chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Abnormally heavy menstrual cycles that last 8+ days (used to last 5-6 days). Heavy clotting spells that last hours, leading to lightheadedness/the verge of fainting. Bleeding through heavy duty tampons in less than an hour. Extreme breakouts on chin, about 10-20 blemishes when approaching menstrual cycle. Severe cramping, doubled over in pain when approaching menstrual cycle/on menstrual cycle. Period is now either early or late, never on time like it had been since I was 13 (I'm now 30).
Information has been received from a consumer concerning her 18 year old daughter with no drug reactions/allergies who was vaccinated with the first dose of GARDASIL in "June 2008". The patient was vaccinated with meningococcal vaccine (manufacturer unknown) on the same day (Lot U2566AA). "Sometime in October 2008", the patient started having seizures. The patient was jerking sometimes and showing seizure episodes. The patient had some seizure attacks in "April 2009" and "June 2009". The patient was brought to the emergency room in "June 2009" and was not admitted in the hospital. The lab diagnostics studies performed: MRI, EEG, CAT SCAN. At the time of report the patient's status was not recovered. Follow-up information was received from a registered nurse indicated the patient received GARDASIL (Lot #660387/1967U) on 16-JUN-2008. Concomitant therapy included meningococcal vaccine (manufacturer unknown) (Lot #U2566AA). Follow-up information was received from a nurse assistant indicated that the patient had an EEG which was reported as "abnormal EEG" on 05-MAY-2009. On 12-MAY-2009 the patient had a MRI which revealed "Right frontal matter hyperintensity". On 14-MAY-2009 the patient was seen by a doctor and was placed on therapy with KEPPRA 750mg BID. The patient was instructed to not drive. The patient was to repeat the EEG and MRI in 6 months. The patient was to move to another state (date unknown) and instructed to find a treating neurologist when she moved. On 18-JUN-2009 the patient went to the emergency room due to "convulsions". The patient was not admitted to the hospital. Convulsion was considered to be an other medical event. Additional information has been requested.  8/12/09 PCP records received. In for PE with normal exam. Vaccines administered.   8/24//09 Neurological consult records received DOS 5/14/09. Assessment: Focal Seizures with possible secondary generalization. Patient presents for assessment of abnormal EEG. First episode of syncope 2/09 or 3/09. Twitching of body. Blurry vision. 2 weeks ago arm began hurting, unable to feel left side of body, passed out. Shaking, 'fuzzy eyesight'. Woke up confused.
ON 9/22/2021, PATIENT CAME INTO THE PHARMACY AND RECEIVED HIS 2ND DOSE OF PFIZER VACCINE WITH HIS MOTHER. AFTER THE ADMINISTRATION, PHARMACIST CLEANED THE EXCESS BLOOD INSIDE THE INJECT-SAFE BARRIER BANDAGE ON THE PATIENT'S LEFT ARM.   DURING THE CLEANING PROCESS, PATIENT LOST CONSCIOUSNESS ON THE CHAIR FOR ABOUT 5 SECONDS. PHARMACY CALLED FOR CODE WHITE AND THE PATIENT'S MOTHER CALLED 911. WHEN HE GAINED HIS CONSCIOUSNESS, PHARMACIST NOTED THAT HIS EYES WERE DILATED, HAD COLD EXTREMITIES, AND A WEAK PULSE. HIS 1ST BP WAS 89/69 AND 2ND BP WAS 87/66. HIS HR WAS AROUND 60 FOR BOTH READINGS. HE WAS SEMI-RESPONSIVE TO SIMPLE QUESTIONS AND HAD EMESIS.   AFTER EMESIS, PATIENT WAS FULLY RESPONSIVE AND DRANK 1 BOTTLE OF WATER WITH A SNACK. THE MOTHER INFORMED THAT HE DID SOME YARD WORK FOR ABOUT 2 HOURS YESTERDAY AND HAD NO BREAKFAST TODAY. THE MOTHER DID NOT CONTINUE THE 911 CALL. PATIENT INFORMED THAT HE DOES NOT FREQUENTLY DRINK WATER. HE HAS NO HISTORY OF ADVERSE REACTIONS TO VACCINES.   AFTER 30 MINUTES OF MONITORING, HE WAS FULLY STABILIZED WITH BP OF 107/79 AND HR OF 70. PHARMACY PROVIDED 2 MORE WATER BOTTLES AND INFORMED THE PATIENT TO SIT DOWN IF HE EXPERIENCES ADDITIONAL DIZZINESS OR NAUSEA AND KEEP HIMSELF HYDRATED THROUGH OUT THE DAY. PATIENT LEFT IN A STABLE CONDITION.
Within 1 hour severe side effects:  body aches, cough (dry like asthma) , fatigue, dizziness, chills, nausea, could not  sleep, Swelling, warmth, burning swellinge first dose size of 1/2 orange.  No fever.  Second  not as severe as the first.  Body aches, muscle pain, dizziness, chills, nausea, painful  injection site not as much swelling,No fever. Blood Sugar spikes: 1/31/2021 280, 2/1/21 2112/27/21 319, 2/28/21 418. 9 days after second vaccine. Purple swelling of both feet. cellulitis rt foot pain worse in lt than rt .PCP to ER (soles, top lower legs black):  susp tibial artery occlusion lt . Heparin.  Farxiga, Ultram, baby aspirin, procardia, metformin.Possible Reynauds.Still pain discoloration and swelling.
This spontaneous report was received from a pharmacist concerning a 60-year-old male patient. The patient's pertinent medical history, concurrent conditions, and concomitant medications were not reported. The patient's drug reactions/allergies included dizziness caused by penicillin. On 22-MAR-2017, the patient was vaccinated with ZOSTAVAX subcutaneously for vaccination (dose, lot number, and expiration date were not reported for both products). On the same date after vaccination, the patient developed warm, red rash with swelling at the injection site, but he did not receive any treatment for the events. The patient sought medical attention by contacting the pharmacist, and the pharmacist declined Varicella-Zoster Virus (VZV) packet. At the time of the report, the symptoms were unresolved, the causality was not reported and it was unknown if lab diagnostics were performed. No further information was available. Additional information has been requested.
Severe shingles outbreak , April, 28,2022- still severe rash , with extreme itching as of May 10, 2022.
pain at the administration site; joint pain "everywhere", mainly on her hands, legs, arms and back; This is a spontaneous report from a contactable consumer (patient). This 81-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2020 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient experienced joint pain and pain at the administration site, asked how long it was expected to last. Patient experienced joint pain "everywhere", mainly on her hands, legs, arms and back. Patient was taking acetaminophen for pain relief, but was not getting any better. Outcome of the events was unknown. The events were reported as non-serious.  Information about Lot/Batch number has been requested.
pt had laceration to rt thumb 8JAN96 recvd Td came back to clinic 10JAN96 c/o red swollen lt deltoid
I started with fatigue day after receiving vaccine.  Last night my glands started hurting and i was short of breath wth exertion.  Today, I am extremely short of breath and pain and pressure in chest and back when I take a deap breath.I have had nausea and vomitting since i got the vaccine.  Also, my arm was sore, red, swollen, and hot
09/02/2005 - Rash noted on trunk, was given Benadryl.  Patient was seen again on 09/08/2005 to recheck, continued with rash and was also treated for right otitis media.  Prescribed amoxicillin 180 mg 3 times a day, and floxin 5 gtts, 2 times a day to each.
First shot caused left side of face to feel numb....been on and off like this since June 25th since symptoms begun the next morning while at work. This was reported to my manager and I left for home to rest that day. Left eye tears and I drool on and off since then.
No known adverse effects; An adult patient received a dose of PROQUAD; This spontaneous report was received from a Licensed Practical Nurse refers to an adult patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 10-MAY-2019, the patient was vaccinated with a dose measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant human albumin) (PROQUAD) (lot # S002496, expiration date: 23-JUL-2020) (strength, dose and anatomical location not reported) subcutaneously as prophylaxis (product administered to patient of inappropriate age). The patient did not have any known adverse effects.  Product quality complaint not involved.
LIPS WERE TINGLING.  PATIENT GIVEN STEROIDS AND BENADRYL.  RECOVERED.   ATTEMPTED TO CALL X 4 FOR F/U BUT NO ANSWER WHEN CALLED
2nd shot, exactly 4 wks after first dose.  lightheaded, fever, chills, body/joint aches, bad headache began about 6 hrs after shot on Thurs.  Temp the next morning (fri) at 0600 was 102.  Slept most of day.  Took 2 Aleve and got temp down to 100, but not lower.  Did not do much for pain or headache.  Temp went back up to 101 around 1700 Fri.  Next morning (Sat), temp was back to normal 97.8 degrees, pain and chills gone. only mild fatigue.  (First shot, only symptom was very fatigued the next day)
lymphadenopathy in the left cervical/neck area; My WBC and Neutrophils are low; My WBC and Neutrophils are low; This is a spontaneous report from a contactable Nurse.   A 46-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection Batch/Lot Number: EL0142) via an intramuscular administered in Arm Left on 13jan2021 08:00 as single for COVID-19 immunisation. Medical history included drug hypersensitivity known allergies: PCN from an unknown date and unknown if ongoing and other medical history was none. Concomitant medications included (IBUPROFEN [IBUPROFEN SODIUM]) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection Batch/Lot Number: EN9899) via intramuscular administered in arm right on dec2020 9:00 am as single dose for COVID-19 immunisation. On 12Feb2021 A month after receiving  2nd COVID 19 vaccine she developed lymphadenopathy in the left cervical/neck area. This has persisted to present.  WBC and Neutrophils were low and shr was seeing a Hem/Oncconcerns (as reported) about Lymphoma or Leukemia or autoimmune disease onset. Workup is pending. I wanted you to be aware of this data point being a possibility of adverse reaction. The patient underwent lab tests and procedures which included neutrophil count: low on 12Feb2021 her WBC and Neutrophils are low, white blood cell count: low on 12Feb2021 her WBC and Neutrophils are low. She had not tested for covid prior and post vaccination. The outcome of all events was not recovered.
hematochezia 12/1/98;lymphonodular hyperplasia rectosigmoid;milk intolerance;intermittent colic abd pain;
Pt. received Bivalent Pfizer @1030, during patients 30 min observation pt.  reported experiencing palpitations, tingling around mouth, swelling /dry mouth, some difficulty swallowing, blurry vision, not feeling like herself and some flushing "redness" on face.  EMS activated @10:56 upon assessment.  AXOx4, airway intact, no visible urticaria. VS competed Q4mins as follows 10:54-HR:115 BP:182/94 Spo2:100  10:56-HR:109 BP:180/95 SPo2:100 11:00-HR:104 BP:178/92 SPo2:100 11:04-HR: 107 BP:185/93 Spo2:100 EMS arrived at approximately 1105, pt. evaluated by EMS and facility physician transported to ED for further evaluation.
This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 12-FEB-2016, the patient was vaccinated with a dose of VAQTA (lot # L002717 and expiration date June 2017, unknown route), which was exposed to temperatures outside of the recommended range. There were no concomitant medications provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Vaccine expired.  Exp. date read as 2022-06-02.  Mistaken for 2022-06
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a male of unspecified age. 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) 1 total, dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  The patient's wife reported that, in MAY-2021 (over a month after vaccination), the patient was tested positive for COVID-19 (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 associated with product Quality complaint: 90000180494. The suspected product quality complaint has been confirmed to be not voided (meet PQC criteria) based on the PQC evaluation/investigation performed. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210547734-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
First shot - no problem. I got it on 3/13/21 by afternoon. Sometime after midnight I had mild tender right upper arm at the site of the shot. Nothing happened next day or after.   After my second shot on 4/11/21 by afternoon, felt nothing till night before going to bed. Next day waking up by 6:30 am for work, I felt waves of body pain almost head to toes. These were accompanied by chills, later I felt little feverish. I took two Ibuprofen pills twice throughout the day that might have made me feel better which is why I could work. Till I slept I was quite down. Today on 4/13/21 I feel much better. Still bit fatigued but none of the severe pains or chills I went through on 4/12/21. Hopefully I won?t have to go through them anytime anymore.
I slept for a full day after the 2nd dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 31Mar2021 11:58 (Lot number: ER8732, Expiration Date: Jul2021) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "heartburn" (ongoing); "Allergies" (ongoing); "blood pressure" (ongoing). Concomitant medication(s) included: TENORMIN taken for blood pressure abnormal, start date: 03Mar2021 (ongoing); HYDROCHLOROTHIAZIDE taken for blood pressure abnormal, start date: 03Mar2021 (ongoing); CLARITINE taken for hypersensitivity (ongoing); PROTONIX [OMEPRAZOLE] taken for dyspepsia, start date: 03Mar2021 (ongoing). Vaccination history included: Bnt162b2 (Anatomical site of injection: Left upper arm, Route of administration: Intramuscular, Batch/Lot number: EN6202, Expiration Date: Jun2021, Time: 11:52 AM), administration date: 10Mar2021, when the patient was 59 years old, for COVID-19 immunization, reaction(s): "Both sides of her Face, lips and tongue went numb", "Both sides of her Face, lips and tongue went numb", "Tongue tingled". The following information was reported: HYPERSOMNIA (non-serious), outcome "unknown", described as "I slept for a full day after the 2nd dose". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Pt has no previous history of Hypertension, Hyperchlorolemia, Chest pain, and IMZ adverse reaction. This pt received FLUAD this morning. Within 15 minutes of flu shot, pt expressed severe chest pain, lower back pain. His BP was 186/95 HR 85. He was in panic and worried about his symptoms might be related with flu shots. We called 911. However, after I gave him 5ml of Benadryl oral solution, 81mg of aspirin chew tablet, 650mg of Tylenol ER, pt stated he felt much better and requested us to cancel 911 which we did. I checked his BP again15 min later, it went down to 182/100 HR 82 but still very high. I consulted with Dr. on pt's symptoms. Dr. advised me to give 1 tablet of NTG0.4mg sub lingual tablet with 30 min observation. I went over possible side effects of NGT and asked pt if he would like to take it. Pt agreed to take it. 30 min after I gave 1 dose of NTG 0.4mg Sub tablet, I re-checked his bp. BP went down to 154/83 HR 85. After his symptoms completely resolved, pt stated that he injured his lower back last night and he has been having stomach problem so he has been self medicated with Tums at home. But he doesn't know why he got the sudden pains. He stayed another 30 min in the store and left with lingering no symptoms.
no adverse event; Pharmacist called in to report that a female patient was inadvertently administered one dose of MMR II on 03/29/2023 and one dose of MMR II today 03/30/2023.  The lot and expiration that is documented represents the dose that was administered on toda; This spontaneous report has been received from a pharmacist, concerning a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions, and allergies were not provided.   On 29-MAR-2023, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) subcutaneous injection as prophylaxis (strength, dose, route of administration, anatomical location, lot number, and expiration date were not provided). Consequently, on 30-MAR-2023, the patient received another dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) subcutaneous injection as prophylaxis (lot number W034592 has been verified to be valid; expiration date reported and established as 10-MAY-2024) (strength, dose, route of administration, and anatomical location were not provided) (inappropriate schedule of product administration). No additional adverse events were reported.
I started to have uncontrollable seizure like tremors only on the left side of my face with slurred  speak.
Patient had shivers and body was shaking. No known fever. Last about an 1/2 hour.
Per wife - 2 days after vaccination, the patient became weak and tired. His wife reports that he started to have rapid, shallow breathing and crackling when laying down. A week later he tested positive for Covid-19. He is currently in the hospital since 10/27/21 with Covid pnuemonia, renal failure, and a blood clot. The wife reported the events to us today due to the blood clot since she thought it might be from the vaccine.  He is currently still in the hospital per her reporting.
Rash around injection site, painful lump, swollen and feels warm. Did not show up until 8 days after injection.
Received shot and had numbness that travel from (RT) arm up to neck - next day could not move arm, and increased pain up to neck. Went to doctor and was admitted into hospital on Tuesday --> Sat. Came home still has no use of arm - has to go to pt. Ended up with pneumonia as well.
Approximately 24 hours after my booster shot I experience the following symptoms: Intermittent chest pain, and painful joints - I took Tylenol and Ibuprofen for treatment the symptoms lasted for a couple of weeks and gradually went away.
Began to receive intense itchy bumps and red lines and hives all over my body, some raised some flat. They come and go randomly it seams, most noticeable after showers and at night. I have not changed any of the products I am using around my house or while showing. I began taking Benadryl tablets and received mild relief. My doctor has also prescribed 2 full steroid treatments of prednisone that have been ineffective. He also had me taking two different antihistamines that I do not know the name of. I am starting a new one tomorrow 2/21/22 and will see the Dr. on Thursday to follow up.
bad headache, high fever, body ache, no energy, slept all day/night      Now brain fog , blurred vision low energy
Initial misuse report received from a healthcare professional on 18 September 2013. Three patients received less than 0.5 ml dose of FLUZONE due to leakage from luer lock hub with Ter sumo safeguard 25 GA 1" needle. (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none
sensitive stomach; wiped out; spend 3 hours through the night going back and forth to the bathroom. didn't throw up; terrible terrible pain/valve movement; Diarrhea; sore arm; most severe stomach pain/stomach cramps; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), ABDOMINAL PAIN UPPER (most severe stomach pain/stomach cramps), PAIN (terrible terrible pain/valve movement), ABDOMINAL DISCOMFORT (sensitive stomach) and DIARRHOEA (Diarrhea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical information was provided by the reporter .  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and ABDOMINAL PAIN UPPER (most severe stomach pain/stomach cramps). On 21-Feb-2021, the patient experienced PAIN (terrible terrible pain/valve movement), DIARRHOEA (Diarrhea) and NAUSEA (spend 3 hours through the night going back and forth to the bathroom. didn't throw up). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (sensitive stomach) and ASTHENIA (wiped out). At the time of the report, PAIN IN EXTREMITY (sore arm), ABDOMINAL PAIN UPPER (most severe stomach pain/stomach cramps), PAIN (terrible terrible pain/valve movement), ABDOMINAL DISCOMFORT (sensitive stomach), DIARRHOEA (Diarrhea), ASTHENIA (wiped out) and NAUSEA (spend 3 hours through the night going back and forth to the bathroom. didn't throw up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient spent about 3 hours going back and forth to the bathroom but didn't throw up.  Concomitant medication also included blood pressure pill.  No treatment information was provided.
Hives/rash on back, stomach, legs and arms.  Dr. prescribed Triamcinolone 0.1% cream and an epi pen in case for the second shot
Redness, swelling, warmth at inj. site. Cellulitis at inj. site. Treated with Sxs care, KEFLEX 500 # 2 bid x 10d.