chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had my menstrual cycle. My last day of my menstrual cycle was 27Apr2021 which was just last week and now I am having my cycle again today; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 05May2021 (Batch/Lot Number: EW0162) as 2nd dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was reported as EK873 or CK873) in the left arm on 13Apr2021 COVID-19 Immunization. The patient reported that she had her menstrual cycle in May2021. Patient's last day of menstrual cycle was on 27Apr2021 which was just last week and now she is having her cycle again today. Patient did not received treatment for the event. Outcome of the event was not recovered.   No follow-up attempts are needed. No further information is expected.
Hives 3 dAys after Hep A VAccine + inFlueNZA. DX at ER (R) middle lobe pneumoNiA. AnAphylAxis, Allergic reActioN. ON 1/12/2020. She wAs given Epinephrine. Solumedrol + ZAntAc + IV Fluids. Returned on 1/12/20 + treAted  for An AsthmA exAcerbAtioN + Allergic reaction tx with 3 DuoNeb tx + DecAdroN + BenAdryl positive for RSV. SENt home oN AmoxicilliAn given breathing tx + Steriod + IV fluiDs.
Pt recvd 2 doses of vax on 18MAR92 & 20APR92 & 30APR92 dx as having Hep A w/icterus, tenderness, aching sensation; Lab eval on 30APR92 revealed neg Hep A IgM antibody, pos Hep B core antibody, SGOT 1252, alkaline phosphatase 129, total bil;
Swollen lips, swollen mouth, swollen tongue, swollen trachea, irritated gums, facial numbness
I administered a subcutaneous injection of MMR with a 25g 5/8" needle to posterior aspect/triceps area of left arm on 10/26/2016. Patient reported feeling a nodule 2 hours after receiving the vaccine with mild erythema and mild tenderness. She did not report it because she has had subcutaneous nodules before after vaccine administration but they typically only last a week. She came in to see Dr. today because she noticed the nodule was still there. Per Dr. report. Nodule is not visible but palpable and in the subcutaneous tissue. It measures 3 x 3 cm and has a mild area of erythema that measures 5 x 5 cm. Neuromuscular activity intact to left arm. She has full range of motion to that arm with no pain. She expresses mild tenderness with palpation of nodule. Patient is required to have a second MMR vaccine for a health science program. She has no documented history of receiving an MMR vaccine. She had a titer negative for measles. Consulted with CDC and MFR. Both said they would get back to me later today. Will follow up with patient and Dr. after advice from CDC and MFR.
FLUZONEN QUAD 18-19 SDV (SANO) 1ml DK1809204586F1 NDC: 49281-0418-50; Severe site pain right upper arm radiating down to fingers. Progressively worse, 3 weeks out cannot grip hand tightly without significant pain and weakness. Cannot push, pull, open items of daily use without pain and weakness. Cannot move arm above head without pain and radiating weakness down entire arm.
Awoke AM of 11AUG93 w/rt wrist pain & swelling then over the next few days all joints of fingers hands-swelling discomfort several days later involvement of knees & ankles; seen in office 22AUG93;
This case was reported by a nurse via call center representative and described the occurrence of erythema of extremities in a 5-year-old female patient who received KINRIX for prophylaxis. On 28th November 2018, the patient received KINRIX. In November 2018, less than a week after receiving KINRIX, the patient experienced erythema of extremities and skin warm. On an unknown date, the outcome of the erythema of extremities and skin warm were unknown. It was unknown if the reporter considered the erythema of extremities and skin warm to be related to KINRIX. Additional details were reported as follows: The reporting nurse was grandmother of patient. She asked if it was a common reaction for a 5 year old to have redness and hot to touch from the top to half way down upper arm after KINRIX vaccine. The reporter had not seen this reaction before. The patient's mother called the office and was told this was a common reaction. The reporter had seen redness before but not hot to touch. When asked about consent for GSK to follow up with the patient's physician regarding event, the reporter stated she should really check with patient's mother first.
SECOND DOSE.  Side effects stared about 16 hours after the vaccine.  Started with slight soreness in left arm.  This remained a slight discomfort. Body tingling sensation turned into body aches.  Most were in the lower back and shoulders.  Random shooting pains in thigh muscles.  First temperature check at 8:00 am was 101.1 it increased throughout the day, peaking at 102.6.   I took 500 mg of Extra Strength Tylenol at 3:30 pm .  The fever dropped to 100.1 by 6:30 pm.  I took another 500 mg.  At 11:00 pm, the fever was up slightly to 101.6.  By 7:30 the next morning, the fever was down to 99.8.  It was gone a few hours later. Headache associated with fever, but not severe. NO fatigue, so I could not sleep off the fever.  I was wide awake and miserable. Felt fine by 8:00 am, so side bad side effects lasted approximately 24 hours.  By approximately 40 hours after the vaccine, I felt fine.  Very minimal soreness in arm remaining.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 24Sep2021 at 01:00 as dose 3 (booster) , single (Lot number: 30145BA) at the age of 70 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 01Apr2022 as dose 4 (booster), single (Lot number: 068H21A) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1 , single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing). Known allergies were reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19. Anti-viral details was covid 19 treatment, paxlovid, treatment start date 22apr2022, treatment stop date=27apr2022, for treatment of covid-19.
red swollen and itchy.  I have a knot on my arm about the size in circumference to a clementine.
Patient reported feeling weakness, muscle aches, a slight fever and headache a few days after the vaccine was administered. Patient will follow up with PCP if symptoms persist.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild
Information has been received on 31-OCT-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 05-FEB-2015, the patient received ZOSTAVAX (lot number, dosage and route of administration not provided) for its intended purpose: the prevention of shingles. As a direct result of ZOSTAVAX, the patient suffered from a shingles outbreak, in addition to chronic pain, rash and lesions to various parts of her body. The patient had her first of five shingles outbreaks on 21-JUN-2015; second outbreak again on 02-AUG-2015; third outbreak on 25-MAY-2016; fourth outbreak on 23-SEP-2016 and her fifth outbreak on 30-APR-2017. As a direct result of the ZOSTAVAX, the patient suffered mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the ZOSTAVAX the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of ZOSTAVAX the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred medical expenses and other economic harm as a direct result of use of ZOSTAVAX. Shingles outbreak on 21-JUN-2015; shingles outbreak on 02-AUG-2015; shingles outbreak on 25-MAY-2016; shingles outbreak on 23-SEP-2016 and shingles outbreak on 30-APR-2017 were considered to be disabling.  Additional information has been requested.
Symptoms: Joint pain with a lot of swelling in ankles and feet and a red flat rash that was hot and a little itchy but if attached at would burn. Treatment:  Medrol dose pack Outcome: the steroids treated the swelling and got better.  Time Course: 10 Days
After a couple of weeks, she felt as if she has no strength and she seems different; After a couple of weeks, she felt as if she has no strength and she seems different; itchiness on the administration site (left arm); pain on the administration site (left arm); felt being hot on certain parts of her bodies; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician) from medical information team. The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 (Batch/Lot number: unknown) at the age of 70 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Dermatographism" (unspecified if ongoing), notes: female who has a known history of Dermatographism. The patient's concomitant medications were not reported. Past drug history included: Propylene glycol, reaction(s): "Allergies", notes: Known allergies: Propylene Glycol. Vaccination history included: Tetanus (She stated that she is still quite unsure if the side effect she had experienced on her left arm was due to her getting shingle shots, tetanus shot on the past 3 years on the same arm.). The following information was reported: VACCINATION SITE PRURITUS (non-serious) with onset 07Apr2021, outcome "unknown", described as "itchiness on the administration site (left arm)"; VACCINATION SITE PAIN (non-serious) with onset 07Apr2021, outcome "unknown", described as "pain on the administration site (left arm)"; FEELING HOT (non-serious) with onset 07Apr2021, outcome "unknown", described as "felt being hot on certain parts of her bodies"; ASTHENIA (non-serious), SENSORY DISTURBANCE (non-serious), outcome "unknown" and all described as "After a couple of weeks, she felt as if she has no strength and she seems different".  Additional information: The patient missed her second dose scheduled on 28Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I went to a specialist which documented hearing loss and tinnitus. I did two rounds of steroids. I went to ER a few times. They came me steroids and antibiotics. Then I also had an antiviral, I saw like three different DRs at that point. I still have hearing loss and Tinnitus and am not taking anything for it. It is not resolving though. I have gone to a rheumatologist and a hematologist.
Became sick on 9-4-2021 Tested Positive for Covid-19 9-8-2021 Hospitalized in local CCU 9-8-2021 Died of Covid-019 9-15-2021
Patient received convalescent plasma treatment on January 6, 2021. Patient received the first dose on the Moderna vaccine within 90 days of being treated with convalescent plasma.
Information has been received from a healthcare worker concerning a 15 year old female who on 07-NOV-2007 was vaccinated with a first dose of GARDASIL (lot # not reported).  On 10-JAN-2008 the patient was vaccinated with a second dose of GARDASIL (lot # not reported).  On 12-MAY-2008 the patient was vaccinated with a third dose of GARDASIL (lot # 0152X).  It was reported that "when attempting to administer the GARDASIL syringe, the plunger would not depress.  According to the medical assistant, the white plastic tray was crushed at the end.  The plastic seal was loose and up at the damaged end.  The carton was not damaged.  The syringe was removed from the package and the needle was placed on the syringe.  The needle was in the patient's arm and the plunger would not depress.  When the needle was removed from the arm, the safety device activated.  The syringe was discarded because the patient fainted and the medical assistant needed to put the syringe in a safe place."  It was also reported that "they have been using the syringe for a while and are familiar with its use.  The product was ordered directly from Merck.  This was a product quality complaint.  The patient was vaccinated successfully with another prefilled syringe.  There were no problems reported.  The SR# is 13050492422.  Additional information has been requested.
2hr p/vax pt devel fever;has S. pneumoniae bacteremia & sinusitis;
Client has been feeling nauseas, weak, and experiencing memory loss since receiving Moderna booster shot. Client has been continuously experiencing these symptoms for the last 3 weeks with no relief.
Post vax, the patient was playing but complained that her arm was sore. She also had a temperature of 101F.
Been receiving severe abdominal pain, lower back pain and spotting exactly 1 week prior to when my period is supposed to start.   This started when I received my first COVID vaccine, and has continued for two period cycles.
Patient presented to ER with diffuse rash over body and minimal shortness of breath.  Patient received Janssen Covid vaccine the day prior.  Patient also on last day of antibiotic regimen (nitrofurantoin) for urinary tract infection.
Takotsubo Cardiomyopathy on 06/27/2021  Hospitalized and released 07/01/2021  Active, healthy, never had any prior heart issues. Happened the morning after a bike ride.
PER MOTHERS VERBAL HISTORY, SHE  NOTICED A RED RASH BILATERALLY ON EACH THIGH AFTER VACCINE ADMINISTRATION ON 11 JUNE 2020. MOTHER MADE  AN APPT TO SEE PROVIDER ON 06/15/2020 FOR PATIENT TO BE EVALUATED BY PEDIATRIC NURSE PRACTITIONER.
Pt had clinic appt with physician for follow up of hospital tests. Requested H1N1 vaccine which was given. Two days later commenced pruritic rash on trunk, back, neck, volar forearms, thighs. Saw Dr today, was prescribed BENADRYL and XYZAL to manage sx.
SEVERE ACHES AND PAINS, HEADACHE, COUGH, SLEEPLESSNESS.
No adverse effect; improperly stored rotateq vaccine administered; This spontaneous report was received from a certified medical assistant referred to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 04-NOV-2019 the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial lot # S005876 expiry date 25-NOV-2019, 1 dosage form, via oral route for prophylaxis (product storage error). The vaccine was stored at a temperature of above 47 degree Fahrenheit (F) (46.9 F) for a time frame of 37 minutes. There was no previous temperature excursion. The digital data logger was involved. The patient did not experience any adverse effects.
Sore injection site within 6 hours. Poor sleep and higher than usual heart rate the 1st night. Fatigue/bedridden the entire 2nd day. Mild fever (99.4F) at one point the 2nd day. Slept well the 2nd night. Mild fatigue the 3rd day but able to do light work.
Pentacel that was reconstituted with 0.7 mL sterile water/ reconstituted with invalid diluent with no reported adverse event; Initial information received on 02-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient to whom pentacel that was reconstituted with 0.7 ml sterile water/ reconstituted with invalid diluent with no reported adverse event whilst vaccine diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 31-May-2022, the patient received a dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) suspension for injection (dose, strength, lot number, expiry date: not reported) via unknown route in unknown administration site as Immunization.  On 31-May-2022, the patient was given diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine that was reconstituted with 0.7 ml sterile water/ reconstituted with invalid diluent with no reported adverse event (product preparation error) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
no additional AE reported; received a dose of PNEUMOVAX 23 today after they received a dose of PNEUMOVAX 23 approximately 8 to 10 weeks ago; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.   On an unknown date approximately in January 2022 (reported as 'approximately 8 to 10 weeks ago'), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, dose number, strength, lot #, expiry date and route of administration were not provided) for prophylaxis.  On 25-MAR-2022, the patient received another dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot #U027357, expiration date: 25-MAR-2023 (dose, dose number, strength and route of administration were not provided) for the same indication (Inappropriate schedule of product administration).  No additional adverse events were reported (No adverse event).
Patient called at 1430 stating development of approx 20 hives on face, arms, chest, and belly within one hour of receiving flu shot.  Took Allergan and Ventolin Inhaler at 1030 and inhaler again at 1430.  Chest feels tight (like asthma), denies numbness or tingling in lips or tongue.  Encouraged Benadryl (if able to take it) and if sx not resolved by hs encouraged ER/Ambulance for difficulty breathing and/or numbness or tingling of lips, tongue, etc.
Tachycardia; frequent palpitations (severe at times); sternal  inflammation and very frequent cracking and popping (never experienced before); sternal  inflammation and very frequent cracking and popping (never experienced before); other chest pains; upper neck and left back/left shoulder also very painful; upper neck and left back/left shoulder also very painful; Increased fatige; Increased need to urinate; insatiable thirst/ "dry mouth" sensation; insatiable thirst/ "dry mouth" sensation; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 23-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 (at the age of 23 years) (Batch/Lot Number: EP7533) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing, irritable bowel syndrome from an unknown date and unknown if ongoing. Concomitant medications included Omeprazole taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicillin and experienced drug hypersensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient reported, he experienced, following vaccination (11Apr). Symptoms persisting for 4 plus months to current date (date not specified) Tachycardia, frequent palpitations (severe at times), sternal inflammation, and very frequent cracking and popping (never experienced before), other chest pains, upper neck and left back/left shoulder also very painful. Increased fatigue, pain when breathing in fully. Increased need to urinate and insatiable thirst, dry mouth sensation. The events resulted in visit to Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received the treatment as Colchicine 0.6mg Once daily for 30 days. The clinical outcome of the event Increased need to urinate, insatiable thirst, dry mouth sensation, was recovered on an unspecified date in 2021 and remaining all other events was not recovered at the time of report.  Follow-up attempts are completed. No further information is expected.
HE COMPLAINED OF FEELING DIZZY. AND SAID "HE NEVER FELT LIKE THIS BEFORE? AND HE SAID HE DIDN'T FEEL SAFE TO DRIVE.  ON SITE EMS RESPONDED. VITALS BELOW. GIVEN WATER AND GRAHAM CRACKERS. HE WAS MONITORED. THEN GOT OUT OF HIS CAR, WALKED AROUND AND FELT WELL ENOUGHT TO GO HOME.
severe chills, headache, fever, heart trouble, muscle aches, eye pain and joint pain.
right side of my face right here my jaw line it went numb; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1, via an unspecified route of administration, administered in arm left on 27Aug2021 (Lot Number: EW0165) as dose 1, single for COVID-19 immunisation. There was no medical history. Concomitant medication included valacyclovir taken for an unspecified indication, start and stop date were not reported. The patient stated that she went to get her first vaccine last Friday (27Aug2021) and on the (name withheld), it said to call if she had any reaction or anything and she was here to report this on the right side of her face right here her jaw line it went numb for about 8 hours. The patient confirmed the date of adverse event on 27Aug2021. The event went away 6 hours (also reported) or so after she got the vaccination. She was just calling to report what happened. She was fine. She just wanted to report what happened, it went away after hours. No treatment was received for the event. The outcome of the event was recovered on 27Aug2021.  Follow-up attempts are completed. No further information is expected.
presyncope  penumonia  Cough:  SOB chest congestion and wheezing  antibiotics prednisone
I developed little itch red bumps on my body primarily my legs. At first it was a couple of them. Over time, it became more and more. I went to my dermatologist. I had photo therapy treatments. It took about 10 weeks of treatment 3x per week to clear up about 95%. It was something that was getting progressively worse at the end of March, beginning of April. Before the vaccine, there was no need for any treatments for the bumps for about 3 years. If I had the occasional bump, I'd put some ointment on it and it would be fine. I was nothing like what I experienced after the vaccine. I had also experienced what is now known as COVID arm. I went on 3/13. I went because the side effects of COVID arm were not as well known at that time and I was concerned. The doctor couldn't determine if it was related to the vaccine. I was given antibiotics. The COVID arm resolved in about 4-5 days.
STABLE ANGINA 2/6/2023 ELEVATED TROPONIN I ACUTE NON ST ELEVATION MI 3/22/2023 ELEVATED TROPONIN I