chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness over left arm - Sore throat -Tongue was tingling at the beginning - Chest heaviness for 2 to 3 minutes.
Approximately 36 to 48 hours post injection, menstruation started although it was not on schedule (I just had one only  2 weeks ago). The bleeding became excessive over the hours, to the amount I have never experienced in my entire life. It also accompanied discomfort such as pain and crumps, which I also have never experienced during regular period. As of today (3 days later), bleeding still remains heavy.
pain when he bent the leg but relief when he stood/felt as if he had a ligament injury; DVT below the left knee; This spontaneous case was reported by a patient and describes the occurrence of DEEP VEIN THROMBOSIS (DVT below the left knee) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Sports injury (in the 1980's that caused a clot) and Clot blood (in the 1980s; has not been on any medication for it until last year (2020)). Concurrent medical conditions included Pulmonary embolism (asymptomatic, in both lungs), Factor V Leiden mutation and Factor VIII deficiency. Concomitant products included APIXABAN (ELIQUIS) for Clot blood.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-May-2021, the patient experienced DEEP VEIN THROMBOSIS (DVT below the left knee) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain when he bent the leg but relief when he stood/felt as if he had a ligament injury). The patient was treated with HEPARIN on 30-May-2021 for DVT, at an unspecified dose and frequency and ENOXAPARIN SODIUM (LOVENOX [ENOXAPARIN SODIUM]) on 30-May-2021 for DVT, at a dose of 80 UNK, bid. At the time of the report, DEEP VEIN THROMBOSIS (DVT below the left knee) and PAIN IN EXTREMITY (pain when he bent the leg but relief when he stood/felt as if he had a ligament injury) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-May-2021, Anti factor VIII antibody test: low (Low) low factor VIII. On 30-May-2021, Factor V Leiden mutation: high (High) high factor V. On 30-May-2021, Fibrin D dimer: 0.56 (Inconclusive) 0.56.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient went to the hospital on 30 May 2021 and was diagnosed with a DVT below the left knee.  He stated he has only taken apixaban for 1 year, not other medications.  The patient stated that apixaban has been working without incident until he received the vaccine.  He also reported he was found to have Factor V "Liden" deficiency and Factor VIII.    Very limited information regarding the events have been provided at this time. Patient's history of prior DVT, asymptomatic PE, Factor V Liden deficiency an Factor VIII are confounding factors to the events. Further information has been requested.; Sender's Comments: Very limited information regarding the events have been provided at this time. Patient's history of prior DVT, asymptomatic PE, Factor V Liden deficiency an Factor VIII are confounding factors to the events. Further information has been requested.
gout like pain in left toe that progressed to ankle, knee and elbow on left side, patient took indomethacin and reported improvement
48 y/o female with past medical history significant for alcohol abuse and smoking presented to the emergency department on 6/27/21 after a fall with large contusion and petechial rash noted. Labs significant for severe thrombocytopenia (PLT 8), mild leukopenia (WBC 4.1), and recurrent transaminitis (AST 557, ALT 975). Of note, patient had been diagnosed with idiopathic transaminitis in October 2020. Patient reports taking multivitamin daily. Babesia and anaplasma screens were negative on 6/28/21. Hematology/oncology consult felt that thrombocytopenia was likely related to receipt of Pfizer Covid-19 vaccine on 6/8/21 (administered at pharmacy). Patient received platelet transfusions, IVIG 1 g/kg daily x 2 doses on 6/29/21 and 6/30/21, prednisone 60 mg PO daily x 2 doses on 6/27/21 and 6/28/21, and dexamethasone 40 mg PO daily x 4 doses 6/29/21 - 7/2/21. Patient was told to avoid vaccination with second dose. Pfizer Covid-19 vaccine recorded as allergy in patient's chart. As of 7/1/21, platelet count had risen to 82.
Hot flashes, rapid heart rate, low blood pressure, nausea, severe headache, dizziness, lightheadedness, seeing flashes/fuzziness, loud ringing in ears, site injection soreness, overall muscle ache, lethargy,  and nerve pain in groin and shooting down front of legs - 8 hours after injection - 24 hours after injection. Hot flashes, overall muscle aches and moderate to extreme fatigue - 24 hours after injection - 7 days after injection. Medications: Tylenol.
This spontaneous report was received from a medical assistant refers to a patient of unknown age. The patient was vaccinated with the first dose of GARDASIL on 14-FEB-2011, the second dose on 23-JUL-2012, and the third dose on 23-AUG-2012. No lot # and administration route was reported. No adverse event was reported. The outcome of patient was unknown. Additional information has been requested.
Information has been received from a registered pharmacist concerning a female patient, who on 30-JUN-2011 was vaccinated with a dose of MMR II (Lot # not reported). On 30-JUN-2011 the patient experienced anaphylaxis reaction. It was reported that the patient received ZYRTEC and famotidine as treatment for the adverse event. The patient sought medical attention in the emergency room. The patient's anaphylaxis reaction persisted. Anaphylaxis reaction was considered to be immediately life-threatening by the pharmacist. Additional information has been requested.
Suspected anaphylactic reaction managed with epinephrine, solumedrol, Benadryl
Delayed left arm redness, swelling, pain measuring 12x 9cm  starting 1/8/2021 after 1/4/2021 received first dose of moderna covid vaccine in left arm at a work facility. Comes to clinic on 1/9/21 for concerns. Denies any immediate reaction concerns. Pt denies any other symptoms such as SOB, throat swelling, hives, tachycardia.  Pt has not tried ice, or anything on it. Describes it as itchy and sore arm. Denies drainage, induration, fever.Pt was treated conservicately with ice and hydrocortisone topical. Has not followed up. Presumable improved.
The next morning when I woke up I had no energy and a little bit of sinus congestion. That lasted 24 hours, the 2nd and 3rd day I felt a little better.  The 4th day I had chest congestion and a fever of 103. The fever lasted for 2 days before I went to urgent care.  That was within 7 days after 2nd dose.  They did a COVID test which came back negative.  They gave me Methyl-prednisolone and an albuterol inhaler. I did start feeling better about a month later.
It started out as a quarter size red mark at the injection site and grew to the size of a quarter dollar and was super itchy.  It created MS hug, making it hard to breathe. The hug lasted about 2 1/2 weeks. My Dr prescribed a steroid cream and prescription Benadryl. After 24 hours from there the swelling and redness went down and there was a white hallow around my arm for about week.
local rxn: purple swollen knot size of tennis ball; hot to touch, painful; rx hot compress; also had URI;
Patient was monitored for 15 minutes. After the 15 minutes she stated that she felt itching in her tongue and throat. Patient described it as a "skin peeling" feeling on her tongue and throat. Patient was observed for 30 total minutes, took a Claritin, had something to eat and felt much better.
Admitted due to progressively worsening dyspnea and hypoxemia.  He developed first specific symptoms on 9/11.  Earlier that week had had some non-specific pain and inflammation in his leg, which he has had many times previously, and started on doxycycline for recurrent celluilitis after scanning to r/o abscess and negative COVID test.  Repeat COVID  testing on 9/12 positive after developing fever, respiratory symptoms, body aches.  O2 sat 95% on RA; was set up for antibody infusion the next day, but when sat was 89% could not get it.  Discharged 9/22/2021.
No AE during this time; Regarding administrating vaccine expired on 28-AUG-2021 and administered on 7-Jan-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Regarding administrating vaccine expired on 28-AUG-2021 and administered on 7-Jan-2022) and NO ADVERSE EVENT (No AE during this time) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 07-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Regarding administrating vaccine expired on 28-AUG-2021 and administered on 7-Jan-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No AE during this time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Regarding administrating vaccine expired on 28-AUG-2021 and administered on 7-Jan-2022) and NO ADVERSE EVENT (No AE during this time) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No AE during this time) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Regarding administrating vaccine expired on 28-AUG-2021 and administered on 7-Jan-2022).    Concomitant medication details not reported by the reporter. Vial size was unknown. NDC number reported as 80777027399. HCP was not sure that the vial was initially stored in the refrigerator. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-731703 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-731703:Same Reporter(Husband case)
Some pain in the injection area; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 26Feb2021 06:15 (Batch/Lot number: unknown) at the age of 28 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Some pain in the injection area". Therapeutic measures were not taken as a result of vaccination site pain. Additional information: The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccination within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date in 2021, the patient reported that, had no issues with the first injection except some pain in the injection area. No therapeutic measure was taken for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event pain in the injection area was resolved on an unspecified date in 2021 at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient began to slump in chair and became lethargic. Patient was laid  on the ground and legs elevated. Breathing was slow and shallow @ 15 breaths/min.BP was fairly stable @108/78 and climbed to 147/93 over 10 min period. EMS was called and patient recovered. Patient was released on own with her boyfriend by 11:10a
fever of 101 degrees F, left arm, and whole body ache. site to LA (tdap site) reddened
PATIENT'S BLOOD PRESSURE DROPPED AFTER RECEIVING THE FLUZONE VACCINE. PT SAID HE FELT DIZZY AND ALMOST FAINTED.  HE WAS SWEATING AND URINATING.  HOWEVER, AFTER A COUPLE OF MINUTES, HE STARTED GETTING BETTER AND HE ASKED FOR WATER.  WE CALLED 911 FOR HIM AND GAVE HIM SOME WATER.  PATIENT WAS COMPLETELY RECOVERING AFTER 10 MINUTES.
After not sleeping well Monday night I woke up on the 23rd of February not feeling 100%. So around 8:00 AM I took two Bayer Back & Body. Around 8:15 / 8:20am I began feeling very dizzy and unable to stand up on my own. I couldn't walk down the hallway without holding onto the wall. This went on all day, long after the effects of the Bayer Back & Body would have worn off . Even at dinner time I was uneasy / unstable walking around. The only time I felt well was when I was lying in bed. By the next morning, Wednesday the 24th, I wasn't 100% that morning either but I went to work and did the work. It was very difficult but by afternoon I was feeling much better. It wasn't until Thursday that I was feeling 100%. I had never felt this way in my life. No it was not Epilepsy related and I had been taking Bayer Back & Body FOR YEARS without problem except maybe taking two, occasionally would feel the caffeine.
patient was administrated with a frozen Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a male patient who received Herpes zoster (Shingrix) (batch number KB97C, expiry date 13th November 2022) for prophylaxis.   On 25th June 2021, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The patient was administrated with a frozen Shingrix vaccine, which led to incorrect storage of drug. The reporter stated that shingrix was frozen by mistake. No adverse event was reported. The reporter consented to follow up
Varicella Zoster Rash beginning 4MAY97, evaluated in office 5MAY97;no tx;
Lightheadedness and vision blurring began about 8 minutes after the vaccine was administered. Vision began to blur until objects were difficult to distinguish. Also experienced body sweating and skin coldness.
On same day, felt swelling around injection site.  Progressed with systemic side effects of dizziness, fatigue, headache.  Lasted about 1 week.  Now improved.
From initial info received on 9/29/04 and 8/16/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 63 year old female pt received a dose of Tetanus Toxoid, lot U1048CA, administered ID in error instead of TUBERCULIN PPD on 8/16/04. The site of administration was not reported. Two days later, on 8/18/04, the pt developed a local reaction consisting of redness and papular lesions. She developed cellulitis from scratching and was treated with an unspecified antibiotic. Per the reporter, the pt recovered from these events. Further info is not anticipated, this case is closed.
Soft tissue swelling to upper L arm where VAR vaccine given 9/5/13. Ibuprofen and cold packs advised.
Within 48 hours of the second shot I had 4 ischemic strokes. Treatment is ongoing with occupation therapy (vision), speech therapy and potential for physical therapy.
no adverse event; an imroperly stored dose of PEDVAX HIB was administered to a patient; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications, or drug reactions or allergies was provided.  On 08-AUG-2022, the patient started therapy with an improperly stored dose of haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot #U026802, expiration date: 03-NOV-2023; strength, route of administration, vaccination scheme frequency, anatomical location, and dose were not reported) administered to prevent haemophilis influenza B infection (product storage error). No additional adverse event was reported (no adverse event).
Severe pain throughout whole body affecting mobility considerably ie; sitting, standing, walking, bending over, getting in and out of car, etc
Was given the 2nd dose of the Moderna COVID 19 vaccine 15 days after receiving the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Was given the 2nd dose of the Moderna COVID 19 vaccine 15 days after receiving the 1st dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first 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 (Was given the 2nd dose of the Moderna COVID 19 vaccine 15 days after receiving the 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Was given the 2nd dose of the Moderna COVID 19 vaccine 15 days after receiving the 1st dose) had resolved.            No concomitant medications were provided by reporter. No treatment medications were reported.
Injection site of Hib and PCV7 is red and has heat coming from it. Doctor recommend Benadryl and compresses. If patient not better - patient is to come back tomorrow.
The patient was administered a volume of 0.25mL instead of the appropriate volume of 0.5mL. The error was recognized the following day and outreach was made to Moderna and CDC for clinical recommendations for the next step. Upon response from the clinical team 9 days later the patient was informed of the error and was given the direction to return to the pharmacy at as soon as possible to receive a complete dose of 0.5mL. No adverse events had been reported. Patient received full dose on 9-17-22
Fever 100.4 on spite of Tylenol, back ache , headache
3/12 @ 10pm: area of approx. 4.5? radius from injection site became extremely tender to touch,  stiffness in entire bicep & tricep areas of arm that received injection. 3/13 @ 1:00 Am: woke up drenched in sweat, tingling sensation across entire face, continued to sweat profusely for about an hour. 3/13 @ 2:30AM: began violently vomiting. Absurd amounts of bile, vomiting lasted until 6Am. 3/13 @ 12PM: awoke to intense pain in left bicep. Upon waking realized the muscle was so tender and tight could not extend arm at the elbow, nor lift arm up to even dress self. Pain did not get better with ice or ADVIL. Fever around 100 F from 12pm on 3/13 till 3/14. Fever did not improve or break with ADVIL or ALEVE. 3/13 @ 4PM: intense  nausea returned, did not begin vomitting again though. Fever continued
This spontaneous report as received from a licensed vocational nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients received improperly stored doses of PROQUAD (Merck) (lot # not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Patient was administered the HPV (Gardasil) #1 vaccine at 12:30 pm. Patient was sitting when the vaccine was administered, she got up from the exam table, standing besides the table. Patient fainted, falling on the floor, hitting her head to left side, pt. said she stopped hearing and saw everything white. She was helped from the floor and placed on exam table on a laying position. She was resting for 1 hour. Pt after 1 hour felt better and left the office walking.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received 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 EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    No concomitant medications were reported. 190 patients (9 different lot numbers) received a vaccine past the beyond used by date. It was unknown if patient received any other vaccines in the 4 weeks prior to the COVID-19 vaccine administration. No treatment medications were reported. This case is for 43rd out of 189 patients.   This case was linked to MOD-2023-704335 (E2B Linked Report).; Sender's Comments:  MOD-2023-704335:case
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient complained of throat tightness and stomach tightness. He did not have trouble breathing. Epi-pen was ready to go once signs of trouble breathing presented. He did not want to wait and asked us to call 911. Upon arrival of paramedics, vitals were all normal with no signs of distress other than throat tightness. Bp and oxygen levels were all normal. Patient wanted to go to ER to rule out anaphylactic reaction.
Post injection stinging sensation radiating down back from shoulder. Decreased range in motion in arm. Started from approximately 30 minutes post-injection. Has maintained since and worsened.   Pain did not decrease with use of Tylenol.
Shot was given on 23rd (Friday), and by  the 25th (Sunday), she woke up with a rash that encircled the vaccine point reaching all the around her shoulder area (the vaccine point was clear about a 1/2 inch in diameter).  The rash was red, patchy, raised and itchy, and she applied the cream.  It felt better and was less raised and less itchy. The rash stayed, but she thought it would resolve. For a couple of days, it stayed red but was less itchy. For 2-3 days, the rash seemed to be getting better, so she stopped applying the cream. Then the rash got re-inflammed, itchy, raised hot, etc  about day day 7.  So she applied the cream again on day 7 and 8.   She stopped, thinking it would resolve, but it began to spread on her bicep area. She came to the pharmacy to show me. I said she should apply hydrocortisone 1% and a cold compress. We filled out this report * will monitor.