chrisvoncsefalvay/vaers-outcomes huggingface dataset:
two weeks after first dose, right hand developed rheumatoid arthritis; very, very severe reaction; This spontaneous case was reported by a patient and describes the occurrence of RHEUMATOID ARTHRITIS (two weeks after first dose, right hand developed rheumatoid arthritis) in a 101-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced RHEUMATOID ARTHRITIS (two weeks after first dose, right hand developed rheumatoid arthritis) (seriousness criterion medically significant) and VACCINATION COMPLICATION (very, very severe reaction). At the time of the report, RHEUMATOID ARTHRITIS (two weeks after first dose, right hand developed rheumatoid arthritis) and VACCINATION COMPLICATION (very, very severe reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products were not provided. Treatment medication were not reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-297622 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient presented to pharmacy 4 days after receiving ZOSTAVAX immunization with complaint of warmth. Upon exam, the injection site looked rather red and felt warm to the touch. Discovering pharmacist immediately contacted PCP and informed them of the reaction. PCP stated to take TYLENOL, monitor the site/keep it clean and come in if symptoms do not appear to resolve. Patient was advised by pharmacist accordingly.
This was an IVF pregnancy.  My 2nd pregnancy.  I got my first positive pregnancy test on Jan. 27th at exactly 4 weeks pregnant.  I received my first vaccine  at 4 weeks 4 days.  I then went in for my first ultrasound at 6 weeks 5 days.  The doctor told me the baby wasn?t developed normally and a miscarriage had already started.  I believe the gestational sac measured about 5 weeks 3 days.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Onset on same day as vaccination.  Entire riht side of body affected.  Hip, arm, shoulder, neck, ears are all bothered.
Initial case was retrieved from the scientific literature on 22 March 2011. The article reported a case of anaphylactic reaction in a child. An unidentified child, with a milk-allergy, received an injection (route and site not reported) of DTAP, manufacturer and lot number not reported. The patient developed an anaphylactic reaction to DTAP. The outcome was not reported. Documents held by sender: None.
Tested positive for COVID and was symptomatic.  I was able to confirm the person was NOT hospitalized.; Tested positive for COVID and was symptomatic.  I was able to confirm the person was NOT hospitalized.; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). An elderly nonpregnant 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 an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to the vaccination. On an unknown date in Aug2021, the patient was tested positive for covid and was symptomatic. It was confirmed that the patient was not hospitalized due to the event. On an unknown date in Aug2021, the patient had lab test to Sars-cov-2 infection and results were positive with symptomatic symptoms. It was unknown if the patient was treated for the event. The outcome of the event was reported as recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Redness and swelling on both arms one day after flu shot.  Treated with Benadryl, soluMedrol, Pepcid.
On November 2nd I started getting a headache in the back of my head, it was dull and I didn't think much of it.  On November 3rd my hand was a bit tingly but assumed it was nerve damage.  On November 5th, after a workout, I got a terrible headache that was debilitating.  That morning I threw up 4 times, had trouble keeping my eyes open, and was having trouble focusing.  My coworker brought me to Emergency Room.  After being admitted and brought back, I don't remember anything until the evening of November 7th.  I was told I was discharged from Emergency Room, and my boyfriend brought me to facility the following day where I was helicoptered to Hospital.  I was there until November 12th.  They found blood clots in my neck and brain.
No symptoms or adverse effects reported; patient received unspecified dose ofVARIVAX that was improperly stored; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. Concomitant therapy included sterile diluent  On 04-NOV-2019, the patient was vaccinated an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S003447, expiration date 04-FEB-2021; strength, dose, route were not provided) for prophylaxis (product storage error).  Temperature excursion of this vaccine was -12.8 degree Celsius for 2 hours and 38 minutes. There was previous temperature excursion and the worst previous temperature excursion was -9.8 degree Celsius for about 112 minutes. No symptoms or adverse effects reported. Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA000010:
This spontaneous report was received from a field representative who was informed by an employee that her daughter was having some "thyroid problems". On an unknown date, the employee's daughter was vaccinated with GARDASIL via an unknown route of administration. Past medical history and concomitant medications were not reported. On an unknown date the patient experienced thyroid problems. The outcome of thyroid problems is unknown. Additional information has been requested.
Patient had breakout of rash from neck to ear on (R) side. After injection she felt low grade fever. Her glands were swollen. The rash was blistering. The symptoms resolved after about 4-5 days.
severe arm pain; shaking; Fever not reduced with TylenolAdvil; Severe chills and chills in spine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (severe arm pain), TREMOR (shaking), PYREXIA (Fever not reduced with TylenolAdvil) and CHILLS (Severe chills and chills in spine) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination.     The patient's past medical history included Colon operation (Colonic interposition). Concurrent medical conditions included Achalasia (Immunosupressed "Colonic interposition" for achalasia: 15/16 previous surgeries) and Iodine allergy.    On 20-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Aug-2021, the patient experienced PAIN IN EXTREMITY (severe arm pain), TREMOR (shaking), PYREXIA (Fever not reduced with TylenolAdvil) and CHILLS (Severe chills and chills in spine). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (severe arm pain), TREMOR (shaking), PYREXIA (Fever not reduced with TylenolAdvil) and CHILLS (Severe chills and chills in spine) had not resolved.            No concomitant medications was reported. The dose of the vaccine was 0.5 milliliter.
Starting Vaginally bleeding 2 days after first Vaccine and havent stopped to date.  It started out light and its now very heavy.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Oct2021 (Batch/Lot number: unknown) at the age of 43 years as dose 1, single and administered in arm left, administration date 05Nov2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VAGINAL HAEMORRHAGE (non-serious) with onset 13Oct2021, outcome "not recovered", described as "Starting Vaginally bleeding 2 days after first Vaccine and havent stopped to date.  It started out light and its now very heavy.". Therapeutic measures were not taken as a result of vaginal haemorrhage.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (16Dec2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
11/2/17 swollen eyes and redness around eyes, shot was administered in the left arm at 11am with left eye being worse. Swelling and redness began within 1 hour of shot to left arm. Took one BENADRYL at 1pm. Swelling progressed called Dr suggested 2 BENADRYL gels. Swelling still evident Friday morning. Still redness around the eyes, Saturday morning swelling lessened but still evident. Redness lessened. Swelling evident Sunday. No redness. Monday morning back to normal.
SUSPECTED COVID-19 INFECTION; PAIN AND SORENESS IN HIS KNEES; HIVES AROUND HIS FRONT AND BACK TORSO; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other company (Novartis) concerned a 64 year old male of an unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. On an unspecified date, the patient previously received 2 doses of covid-19 vaccine from unspecified manufacturer (dose number in series 1) (form of admin, route of admin, batch number and expiry date were not reported), dose was not reported, administered for covid-19 prophylaxis.  It was unknown whether patient had any adverse event following covid-19 vaccine from unspecified manufacturer (dose number in series 1). The patient received third dose with covid-19 vaccine ad26.cov2.s (dose number in series 2), (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis which was associated with revaccination with different covid-19 vaccine (dose number in series 2). The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient got sick with suspected covid-19 infection, and also started to experience hives around his front and back torso and experiencing swelling in his hands, palms, fingers, and feet when there's excessive pressure or exertion (dose number in series 2). In the evenings his temperature was like he had the flu and felt a slight change in his breathing and also stated that he started to experience pain and soreness in his knees (dose number in series 2). Treatment medications (dates unspecified) included: cetirizine hydrochloride. Reporter stated that symptoms he was experiencing was not going away and with high dose he feel more irritable. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, hives around his front and back torso, pain and soreness in his knees and revaccination with different covid-19 vaccine was not reported. This report was non-serious. This case, involving the same patient is linked to 20230628322.
This spontaneous report was received from a nurse practitioner and refers to a 67 days old patient of unknown gender. No information regarding the patient's concurrent condition, medical history, concomitant medications and drug reactions or allergies was provided. On 26-OCT-2018, the patient was inadvertently vaccinated with one dose of VAQTA 25/0.5 (units not provided) injection, lot # R013859, expiration date 14-JUN-2019, intramuscularly, instead of RECOMBIVAX HB that was intended (wrong vaccine administered, inappropriate age at vaccine administration). No adverse effects were reported.
Vaccine given on 6/11/13, redness, swelling, knot noted by patient and parent. Itchy - pain - redness measuring 4.75" x 5".
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a male of unspecified age. 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: Unk) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported. On 23-MAY-2021, the patient did not develop the antibodies (patient experienced confirmed immunological vaccine failure). Laboratory data included: Antibody test (NR: not provided) NEGATIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210556475-covid-19 vaccine ad26.cov2.s-Confirmed immunological vaccine 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
Information has been received from a nurse concerning a 4 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date the patient was vaccinated with one dose of VARIVAX lot # N008077, expiry date 09-MAR-2019, subcutaneously for prophylaxis, following temperature excursions of -12.3 Celsius degree for 30 minutes and -9.8 Celsius degree for 3 hours 30 minutes (product storage error). A data logger was involved. No adverse effect was report. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1711USA010721:  US-009507513-1711USA010723: US-009507513-1711USA010724: US-009507513-1711USA010725: US-009507513-1711USA010726: US-009507513-1711USA010727: US-009507513-1711USA010728: US-009507513-1711USA010729: US-009507513-1711USA010730: US-009507513-1711USA000697:
After reconciling the clinic's inventory and lot number, it was noted that the child received a diluted dose (diluted with 1.3 mls of Normal Saline)  of the adult vial (0.2mls injected, 10-20mcgs of diluted adult vaccine likely administered).  The child did not suffer from any adverse reactions nor an increased immune response therefore not treatment was needed.
Patient presented two days after receiving his 2nd dose of his shingles vaccine with a red rash that was warm to the touch on the arm he received his vaccination on. The rash was about 5-6 inches long and about 1-2 inches below where the vaccine was actually administered. Patient stated he did not have this reaction after receiving his first dose. No treatment had been pursued.
6 days after vaccine patient developed fever, chills, vomiting & diarrhea.
Paralysis from the waist up including arms, hands  and face for approximately 20 min.  Difficult breathing,  increased heart rate.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 21-Jul-2022; No adverse event; Administered the vaccine to patient after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 21-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 35-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 21-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 21-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 21-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 21-Jul-2022).    Concomitant medication information was not provided by the reporter.  Reportedly, Patient received half dose.  Date the vial was initially stored in the refrigerator was 04-Jun-2022.    Vial did not undergone any temperature excursions.  Treatment information was not provided by the reporter.
Patient received vaccination AM of 2/27...called our pharmacy PM of 2/27 stating she was having extreme pain in the arm and could not move it.  She went on to say movement from the elbow to the hand was fine but was having a hard time lifting her arm.
Within 10 minutes of vaccine administration, pt began to experience tongue "fullness" and lip numbness. Progressed to tongue numbness. VSS and lungs clear. Benadryl given with relief of sx's in 20 minutes.
15-20 minutes past vaccination, client c/o increased heart rate, dizziness and throat closing. VSS-B/P 140/80, HR-70. Client able to talk and walk, 911 called for further evaluation. Client transported by medic to hospital.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Apr2021 (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: NECK PAIN (non-serious), ARTHRALGIA (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 16Apr2021, outcome "unknown" and all described as "pain in her left arm (arm of injection) that radiated to her neck & shoulder"; TINNITUS (non-serious) with onset 2021, outcome "unknown", described as "She has ringing in her left ear"; FACIAL DISCOMFORT (non-serious), MUSCLE TIGHTNESS (non-serious) all with onset 2021, outcome "unknown" and all described as "Facial & jaw tightness"; TREMOR (non-serious) with onset 2021, outcome "unknown", described as "vibration feeling in body when in certain places". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of neck pain, tinnitus, facial discomfort, muscle tightness, tremor, arthralgia, vaccination site pain, and treatment included essential oils. Additional information: Caller received her first Pfizer Covid-19 Vaccine on 13April2021. About three days later she experienced pain in her left arm (arm of injection) that radiated to her neck & shoulder. She has seen several doctors & tried essential oils. Spoke from the attached document under "Side effects that have been reported with the Pfizer-BioNTech COVID-19 Vaccine include: arm pain. Facial & jaw tightness, weakness (greater strength on one side of the body), vibration feeling in body when in certain places. Response: Spoke from the attached document under "adverse reaction/side effects." No reports at this time. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
stabbing pain in hands and feet, sever body aches, migraine, fever 100.6, hallucinogenic dreams lasted 48 hours total
Patient has redness and swelling at injection site about 3 inches in diameter and says it feels hot. Has also been itching at site. Patient says appeared day after immunization but went away, then returned a few days later
DR 1 DAY AFTER VACCINES GIVEN PATIENT PRESENTED TO ER PER MOTHER, PATIENT UNRESPONSIVE 20 MINUTES THEN HAD SEIZURE.  PATIENT ADMITTED TO HOSPITAL PER DR.  TEMP 102 UPON ARRIVAL. 11/10/2009 hospital records from 8/28-8/30/2009. Patient presents with fever and lethargy. T'd with IV ABX, Acyclovir. Septic w/up neg. Dc Dx: Fever with altered mental status.
Patient came through the drive thru complaining of soreness and sweating/shaking. Patient said she felt like she was getting sick. I asked if she had diabetes, asthma/COPD, and tried to screen for why we gave the pneumonia vaccine. Patient said she was around someone else who had pneumonia. This patient does not have any conditions qualifying her for the vaccine and we broke protocol administering it.
Approximately 1015-1030 am after receiving booster of Modena vaccine at 7:30 am I stated to get a headache and queasy stomach.  As morning progressed headache worsened .  By 3:00pm I felt cold, somewhat aches and took an Advil. Felt better by 6:00pm. Stomach still felt queasy did not eat but thirsty. Tried to stay hydrated as instructed. Went to bed 10:00 pm and felt cold again. That is when I took temp 99.  Headache is in full force sick to stomach and have chills and shakes really bad. Felt this way until 2:00 am. I had no sleep and felt very weak tried to get out of bed felt dizzy. Was sick all day on Wednesday the 10th took some Tylenol. Thursday the 11th woke up feeling somewhat better but still with headache and no appetite and nausea. Symptoms came and went on Thursday and Friday, Saturday headaches and nausea continued. Sunday feeling much better.
Approximately 3 days After first dose of Pfizer on 4-7-21, right ear started to get stuffy and then got so stuffy I could not hear out of it. Went to the Dr. and it looked like fluid in my ear and gave me a shot of anti-biotics. Was still having issues with hearing months later so went to Capital Otolaryngology and discovered I had hearing loss and also suffer from tinnitus.
I am not sure when the unset occurred only know that is when I noticed my sons leg while giving him a bath. He complained of pain but I thought it was just sore because of the shot. Where he recieved the shot is blotchy and red, and it had a large hard swelling region around it. I took him back to the clinic and they recommended I report the reaction and to come back if symptoms get worse.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Tinnitus-Medium