chrisvoncsefalvay/vaers-outcomes huggingface dataset:
period started significantly earlier than it should have; previous period ended 4/5/21 my next one wasn't due to start until 5/6/21. I have a very regular menstrual cycle and do not experience spotting between cycles. I started bleeding again 4/15/21 5 hours after receiving the first dose of the vaccine; had worse cramps than I have ever had the entire time that I have been menstruating; This is a spontaneous report from a non-contactable consumer. A 28-year-old 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 right arm on 15Apr2021 at 11:30 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history and did not have any allergies to medications, food, or other products. It was unknown if the patient was pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 15Apr2021 at 16:30, the patient's period started significantly earlier than it should have. Previous period ended on 05Apr2021 and the next one was not due to start until 06May2021. The patient reported that she had a very regular menstrual cycle and do not experience spotting between cycles. It started bleeding again on 15Apr2021, 5 hours after receiving the first dose of the vaccine and also had worse cramps that she ever had the entire time she had been menstruating. The patient reported that if this continued through the weekend, she would make a doctors appointment. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events period started significantly earlier than it should have, started bleeding again 5 hours after receiving the first dose of the vaccine and the worse cramps that she ever had the entire time she had been menstruating was not recovered at this time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swelling and erythema at Lt site of immunization 10 days after immunization. No signs of injection - No treatment given - Local reaction presumed to be due to VARIVAX vaccine
Within ~5 min of vaccine administration, I developed a vasovagal reaction while sitting down. Became sweaty, nauseous, and my blood pressure dropped to 85/57.  Took roughly 30 min for pulse and bp to return to normal.   Within 8 hours I developed a fever 100.5-101 degrees and body aches.
Pt received flu shot and PREVNAR13 (separate arms) at approx. 2:53 PM. Pt said she went out to dinner that night and about 8 PM when she was sitting, she suddenly felt her legs to be really sore, and after dinner she said she was very cold and shivering. In the next AM she was back to being normal. Pt came into to Rx today 11/15/14 to pick up med's and reported these side effects.
Covid arm. Large red itchy area below injection site on day 8.  Fading slowly, no longer itchy but still visible on day 28.
No adverse event, was instructed by HCP on 1/25/21 to fill out VAERS for an individual who is under 18 who was inadvertently administered a Moderna vaccine.
Outbreak of varicella lesions scattered on trunk on (Lt) side/flank dermatome (as shingles).
Gave patient Shot.  Patient stated it burned, and stated that he wasn't feeling well.  Head started to slump, and patient passed out.  Called 911.  Patient passed out 4 times including once while EMS was present.
Migraine lasting 10 days, Additional head pain similar to Bells Palsy onset.
Pt felt dizzy.  Had a syncopal event.  Recovered after 15seconds.  VSS 118/79, HR 76, RR 16.  Pt provided water and snack.  Pt had not eaten.  Pt stayed an extra 15mins/  Pt stable and discharged from vaccination site with mother.
sore throat; mononucleosis; she had a fever of 101.6; This is a spontaneous report from a contactable consumer. An 18-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 02Feb2021 (Batch/Lot number was not reported) as dose 1, single (at the age of 18 years) for covid-19 immunisation. Medical history included rash from unknown date, tired on 13Jan2021 (tired from 13Jan2021 until 14Feb2021 and she never fully recovered from that tiredness from January), sick in Jan2021, (sick middle of January for viral and was placed on Amoxicillin), and sore throat on unknown date. The patient's concomitant medications were not reported. The patient had a fever of 101.6 on 12Feb2021; experienced mononucleosis on 16Feb2021, and sore throat on an unspecified date. On12Feb2021, the patient came home and looked horrible, and they took her temperature and she had a fever of 101.6. Caller states that her daughter had a fever for the entire week, and they saw the doctor that Monday and Wednesday, and on Tuesday 16Feb2021, her daughter was tested for Mono and it came back on 18Feb2021, as positive for Mono. Caller states that she was not positive that her daughter did not have Mono back in January, because the doctors did not test for it back then. Caller states that the doctor called them today and the Strep test came back today positive for Strep S, but the doctor said that usually does not mean anything because people always have some strep in their throats, but maybe because of the Mono, it might be causing more problems. The reported states that Saturday(unspecified date), was her daughter's last day with a fever. Caller states that her daughter's fever was high on Friday, and Saturday it was lower, and Sunday was the first day with no fever. Caller states that Mono lasts a while, and she was wondering if it is okay for her daughter to get her second dose of the product tomorrow (23Feb2021), regardless of the Mono diagnosis. It was further mentioned that the patient was sick middle of January for viral and was placed on Amoxicillin, daughter does not have a fever as of yesterday. The patient underwent lab tests and procedures which included (fever) body temperature: 101.6  and strep test negative on an unknown date; on 16Feb2021, mono was positive; and on 22Feb2021, strep test was positive (Strep test came back today positive for Strep S). The outcome of the event fever was recovered on an unknown date and unknown outcome for the other events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Short Term:  Pain at the injection site that went up to my neck and down to my fingers lasting over a week.  Starting the next  day 24 hours of fever, fatigue etc.  Long Term: Constant muscle weakness and dizziness. I now stumble and lose my balance a lot.  Standing up with my eyes closed is extremely difficult. I lose my balance constantly and my legs and arms always feel shaky and weak, like I?ve just been lifting heavy weights when I have not. I?ve always had a little bit of brain fog, but now it?s exponentially worse. My memory has gotten oddly bad. I forget things I?m talking about or in the middle of doing now.
Pt presented to local ER on 5/17/01 with respiratory failure. Intubated and transferred to another hospital where he did well and was discharged home on 5/19/01. Dx was a suspected ingestion. Seen in office of 5/25/01 and doing well.
1 of 3 pts who exp a local reaction;  pt devel redness, swelling & itching @ inject site reaction; soaks applied to site; pt recovered;
Rash, UrticariaPruritus, axillary adenopathy Narrative:
Severe chills x 6 hours, fever (up to 102.5)x 18 hours, headache x 24 hours, body aches x 30 hours
pt recvd vax;crying constantly,pain & redness & swelling at site of inject; T 105;seen in er at 12pm; T then 102; discharged w/ atb; dx: cellulitis;
At 36 hours after the injection, I began to develop a skin rash, initially only on the underside of my right forearm. Over the following hours, the rash covered the entire underside of both forearms, from elbow to wrist; rash also extended from armpits down the side of the ribcage on both sides. Some rash also appeared across the ribcage and on the back, at the base of the spine down to the sacrailiac. Currently nearing 72 hours after injection.  I also experienced considerable chills and muscle/joint aches, which has improved, but which has not yet disappeared.
About 40 min after flu shot: tingling on (R) side of face and (R) arm.
This initial non-serious spontaneous case, was received on 19-Sep-2017, reported by other non-health professional, concerning a 59-year-old, adult, male patient. The patient's current condition included epilepsy since an unspecified date. The patient's concomitant medications included KEPPRA, TOPAMAX, LAMICTAL, and XANAX. On 18-Sep-2017, the patient received FLUCELVAX QIV (dose: 0.5 ml, route of administration, batch number, expiry date, trade name manufacturer name: not reported). On the same day, after vaccination, the patient experienced headache and had ADVIL (reported as 2 when headache) as treatment medication. After one hour of medication, the patient had not resolved from the headache. It was reported that, headache was not related to epileptic seizure because when the patient had a seizure he would be unaware of what was going on, but he was aware at that moment. In the evening, the patient had felt better and an hour later, the headache started again and the pain persisted but not as bad. The patient took medications (ADVIL) and slept. Next day, at the time of this report, the patient's mother stated that, the patient was better (headache was mild), but tired and was taking rest. The patient had not recovered from the event. The reporter assessed the event as non-serious.
Patient reports feeling like she has the flu, with symptoms of chills,  being achy, joint pain/stiffness, and a feeling of "pins and needles"/extra sensitive (for example can feel her hair). Started the night of dose.
Bilateral tinnitus of 8000 Hz at 20db of spontaneous onset two weeks after application of the first dose of the vaccine against COVID 19 on 03/26/2021  Treatment Methylprednisolone 4mg administered twice, in 2022 and in 2023 Emgality 120mg administered by 18 months, currently in treatment.   Result: NO resolution of tinnitus
i had gotten multiple pulmonary embolisms approxiamately 3 weeks after 2nd vaccine
+ Covid test 11/24/2021, died 12/2/2021.  Was in SNF.  Had 2 Moderna vaccines but no 3rd dose, no booster, no MAB.  Stopped dialysis and went on hospice due to too sick to complete dialysis.
Admitted to hosp w/in 24 hrs of receiving immun w/temp 104 & sz;
Inadvertently gave adult dose to 14 yr old, no reaction reported by patient or his mother
Felt lightheaded and cool.  Seen in ED and found to have platelet count of 47,000.  Later, had bone marrow biopsy which was negative.  Platelet count has since risen to normal values. 12/14/2009 and 12/24/2009  ED records for 11/14 and 11/16/2009 patient with c/o's fatigue, syncope DC DX Acute Thrombocytopenia
This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles and nerve pain. On an unknown date, the outcome of the shingles was unknown and the outcome of the nerve pain was not recovered/not resolved. It was unknown if the reporter considered the shingles and nerve pain to be related to Shingles vaccine. Additional details provided were as follows: The case was reported by patient herself. The age at vaccination was not provided. The patient received a dose of Shingles vaccine. The patient stated that, he/she got over shingles and gradually felt back to normal but still got some nerve pain, but it was tolerable. Follow-up would not be possible as no contact details available.
heart disorder; Inappropriate schedule of vaccine administered; started feeling short of breath; pain in the back and chest; pain in the back and chest; pain bone; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CARDIAC DISORDER (heart disorder) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007S21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Blood pressure high (Patient was diagnosed at the hospital) on 19-Mar-2021.    On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced BONE PAIN (pain bone) and CHILLS (chills). On 16-May-2021, the patient experienced DYSPNOEA (started feeling short of breath), CHEST PAIN (pain in the back and chest) and BACK PAIN (pain in the back and chest). On 19-May-2021, the patient experienced CARDIAC DISORDER (heart disorder) (seriousness criterion hospitalization). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Inappropriate schedule of vaccine administered). The patient was hospitalized on 19-Mar-2021 due to CARDIAC DISORDER. The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 06-Apr-2021, BONE PAIN (pain bone) and CHILLS (chills) had resolved. At the time of the report, CARDIAC DISORDER (heart disorder), DYSPNOEA (started feeling short of breath), CHEST PAIN (pain in the back and chest), BACK PAIN (pain in the back and chest) and PRODUCT DOSE OMISSION ISSUE (Inappropriate schedule of vaccine administered) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received medications for diabetes and high blood pressure however, drug names were not provided.  Company comment: This case concerns a 49-year-old male patient who missed the appointment to be given the second dose of the vaccine because of symptoms (Product dose omission). The other events show temporal association with the use of mRNA-1273 and, a causal relationship cannot be excluded. Nausea is consistent with the product known safety profile of the product. The event of product dose omission is not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: No new information was received.; Sender's Comments: This case concerns a 49-year-old male patient who missed the appointment to be given the second dose of the vaccine because of symptoms (Product dose omission). The other events show temporal association with the use of mRNA-1273 and, a causal relationship cannot be excluded. Nausea is consistent with the product known safety profile of the product. The event of product dose omission is not applicable.
Tested positive for Covid; Tested positive for Covid; This is a spontaneous report from a contactable pharmacist (Patient's mother). A 16-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 27Aug2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient on an unspecified date in 2021, tested positive for COVID. The patient underwent lab tests and procedures which included COVID test: positive on an unspecified date in 2021 tested positive for COVID. The clinical outcome for the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported Covid-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status and various other contributory factors. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and drug ineffective is : expected. The case will be reassessed further upon receipt of additional information. 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.
Headache, feeling very tired, muscle aches, nausea, symptoms lasted about 6 hours, took acetaminophen and slept
Very sore L arm, denies bruising or rash at injection site. Treated with OTC ibuprofen.
a 66 yr old female  In observation area began c/o dry throat, itchiness in eyes, diaphoresis and dizziness @17-20 minutes post Moderna COVID vaccine. Prior to this pt was interacting with RN doing V safe registration. Pt requested  Water, drank 8 ounces of water without swallowing difficulty.  Then pt became pale and requested PO Benadryl.  Per adverse drug reaction kit, 25 mg /10 ml PO Benardyl given.  Lot # 502935 exp 2/28/22 BP 146/87 large cuff on left arm -pt reported "I have high blood pressure"  Pt advised to wait additional 15 minutes. Within 5 minutes pt skin pallor resolved, diaphoresis resolved along with dry throat and eye itchiness.  Within 10 minutes pt drank another mini water bottle and again stated " I feel much better" Advised pt to call daughter from parking garage area to help assist pt to d/c. pts daughter is an RN also. Pt was able to ambulate independently though c/o feeling slightly tired stated "Benadryl usually makes me very sleepy" Pt d/c to home w/daughter @6:35 pm. Advised to call KP advice PRN any s/s worsening and to notify MD for precautions prior to second dose of Moderna scheduled. Pt agreed w/plan and verbalized understanding.
Migraine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 25May2021 14:00 (Batch/Lot number: unknown) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "diagnosed allergies" (unspecified if ongoing); "compromised immune status" (unspecified if ongoing); "respiratory illness" (unspecified if ongoing); "genetic/chromosomal abnormalities" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "obesity" (unspecified if ongoing); "Addison's disease", start date: 1995 (ongoing), notes: Addison's disease and has been on Prednisone Steroids since then. , Onset Date: 1995, Stop Date: Ongoing.; "Prinzmetal Angina" (ongoing), notes: she has Prinzmetal Angina diagnosed  2 years ago and ongoing; "Persistent AFIB" (ongoing), notes: Persistent AFIB, diagnosed 3 years ago., She has a card Heart for heart monitor and pacemaker. The patient's concomitant medications were not reported. The following information was reported: MIGRAINE (non-serious) with onset 25May2021 15:00, outcome "recovered" (28May2021), described as "Migraine".  Additional information: The patient not received any other vaccinations within four weeks. The patient was not diagnosed with Covid-19 prior vaccination. Migraine 3 days. If she did not get better, she would go to the hospital, but she did not. They had headache on the paper, but not Migraine. This was her first. She has a card Heart for heart monitor and pacemaker all prior. She was trying to stay alive.  She can't make her own cortisol and has Addison's disease.  Her adrenal glands don't work. This happened before the vaccination been since 1995. She was just a little bit mad with Pfizer. Pfizer and Bristol Meyer they keep going up on the Eliquis. She has AFIB and was a haemophiliac and needs the Eliquis. They won't let anyone get generic until 2031. She was a haemophiliac and had AFIB prior to receiving the vaccination. She said she saw where people had to check with their doctor if they have heart disease and she has Prinzmetal Angina diagnosed 2 years ago and ongoing.  Persistent AFIB, diagnosed 3 years ago and ongoing. She hates both.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Right sided pain and paresthesias to face, upper extremity, lower extremity starting 5-7 days after receiving multiple shots; painful right sided lymphadenopathy at temple, ear, anterior neck; symptoms have improved slowly but not resolved - tried NSAID's and Neurontin with limited success.
This spontaneous report as received from a other health professional refers to a 12 month old patient. On 30-JUL-2014 the patient was vaccinated with M-M-R II (lot # H011885, expiration date: 25-JUN-2014) 0.5 ml, subcutaneously, which was expired. This is one of several reports received from the same source. Additional information has been requested.
4 Days after the vaccine, I started having a burning, itchy, tingling sessions from the lower back/belly button to my ankles.  I had a red patchy rash on my lower stomach, lower back and back of my thighs.  This last for about 4 days, the rash rash on my stomach turned to scabs as if I had cuts.  Day 5 my lower stomach was extremely dry - this has last from Day 5 until today (14) it is so dry, that my skin is peeling.  Days 8-10 I had a headache that worsened each day - I take 2 aleeve on day 7 and the headache stopped.
left axillary pain, lymphadenopathy and swelling, left arm pain, left breast pain and swelling. Joint pain, body aches, headaches, tiredness
Employee received MODERNA vaccine on 12/28/2020 and had no symptoms on first day, then on 12/29/2020-2nd day employee experienced body aches, fatigue, nausea, and low grade fever-99.4, with no chills. Then on 12/30/2020-3rd day employee had body aches, and mild nausea only, by the 4th day employee feeling much better with no further symptoms.
Pt became flush and had a headache.  One side of his jaw became swollen.  Had difficulty swallowing. Went to ER. Was given 2 Benadryl tablets and observed for 1 hour.  Then pt was released.
09/06/21 The patient presents with vomiting x2 days ago with associated abdominal pain radiating to the back. Pt states that Saturday afternoon, she drank an old prune juice and had multiple vomiting episodes. Afterwards, she felt relief. She woke on Sunday with vomiting and epigastric pain that radiates to her back, bringing her to the ED. Denies fever, chills, sore throat, cough, SOB, CP, diarrhea, dizziness, HA, dysuria, and hematuria.  The onset was 2  days agoAssociated symptoms: abdominal pain, back pain, denies diarrhea, denies fever, denies chills, denies chest pain, denies shortness of breath, denies headache, denies dizziness and denies blood in stool.
On 05/16/2021 pt woke up to a rash/hives on the injection site of the left deltoid. The site was warm to the touch. This same reaction happened when the patient received her first dose back on 02/06/2021 which was also reported to VAERS at that time. She called her dr who treated this the same way as last time with a course of cephalexin. Upon completing 24 hours of cephalexin the hives and warmth seemed to slowly subside.