chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pre period symptoms, emotional and psychological symptoms are totally different; My period occurs later and lighter; My period occurs later and lighter; Dose 1: 17Jan2022; Dose 2: 31Jan2022; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received bnt162b2 (BNT162B2) on 31Jan2022 at 11:00 as dose 2, single (Lot number: unknown), at the age of 40 years, in the left arm, for COVID-19 immunisation. Relevant medical history included: "Chronic infection" (unspecified if ongoing), notes: Chronic sinus infections and "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. The patient received unspecified birth control pills. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: Unknown; Anatomical Location: Left arm; Administration Time: 10:00), administration date: 17Jan2022, when the patient was 40 years old, for COVID-19 immunisation.  The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 31Jan2022 at 11:00, outcome "unknown", described as "Dose 1: 17Jan2022; Dose 2: 31Jan2022"; PREMENSTRUAL SYNDROME (non-serious) with onset 01Mar2022, outcome "unknown", described as "Pre period symptoms, emotional and psychological symptoms are totally different"; MENSTRUATION DELAYED (non-serious), HYPOMENORRHOEA (non-serious) all with onset 01Mar2022, outcome "unknown", and all described as "My period occurs later and lighter". Therapeutic measures were not taken as a result of premenstrual syndrome, menstruation delayed and hypomenorrhoea.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient received unspecified birth control pills since age 25. Prior to vaccination, the patient was diagnosed with COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Severe chills and weekness. Started coughing severly and continued getting worse till I went into ER at Hospital. After receiving the second dose on 4/1/2021, coughing got worse again till this day. I am seeing a Pulmonologist presently.
This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 57-year-old female patient who received SHINGRIX for prophylaxis. On 30th August 2018 16:00, the patient received the 2nd dose of SHINGRIX. In August 2018, 4 hrs after receiving SHINGRIX, the patient experienced injection site pain, general body pain, muscle weakness and mobility decreased. On an unknown date, the outcome of the injection site pain, muscle weakness and mobility decreased were not recovered/not resolved and the outcome of the general body pain was unknown. It was unknown if the reporter considered the injection site pain, general body pain, muscle weakness and mobility decreased to be related to SHINGRIX. Additional information was reported as follows: The batch number and expiry date for SHINGRIX was not reported. The patient was vaccinated with SHINGRIX on the left deltoid. The patient was vaccinated with SHINGRIX at a local pharmacy. Approximately 4 hours later after vaccination with SHINGRIX, the patient experienced injection site pain, muscle weakness that is inability to lift arm above elbow. The patient also complained of body aches.
Patient received a tetanus and flu shot in left arm and a PNEUMOVAX in right arm all in one setting on 9/24/18. Healthcare professional suggested it would be best to put the PNEUMOVAX in a seperate arm, due to potential side effects that were discussed during imz consent review. Patient reported back to the pharmacy the following day (9/25) and Per patient left arm had no side effects at all, but right arm (the arm that received PNEUMOVAX) began itching around an hour after receiving the vaccine. And then that arm started progressively increasing in size and she said at around 9 to 10pm that evening arm got very swollen and was burning up. She also reported chills, arm turning rock hard, burning up in arm, and severe soreness from shoulder down to slightly above the crease of her elbow. Patient said she went to emergency room late that night, where doctor gave her liquid prednisone. Patient reported a notice in improvement in symptoms today, but not complete recovery. I re-reviewed the VIS statement again today with patient to review again that the side effects she experienced have been previously reported with this vaccine. Patient said she is continuing with oral pain relief today of tylenol or ibuprofen and I suggested using ice as well. (these again were discussed during imz consent review, but re-went over again, today).
Vaccine has not been administered >36 days after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Vaccine has not been administered >36 days after 1st dose) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient got very sick with COVID. She was in the hospital on a ventilator for a week and almost died due to COVID. She didn't get discharged from the hospital until SEP 2020.) in July 2020. Concomitant products included SERTRALINE, LOSARTAN, BENZTROPINE [BENZATROPINE] and ATORVASTATIN for an unknown indication.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Vaccine has not been administered >36 days after 1st dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Vaccine has not been administered >36 days after 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was supposed to receive her second dose in JUN-2021.  No treatment information was provided.
Patient states redness developed several inches below injection site, area was warm to the touch, sore and red. Patient stated she took some Benadryl and the area has become less red and sore with time.
Approx 48-72 hours after flumist given developed fever to 103 degrees, lasting around 24 hours plus hives on face and back lasting around 48 plus hours -note- immunization not given here. MD saw pt vaccine obtained privately by patient and not given here.
Patient called 10am 10/10/21 and sais her left arm where she had gotten her Pneumovax 23 injection was very swollen and painfil and felt like tissue even under arm and into her side was red and  affected. I asked is she had tried anything to relieve and she had not. I reccomended some antihistamine and ice and if too uncomfortable to go in to urgent care to be see if no relief.
I had intense headaches with extreme sound sensitivity to all 3 vaccines; I had intense headaches with extreme sound sensitivity to all 3 vaccines; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Mar2021 12:00 (Lot number: ER8730) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "ITP (idiopathic thrombocytopenia)" (unspecified if ongoing), notes: ITP (idiopathic thrombocytopenia); "Known allergies: Cioro" (unspecified if ongoing), notes: Known allergies: Cioro. There were no concomitant medications. The following information was reported: HEADACHE (non-serious), HYPERACUSIS (non-serious) all with onset 2021, outcome "unknown" and all described as "I had intense headaches with extreme sound sensitivity to all 3 vaccines".  No follow-up attempts are possible. No further information is expected.
heart palpitations starting 3 days later, continued 1X/daily; on day 21 had tachycardia HR 136-148 for 3 hours; on day 23 had tachycardia HR > 170 -- lasted about 30 minutes, seen at ER but had already started to come down.  After that, have not had strong palpitations or tachycardia.
5JUL91 evening took child to ER because leg swollen & couldn't walk, bad diaper rash, severe diarrhea, & vomiting, eye infect;
Information has been received from a medical assistant referring to multiple patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On multiple unspecified dates, these patients received improperly stored RECOMBIVAX HB (lot# L044707, expiration date 06-OCT-2018) (dose and route not provided). The improperly stored RECOMBIVAX HB were exposed to temperatures ranging from a minimum of 31.9F and a maximum of 35.5F for a cumulative time frame of 1 hour. No previous excursions. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
pt recv vax 1997 & devel alopecia areata on posterior scalp;tx rogaine;
red, itchy patch on back of neck. This also happened after my second vaccine + went away after 2-3 months
shortness of breath; tightness in my throat; anxious which has made the throat tightness worse.; Felt tired; nausea; fever; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), THROAT TIGHTNESS (tightness in my throat), ANXIETY (anxious which has made the throat tightness worse.), FATIGUE (Felt tired) and NAUSEA (nausea) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 vaccination: Johnson and Johnson covid-19 vaccine (Intramuscular injection and lot number 1805022) on 12-Mar-2021. Past adverse reactions to the above products included No adverse event with Johnson and Johnson covid-19 vaccine.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (shortness of breath), THROAT TIGHTNESS (tightness in my throat), ANXIETY (anxious which has made the throat tightness worse.), FATIGUE (Felt tired), NAUSEA (nausea) and PYREXIA (fever). The patient was treated with IBUPROFEN on 24-Dec-2021 at an unspecified dose and frequency. At the time of the report, DYSPNOEA (shortness of breath), THROAT TIGHTNESS (tightness in my throat), ANXIETY (anxious which has made the throat tightness worse.), FATIGUE (Felt tired), NAUSEA (nausea) and PYREXIA (fever) outcome was unknown.            No concomitant medication was provided  Patient reported that tightness feels like someone's hands are around her throat. She took 2 extra strength ibuprofen on 24DEC2021 for her symptoms, which made her feel better. She notes that this feels worse when she is stressed
PATIENT CAME BACK UP TO THE COUNTER WITHIN 20 MINUTES AND HE HAD A LUMP ON HIS ARM JUST TO THE RIGHT AND BELOW WHERE SHOT WAS GIVEN. THE LUMP WAS HARD BUT NOT RED OR WARM TO THE TOUCH. PATIENT STATED THE AREA DID NOT HURT BUT WAS A LITTLE ITCHY.  ADVISED PATIENT IF NOT HURTING TO MASSAGE AREA. PATIENT WIFE ASKED IF HE COULD ICE THE AREA AND TAKE A BENADRYL, I LET HER KNOW ICE AND BENADRYL WOULD BE FINE.
Chills started approx. 3 hours after injection lasting 5 hours, then leg aches lasting all night. Fatigue lasting for all of next day. Trouble breathing 1 time about 6 hours after injection. I have had flu vaccines every year and never had this reaction.
First dose administered 5/17/21, second dose administered outside recommended 6-week interval on 7/12/21  (56 days). No adverse events reported by patient.
Local erythema on left deltoid measuring approx. 2 1/2" in diameter and painful.
01/19/2022 COVID-19, 01/31/2022 COVID-19 BRONCHITIS.
HEART ATTACK; BIT OF GLARE IN  EYESIGHT; RAPID AND EXTREME SIDE EFFECTS; This spontaneous report received from a patient of 4 decade old, of unspecified sex and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: pre multiple sclerosis symptoms. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN)1 total was administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  The patient reported that on an unspecified date, the patient experienced the largest heart attack ever(shooting pain to back and the very intense tingling in arm), bit of glare in eyesight and rapid and extreme side effects.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart attack, shooting pain to my back, tingling in my arm/arm felt like taken bullet, bit of glare in my eyesight, rapid and extreme side effects was not reported. This report was serious (Other Medically Important Condition); Sender's Comments: V0: 20210910814-Covid-19 Vaccine Ad26.Cov2.S- Heart attack. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
On 7/02/2021, the patient received the first dose of the MODERNA vaccine.  Included in the questions was patient history- patient was allergic to various medicines including aspirin, codeine and foods containing gluten. Included in conditions were hypertension, prolapsed valve and thalassemia, as immunologic conditions. In the interview, she stated she had BENADRYL in her purse but had not taken anything and I, Pharmacy immunizer, told her to wait 30 hours in observation and that we had IV BENADRYL and EPI PEN in case of any emergency and would activate any protocol in the event of. After informing her of possible side effects such as fever, headache, nausea, vomiting, diarrhea, fatigue and to use some ice in the event of inflammation around the area of injection; we proceeded to vaccinate the patient in her left arm. On 7/09/2021 her husband came by in the morning and informed us of that the patient had vomiting that night and days 4-5 after the vaccination. Patient had facial swelling and around her eyes and took 25mg of BENDARYL x 2days. On 3pm, I proceeded to call Doctor to inform them of the incident but they did not answer. I called the patient's husband and he told me she was fine and I asked him if he had another phone or cell number to the doctor who had given the authorization for the vaccination, because I couldn't find it. To this, the patient's husband told me that the doctor was not in today and that the patient was due to see her the following Monday (7/12) or Tuesday (7/13) and would notify her.
regional reaction involving skin swelling, erythema and inflammation from injection site distally to just past the elbow, no lymphadenopathy at this time post injection day 2
Was rolling over daily and stopped suddenly.  Child took 2 months to learn to roll over again. Changes in the childs personality.  He was always laid back and easy going and became fussy and irritable.  This also last about 2 months. Child would have head shakes.  He developed short, rapid head shaking like that of someone with Parkinsons. This would occur every few days for a matter of seconds and lasted about 2 months as well.
Developed a blister type rash on 5/16 and 5/17/02. This was on her arms, legs, back, neck, face and stomach. States not itch. Then were no scabs. It went away, but on 5/27/02 it returned in the same places (approx 20 blisters). It did itch and form scabs, mother had a blister on her thumbs, shoulder, and two on her back at the time time. FMD was not sure what this rash was caused by 6/16/02.
passed out/unconscious; feel weak; dizzy; not normal; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in arm left on 26Mar2021 09:45AM (Lot Number: ER8730) as single dose for COVID-19 immunisation. The patient had COVID prior vaccination. The patient had no other medical history or known allergies. The patient's concomitant medications were reported as none. The patient did not have COVID test post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After taking the vaccine the patient waited for 15 minutes prior to departing the facility in order to make sure there was no adverse reactions. At approximately 10:15 10:30 AM the patient drove back home. After driving for about five minutes while stopped at a traffic light the patient completely passed out at 10:45, he was unconscious for approximately 2 to 3 minutes, almost crashed his car and EMT support had to be called. The patient regained his conscience but it took him over a half hour to feel 50% better. Until 8:30 PM 26Mar2021, the patient still felt weak and dizzy and not normal. No treatment was received for events. The outcome of events was recovering.
Irritable bowel syndrome; Dry eyes; occular migraines; reflux severe; This spontaneous case was reported by a consumer and describes the occurrence of DRY EYE (Dry eyes), RETINAL MIGRAINE (occular migraines), GASTROOESOPHAGEAL REFLUX DISEASE (reflux severe) and IRRITABLE BOWEL SYNDROME (Irritable bowel syndrome) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hashimoto's disease since June 2007, Raynaud's syndrome, Migraine since 07-Jan-2021, Drug allergy, Drug allergy and Drug allergy. Concomitant products included THYROID (ARMOUR THYROID) for Hashimoto's thyroiditis, ACEBUTOLOL for Premature ventricular contractions, AMLODIPINE for Premature ventricular contractions, Raynaud's syndrome and Blood pressure, CALCIUM LACTATE, CALCIUM PHOSPHATE, COLECALCIFEROL (CALCIUM & VITAMIN D [CALCIUM LACTATE;CALCIUM PHOSPHATE;COLECALCIFEROL]) and ASCORBIC ACID, ZINC CITRATE (ZINC + VITAMIN C) for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2021, the patient experienced RETINAL MIGRAINE (occular migraines) and GASTROOESOPHAGEAL REFLUX DISEASE (reflux severe). In February 2021, the patient experienced DRY EYE (Dry eyes). On an unknown date, the patient experienced IRRITABLE BOWEL SYNDROME (Irritable bowel syndrome). The patient was treated with FAMOTIDINE (PEPCID AC) at a dose of 40 mg. At the time of the report, DRY EYE (Dry eyes), RETINAL MIGRAINE (occular migraines), GASTROOESOPHAGEAL REFLUX DISEASE (reflux severe) and IRRITABLE BOWEL SYNDROME (Irritable bowel syndrome) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Colonoscopy: normal (normal) normal. On an unknown date, Endoscopy: normal (normal) normal.         Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up information received contains added events: irritable bowl syndrome, dizziness, stomach pain, reflux severe and added concomitant and treatment medication. Lab tests: Colonoscopy, endoscopy, CT scan and high resolution manometry test are  added
Pt called on the day after getting vaccine and stated they had soreness and redness and warm to the touch.  Pt went to Doctor the next day and was given a shot of steroid and antibiotic according to patient, and was told she had either an infection at the injection site, or a bad reaction to the vaccine.  Patient also stated she had a worse reaction to the J&J Covid-19 Vaccine.
Eyes dilated, blurring within 5 mins. of vaccine administration. 12:45pm 12:46pm End of 15 min med administration 12:55pm Patient report of feeling better-left site.
Pt complained of right flank pain starting 5/25/2021 and though he had kidney stone. Pt presented to office 5/27/2021 and pain on exam appeared to be more pleuritic. Pt denied shortness of breath an d pulse ox was 94%. Pt declined ER evaluation. Pt was started on xarelto 15 mg bid and STAT CT of chest was done morning of 5/28/2021 which confirmed bilateral pulmonary emboli directed toward lower lobes, moderate clot burden. Given clot burden patient was admitted for IV heparin therapy. Venous duplex of lower extremties showed no evidence of acute DVT in visualized segments though there was a possible venous valve, vessel wall scarring o a small amount of non occlusive thrombus of the left profunda vein.
Nausea, vomiting, fever, muscle aches, chills & fatigue. Fever lasted on and off for 3 days as well as GI upset.
Four hours after receiving moderna in my right arm, my left hand and arm began to quickly swell.  I had breast cancer 23 years ago and my arm did swell at that time due to removed lymph nodes.  There have been no problems since until now.  I did see my doctor and she advised that I not receive the second dose, making the final decision mine.  My hand is still swollen though slowly improving and I am wearing compressor sleeve and glove.  Had I known ahead of time that this might happen, I would have worn the sleeve and glove before receiving the vaccine.  Just sending this as an FYI.
Patient received all three vaccines.  We remained in the room for approximately 3-5 minutes after the vaccines were complete visiting and finishing up questions.  There were no signs of distress, lightheadedness or dizziness.  Patient left the room and stated to mom that her legs hurt and she was dizzy.  Mom was able to get patient to the floor safely by sliding her down the wall and laying her on the floor.  Mom stated that the patient did not hit anything on her way down nor when she was laid out on the floor.  A pillow was brought to put under the patients head and mom put patients feet above her heart.  I grabbed juice for the patient and we let her lay for a few minutes.  The team manager Dr. was brought to the patient and we then moved her to a patient room out of the hallway to assess further.  she remained with us for another 15 minutes and was able to complete a juice while sitting with mom.  She had stopped sweating, had color back to her face and no longer felt dizzy or lightheaded so the patient and mom where let go from the office.
Pt recvd vax 11FEB94 & stated injection hurt & p/vax stated felt faint & fingers on lt hand tingled; 14FEB93 felt really sick; h/a, neck pain, & soreness in arm; c/o significant shoulder pain w/difficulty moving it;
1 hour after receiving immunization, pruritis began. 2 hours after immunization, rash began covering axilla, chest and neck, back of neck. Awoke this morning with sore throat, decreased fever. Tylenol and Benadryl with improvement.
APPROXIMATELY 20 MINUTES AFTER VACCINE ADMINISTRATION, PT REPORTED THAT SHE FELT AS IF HER THROAT WAS TIGHTENING. PT STATED THAT 1 WEEK PRIOR SHE EXPERIENCED THE SAME SYMPTOMS WITH HER COVID-19 VACCINE, REPORTED SHE WAS GIVEN BENADRYL AND SYMPTOMS SUBSIDED. PT HAS EPIPEN AND ALBUTEROL PRESCRIPTION BUT DID NOT HAVE THE MEDS WITH HER. SAT PT DOWN IN CHAIR, ADMINISTERED 50 MG OF ORAL LIQUID BENADRYL AND MONITORED PT. PT REPORTED THAT HER THROAT FELT NORMAL SHORTLY AFTER TAKING BENADRYL. STAY WITH PT FOR 30 MINUTES AFTER ADVERSE EVENT TX WAS GIVEN. LUNG CLEAR TO AUSCULTATION THROUGHOUT. NO SIGNS OF DISTRESS. EDUCATED PT ON STEPS TO TAKE IF SYMPTOMS RETURN/WORSEN.  PT DENIED NEEDING TO SEEK FURTHER TREATMENT FOR SYMPTOMS AT THIS TIME.