chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Accelerated heart rate through the first day. Unbearable itching from ankles through to scalp.  Legs, core, back, shoulders, neck were the worst areas.  The itching caused welts and scabs. Started over the counter Benadryl  both oral and topical on 10/30 in the am.  Called doctor office and started other medication on Monday 11/1 in the am to be taken for 5 days.  At the end of 5 days the symptoms were slightly better, but itching persisted.  Contacted doctor again 11/5 and currently under another dose of 3 different drugs.  Symptoms are starting to improve, welts / scabs are still present in a few areas.
Severe fatigue, nausea, diarrhea, unable to get out of bed; occurred < 24 hours after 2nd covid vaccine.  Other symptoms I noticed after the vaccine - 1 month later - parotid gland infection Left side; arthritis in hands developed Left middle finger pain - never had before; Parotid gland infection resulted in visits to a dentist, ER, ENT physician to diagnose. Very expensive. I also had a recurrence of the parotid gland infection 3 months after initial infection. After receiving the Pfizer booster in December, my heart has been skipping beats and bounding; intermittent pain in my left hand.
Patient called on Nov 11, 2021 and said that she had a lot of pain in the shoulder and also the neck.  Patient did state that she thinks that the shot was given higher in the arm than she suspected and she had not had a shot hurt as much as this before.
Very heavy period when I had period during my booster shot, then the month after my period started light and became extremely heavy for several days, total period lasted 12 days as opposed to the usual 7 for me. Had a similar experience at dose 2 of moderna vaccine in the spring but the booster seemed to be a lot worse
PT ADMITTED TO ER ON 1/8/23 FOLLOWING WEEK LONG PAIN AND DISCOMFORT: EYES, CHEST. DISCHARGED WITH DIAGNOSIS OF TRANSVERSE MYELITIS (SUSPECT VACCINE INDUCED)
Loss of vision; pain down back; impaired ability to move; This is a spontaneous report received from a contactable consumer, the patient. A female patient (over 50) of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced loss of vision, pain down back after second injection and impaired ability to move. The patient was tested for MS after all symptoms came back negative. Outcome of the event was unknown.  Follow up attempts needed. Further information is expected.
redness and swelling in the area of the injection, increasing heat and pain, glands swollen under arm of injection arm on day 2, Day 3 redness spread further away from the injection site and increased in redness, upper arm became very itchy and sensitive to touch, day 4 arm became swollen down to below the elbow and biceps area, applied cold compress to relieve discomfort.  Researched and day 5 took one antihistamine in a.m. and helped with the itchiness, swelling has come down a small bit, still very warm to the touch.    Continuing course of cold compress and antihistamine daily.
Approximately 27 hours after receiving the injection I had approximately 15 minutes of uncontrollable shaking. I stopped when I got into a hot shower. I also had a headache and muscle aches and pains the day after the injection. Approximately 72 hours after the injection I developed ringing in my ears and it is continuing now.
many unusual cloths in the menstrual blood.; Bleeding since ovulation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Apr2022 at 16:00 as dose 3 (booster), single (Lot number: FK9895) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety/ depression" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "Endometriosis" (unspecified if ongoing); "Covid" (unspecified if ongoing); "Interchange of vaccine products" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT; LEVOTHYROXIN. Vaccination history included: covishield (Dose 1, Product: COVID 19, Brand: Covishield, Lot number: 215VCD126Z, Dose administration time: 04:00 PM, Vaccine location: Left arm), administration date: 08Jun2021, when the patient was 38-year-old, for Covid-19 immunization; covishield (Dose 2, Product: COVID 19, Brand: Covishield, Lot number: 217VCD243Z, Dose administration time: 12:00 PM, Vaccine location: Left arm), administration date: 31Aug2021, when the patient was 39-year-old, for Covid-19 immunization. The following information was reported: INTERMENSTRUAL BLEEDING (non-serious) with onset 11Apr2022 at 08:00, outcome "not recovered", described as "Bleeding since ovulation"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 11Apr2022 at 08:00, outcome "not recovered", described as "many unusual cloths in the menstrual blood.". Therapeutic measures were not taken as a result of heavy menstrual bleeding, intermenstrual bleeding.  Additional information: The clinical course was reported as the patient had not other vaccine in four weeks. Patient had received other medications in two weeks with Zoloft and levothyroxine. The patient had covid prior vaccination and had not covid tested post vaccination. Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Pt given dialysis formulation of Hep B (recombinant) vax 16NOV90; Lab eval on 20NOV90 revealed Hep B surface antigen positive & anti-HBs antigen negative; Repeat lab eval on 01DEC90 revealed HBSAG & anti-HBs both negative;
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore time to time) and VACCINATION SITE SWELLING (a hard bump and swollen left arm,) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029f21a, 038r21a and 046a21a) for COVID-19 vaccination. No Medical History information was reported.On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Dec-2021, the patient experienced VACCINATION SITE PAIN (sore time to time). On 05-Dec-2021, the patient experienced VACCINATION SITE SWELLING (a hard bump and swollen left arm,). At the time of the report, VACCINATION SITE PAIN (sore time to time) and VACCINATION SITE SWELLING (a hard bump and swollen left arm,) outcome was unknown.Concomitant medication was not provided. Treatment information was not provided. Patient stated side effects experienced after getting the Moderna covid19 Booster was normal and wasn't like a blood clot.
Patient waited 15 minutes after vaccination in drug store afternoon of 4/2/21, then departed.  Headache began shortly after leaving.  He returned to work, and began feeling fatigued, light-headed, and nauseous.  His right arm was swollen and "solid" from the elbow up.  He proceeded to emergency department.  Blood pressure was 198/118.  Emergency department staff drew labs, and said he was dehydrated, hypocalcemic and hypokalemic.  Patient had also forgotten to take his blood pressure medication that morning.  Reports no dyspnea or rash.  He said he felt fine Monday 4/ 5/21 afternoon.
Onset of symptoms started 8/28-/8/29, and worsened 8/30 to vomiting, rapid heart rate and tightness in chest, fever, fatigue, and aches. Since then heart rate has been erratic and fluttering. Symptoms seemed to ease gradually around 9/13, and are continuing to improve through the month. Heart monitor was ordered.
Initial injection administered was empty syringe, resulting in pain and bleeding at injection site. Error was identified immediately and actual injection was administered into left arm.
A patient received a shingrix shot from our pharmacy on 11/3/22. She had a typical reaction of redness, and swelling at the injection site.   These side effects resolved within the normal 2-3 day range.  However today the injection site is itching, swollen and red to her elbow.  She does not have a fever or trouble breathing.  I advised her to follow up with her doctor in the morning.
Patient was administered a 3rd full dose (0.5ml) instead of 0.25ml and it was administered 1 month after second dose instead of 5 months post 2nd dose.  Patient reported a slight fever but nothing else.
ON BOTH 1ST INJECT(3-21-90) AND 2ND INJECT(4-25-90) PT E6PER SAME DAY DIZZINESS AFTER INJECTION. NO TREATMENT GIVEN. DIZZINESS WENT AWAY AFTER 1ST INJECTION BUT OUTCOME OF 2ND NOT KNOWN.
Pt called a few hours after receiving vaccine and reporting tightness in chest and SOB. She was instructed to call 911 for a suspected anaphylactic reaction. We made 2 calls each day to pt and were unable to reach her until 9/17, at which time she reported she did not seek medical attention and was feeling normal
arm sore; fever; extreme body aches; headache; tiredness; slept alot; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EWO153) via an unspecified route of administration in the left arm on 09Apr2021 at 16:15 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high, thyroid and COVID-19. The patient did not have any known allergies. The patient received unspecified medications within two weeks of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 22:00, the patient experienced arm sore, fever, extreme body aches, headache, tiredness, slept a lot and felt like her COVID that she had. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events arm sore, fever, extreme body aches, headache, tiredness and slept a lot were recovering at the time of this report.    No follow-up attempts are possible. No further information is expected.
Patient received 0.25mL booster dose of Moderna COVID-19 vaccine on Friday October 29, 2021 at 2:16 PM. She initially received the Janssen COVID-19 vaccine on June 15, 2021 with no adverse reaction. At approximately 2:23 PM patient called for assistance from the waiting area near the pharmacy where the vaccine was given. Her chief complaint was a tingling sensation and itchiness all over her body. After assessing the patient and determining the itch was also present at her throat with visual signs of respiratory discomfort, I administered a 0.3mg dose of epinephrine which the patient was carrying in her purse. EMS was called, and clinic nurses arrived shortly after to triage the patient. Nurses confirmed her vital signs were within normal limits. EMS arrived approximately 5 minutes after calling and patient was taken to ER for treatment. Follow up call with patient revealed she had received benadryl in the ER and was subsequently discharged.
I received my 2nd booster on 03/31/2022 and my symptoms started on 05/04/2022. On 01/21/2021 I woke up in the middle of the night with nausea, disoriented. I never threw up. I was sweating a lot and I didn't know how long I was in the bathroom for. On 02/12/2021 I noticed the COVID nail toes and finger nails, and it was more noticeable. On the thumb and finger nail. It comes and goes after every vaccine. It doesn't go away completely but it is noticeable. On 05/04/2022 I went to my doctor for a regular check up they took blood. On the 05/05/2022 I got my blood results and my CBC was way up then before. I have all the reports if you need. Immature granule I did research about it. I knew I  had inflammation. My monoxide level went up, basophil went down. Eosinophil went up. In August my doctor will do another CBC test. My red blood cells and white blood cells were fine. We are all still figuring it out. My family has autoimmune diseases with type 1 diabetics, Crohn's disease and Felica disease. My bowl movements were frequent it's not like diarrhea. I cut down to gluten and it was fine after couple of days. I have no proof that its linked to the vaccine but am just reporting since this is the change I had after booster shot.
No other AE; patient received their second dose of GARDASIL 9 late; This spontaneous report was received from a pharmacist and refers to a 43-year-old patient. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.  On 10-FEB-2023, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On 09-AUG-2023, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Inappropriate schedule of product administration). No symptoms or further details reported. No other adverse event and no product quality complaint.
SORE ARMS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-MAY-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 09-MAY-2021, the subject experienced sore arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arms was not reported. This report was non-serious. This case, involving the same patient is linked to 20210519312.
5:30pm 1/25/2022 received vaccination 4:00am 1/26/2022 woke up with fever, took 1000mg acetaminophen  5:30am 1/26/2022 had diarrhea & threw up  6:30am 1/26/2022 drank a few sips of Sprite, ate a few saltine crackers. Fever 100 Fahrenheit  10:00am 1/26/2022  had diarrhea & threw up  10:30am 1/26/2022 took 50mg Dramamine. Ate a few spoons of apple sauce, drank a few sips of ginger ale, drank a few sips of Gatorade. Fever 101 Fahrenheit  12:30pm 1/26/2022 had diarrhea & threw up  2:00pm 1/26/2022 drank a few sips of Gatorade, reported reaction to pharmacy, fever 102 Fahrenheit
redness at the injection site; swelling at the injection site; administered the vaccines using a TB sized syringe; This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2020, the patient received Shingrix. In July 2020, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site swelling and drug administered in wrong device. On an unknown date, the outcome of the injection site erythema, injection site swelling and drug administered in wrong device were unknown.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix on either 23rd July 2020 or 24th July 2020.  The patient reported that registered pharmacist administered the vaccines using a TB sized syringe, and also reported having redness and swelling at the injection site.  The reporter did not consent to follow up. No additional information was provided.
On 6-29, I left on a cruise ship traveling domestically. On 7-4-2022, I started having a sore throat and cough. These symptoms continued and on 7-7, I went to the cruise ship's medical office and tested positive for COVID-19. I went in to isolation on the ship. I returned home on 7-9 and did not go to see a doctor. I did text my doctor letting them know that I tested positive. He stated to ride it out and no medications or tests were performed. I am reported my breakthrough case of COVID-19.
On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was Refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Given vaccine 1/14/2013 - returned 1/15/2013 slight redness cool soaks & tropical prednisone. Returned again ordered KEFLEX as redness increased and lump. x bid x 10 days. Went to her MD 1/18 - returned 1/19 no vesicles on arm. Returned 1/22 arm less erythema.
2nd dose taken after 90 days as recommended; Hurting left arm at injection; Headache; Tired feeling; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose taken after 90 days as recommended), VACCINATION SITE PAIN (Hurting left arm at injection), HEADACHE (Headache) and FATIGUE (Tired feeling) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007A21A and 011L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (She had Covid after the 1st dose).   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose taken after 90 days as recommended), VACCINATION SITE PAIN (Hurting left arm at injection), HEADACHE (Headache) and FATIGUE (Tired feeling). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose taken after 90 days as recommended), VACCINATION SITE PAIN (Hurting left arm at injection), HEADACHE (Headache) and FATIGUE (Tired feeling) outcome was unknown.            No concomitant medications were provided. No treatment drugs were reported. Action taken with mRNA-1273 in response to the event was not applicable   This case was linked to MOD-2021-011079, MOD-2021-026867 (E2B Linked Report).; Sender's Comments:  MOD-2021-011079:Crosslinked case MOD-2021-026867:Crosslinked case
pt noticed that arm hurt right away;pain became worse 12FEB97 & couldn't lie on the lt side when went to bed;felt hot;took ASA on 14FEB97 noticed that lt upper arm felt hot & there was a large area of induration & inflammation;n & chills;
during administration of vaccine dose and the fluid leaked right down the patient's arm/no AE; during administration of vaccine dose and the fluid leaked right down the patient's arm/no AE; vaccine was leaking from where the needle connects to syringe/no AE; Initial information received on 09-Oct-2019 regarding an unsolicited valid non-serious case (GMI inquiry number: 00309757) received from a consumer or non-health care professional.  This case involves a 74-year-old female patient who received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] and during administration of vaccine, whole time dose and the fluid leaked and dribbled right down the patient's arm (exposure via skin contact and underdose) as vaccine was leaking from where the needle connects to syringe (syringe issue).  Medical history, medical treatment, vaccination and family history were not provided.  It was reported that patient no other vaccine as concomitant medication.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [prefilled syringes,lot UJ478AA, expiry date: 30-Jun-2021] via an intramuscular route at the right arm administration site for prophylactic vaccination.  It was of exposure via skin contact, vaccine underdose and syringe leak.   At the time of report, no adverse event was reported.  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 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.
pain in the arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (pain in the arm) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     Patient received unspecified antibiotics and steroid drugs.  The patient's past medical history included Foot surgery (surgeries in her feet/bones) in 2017 and Bone operation (surgeries in her feet/bones) in 2017. Concurrent medical conditions included Hypothyroidism.    On 07-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in the arm). At the time of the report, PAIN IN EXTREMITY (pain in the arm) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  patient did not remember if she received any other vaccine in the 4 weeks prior to receiving the Moderna vaccines.  Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-737707 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737707:Monovalent Dose
No additional AE reported; Patient was administered improperly stored, separate PNEUMOVAX 23; This spontaneous report has been received from a office manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 23-DEC-2022, the patient was vaccinated with a improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, see event description, lot number W007035 verified as valid, expiration date reported as 23-OCT-2023, and upon internal review established as 20-OCT-2023, administered for prophylaxis (strength, and route of administration were not provided) at a temperature of 55.0 degree Fahrenheit for 153 hours (product storage error).  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2301USA007635:02320477