chrisvoncsefalvay/vaers-outcomes huggingface dataset:
heavy period flow; I experienced pressure and discomfort in my uterus for several days; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 30-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; #lot: EW0171) via an unspecified route of administration, administered in right arm on 28Apr2021 14:00 (at the age of 30-years-old) as single dose for covid-19 immunization. The patient had no other medical history, no known allergies and patient's concomitant medications were not reported. The patient previously received first dose of (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; #lot: EW0153) via an unspecified route of administration, administered in right arm on 05Apr2021 at 02:00 PM as single dose for covid-19 immunization and took nexplanon for birth control. Patient stated that she was very petite and have been on Nexplanon for 14 years. Patient did not receive other vaccine within 4 weeks. Patient did not have covid 19 prior vaccination. On 01May2021 08:00 AM, the patient experienced pressure and discomfort in her uterus for several days and then had a heavy period flow which lasted 7 days. While this may seem normal for some, it is not for her. Her periods are always light and spotty. She had never experienced period pain in her life. She realizes her case may be uncommon but the changes she experienced were stark and noticeable. She had a few regular periods since so she believes it was a onetime reaction, but she doesn't know for sure. Patient was not tested for covid 19 post vaccination. No treatment received for adverse events. The outcome of the event heavy period flow was recovered on 08May2021 and for remaining event was unknown.  Follow-up attempts are completed. No further information is expected.
Tested positive for COVID on December 31, 2020, Symptoms started on December 26, 2020,
Expired vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine) had resolved.            No concomitant medications were reported. No treatment medications were reported.
Erythematous rash on right deltoid extending to bicep approx 3in x 5in; warm and tender to the touch.
Monovalent COVID vaccine given on 9/6 as a booster when BiValent should have been given
She received GARDASIL 9 while pregnant; This spontaneous prospective pregnancy report was received from a 25-year-old female patient regarding herself. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. It was mentioned that she had no allergies.  On 16-DEC-2020, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), intramuscular for prophylaxis (lot# and additional dosage regimen information was not reported), while she was pregnant. The patient explained that at the time of vaccination on 16-DEC-2020, she did not know she was pregnant, therefore she answered "no" when she was asked that question. Then, on 02-JAN-2021, she found out she was pregnant, but she was told by a healthcare professional that she likely became pregnant back in November 2020. The date of her last menstrual period was reported as November 2020.
Fever starting 12 hours after injection and continuing intermittently for the following 24-48 hours. Swelling, tenderness of armpit area on injection side, fatigue, achey body
I experienced right shoulder pain the day after the injection.  On a scale of 1 to 10 the pain was a 4, the next day the pain was gone and I had no other systems.
She got her vaccine and immediately had the stinging and could feel it going up her shoulder and into her neck and felt very weak.  She then could feel that her throat was full and could still breath, and then felt herself clearing her throat and called the attendant over and she told her to take a Benadryl which they gave her.  She then waited for about 45 minutes and felt better.  She then went home and had stomach cramps which finally went away, possibly related to her nerves.  She did call her doctor who told her to take Benadryl before taking the 2nd vaccine, which her PA told her that she should wait until after she got the vaccine, so is unsure if she should or not.  She was scheduled to have the 2nd on 4/6/21 but did not get it.
It is hot and hurts; Like a welt about 2 inches from injection site; It is hot and hurts; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE WARMTH (It is hot and hurts), VACCINATION SITE URTICARIA (Like a welt about 2 inches from injection site) and VACCINATION SITE PAIN (It is hot and hurts) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (It is hot and hurts), VACCINATION SITE URTICARIA (Like a welt about 2 inches from injection site) and VACCINATION SITE PAIN (It is hot and hurts). At the time of the report, VACCINATION SITE WARMTH (It is hot and hurts), VACCINATION SITE URTICARIA (Like a welt about 2 inches from injection site) and VACCINATION SITE PAIN (It is hot and hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medication was reported.
The temperature reached was 32.2F for a total excursion time of 39 hours with no reported adverse event; MENQUADFI being administered post excursion with no reported adverse event; Initial information was received on 23-Feb-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 11 years old female patient who was being administered by meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] post excursion and the temperature reached was 32.2f for a total excursion time of 39 hours with no reported adverse event.  The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (Boostrix) for immunisation; and HPV vaccine VLP RL1 9V (yeast) (Gardasil 9) for immunisation.  On an unknown date, the temperature reached was 32.2f for a total excursion time of 39 hours (product storage error) (latency: Unknown) and on 22-Feb-2023, the patient received 0.5 ml Total dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection (lot number: U7576AB, expiration date: 28-Feb-2025, strength: unknown) via intramuscular route in the right deltoid for Immunization (immunization) post excursion with no reported adverse event (poor quality product administered) (latency: same day).  It was reported that "The caller advised the temperature dropped down to -30 degrees outside causing the building temperature and refrigerators to drop. The products involved are MENQUADFI, PENTACEL, and FLUZONE QIV NP. The temperature reached was 32.2F for a total excursion time of 39 hours. The caller requested stability data. Extended stability data covers the excursion with the exception of the MENQUADFI. The caller advised there were 3 patient to receive MENQUADFI post-excursion and reported above temperature excursion, along with 4 patients that received MENQUADFI post excursion."  No lab data reported.  Action taken: not applicable.  Outcome: Unknown for both the events  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 guidelines. 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.; Sender's Comments:  US-SA-2023SA064856:01504785
On 10/14/13: Numbness and tingling throughout arm where injection administered.  Difficulty typing and doing tasks with left arm/hand.  On 10/15/2013: Sudden and painful vomiting 4AM-8AM; Fever ranging from 100-102; Intense body ache; Intense headache; Feeling of back being broken- very bad lower back pain; Restless leg feeling- very painful- trouble bearing weight on legs or keeping legs still.
Very high fever and lethargy lasting 3 days; hard, large lump at injection site.
Ppt states a pain when she has her arm in certain position. There is no swelling and no redness at site of injection.
pt recvd vax; pruritic rash on wrists, face, arms, axillae features similar to contact dermatitis, but pt had similar rxn to prior flu shot; no exposure to poison oak or irritants;
Diarrhea, fever, chills, shaking, severe nausea, loss of appetite for 2-3 days.
Diagnosed at Emergency Room on Jan 6, 2022 via ultrasound with Deep Vein Thrombosis in lower left calf.  No other known risk factors or proximate causes identified.  I am not overweight, do no smoke, have not been on any long-haul plane flights or road trips, have been running 4-8 miles per week.
Hot flash, lightheaded, dizziness, queasiness, shakiness, blurred vision, headache for 45 minutes that started 5 minutes after administration.
Hyper salivation immediately after administration, lasted approx 30 min.  Pain in arm at injection site hot swelling significant for 1 week.  Permanent symptoms: Fatigue, brain fog, Lymphadenopathy that has lasted since vaccine- still enlarged and abnormal. Reactivation of Epstein Barr virus, Rash on back of head that has persisted ever since.
Was administered Moderna vaccine from a vial having been opened for over 12 hours; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Was administered Moderna vaccine from a vial having been opened for over 12 hours) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety disorder and Impaired fasting glucose.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Was administered Moderna vaccine from a vial having been opened for over 12 hours). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Was administered Moderna vaccine from a vial having been opened for over 12 hours) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.
Early November experienced fever, chills, muscle aches, pain which lasted a few days. Yesterday barely walking, sore throat, fever, chills/shivering, diarrhea, only gave her TYLENOL yesterday and NYQUIL last night.
Pt experienced syncope along with nausea and vomiting shortly after given vaccine. Mom stated this was his normal reaction to receiving vaccines and that she was not concerned. Pt was given water and waited 30 minutes in the parking lot to recover.  HR WNL and pt A&Ox4. Mom wanted to take him home.
Developed diffuse macular papular rash in groin on post vaccine day 1, day 2 rash covered lower extremities bilaterally from knees to ankles, day 3 rash spread to arms and torso. Is pruritic. Initially started on steroids by PCM, discontinued by Allergy, sent to Derm who diagnosed the rash as varicella rash, gave antihistamines for itching at night and cortisone topical cream.
Systemic: Cardiac Disorder (diagnosed by MD)-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Additional Details: pt felt like she had a heart attack, went to urgent care / ER, they did EKG but result was negative.
This spontaneous report was received from an office manager, and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies was provided. On 20-MAR-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9, (lot # N022728 with an expiration date in31-MAY-2020), for prophylaxis, (dose, frequency and route were not provided), that underwent multiples temperature excursions with a temperature below of 32 degrees Fahrenheit, during an unknown time frame. Digital data logger was involved. No adverse effects were reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1804USA003815; US-009507513-1804USA003816; US-009507513-1804USA003818; US-009507513-1804USA003819; US-009507513-1804USA003820; US-009507513-1804USA003821; US-009507513-1804USA003822; US-009507513-1804USA003823; US-009507513-1804USA003824; US-009507513-1804USA003769.
About 30 minutes - 1 hour after receiving the vaccine she had flushed cheeks, chills, fever, dizziness, and injection site tenderness. She is still experiencing a fever of 102.5 and chills the next day.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 02-FEB-2015 the patient was inadvertently vaccinated with ZOSTAVAX (dose and frequency were not reported) (lot # J011333 and expiry date: 13-DEC-2014) which passed expiry date. No adverse effects were reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the two reports received from the same reporter. Additional information has been requested.
Information has been received from an office manager and a physician concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On unknown dates in October 2016 (reported as "since 01-OCT-2016"), the patients were vaccinated with improperly stored VAQTA (dose and route were unknown; lot # L015460 with expiration date 20-JUL-2017 and lot # M015290 with expiration date 20-SEP-2017). The vaccines were exposed under temperature of 30.6 degrees Fahrenheit for 29 hours 30 minutes. There were no previous temperature excursions. Data Logger was involved. No adverse experience had been reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pateint noticed a "bump" on the left  side of her neck and then the next day she noticed two more bumps: one on her right side of her neck and the other on her  lower right side of her back, above her waistline. Employee reports that these "bumps" are moderately itchy at site.  Patient placed on  valacyclovir 1 g three times a day for the next seven days to treat this to treat chickenpox.
The patients left upper arm began to feel mildly itchy ~15 minutes after COVID vaccine administration to the left deltoid. The area was free from hives, redness, and rash. The patient was monitored for an extra 10 minutes. He reported that the itchy sensation had decreased and was not bothering him. He reported no other symptoms.
Swollen arm, redness, pain from injection site to elbow. Treated with ibuprofen and BENADRYL.
C/O severe headache, febrile x's 2 days, headache continued along with fever, nausea and vomiting...was taken to family physician the following Monday, and was started on an antibiotic, seemed to feel ok while on antibiotic, as soon as it was completed, became febrile again, saw MD, and was started on a second antibiotic, took a total of approx 3 weeks to be symptom free.
Rash, swollen, pink right upper arm, non tender without limitation of motion, itchy.  Keflex (250) 1 tsp TID/Motrin/Benadryl.
Tachycardia within 10 minutes of dose administration. Extreme headache, dizziness and sinus tachycardia starting 8/27/21. Later, it was diagnosed as Occipital Neuralgia. On going postural tachycardia which was diagnosed as Postural Orthostatic Tachycardia Syndrome (POTS) on 10/1/2021. It was confirmed that the above conditions are due to adverse effects of COVID vaccine at a Unknown hospital in December 2021. Patient continues to deal with the above symptoms along with positional headache which started around April 2022.
Information has been received from a physician concerning a 12 month old male who on 15-AUG-2006 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live. Subsequently, the patient developed a rash all over his body. Unspecified medical attention was sought. No outcome was reported. No product quality complaint was involved. Additional information has been requested.
Initial report received on 30 July 2013 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 14-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received the following vaccinations: PENTACEL (dose 1) lot number C4231AA received on 27 June 2012, PENTACEL (dose 2) lot number C4269AA received on 05 September 2012, and DAPTACEL (dose 3) lot number C4186AA on 01 November 2012. The subject developed a cough on 05 July 2013, approximately 246 days after the last dose, and a paroxysmal cough without a whoop on 12 July 2013. The subject also developed cold like symptoms on 05 July 2013, and posttussive vomiting and sleep disturbance (start dates not reported). Laboratory testing included positive PCR on 17 July 2013. Chest x-ray findings were negative. Corrective treatments consisted of azithromycin starting on 18 July 2013 for 5 days. The subject was not hospitalized. At the time of final contact on 23 July 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 18 days. Investigator causality assessment is not required as per protocol. This is one case out of a cumulative total of 204 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 30 July 2013. These 204 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Documents held by sender: None.
It just became a concern over the course of three or four months. I noticed I was gaining weight and losing hair. I say my bone Doctor it was a routine check up appoint. I don't want to say it was the vaccine, I just don't know. I am not trying to say one way or another I am just stated what I noticed.
The pt developed erythema, swelling, and fever two days after the vaccine administration involving the area from top of shoulder to elbow lasting 24 hrs.
AFTER REMOVING THE NEEDLE FROM, THE PATIENT, BEFORE RETRACTING, THE NEEDLE PRICKED THE IMMUNIZER'S LEFT MIDDLE FINGER
All side effects fell within normal range of effects, except around 10 am on Saturday I broke out into hives. Worst on my legs, some on my arms and hips. With Zyrtec and a bath they went away in an hour or so.
Child's guardian (grandfather) called stating child had 2 seizures and a fever of 101.7, since having flu shot yesterday (12-10-13). Tylenol brought fever down to 100.4. Grandfather stated child has history of Cerebral Palsy, Autism, and Seizures (last known seizure 2 yrs ago).
Vestibular Neuronitis/Labyrnthitis; Vestibular Neuronitis/Labyrnthitis; This is a spontaneous report from a contactable physician (Patient herself). A 42-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL3246; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 22Jan2021 09:00 as unknown single dose for COVID-19 immunization. Medical history included drug hypersensitivity, allergies to medications, food, or other products: Sulfur from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. On 16Mar2021 the patient experienced vestibular neuronitis/labyrnthitis. The adverse event resulted in Emergency room/department or urgent care visit. Therapeutic measures were taken as a result of vestibular neuronitis/labyrnthitis as patient had received Valium, IV hydration. Since the vaccination, the patient was not tested for COVID-19. The outcome of events was unknown.  Additional information has been requested.; Sender's Comments: Based on the information currently available,The casual association between the reported event "Labyrinthitis,Vestibular neuronitis   "and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Heavy heavy menstrual bleeding.  Won?t stop.  Clotting bad.  This happened to me after the second shot as well so I figured I need to report this.
Same day fever, vomit and next day diarrhea. ZOFRAN for nausea; Advised good hydration.
Client reported headache and stomachache within 10 minutes receiving Intranasal H1N1 vaccine. Pulse=104. No other symptoms reported. Was observed for 15 minutes and feeling better. Spoke to pediatrician and client allowed to leave the clinic.
31Jan91 developed increased T 102, 1Feb91 increased T 103.8, Seen by MD, Amoxicillin started
Rash on arm, trunk and neck area, swelling in facial area, elevated blood pressure. Patient went to PCP and received blood pressure medication.
problems with her fingers due to her arthritis; This is a spontaneous report from a contactable consumer (patient's husband). A 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 25Mar2021 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, reporter's wife had problems with her fingersnand she took Ibuprofen (Duexis) 800 mg due to arthritis. He stated she was prescribed to take three a day and already took one this morning but afterwards realized that it may interact with her second dose of the vaccine tomorrow. To let caller know that while there were side effects/adverse effects reported in the clinical trial study, there is not a data breakdown as far as side effects experienced by participants who were on certain types of medications. At the time of reporting, outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.