chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID BREAKTHROUGH ED at hospital with the CC of: lower abdominal pain, staff referred to facility via ETC for management of GIB  presenting with gastroenteritis, melena, and incidental covid-19 infection with right lung pneumonia. FIRST DOSE 8/2/21.
swelling discomfort of ulnar aspect of forearm, sinus headache, fever and extreme chills
No adverse event; 47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-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)) (batch no. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Jul-2023, 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 06-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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 (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.).    Patient was over 18 years of age. No relevant concomitant medications were reported. Staff gave patients vaccines past the use date of 18 Jun 2023. On 06 July 2023, 6 patients were administered at administration site 2. No treatment medication reported.   This case was for the 44th patient out of 47 reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-732752 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Live Follow-up received contains Vaccine information reported and narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732752:Master case (Patient 1)
On the first and second day, the injection site was red and swollen to the point it was hard. It was painful to lift my arm up to reach for things. I couldn't sleep on the side that I got the shot on. The pain and redness dissipated on the third day, but the swelling persisted, leaving a welt on my arm. There was sporadic stinging on the third day as well, only on a few closely timed occasions. Today, I still have a welt on my arm at the injection site that is sensitive, slightly warm and hard. I can't find any data on how long side effects can/should last.
A week later my lymph nodes were swollen and I'm unable to get a mammograms.
Administered to patient who was 11 years of age at time of vaccination.  Guardian admits to falsification of DOB.
pt exp hives; itchy over body;then SOB; difficult breathing; to ER; BP very low; pulse undetectable;
He had some swelling a lot of swelling after his second shot; swelling in his feet about a month after getting the second dose/his legs were swollen/swelling in the lower extremities; he is getting edema/pitting edema; This is a spontaneous report from a contactable Nurse. A 66-years-old male patient (reporter's husband) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on an unspecified date 2021 (age at the time of vaccination 66-years-old), as a single dose for COVID-19 immunization. The patient's medical history included Flu, he always has reactions, caller states her husband gets the flu, every year and has reactions to the shot; His family had covid earlier, a year ago and his symptoms are moving fast, so I'm wondering if this is the variant. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration, on an unspecified date Mar2021 (age at the time of vaccination 66-years-old), as a single dose for COVID-19 immunization and experienced soreness in bones, alot of inflammation, felt bad, and swollen feet. On an unspecified date 2021, the patient experienced He had some swelling a lot of swelling after his second shot, swelling in his feet about a month after getting the second dose/his legs were swollen/swelling in the lower extremities, and he is getting edema/pitting edema. On an unspecified date, the patient underwent lab tests and procedures which included heart scan, Computerised tomogram coronary artery: heart was swollen Endocarditis, it was look like his heart was swollen Endocarditis or if there was anything Myocarditis; and on an unspecified date 2021 heart scan, Computerised tomogram coronary artery: wonderful, everything was wonderful; and on an unspecified date 2021 scan of his feet: wonderful. Treatment was received. The outcome of the events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Abnormal bleeding from uterus. My period the bleeding continued with a small amount of most of the time,  with occasional heavy bleeding like the day 2 of a period; anemia-like dizziness and fatigue; anemia-like dizziness and fatigue; bloating; less appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 07May2021 13:45 (Lot number: EW0153) at the age of 31 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergies: hay fever" (unspecified if ongoing), notes: hay fever. The patient's concomitant medications were not reported. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 15May2021 07:00, outcome "recovering", described as "Abnormal bleeding from uterus. My period the bleeding continued with a small amount of most of the time,  with occasional heavy bleeding like the day 2 of a period"; DIZZINESS (non-serious), FATIGUE (non-serious) all with onset 15May2021 07:00, outcome "recovering" and all described as "anemia-like dizziness and fatigue"; ABDOMINAL DISTENSION (non-serious) with onset 15May2021 07:00, outcome "recovering", described as "bloating"; DECREASED APPETITE (non-serious) with onset 15May2021 07:00, outcome "recovering", described as "less appetite". The events "abnormal bleeding from uterus. my period the bleeding continued with a small amount of most of the time,  with occasional heavy bleeding like the day 2 of a period", "anemia-like dizziness and fatigue", "anemia-like dizziness and fatigue", "bloating" and "less appetite" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of menstrual disorder, dizziness, fatigue, abdominal distension, decreased appetite.  Additional information: No other vaccine in four weeks. No Covid prior vaccination. No Covid tested post vaccination. Patient took 2nd vaccine shot on 27May and had headaches and cold-like symptoms for 1 day but not so bad. The bleeding has increased from the next day but ended in a week. Patient took a blood test but results were all in normal region. This week patient feel dizzy sometimes.  No follow-up attempts are possible. No further information is expected.
Left arm redness and swelling at site of injection, 6cm diameter that appeared day 8 after injection, no fever. Tender to touch, examined 3/22/21.
Cried-screamed from 2:45-3:15 PM. Then from 4:00-7:00 PM. R Temp 102. Right leg swollen and red at site of injection.
Hives developed later in the evening the day Tdap was administered. Per Dr recommended BENADRYL. Follow up call on 8/26/11 no answer, two voice mails left for pt. Pt to call office back.
I experienced chills, so bad that I could not get warmed up. I had a sweat suit on and I still was freezing. I had a pain in my right arm pit, had to put a pillow under my arm. All my joints and my muscle joints ached body ached terribly.  I was shivering under covers and I could not get warm. I also could not sleep at night due to how cold I felt and how terrible I felt.  My symptoms went away about three days later.
Case previously recorded as MA2009-4340. Received the following information via Medical Communications from a healthcare professional on 17 NOV 2009: A 41-year-old female patient was vaccinated i.m with S-OIV FLUVIRIN (batch number 1009221P1) on 10 NOV 2009 at 05:00 p.m. Within one hour after vaccination the patient experienced an itchy sensation, raspy voice and hives. The following morning she began to have wheezing and was treated with some steroids. The adverse event resolved shortly after the steroid treatment. MedCom ref. no.: NA09-008343.
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns an 65 year old patient. Weight: not provided: height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): On 19-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, route of administration: intramuscular. Batch number: WWT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 19-Sep-2016, doses were administered. Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
Left eye twitching uncontrollably. No treatment, waiting and hoping it will go away.
Report received from a neurologist concerning a pt who experienced peripheral neuropathy 5 days post vax. Reported date of vax and reaction start date were approximate. Case reassessed to be serious on receipt of follow-up information form the neurologist. This pt developed neuropathy and loss of coordination and reflex strength. The vaccinee was also reported as 'dysesthetic poor'. The vaccinee was treated with steroids. Symptoms were stated by the reporter to be disabling/incapacitating. No stop date was given for the symptoms. Numerous labs and tests were consistent with neuropathy.
Large local reaction (L) arm - hot, red, swollen and tender. Cough - no wheeze.
Pt. states that after receiving the Booster 3rd dose of Moderna 09/10/2021, started experiencing symptoms 09/11/2021 of Low Blood Pressure (88/58), feeling of low blood sugar, and weakness lasting 48hrs. No noted Primary visit. Symptoms have subsided.
Starting March 2 ,Fever, body aches , extreme fatigue, sore arm.  Then on March 16   vertigo (spinning room with movement), extreme fatigue again. I still have vertigo and extreme fatigue today (March 20,2021)
vaccine given 29 hours after vial had been punctured; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 29 hours after vial had been punctured) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 29 hours after vial had been punctured). On 17-Jun-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 29 hours after vial had been punctured) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No treatment information was reported.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
This case was reported by a pharmacist via call center representative and described the occurrence of injected limb mobility decreased in a 69-year-old female patient who received HAVRIX 1440 adult (batch number MB3Y2, expiry date 10th June 2018). Concomitant products included FLUZONE. On 4th October 2016, the patient received the 1st dose of HAVRIX 1440 adult (intramuscular) 1 ml. In October 2016, less than a month after receiving HAVRIX 1440 adult, the patient experienced injected limb mobility decreased. On an unknown date, the outcome of the injected limb mobility decreased was not recovered/not resolved. The reporter considered the injected limb mobility decreased to be probably related to HAVRIX 1440 adult. Additional details were provided as follows: At 12:20 hours, the patient received HAVRIX 1440 adult vaccine in her right deltoid and had difficulty in lifting arm. On the same day, the patient concomitantly received FLUZONE (batch number: UI664AA, expiry date: 6th April 2017) in her left deltoid.
Approximately 12 hours after the immunization the patient began having common symptoms of myalgia, fatigue, headache, and nasuea.   Over the course of the next number of hours the patient began noticing a wobbly sensation and unsteadiness with walking.  She also began noticing some urinary retention and bowel urgency.  Also, symptoms of tingling, numbness, and weakness was noted in all extremities.  Starting on day #2 post-immuniaztion the majority of symptoms began to slowly and steadily resolve.  At one week out, however, the bowel, bladder, and left-sided numbness, decreased pain and temperature sensation, and mild generalized weakness still remained.   On the 7th of September the patient saw her primary care provider who spoke with a neurologist on the same day.  A non-con CT of the skull was obtained  on the same day without specific findings.  On September 19th a follow-on MRI of the brain and cervical spine was obtained with and without contrast.  Again, the Brain was reassugingly without findings, but white-matter disease was noted at the C-2 level; T-2 signal partially enhanced anterolaterally to the right.  That same day the patient started three days dosing of IV methylprednisolone, 1 gram daily.  She has since continued on a month-long oral prednisone taper.  Some symptom improvement still continues, while complete resolution is not near yet.  PT& OT are starting in about one week.
A few hours after receiving  my 2nd dose of Moderna I noticed my arm was very itchy under the band-aid. Before going to bed I noticed that I had a red welt at the injection site that was warm to the touch and very uncomfortable. I took some tylenol for the discomfort and put topicle benedryl on the affected site as well. At 4 am the next morning my arm was even more sore so I got ice and kept it on there until I woke up  a few hours later. The welt did grow a bit bigger but seems to have stayed the same size and today is 48 hours after. It is still a little itchy, and warm to the touch. I will continue to put ice on it and apply the anti itch cream as well.
Patient received first dose of Moderna covid-19 vaccine on 5/10/21 and received 2nd dose of Moderna covid-19 vaccine on 5/23/21. Per patient ad no reaction to first dose except a sore arm for 1 day. Patient has no medical conditions and does not take any medications.  patient observed for 30 minutes had no reactions and released.
LU arm deltoid red/hot swollen 12 cm outline/3 cm below shoulder jt/fever tactile DTaP/IPV given
Pt recvd 2nd hep B vax 29MAY90.19NOV90 pt exposed to HBsAG via puncture wound & pt found to reactive to HBsAG, HBsAB, & HBcAB.Pt either hep B carrier or had chronic active hepatitis.
There was an excursion from the freezer; administered to 118 patients; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (administered to 118 patients) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination. No Medical History information was reported.On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (administered to 118 patients). On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (administered to 118 patients) had resolved. Not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter.  No treatment information provided.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. On 08-MAY-2015 the patient was vaccinated with an improperly stored dose of MMR II, 0.5 ml, subcutaneous (dose number, lot number and expiration date were unspecified. No concomitant therapies were reported. No adverse experience reported. The outcome of the event was unknown. Additional information has been requested.
Patient refers had to go to ER due to arm pain, after Xray was taken they told the patient, nerve was affected after vaccination. She now has to go to the physiatry for therapies
3/11/20 seen for right upper arm erythema, tenderness, and warmth- treated with Cephalexin 500 mg bid x10 days, which resolved, seen 6/5 for ongoing right arm pain and pain with range of motion
actually think I got virus; It is so bad I end up throwing up; cough; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Jun-2021 and was forwarded to Moderna on 17-Jun-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough), SUSPECTED COVID-19 (actually think I got virus) and VOMITING (It is so bad I end up throwing up) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (cough), SUSPECTED COVID-19 (actually think I got virus) and VOMITING (It is so bad I end up throwing up). At the time of the report, COUGH (cough), SUSPECTED COVID-19 (actually think I got virus) and VOMITING (It is so bad I end up throwing up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.    Reporter did not allow further contact
Administered vaccine closer to left shoulder than full deltoid muscle.  Patient reported increased pain during administration.  Pain reported 1/10 later in the day. 3/10 the following day with ibuprofen.  Today at day 7, discomfort improved to 1/10 without medication, complaints of stiffness, discomfort with putting on clothing shirt. Full passive ROM on exam. Discomfort reported with flexion and extension.
A physician reported that a 23 month old female received a 4th dose of Prevnar and a 3rd dose of Comvax and also Acel-Imune on 8/27/01. On 3/6/02, the child developed lobar pneumonia.
Developed oral shingles. Approximate onset date of symptoms was 12-15-22. Initial symptoms were jaw/mouth pain, chills, headache. Developed  sores in mouth on 12-21-22. Shingles initially diagnosed by dentist on 12-21-22 and diagnosis confirmed by PCP on same date via televisit. Only treatment received was ibuprofen/ acetaminophen/topical medication for pain.
Headache, chills, fever and body aches that started around 2 pm on vaccination day (3/31/21) and lasted until 11:30 pm the next day (4/1/21)
This case was reported by a nurse via sales rep and described the occurrence of headache in a 16-year-old female patient who received BEXSERO. Co-suspect products included HAVRIX and MENVEO. On 16th April 2018, the patient received BEXSERO, HAVRIX and MENVEO. In April 2018, less than a week after receiving BEXSERO, HAVRIX and MENVEO, the patient experienced headache and dizziness. On an unknown date, the outcome of the headache and dizziness were unknown. The reporter considered the headache and dizziness to be unrelated to BEXSERO, HAVRIX and MENVEO. Additional details were provided as follows: The age at vaccination was reported but could be 15 years or 16 years. Exact spelling of nurse's name was not provided.
Headache, muscle aches, fatigue, rash at injection site (rash started a week after injection)
Chills then fever. Injection site painful with swelling and hot to touch. Fatigue, muscle and joint pain. loss of sense of smell and change of taste. Feeling awful  sore throat.
p/vax pt devel a blisters @ the inj site;MD does not know if it is varicella because pt was snot seen in office;
pt recvd vax; pt devel flu-like symptoms consisting of nausea, aches & a headache;