and continued til her 2nd dose was due 21 days later. She reported the symptoms as mild, not requiring medical treatment.
none , pt. was scheduled to received her 2nd dose (primary series) of covid Moderna Vaccine instead  pt received a bivalent Covid Moderna
patient waited 30minutes post vaccination. Then left and came back approx. 10 minutes later, patient came back due to having right side of face, neck, and tongue numbness and tightness. No chest pain, No Shortness of breath. 1825 she did report to staff she had difficulty swallowing. Patient was given Benadryl at 1853, 1930, 2004.  vitals were monitored during this time also.
Fever, chills, really bad headache. Took  200 mg of Acetaminophen at 9:AM  (after 8 hours), and slept all day. Felt fine  when I woke up. around dinner time.
PM - after removing band-aid noticed some swelling by A.M. swollen, red, warm to touch. Saw provider antibiotic prescribed - to take it necessary also had fever and achy.
Induration that caused the flesh to be firm from the skin surface to the bone (femur) and erythematous in an area 1.5cm X 2cm (at Prevnar injection site).
get shingles of the eye; This case was reported by a consumer via interactive digital media and described the occurrence of ophthalmic herpes zoster in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 3 months after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the ophthalmic herpes zoster was unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient reported that he/she got shingles of eye 3 months after his/her 2nd dose of Shingrix. The patient asked that what he/she did the wrong. The follow-up could not be possible as no contact details were available.
Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose).    No concomitant product reported by reporter.  It was reported that 100 patients were administered an invalid dose of Moderna COVID-19 bivalent booster. The nurse had no standing order other than what they had for second booster, when administering bivalent boosters, so they assumed same dose as second booster and administered 0.25mL to uncompromised adults.  This case was for one of the patient among the 100 patients who were administered an invalid dose of Moderna COVID-19 bivalent booster.   It was reported that CDC had recommended to revaccinate the patients with full dose of 0.5mL.  No treatment medication reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-646512 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-646512:Master case
Red, hot to the touch on upper left arm, fever, extremely fatigued & headache.