chrisvoncsefalvay/vaers-outcomes huggingface dataset:
GOT COVID; This spontaneous report received from a patient via a company representative via social media  concerned a patient of unspecified age, sex, race, ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received dose 1 with covid-19 vaccine ad26.cov2.s (Dose number in series 1), (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. On an unspecified date, the patient was diagnosed with cancer (unspecified) and lupus (Dose number in series 1). The patient received booster 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. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 27-JUL-2022, the patient got covid (Dose number in series 2). It was reported that "Hey guess what. Cancer diagnosis. Lupus diagnosis. Fully vaccinated And boosted. Today I got Covid. Care to comment. Do anything about it. Guidance at all. Guarantee I will not here from you." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got covid was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000244167. This case, involving the same patient is linked to 20220759828 (Dose number in series 1).
R arm pain and decreased active range of motion starting about one week after second injection. She had had injection site pain initially but the whole arm pain and difficulty with movement of shoulder started approximately one week later.
Arm pain, nausea, fever as high as 100.6, headache. Felt lousy and stayed in bed all day 1/18, felt a little better 1/19 but occasional nausea, headache continued for 2-3 days, arm tenderness continued almost a week. I had a negative reaction (similar) to the first shot in the series, but this was definitely worse.
2 months ago we noticed that she was urinating frequently and asking for water a lot. We also noticed that she was dribbling and thought she had a UTI and took her to her primary doctor. The doctor found glucose in her urine and her blood sugar was 472. She was admitted to the hospital on January 30, 2023 and discharged on Tuesday. They provided insulin and prescribed HUMALOG and LANTUS. She was diagnosed with Type 1 diabetes which is a chronic illness. Her symptoms have not improved.
This case was reported by a pharmacist via call center representative and described the occurrence of immunology nos abdominal in a 68-year-old male patient who received ENGERIX B (batch number 9H2H2, expiry date 30th January 2016). On 13th March 2015, the patient received ENGERIX B. On 16th March 2015, 3 days after receiving ENGERIX B, the patient experienced immunology nos abnormal. On an unknown date, the outcome of the immunology nos abnormal was unchanged. It was unknown if the reporter considered the immunology nos abnormal to be related to ENGERIX B. Additional information received: A patient was given a booster dose of ENGERIX-B on 13 March 2014, and on 16 March 2015, the patient had positive blood work for hepatitis B surface antigen (antigenemia).
migraine headache; fatigue; nausea; 56 y/o male received Comirnaty booster vaccine the evening of 01Oct2021; 56 y/o male received Comirnaty booster vaccine the evening of 01Oct2021; This is a spontaneous report from a Non-contactable consumer (patient). A 56-years-old male patient received third dose of BNT162b2 (COMIRNATY, solution for injection, Lot Number: 30145BA), via an unspecified route on 01Oct2021 (at the age of 56-years) as dose 3 (booster), single for covid-19 immunisation. The patient medical history included migraine headaches. The patient concomitant medications were not reported. Patient previously received first dose BNT162b2 (COMIRNATY, solution for injection, Lot Number: unknown), via an unspecified route on unspecified date (at the age of 56-years) as dose 1, single and second dose BNT162b2 (COMIRNATY, solution for injection, Lot Number: unknown), via an unspecified route on 08Jan2021 (at the age of 56-years) as dose 2, single for covid-19 immunisation experienced migraine headaches. Patient received Comirnaty booster vaccine the evening of 01Oct2021. The patient experienced a classic migraine headache with fatigue and nausea on 02Oct2021. Patient took sumatriptan 50 mg PO and slept an additional 3 hours mid-day on 02Oct2021, with immediate resolution of all of these symptoms upon awakening. He had a long history of migraine headaches and experienced the same symptoms after dose # 2 of the Pfizer-BioNTech COVID-19 vaccine on 08Jan2021, however that time the migraine, fatigue and nausea persisted intermittently over 2 days before they completely resolved. The outcome of the events migraine headache with fatigue and nausea was resolved on 02Oct2021.  No follow-up attempts are possible. No further information is expected.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 16-APR-2013, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles but rather caused the patient to contract a persistent and severe strain of herpes zoster. After receiving the ZOSTAVAX vaccine (date not reported), the patient developed burning, pain, and light sensitivity in his left eye, accompanied by headaches. In response to these complaints, on or about 30-AUG-2016, the patient presented to ophthalmologist, and on examination was found to have elevated left eye pressure, and a laser procedure was performed to reduce the left eye pressure. The patient continued to suffer from burning, light sensitivity, and reduced vision in his left eye. On 07-SEP-2016, the patient returned to ophthalmologist and was diagnosed as suffering from left eye zoster iridocyclitis. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, including partial blindness in his left eye, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Upon internal review, herpes zoster iridocyclitis and partial blindness in left eye were determined to be medically significant. Additional information has been requested.
Side effects day 1-4: severe fatigue, low grade fever, body aches, minor/slight headache, extremely sore/painful arm, nausea after eating. 1 week post 1st shot: "covid arm" swelling at injection site, swollen/ raised, red, hot to touch (over 100° on injection location-no fever anywhere else), itchy, extremely painful.
stiffness; poor bladder control; sore muscles; Excruciating pain; difficulty with mobility; Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Excruciating pain), PAIN IN EXTREMITY (Sore left arm), MOBILITY DECREASED (difficulty with mobility), MUSCULOSKELETAL STIFFNESS (stiffness) and URINARY INCONTINENCE (poor bladder control) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A31A and 038821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore left arm). On 06-May-2021, the patient experienced PAIN (Excruciating pain) and MOBILITY DECREASED (difficulty with mobility). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness), URINARY INCONTINENCE (poor bladder control) and MYALGIA (sore muscles). On 10-May-2021, PAIN (Excruciating pain) and MOBILITY DECREASED (difficulty with mobility) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (Sore left arm), MUSCULOSKELETAL STIFFNESS (stiffness), URINARY INCONTINENCE (poor bladder control) and MYALGIA (sore muscles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant drugs. Treatment was taken but not mentioned the drug.   This case was linked to-MOD-2021-117973 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes:  Sender's Comments:  MOD-2021-117973:Second Dose Case
Nausea, Dizziness, Lightheadedness, Brain Fog.  When I am sitting everything around me seems to be moving further away, sound gets quieter, things seem strange. Sometimes feels like a floating feeling.
fever, chills, headache, overall aches.  Started 11 hours after receiving vaccination.  symptoms (although not as uncomfortable) still continuing at 42 hour mark
Did not feel good / felt sick; swollen arm and plams; fever of 102F; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Did not feel good / felt sick), PERIPHERAL SWELLING (swollen arm and plams) and PYREXIA (fever of 102F) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient had COVID-19 in December 2020.).    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced MALAISE (Did not feel good / felt sick), PERIPHERAL SWELLING (swollen arm and plams) and PYREXIA (fever of 102F). At the time of the report, MALAISE (Did not feel good / felt sick), PERIPHERAL SWELLING (swollen arm and plams) and PYREXIA (fever of 102F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Patient took Tylenol 2 tabs then also fever doesn't subside.    Reporter did not allow further contact
Patient received a Pediatric Hep B vaccine (recombivax 0.5mL) in place of a Adult version. Patient later returned to office on 8/9/23 to receive another dose of 0.5mL recombivax to make up the difference.
Itchy hot red blisters that resembled herpes. Located under breast, chest, in armpits, on left forearm, back beneath shoulder blades, and groin area. The bumps appeared with 3 days of each other and took about 4 weeks to clear up. Some were so itchy I scratched them off which left me with scars.
Information has been received from a registered nurse concerning a 20 year old white female with hypersensitivity to amoxicillin and cephalosporins who on 08-AUG-2007 at 10:00, was vaccinated IM in the right arm with a 0.5 ml first dose of Gardasil (lot # 654741/1208F).  Concomitant vaccination included Tdap administered intramuscularly in the left arm. There were no illneses at the time of the vaccination and no adverse events that followed prior vaccinations. On 08-AUG-2007, approximately 6 minutes after vaccination, the patient bacame dizzy (also reported as fainted) and fell forward(previuosly reported as toppled) off of the examination table and hit her head on a cabinet in the exam room.  The patient experienced a 2 inch laceration on her forehead.  The patient received stitches and was put on pain medication (unspecified) and antibiotics (unspecified).  The patient was examined by the physician and the neuroexam was normal. The nurse reported the patient did not have anything to eat prior to the appointment. The patient was referred to a plastic surgeon. The patient recovered on an unspecified date. Additional information is not expected.
By history: 11/14 swelling & stiffness L knee 11/18 swelling & stiffness Rt knee 11/24 aching L axilla 11/26 pain in fingers. All symptoms have resolved.
Patient reported feeling nauseous, anxious, dizzy, shaky about 15 minutes after receiving her flu vaccination. Patient was nervous at time of vaccination.
Started getting chills around 8:00pm. Some nausea and injection site soreness also. Took temp around 9:30 and it was 102. Took temp about 15 min later and temp was up to 106. Took Tylenol and temp was back to normal about 2 hours later.
Dose error. Patient was to receive 0.3 ml IM and was administered 0.5 ml. IM
I believe these symptoms are consistent with the reports of myocarditis; Headache; Shortness of breath; Chest tightness all sustained between 12-24 hours after receiving 2nd dose; This is a spontaneous report from a non-contactable consumer, the patient. A 24-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EWO198), via an unspecified route of administration, administered in Arm Left on 05Jul2021 at 20:15 (at the age of 24-years-old) as single dose for covid-19 immunization. Facility type vaccine was Pharmacy or Drug Store. Medical history included known allergies to Penicillin from an unknown date and unknown if ongoing, covid-19 from an unknown date and unknown if ongoing (If covid prior vaccination: Yes). There were no concomitant medications. Historical vaccine included previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), via an unspecified route of administration, administered in Arm Left on 14Jun2021 at 20:15 (at the age of 24-years-old) (Batch/Lot Number: EWO181) as single dose for covid-19 immunization and did not experience any adverse reaction. No other vaccine administered in four weeks. Adverse event description stated by patient as on 06Jul2021 at 08:00 was headache, shortness of breath, and chest tightness all sustained between 12-24 hours after receiving 2nd dose. Took 2 Tylenol 24hrs after 2nd dose, symptoms dissipated, reappeared next morning, albeit reduced severity. I believe these symptoms are consistent with the reports of myocarditis (though the symptoms are admittedly nondescript) experienced by others in my demographic group following the 2nd dose. Patient was tested covid post vaccination. The patient underwent lab tests and procedures which included Nasal Swab test on 07Jul2021 with unknown result. The patient received treatment for the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
6/29: usual state of health until Saturday  6/26/21 when he began to experience chest pain. Due to the pain persisting for 2 days, parents brought him to the ED.  He describes the pain as "pounding" and lasting for up to "half an hour".  He reports no recent illnesses or fevers, but does note that he received the second dose of the Pfizer vaccine 4 days ago (6/25/2021).  In the ED he had a CXR, EKG and screening labs which showed elevated troponin.  Secondary to this the decision was made to admit patient for continued evaluation and management of possible myocarditis. troponin up to 0.6 at 2100. SARS-CoV-2 PCR is negative. 6/30: IVIG administered overnight due to increasing troponin. troponin now 0.36. chest pain resolved. 7/1: troponin trending down to 0.06. No complaints of chest pain. discharged home.
The day after 2nd vaccine the patient experienced twitching of the eyelids.; This is a spontaneous report received from a non-contactable consumer (Non-healthcare Professional reporting for a patient). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on 02Feb2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. It was reported that, on 03Feb2021, the day after 2nd vaccine the patient experienced twitching of the eyelids. The outcome of the event was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Ringing in ears, loss of hearing.  Ringing (Tinnitus) in both ears, loss of hearing in and more intense "ringing" in right ear.  Fatigue.   Have not yet visited a doctor, was hoping symptoms would subside or go away naturally.
Initial information received on 20-Jun-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case involves a 40 years old (reported as in 40s) female patient who was administered ADACEL intravenously. This is the case of actual medication error due to inappropriate route of vaccination. Medical history: It was reported that male trauma patient in 40s. On 20-Jun-2018, the patient received a dose of suspect ADACEL (lot U6092BA, expiry date not reported) via intravascular route in unknown administration site. It was not clear if the patient experienced any adverse event. Lab data and corrective treatment: not applicable. 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. Documents held by sender: none.
Cough  Exposure to COVID-19 virus  Fatigue, unspecified type
GIVEN ROTAVIRUS, PEDIARIX IN THAT ORDER, BABY BECAME PALE, LIMP, NO LOC, NORMAL VITAL SIGNS, 02 SAT NORMAL, NO TREATMENT, GRADUALLY RETURNED TO BASELINE AT 11:30AM
swollen legs; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient) reported that A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Patient received the first dose on 17Mar2021. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced swollen legs 30mins after taking the 2nd dose. She was then put to the ER due to the reaction. Outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Within 5 minutes of receiving vaccine, patient developed hives on her arms that began to itch. She began feeling very flushed and was brought to the emergency room by wheelchair. She was given IV BENADRYL and SOLU-MEDROL.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 75 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Feb2021 10:30 (Lot number: EN6201) at the age of 75 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "Sulfa" (unspecified if ongoing); "iodine" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Keflex, reaction(s): "allergy"; Naproxen, reaction(s): "allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EI9265, Location of injection: Arm Left, Vaccine Administration Time: 10:30 AM), administration date: 01Feb2021, when the patient was 75 years old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 2021, outcome "unknown", described as "I experienced severe body aches"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "chills"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache". Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no covid prior vaccination and was not tested for covid post vaccination. Follow-up attempts are completed. No further information is expected.
Had 2 grand mal seizures 2 days after getting vaccine. Have had brain fogginess, right side numbness and pain in face, arm and leg, increased anxiety.
On the 11 day start having a big scary anxiety attack ,lasting to days until taken to Emergency room then they gave me LORazepam. Works for a few hours ,then come back
seizure like activity for 5-10 seconds; Vasovagal episode with seizures; This spontaneous report was received from a registered nurse and refers to a 17-year-old female patient. The patient's medical history included fainting with other unspecified immunizations. The patient did not have any concomitant medications, drug reactions or allergies. On 30-SEP-2019, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R027577, expiration date 23-JUN-2019, one dose, intramuscularly prevent cancer.  On the same day after the patient received injection, she experienced vasovagal episode with seizure like activity for 5-10 seconds and nausea. The patient sought medical attention and received cool compress to the her head and laid down while having her vital signs monitored. None lab diagnostics/ studies were performed. The outcome of the events was reported as recovered. The relatedness between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided. Upon internal review, seizure like activity was determined to be medically significant.
Pt recvd hep B vax on 22DEC89,29JAN90, & 02JUL90.07AUG90 test results were neg for HBSAB.Addt'l dose of vax given;test results again neg for HBSAB.
temperature of 99.3F, 98.3F, 99.2F, 99.7F; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received his first dose of bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not reported), via an unspecified route of administration on 04Jan2021 at single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On Tuesday (05Jan2021), she woke up with a temperature of 99.3F. On Thursday (07Jan2021) evening, she had a temperature of 98.3F, then she took Tylenol and her temperature was back to normal which she noted that her temperature is 97.6F. Yesterday (08Jan2021) at 6pm, she had a temperature of 99.2F and she took Tylenol at 10PM and her temperature was 98.3F. Her temperature today (09Jan2021) was 99.7F and she didn't take Tylenol. The outcome of event was unknown.  Information about lot/batch has been requested.
shingles; This is a spontaneous report from a Pfizer sponsored program received from a contactable female consumer. A female patient of an unspecified age received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced shingles on Feb2021. It was reported that Two weeks ago after she took the 1st dose of Covid-19 vaccine, she started to have shingles up until now. Outcome of the event was not recovered.  Information about lot/batch number has been requested.