chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ongoing variability in menstrual cycle; started period again today after 2 weeks; bled all of January; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (ongoing variability in menstrual cycle), POLYMENORRHOEA (started period again today after 2 weeks) and HEAVY MENSTRUAL BLEEDING (bled all of January) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A and 033C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced HEAVY MENSTRUAL BLEEDING (bled all of January). On 15-Feb-2022, the patient experienced POLYMENORRHOEA (started period again today after 2 weeks). On an unknown date, the patient experienced MENSTRUAL DISORDER (ongoing variability in menstrual cycle). At the time of the report, MENSTRUAL DISORDER (ongoing variability in menstrual cycle), POLYMENORRHOEA (started period again today after 2 weeks) and HEAVY MENSTRUAL BLEEDING (bled all of January) had not resolved.            No concomitant medication was reported. The patient experiencing ongoing variability in menstrual cycle to the point where it was unacceptable. Had followed up with OBGYN to do ultrasounds looking for cause. No attributable cause. She reported to V-safe. It had been stated that wanted to report to AE hotline feels "it needs to be taken more seriously by Moderna" States she was frustrated because she bled all of January said just started period again today after only 2 weeks.  No treatment medication was reported.   This case was linked to MOD-2022-483629 (Patient Link).
pt recvd vax & cried a little, fell asleep in car & into house; woke 1/2 hr later started to cry, given APPA started to cry; cont to scream & cry; fever 101 R; cried alot for 3 days;
fainted many times; ongoing diarrhea; This spontaneous case was reported by a non-health professional and describes the occurrence of SYNCOPE (fainted many times) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001c21a) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On an unknown date, the patient experienced SYNCOPE (fainted many times) (seriousness criterion medically significant) and DIARRHOEA (ongoing diarrhea). At the time of the report, SYNCOPE (fainted many times) outcome was unknown and DIARRHOEA (ongoing diarrhea) had not resolved.            Action taken with mRNA-1273 in response to the events was not applicable.  Concomitant and treatment information were not provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pt received a third dose of Shingrix (first two doses were given in 2018)
Pt. admitted on 23 jan 21 with AMS, Chest pain; Shortness of breath.  He was discharged on 21 Jan 21
Headache starting Saturday night following injection, lymph node swollen. Temperature at 38.1 at 1:45 on 5.9 Sunday. Temperature was 38.4 at 7:30 in the morning, with high heart rate of 110-120 bpm resulting in intermittent chest discomfort. Highest temperature was at 39.5 at 20:00 Sunday. Temperature fluctuates from 38.1 to 38.5 on Monday from 06:50 to 13:00, with HR at 105 bpm.
AFTER ADMINISTERING THE PAPILLOMA VIRUS VACCINE (GARDASIL), THE PATIENT PRESENTED WITH DIZZINESS, TREMBLING AND EYE DEVIATION.
Dizziness, Disorientation, Visual Disturbances (looked like looking through a bubble), Throat swelling, tongue swelling
Patient came to the pharmacy 1 month after shot complaining of sore arm, stating after the shot her arm was hurting to the point where she couldn't use it. Advised to take OTCs and go to MDs office is issues persist.
Red bump at site of injection; Nausea; Headache; Tiredness; dark mark on my skin where the redbump was and it's been three weeks; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Mar2021 at 14:00 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. No relevant medical history. Concomitant medications included sertraline hydrochloride (ZOLOFT) and trazodone (MANUFACTURER UNKNOWN) started from unknown date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. On 15Mar2021 at 14:15 the patient experienced nausea, headache, tiredness and red bump at site of injection(vaccination site erythema). She also had a dark mark on her skin where the red bump(vaccination site lump) was and it had been three weeks. The patient did not receive any treatment for the events. The events did not result in any of these doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event nausea, headache, tiredness, red bump at site of injection and a dark mark on her skin where the red bump was recovered on unknown date in 2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained
After 12hrs of covid vaccine 2nd shot i feel dizzy and tired/fatigue then feeling cold,feverish  and having body aches and headache.i just rest in bed and took advil that night and tylenol on the 2nd day.until now on and off feeling fatigue,body aches, headache and fever.
I woke up at 7:00am on 12/28/22, not feeling well, I was tested for COVID-19, the test came back negative. I was given antibiotics. On the December 31, 2022, I felt like I had been punched in the face, I used a home COVID-19 test, that came back positive. I went to the Local Urgent Care, they retested me, their test also came back positive. They did not prescribe any medication because I am taking statin medication. I was told to rest, get plenty of fluids and rest. I was sent to a pulmonologist by PCP as I was left with wheezing after getting over COVID-19. The pulmonologist has prescribed a nebulizer and an emergency inhaler, and another inhaler.
Injection site feeling warm to the touch; Redcircle about two inches at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site feeling warm to the touch) and VACCINATION SITE ERYTHEMA (Redcircle about two inches at the injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Injection site feeling warm to the touch) and VACCINATION SITE ERYTHEMA (Redcircle about two inches at the injection site). At the time of the report, VACCINATION SITE WARMTH (Injection site feeling warm to the touch) and VACCINATION SITE ERYTHEMA (Redcircle about two inches at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow up received on 09 Aug 2021 and updated outcome of events to recovered.
Initial reaction was noted on 03/22/21, pt reports she developed GI complaints, nausea, diarrhea which lasted for one day. Then the next day she developed nerve pain, and felt fatigue and exhausted, felt like a recurrence of the shingles, states the neuropathy effected the same area as before, to the left of chest, ribcage, and back. This lasted for 1 week, then had a couple of days where she felt better, then developed a rash to the upper back and shoulder blades on 4/6/21.
Only Tylenol dose 2 - patient experienced pain hot flashes and burning sensation in mouth and throat with heartburn.  Symptoms were more severe, awakened from sleep.
The day after vaccination with MENACTRA student reported experienced itching and hives on her stomach and back to mom later in the day.  Mom called our facility.  At 4:30-5pm spoke with nurse and doctor.  Advised to go to Urgent Care and come back the next day if necessary. Didn't go to emergency care but took Benedryl.  Rash cleared up in intesity but shifted from trunk to thighs, arm pits, back. Student later reported that she also had slight sore throat and congestion on the day after shot, but this cleared up with antihistamine.
QUADRACEL was administered to an 11 year old patient for catch-up immunizations with no reported adverse event; Initial information received on 08-Feb-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 years old female patient who was administered DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (Quadracel) for catch-up immunizations with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis B Vaccine (Hepatitis B Vaccine) for Prophylactic vaccination; Measles Vaccine, Mumps Vaccine, Rubella Vaccine (MMR) for Prophylactic vaccination; and Varicella Zoster Vaccine (Varicella Vaccine) for Prophylactic vaccination.  On 05-Jan-2022, the patient received a dose of 0.5 ml of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (formulation, strength: unknown) lot C5862BA, expiration: 01-Apr-2023, via intramuscular route in the left deltoid.  On 05-JAN-2022 the Quadracel was administered to an 11-year-old patient for catch-up immunizations with no reported adverse event (product administered to patient of inappropriate age) same day following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  Action taken was 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.
FEVER STARTED FIRST (101), THEN "FAINTED" 04/16/14 AT 08:00 A.M., FOR BRIEF PERIOD, "HIT HEAD AGAINST WALL" PER HUSBAND, RECOVERED QUICKLY. STILL HAS FEVER 04/17/14, 99.9 AT 11:00 A.M. PER HUSBAND. MAIN COMPLAINT IS ARM IS HARD AND SORE, DOES NOT WANT TO TOUCH IT. HAS BEEN TAKING TYLENOL.
Tinnitus (ringing of the ears) that started no later than 2 hours post injection. Left ear pain that started no later than 2 hours post injection. Pressure in left ear that leaves a popping sensation weekly.  Best described as the popping from pressure changes in altitude & after a flight.  Tinnitus (ringing of the ears) in both the left and right ears daily - this has not stopped since the injection.  Lastly, I can tell that my hearing has decreased all around through these symptoms.  I was put on a steroid to reduce the pressure in my left ear but there is currently not a cure for tinnitus.
PATIENT FAINTED ABOUT 10 MINUTES AFTER RECEIVING PFIZER COVID 19 VACCINATION. HE WAS UNRESPONSIVE BUT BREATHING AND PULSE REGULAR. KEEP TRYING TO ROUSE AND PUT COLD CLOTH ON NECK AND PATIENT TRIED TO PUSH AWAY. WANTED TO KNOW WHAT HAD HAPPENED AND WE TOLD HIM HE HAD FAINTED AFTER GETTING HIS VACCINATION. I TOOK HIS BLOOD PRESSURE AT 4:46 AND IT WAS 126/53 . HE DRANK SOME WATER AND MY TECH ASKED HIM QUESTIONS ABOUT WHAT DAY IT WAS AND HIS BIRTHDAY AND HE WAS ABLE TO ANSWER CORRECTLY. HE WAS VERY PALE AND GLASSY EYED. TOOK BLOOD PRESSURE AGAIN AT
Approx 2 min after vaccine pt became red-hives, sl swelling in area rash. No resp distress, no drooling.
The patient was to receive Flucelvax and instead received Fluad 65+. Information was looked up and evidence by research and manufacturers the patient experimented stronger local side effects due to the vaccine.
Approx 8 hours after injection I woke with fever, chills, body aches, nausea and vomiting. I ran a fever for approx 36 hours. Pain, redness and swelling around injection site (approx 3"x3" area) also warm to the touch.  An itchy rash has developed around the injection site 6 days after injection. It is also sore and warm to the touch.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 at 12:00 as dose 5 (booster), single (Lot number: GH9693) at the age of 66 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Doxycycline, reaction(s): "known allergies: Doxycycline"; Codeine, reaction(s): "known allergies: Codeine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 07Sep2023 to 12Sep2023.
This spontaneous report as received from a licensed vocational nurse refers to an unspecified number of patients of unknown age and gender. There was no information about patients' pertinent medical histories, concomitant medications and drug reactions or allergies provided. On an unknown dates, the patients were vaccinated with an improperly stored dose of GARDASIL 9 (lot# L018351, expiration date 11-AUG-2017, dose, anatomical location and route of administration were not reported). The vaccine was exposed to the temperature 9 Celsius degree for 10 minutes. No previous temperature excursion was reported. No adverse symptoms reported. Additional information has been requested.
On 11/25/2001 the patient states she was ill with muscle aches, felt feverish, sneezing, sore throat and green nasal secretion. The patient states she was feeling better on 11/25/2001. On 11/26/2001 the patient made a follow up phone call and states she is at work and feels better.
MMR vaccine given left deltoid area: immediately afterwards. Localized erythema, mild swelling. Size of a lime. Benadryl 1 tsp given. Patient monitored far 45 minutes.
Information has been received from a 30 year old female pharmacist with no pertinent medical history and no known drug reactions/allergies, who on approximately 01-OCT-2010, in early October 2010, was vaccinated IM with a 0.5ml dose of MMR II (Lot number not provided). There was no concomitant medication. The pharmacist reported that she was vaccinated and she experienced pain at the injection site for the whole day. The patient did not seek medical attention. No treatment was provided. No lab diagnostic studies were performed. At the time of the report the patient had recovered (date unspecified). Additional information has been requested.
The fist 48 hours had a sore shoulder. On the 7 1/2th day I felt a pinching sensation, slightly sore at injection point. This morning I noticed the injection site red and slightly more sore than usual.
Left side of neck I had two small lumps, it is been a month since vaccination and I still have the lump; This is a spontaneous report from a contactable other hcp. A 30-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 16Mar2021 12:30 (Batch/Lot Number: 59267-1000-02) (at the age of 30-years-old) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other medications within 2 weeks of vaccination. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Patient did not have Allergies to medications, food, or other products . On an unspecified date patient experienced , on the neck part of the left side I got two balls, it's been 1 month of the vaccine and I still have a ball, talk to the pharmacy and they told me it was part of a mammogram, that to think that's nothing to do with what came out. The patient underwent lab tests and procedures which included mammogram of unknown results . Patient did not receive any treatment for the adverse event. Outcome of the event was Not recovered/Not resolved.  No follow-up attempts are needed. No further information is expected.
patient experienced multiple satellite lesions on neck/shoulders/back/chest/arms suddenly appearing on day 12 after vaccination.  He had only been instructed to wear a shirt to cover the vaccine site.  Patient was otherwise doing well with no systemic symptoms.
PT BEGAN WITH MILD ITCHING THAT PROGRESSED.  PT GIVEN 50 MG PO BENADRYL AND SX RESOLVED REQUIRING NO FURTHER INTERVENTION.  VSS. PT ABLE TO BE DISMISSED HOME/ENCOURAGED RIDE
angioedema to lips; generalized hives (legs, arms, back, stomach); This is a spontaneous report from a contactable consumer (patient). An 18-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 27Apr2021 17:00 (Lot Number: ER8736) at the age of 18-year-old at a single dose for covid-19 immunisation. The patient was not pregnant. The patient medical history included mitral valve defect, seasonal allergies and allergies to peanuts, nuts, goldfish and cheez it crackers. Concomitant medications received in two weeks included minocycline; loratadine, colecalciferol (D3) and multivitamin gummies once a day, these medications taken for an unspecified indication, start and stop date were not reported. No other vaccine administered in four weeks. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 05Apr2021 10:30 (Lot Number: EW0150) at a single dose for covid-19 immunisation. The patient experienced angioedema to lips and generalized hives (legs, arms, back, stomach) on 28Apr2021 03:00 and received benadryl 25 mg, then claritin 20mg later in afternoon as treatment. The patient did not get covid prior vaccination and no covid test post vaccination. The outcome of the events was recovered in Apr2021.
Information has been received from a registered nurse concerning a 5 year old male with no pertinent medical history or drug allergies, who on 02-MAR-2007 was vaccinate with the first 0.5 mL SC dose of varicella virus vaccine live (Oka/Merck) (Lot# 656070/1492F) in the arm. Concomitant therapy included Zyrtec and montelukast sodium (MSD). On 27-JUL-2007 the patient developed breakthrough chickenpox and presented with 16 insect bite-like lesions all over his body. Unspecified medical attention was sought. No labs or diagnostic studies were performed. Subsequently, the patient recovered. There was no product quality complaint. Additional information has been requested.
Internal tremor with paresthesia in all limbs, stabbing pain ininterscapular area, blood pressure fluctuation; This is a literature report for the following literature source(s).  An adult female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's family history included: "Systemic lupus erythematosus" (unspecified if ongoing), notes: autoimmune diseases. The patient's concomitant medications were not reported. The following information was reported: NEUROLOGICAL SYMPTOM (medically significant), 10 hrs after the suspect product(s) administration, outcome "unknown", described as "Internal tremor with paresthesia in all limbs, stabbing pain ininterscapular area, blood pressure fluctuation". The patient underwent the following laboratory tests and procedures: Heart rate: Unknown results; Immunohistochemistry: Unknown results; anti-C1q: Unknown results; Unknown results; Unknown results; Unknown results; Unknown results; Unknown results; Magnetic resonance imaging head: Normal brain and lumbar spinal cord; Neurological examination: Normal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association be-tween the event and the suspect drug cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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. ,Linked Report(s) : US-PFIZER INC-202200764439 Same article/ drug and different patient/event
Case number PHEH2013US008330, is an initial spontaneous report received from a pharmacist on 09 APR 2013. This report refers to an unspecified age and gender patient. The patient received only Men C, Y, W-135 liquid conjugate component of MENVEO, batch number: not reported) intramuscularly  without being reconstituted with Men A on an unspecified date. It is reported that an extra Men A lyophilized powder vial is left out in the refrigerator, which led them to conclude that a medication error occurred. No adverse event was occurred following this administration error.
Patient got Moderna (Lot: 037A21B) for her first dose and came back in 4 weeks for dose 2. That day our vaccination clinic was doing  both Moderna and Pfizer dose 2. I, the provider, was told by the front staff that the next cycle/room of patients were all Pfizer patients. The patient received a Pfizer dose (Lot: ER8735) with the rest of the room and the mistake was noticed after receiving her card to fill out. In the 30 minutes that the patient was there after the vaccine, she experienced no symptoms or side effects. Before patient left, she was told of all side effects and to seek out medical care if she were to experience any adverse side effects such as severe headaches, shortness of breath, chest pain, paralysis, or etc..