chrisvoncsefalvay/vaers-outcomes huggingface dataset:
heavy and painful periods; heavy and painful periods; This spontaneous case was reported by an other health care professional and describes the occurrence of HEAVY MENSTRUAL BLEEDING (heavy and painful periods) and DYSMENORRHEA (heavy and painful periods) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEAVY MENSTRUAL BLEEDING (heavy and painful periods) and DYSMENORRHEA (heavy and painful periods). At the time of the report, HEAVY MENSTRUAL BLEEDING (heavy and painful periods) and DYSMENORRHEA (heavy and painful periods) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment related information has been reported.
Dizzy spell Saturday lasting 2 seconds. Again on Monday while driving.; Initial information received on 14-Jul-2022 regarding an unsolicited valid  courtesy non-serious case received from a consumer/non-hcp.  This case involves a 53 years old female patient who had dizzy spell Saturday lasting 2 seconds. again, on Monday while driving while receiving vaccine TETANUS TOXOID.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect TETANUS TOXOID produced by unknown manufacturer (formulation, strength: unknown) lot number not reported via unknown route in unknown administration site for Tetanus.Lot number was requested.  On an unknown date the patient had dizzy spell Saturday lasting 2 seconds. Again, on Monday while driving. (dizziness) (unknown latency) following the administration of TETANUS TOXOID.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (Dizzy spell Saturday lasting 2 seconds. Again, on Monday while driving.).  At time of reporting, the outcome was Unknown for the event .
Severe full body hives and throat tightness 18 days following first covid vaccine, and an even worse case of full body hives and throat tightness 5 days following the second covid vaccine
10 days post vaccination (approx 1/8/21), developed large area of erythema, pain and swelling that is progressing and has now made it difficult to move her arm
rash all over body and swelling of body, including massive swelling to face and head.   I dont know the brand, lot or manufacturer of the vaccine.
This spontaneous report as received from a registered nurse refers to multiple, unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates the patients were vaccinated with improperly stored dose of ROTATEQ via unreported route (batch# L037574, exp. 01-JUL-2017;  L038536, exp. 19-AUG-2017; L013034, exp. 28-JAN-2017; L039297; exp-19-JUN-2017). Concomitant medication was not mentioned. The vaccines underwent a temperature excursion by being stored at 0.9 degree centigrade for a time frame of 11 hours 35 minutes (incorrect product storage) on 18-MAR-2016. The call was a result of "data logger". There was no previous temperature excursion mentioned. No adverse effects were reported. Product quality complaint was not filed. Additional information has been requested. This is one of the four reports received from the same reporter.
About six weeks after getting the vaccine I started to have a little bleeding. When I had an Ultrasound there was no heart beat. I would have been seven weeks pregnant. I had a D&C on 05/05/2021. I have not had any problems since then. Due Date-12/2021 Pregnancy 2nd
Extreme Fatique 20 minutes after injection of Pfizer 3rd Covid booser vaccine  Very ill for 3 days after booster shot consisting of fatique and chills After being sick for 3 days, I developed a rapid heart rate. Saw a Cardiologist on 1/12/22. EKG was Normal Started wearable heart monitor for 7 days: 1/14/22-1/20/22 Echocardiogram on 1/25/22. Results were normal.   Please Note: I was also sick for 2 days after I received the 2nd Pfizer booster shot on 4/5/21 in my right arm (Pfizer 7/21 ER8735). I believe I developed ongoing arthritis in my hands after the 1st Pfizer shot in  my right arm on 3/15/21 (Pfizer 7/21 EP7534).
Post vax, the pt developed redness, swelling, and pain at the injection site. Due to worsening symptoms, pt came to ER for medical help. Swelling and redness progressed to whole upper arm and passed down to elbow and the injection site appeared to be suggestive of cellulitis. Pt was given Ancef and started on oral antibiotics along with Tylenol and Motrin for temp and/or pain. Pt returned to ER in 24 hours for a recheck. Symptoms had improved when he was seen the 2nd time.
swelling in throat, feels like mouth is broken out on roof of mouth; 27OCT93 ear running & hurting; PMD treated w/Advil, pred, Tetracycline, Chlorpheniramine maleate & some shot; 1NOV93 pt tired;
2nd dose was not administered yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 30th June 2021).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 07-NOV-2022 Reporters comment:  The patient received the first dose of shingrix and the second dose was not administered yet. The reporter asked should restart the series or administer 2nd dose. The vaccine administration facility was the same as primary reporter. No lot number nor expiration date of the dose was available. The age nor date of birth for the patient was requested for omission. The reporter did not consent to follow-up. Additional Supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Patient developed rash and itching that spread from the injection site to middle of chest and down abdomen to waist. She experienced itching that was relieved with Benadryl. The rash also improved after administration of Benadryl.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a 66 year old female of unknown race and ethnicity. 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: Unknown, expiry: Unknown) dose was not reported, 1 total administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in APR-2021, the patient experienced symptoms such as loss of taste and lethargy. On an unspecified date in APR-2021, the patient underwent COVID-19 virus test which showed positive result (suspected clinical vaccination failure and suspected COVID-19 infection). 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 product quality complaint: 90000190700. This case, from the same reporter is linked to 20210846926.; Sender's Comments: V0: 20210846583-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
redness, hot and felt sore at injection site and below; redness, hot and felt sore at injection site and below; redness, hot and felt sore at injection site and below; Slept all day; Extremely tired; swelling; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Slept all day), VACCINATION SITE WARMTH (redness, hot and felt sore at injection site and below), SWELLING (swelling), FATIGUE (Extremely tired) and VACCINATION SITE ERYTHEMA (redness, hot and felt sore at injection site and below) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concomitant products included LISINOPRIL for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced SOMNOLENCE (Slept all day) and FATIGUE (Extremely tired). On 15-Mar-2021, the patient experienced VACCINATION SITE WARMTH (redness, hot and felt sore at injection site and below), VACCINATION SITE ERYTHEMA (redness, hot and felt sore at injection site and below) and VACCINATION SITE PAIN (redness, hot and felt sore at injection site and below). On an unknown date, the patient experienced SWELLING (swelling). At the time of the report, SOMNOLENCE (Slept all day), VACCINATION SITE WARMTH (redness, hot and felt sore at injection site and below), FATIGUE (Extremely tired) and VACCINATION SITE PAIN (redness, hot and felt sore at injection site and below) outcome was unknown and SWELLING (swelling) and VACCINATION SITE ERYTHEMA (redness, hot and felt sore at injection site and below) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment included cold compresses.   This case was linked to MOD-2021-219933 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Updated reporter contact details, Outcome of events vaccination site erythema changed from unknown to recovered/resolved. Added medical history and 1 new event of swelling.
Headache, chills, half dollar red spot at injection site - 3 days. Allergy like symptoms, runny nose - 2 days. Sore in nose - 5 days. No treatment necessary.
On 10/6/17 - late morning rec'd flu vaccine in (L) arm. By 7 pm N/V, fever 100 degrees, weakness - aching joints - was ill until Sun AM. Weakness persisted for add'l 2-3 days.
Patient began experiencing severe adverse symtpoms on 8/25/2021 at 2am. She went to the ER and they gave her some IVs, Benedryl, pain meds, chest X-ray, ekg.  Side effects reported: Fever  SOB/Trouble breathing Chest Pain Sore Throat Headache Body Aches Joint pain Vomiting Nausea Dehydration Allergic Reaction/Swollen Face Feelings of having a fast-beating, fluttering, or pounding heart Chills Dizziness Weakness
Pt was admitted on 12/21/2021 for bilateral lower extremity weakness and a UTI.  He was tested for COVID due to his wife testing positive and being his visitor over the last 2 months.
I had COVID-19 and I feel like if I did not have the vaccines then I would have died. I started getting symptoms of fever of 100.7, sore throat, achy, sneezing, runny nose, and coughing. I took an at home COVID-19 test which was positive. My husband eventually got COVID-19 as well about one week later. My symptoms progressed with chills and like a very bad flu. I was in bed for over a week. I sent my doctor a text message that I was positive. I was prescribed PAXLOVID. I am still sick and my lingering symptoms are cough, extreme fatigue and exhaustion, with hot and cold sweats.
Severe HSV2 outbreak 24-48 hours after injection. Gave acyclovir, calmed symptoms down. Stopped and 2 days later returned with rectal HSV, started 5 days acyclovir again, stopped and 2 days later had eye pain. Switched to valcyclovir for 30 days.
Pt developed blisters and bullae on legs and body 2 days post vax. She was seen at ER and transferred to a hospital where she stayed for 3 days.
Intense body aches. Temperature. Headache. Ear ache. Neck ache.
This report was received from the investigator of a trial on 20 May 2010. A 30 year-old male subject received the following vaccine on 06 March 2009: ACAM2000 (lot number not reported). Twenty-eight days after vaccination on 03 April 2009, the subject was diagnosed with unspecified disease of the pericardium. The subject had an abnormal Troponin I result of 10.31 (units and reference range not provided) and an abnormal electrocardiogram (results not provided) on 19 March 2009. Normal MRIs of the spinal cord and heart were done on 20 March 2009. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study.
Pt recvd vax 5NOV92 & 5 days following vax devel erythema multiforme; No further details were provided;
He developed mild chest pain and SOB 1 day following vaccination. His symptoms progressed over 48 hours. He developed more severe chest pain. He had neck pain with radiation down his left arm, and dyspnea on exertion. Chest pain became severe. He presented to hospital and diagnosed with acute myopericarditis.
flu; Initial information received on 24-Nov-2022 regarding an unsolicited valid Social Media non-serious case via consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who had flu after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), Concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, form, batch lot number, expiry date: Unknown) via unknown route in unknown administration site for Prophylactic vaccination. Information on batch lot number and expiry date was requested.  On an unknown date the patient had a non-serious event of flu (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown.
10JUN91 pt given  TTOX IM lt deltoid 11JUN91; pt's mom reported pt having fever 102-103, advised to take APAP; 12JUN91 MD asked mom to bring pt to office; 12JUN91 pt seen BP 90/64, t100.6 c/o lt arm sore & swollen;
Patient described injection with Zostavax as painful, although another patient was immunized five minutes earlier from same batch of vaccine and did not have a complaint. The patient that had pain developed a diffuse severe erythema and induration that extended from the injection site of right lateral upper extremity almost to the elbow with warmth and moderate tenderness to palpation the day after injection. Three weeks later, on 07/01 the patient experienced what was intially thought to be a UTI, with severe burning for two days but urinalysis was negative for UTI. Was placed on antibiotics and pyridium with no relief. Two days later a very painful skin eruption occurred with labial blisters appearing clinically like HSVII lesions. Pt was monogamous with a disabled spouse and no sexual encounters for a period of seven years prior and no history of std diagnosis or exposure. Subsequent HSVI and II serum testing resulted negative. Patient was empirically started on a regimen of Ciprofloxacin 500 mg BID X 7 days and Acyclovir 400 mg 5Xday. Blood collection was taken for additional testing for Herpes Zoster infection and was positive for active infection.  Blisters eventually resolved after a period of five days, but patient described pain on a scale of 5/10 to labia, lower buttock and hip for an additional 6 days before finally resolving. Interestingly enough, an additional person, male aged 65 who was a close contact with the patient developed a zoster like rash to his right maxillary area and extending to right eyelid and supraorbital region that subsequently also tested positive for Herpes Zoster. He was started on acyclovir in the same dosage and the rash resolved very quickly without further complication.
Information has been received from a physician concerning a 17 year old female who was vaccinated intramuscularly with the first dose of Gardasil. Subsequently the patient had "skipped her menstrual cycle for 2 months." The patient recovered from her skipped menstrual cycle. No further information was provided. Additional information has been requested.
Fatigue, fever, chills, muscle aches, sore arm for 1 day
I was very cold..chills at times.  I could not get warm - even with electric mattress pad on high.  At 11:00 pm I took two Tylenol.  When I woke at 1:00 I was not longer cold or had the childs.  I had a fever of 100.4.   When I woke at 4:30 it was gone.  I was tired and sluggish all day but felt better. I bled alot when I received my shot. By Wednesday night my arm was very sore, had a small bruise, and itched a bit.
Pt received DTAP vaccine and within a 1/2 hour of vaccination site had a reaction.  There was erythema and warmth at the injection site.  No anaphylaxis.
approx 8 hrs p/vax devel sore arm, hot flashes & nausea; tx began in evening & were gone in AM; no rx;
Pt had a cyanotic event at 14:00 on 11/08/00. His feet and legs up to his waist, turned blue. Mom stated he wasn't breathing for approx. 2 minutes until he turned "pink". 10 minutes went by before he had a faint cry. No rescue breaths given. Taken to ER by EMS. He was transferred to another hospital.
A floater left a vial of moderna overnight and a dose was  drawn from a vial that had been punctured > 12 hours.
Patient received dose 3 days out of window, 14 days after 1st dose.
suspected vaccination failure/got the shot, got shingles; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in unspecified number of patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details provided were as follows: The age at vaccination was not applicable for this report. The patient reported that everybody he/she know that didn't have Shingles and then went and got the shot, afterwards got shingles. The reporter felt sorry for those who had shingles, but he/she just stated that there was probably a better way to prevent Shingles (boost immune systems) or herbal or allopathic medicine to deal with Shingles once he/she get it. The reporter reported that to everyone he/she know, the shot introduced into the body something that set shingles in motion and it erupted after the shot. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not be possible as no contact details available.
Fever of 103 degrees Fahrenheit, after second vaccine; Caller states her daughter left work and came home sick around midnight.; This is a spontaneous report from a contactable consumer (Patient's mother). A female patient of an unspecified age received second dose of BNT162B2 (BNT162B2) via an unspecified route of administration on 13Jul2021 at 18:30 (Batch/Lot Number: FA6780) as DOSE 2, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced fever of 103 degrees fahrenheit, after second vaccine on an unspecified date. Reporter states her daughter left work and came home sick around midnight on an unspecified date. The patient underwent lab tests and procedures which included body temperature: 103 degrees fahrenheit on an unspecified date. Outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Headache; Rash; swollen; increased tempature at injection site; pain; dose 1- 26May2021 09:15  and dose 2- 26May2021; This is a spontaneous report from a contactable consumer (patient). A 48-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0178), via an unspecified route of administration, administered in left arm on 26May2021 09:15 (at the age of 48 years) as dose 1, single for COVID-19 immunization. The patient also received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0191), via an unspecified route of administration, administered in left upper arm on 26May2021 (at the age of 48 years) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. The patients concomitant medications included lisinopril (LISINOPRIL); calcium (CALCIUM); colecalciferol (VIT D3); zolpidem tartrate (AMBIEN); lamotrigine (LAMICTAL); fluoxetine hydrochloride (PROZAC). Other vaccine in four weeks were none. The patient did not have covid prior vaccination. The patient had no known allergies. On 18Jun2021 the patient experienced headache, rash, swollen, increased temperature at injection site and pain included with these. The patient did not receive treatment for the events. The patient underwent lab tests and procedures which included covid test post vaccination, Nasal Swab (Biofire Diagnostic with Filmarray system): negative on 11Jun2021. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
shingles in his forehead and close to his eye but not in eye; lesions; swelling, pain and inflammation; swelling, pain and inflammation; swelling, pain and inflammation; This is a spontaneous report from a contactable consumer. A 93-year-old male patient received the first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number: EL3302), via unspecified route of administration on 22Jan2021 at 14:00 (at the age of 93-years-old) as a single dose for COVID-19 immunisation. It was reported that patient had a lot of medical conditions and takes a lot of medications (unspecified) (but nothing she thinks is related to the vaccine). Additional vaccines administered on same date of the pfizer suspect was none. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 07Feb2021 patient had lesions showed up and he was diagnosed with shingles he had symptoms 2-3 days prior: he was on a medical treatment with a viral medication, prednisone, ibuprofen and Tylenol. On Tuesday they went to see his ophthalmologist because he has shingles in his forehead and close to his eye but not in eye, his ophthalmologist said that after 10 days with the viral medication and 5 days with prednisone, he should be able to get the second dose of the vaccine. She would like to know if the vaccine could have caused him shingles. He was on a viral medication and was put on prednisone for swelling and inflammation on an unknown date in Feb2021. The patient was also alternating Tylenol and Advil for pain. The patient did not visit emergency room. The outcome of the events lesions, swelling, pain and inflammation was unknown while for shingles was not recovered.