chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021 at 9:20 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Apr-2021 at 9:20 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 31.91.  Concomitant products were not provided.  On 27-Apr-2021, Excursion time was 09 AM, with temperature as 35, respectively. Total doses given for the day was 42 for 9AM vials. Condition of vaccine prior to administration was not frozen. 9 AM vaccine was moved to fridge on 19-Apr-2021 and. Vial was moved to clinic on 27-apr-2021. Vaccine BUD date was 19-May-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Severe Body Aches,  fever for 10 hours, up to  101.5 with Tylenol in my system .
sick; Initial information received on 08-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer via media.  This case involves patient (unknown demographics) who experienced sick (illness), while he/she received vaccine INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.  Medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was also reported that the race to 200M Facebook page. Reported adverse event Information: Well got it. The one and only time patient got the shot never got it again and have never been sick again It is unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  There will be no information available on the batch number for this case.
tested positive for covid 19; This is a spontaneous report from a contactable consumer patient. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 28Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation, age at vaccination unknown. The patient medical history and concomitant medications were not reported. The patient reported he got the first dose of the Pfizer COVID vaccine on 28Jan2021 and tested positive for COVID-19 on 05Feb2021. He was hospitalized from an unspecified date for 21 days and now he is looking to get his second dose. He mentioned that the vaccination site where he got the first one is not having vaccine administration anymore and he is looking for a place where he can get the second dose. Outcome of the event was unknown.  Information on the lot number has been requested.
She started to bleed from her nose while sleeping . It has happened to her three times. It had never happened to her until after she was vaccinated.
Left shoulder and arm pain began immediately and has not resolved. Left arm/hand numbness and tingling began about 1.5 - 2 weeks after vaccine was administered. Orthopedist reported scarring in the deltoid and ordered physical therapy.  Neurology evaluation pending. Tdap and Flu given in left deltoid. MMR given in right arm.
About 9:30 arm began to get sore(expected) about 11:00 started with a headache, then chills, fever, achy from head to toe but mostly back and sides, nauseous, lethargic and couldn't sleep
25 minutes after my first Pfizer vaccine (left arm) the left side of my face and left side of tongue became numb. It started along the jaw line and moved up to outer corner of my left eye. No facial paralysis. This lasted 3 days. The second shot on 3/31 (Pfizer left arm) the numbness started immediately. I was advised by my doctor to take Benadryl which I did when I got home.  It seemed to be getting better but it didn't. Today is May 4, 2021 and it is still numb.
Patient presented to the ED on 3/25/2021. He presented to the ED again on 4/18/21 and was subsequently hospitalized within 6 weeks of receiving COVID vaccination.
pt recvd vax & 20AUG93; 2SEP93 devel rash & exp joint pain; No further details were provided;
lt shoulder exhibits edema, erythema, tenderness 6in diameter surrounding inj site;mom reports arm was nl when dressed pt this AM;
Information has been received from a licensed practical nurse concerning a female patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23.  Subsequently, the patient experienced an unknown adverse event.  At the time of this report, the patient's outcome was unknown.  Additional information has been requested.
Muscle stiffness/rigidity- difficulty straightening arm at the elbow, had moderate pain
1 hr p/vax pt devel occiptal h/a, bilateral upper back & lt shoulder upper arm pain on 22JUN94, seen in office 23JUN; on exam no visible affect; mild tenderness; t101;
pt brought to ED unresponsive; shortly after arrived, pt passed away; COD was COVID 19; unknown date of positive test for COVID
Started having shortness of breath at 3 am.  Presented to ED, found to be tachycardic with normal O2 sat.  D dimer positive, CT scan showed bilateral segmental and subsegmental PEs.  Repeat history confirmed no shortness of breath, chest pain, other symptoms prior to vaccination.
Significant swelling approximately the size of a baseball  and excruciating pain  under the right arm  for more than four days.  The swelling and pain started on 01/29/2021. Unable to lift right arm above head for three days. Warm pack applied intermittently. Alternated Tylenol 1000 mg and Ibuprofen 800 mg taken via mouth. On day four swelling started reduce. Able to move my right arm with minor pain . Able to lift my right arm above head with moderate pain.
Swelling, pain, redness at injection site. Fever and swelling of face within 24 hours lasting 6 days.
Information has been received from a licensed practical nurse (L.P.N.) concerning a 22 year old female with no known drug allergies and pertinent medical history who on 30-DEC-2009 was vaccinated IM with a 0.5 ml dose of GARDASIL (lot # 662518/0087Y). Concomitant therapy included LOESTRIN FE. It was reported that the patient developed swollen lymph nodes in her neck after administration of GARDASIL. The patient stated that she could notice them in the mirror. The patient did not have any other symptoms. The patient sought medical attention via telephone. No lab test was performed. On 04-JAN-2010 the patient recovered from swollen lymph nodes. Follow up information has been received from a licensed practical nurse concerning a 22 year old female patient with no known drug allergy and no illness at time of vaccination who in the afternoon of 30-DEC-2009 was vaccinated with the first dose of GARDASIL (lot # 662518/0087Y) in her right deltoid. On 01-JAN-2010 (previously reported as 02-JAN-2010), the patient awoke to find her neck swollen. The patient's lymph nodes in her neck were enlarged. The patient phoned to the doctor on call. Since the patient had no other adverse reactions, she was advised to monitor. The patient stated that 2 days later the lymph nodes returned to normal. On 03-JAN-2010 (previously reported as 04-JAN-2010) the patient recovered. In the morning of 23-FEB-2010 the patient was vaccinated with the second dose of GARDASIL (lot # 663559/1178Y) in her left deltoid. No further information is available.
Admitted on 10/4/2021 with 15-day history of fever starting after his second Covid vaccine and associated with body aches, diffuse nontraumatic bruising, fatigue, nausea, dizziness, sore throat, hand shaking, and chills. In the ED the patient's CBC demonstrated leukopenia at 2.4 with hemoglobin level of 4.9 and hematocrit of 13.8.  Patient had a platelet count of 19.  The patient's electrolytes are within normal limits with a normal creatinine and normal LFTs.  The patient's lactic acid was 1.9, his CRP was 17.7, his ESR is 25, and LDH of 952.  Based on the patient's presentation he is scheduled to transfuse 2 units of PRBC and 1 unit of platelets.  The patient had urine and blood cultures collected and was started on cefepime IV and received 1 L bolus of NS.  On presentation the patient met sepsis criteria based on tachycardia, fever of 104.5, and suspected infection. He has received Medona COVID-19 vaccination. Had 4 days fever after first dose. Second dose was received 9/20/2021.  Patient reports discomfort started the second day after the day after vaccination including fever, muscle ache, headache, fatigue, dizziness and near syncope.  Reticulocyte 0.2%, absolute reticulocyte count less than 0.01 Bone marrow biopsy was performed on 10/5/2021, peripheral blood for flow cytometry was collected.  1 more unit PRBC was given.  On 10/5/2021 3 PM repeat CBC showed WBC 1.9, hematocrit 16.6, hemoglobin 6, platelet 23.  Fibrinogen 553, PTT 18.3, INR 1.5.  uric acid 6.9, triglyceride 250. EBV IgG positive, EBV IgM negative.  CMV IgG positive, IgM negative.  HIV negative.  Hepatitis panel negative, respiratory panel negative, MRSA screen negative.   On 10/7/2021, Per Oncology, patient has evidence to diagnose as B cell ALL, BM biopsy (10/5/2021) Flowcytometry report: 95% blasts, Acute B cell leukemia.
administered Infanrix today 20Jun2023 from lot number 7KM93, which had an expiration date of 10Jun2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 15-month-old patient who received DTPa (Infanrix) (batch number 7KM94, expiry date 10-JUN-2023) for prophylaxis.   On 20-JUN-2023, the patient received Infanrix. On 20-JUN-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: administered Infanrix today 20Jun2023 from lot number 7KM93, which had an expiration date of 10Jun2023). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-JUN-2023 At the time of reporting, the dose had not been repeated. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  The reporter reported that a patient was administered expired Infanrix, which led to expired vaccine used.
Yesterday morning when I received the vaccine around 8:00, within an hour, my left arm where the vaccine was administered, my wrists and gradually back muscles started to feel very achy like the flu.  My left arm and both armpits started to feel painful and sensitive.  In the afternoon, I started to develop chills and a fever.  Around 5:00 yesterday afternoon, I started shaking uncontrollable for about a half hour until I drank some hot tea to help the shaking stop.  The achy feeling, chills and fever got worse during the night and my head started hurting as well.  I could not sleep on my left side because it was too painful.  I took an Aleve PM to help with pain and to help me sleep.  When I woke up this morning around 5:00 am, I felt nauseated and could not stand for any length of time before having to lie back down.  I started to feel gradually better around 10:00 a.m.  and through the afternoon.  It is 7:00 right now and I am feeling tired and am still feeling soreness on my left arm and both armpits especially when I lift up my arms.   I have had flu shots every year for the past 20 years and have never had a reaction like this to any of those vaccines.
One day post vax, pt developed a "welt-like rash all over body and was itchy." He was treated with Benadryl. The pt recovered by 2/20/01. A copy of this report has been forwarded to Aventis Pasteur, manufacturer of the concomitantly administered vaccines.
patient called saying she had a fever of 102-99 for 4 days. then that friday she blacked out , developed huge rash all over her body and face. had someone look at it, said possible infection at injection site. casued chest pressure,severe cough, and hard to swallow. and increased joint pain
Breakthrough case admission after three vaccines Pfizer 2/25/21 Lot# EN6200;  Pfizer 3/18/21 Lot# EN6208;  Pfizer 9/27/21 Lot# FF2587
Rash, fever greater than 105, neurological symptoms in speech (talking incoherently), episodes of POTS
7MAY99 pt seen @ clinic reported rash on each shoulder, itchy, sand paper quality p/each shot;also was a little out of it p/each shot;fine each time p/24hr;
Believe I may have passed a blood clot through urine or vagina early this morning. It appeared to be quarter sized. Non painful, one time event. Also have intense back pain and leg aching. Still feverish and have mild headache as well.
Starting within 24 hours after the injection I developed "covid arm".   Extreme swelling from shoulder to elbow,  extremely hot to touch, very painful, bright red, throbbing pain.       While the redness and swelling have went down I still experience elbow pain with numbness and tingling in my forearm and fingers.
She has been experiencing "the most painful periods in her life" since April.; This is a spontaneous report from a contactable consumer. A 48-year-old female patient received bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration on Apr2021 (Batch/Lot Number: EP6955) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's Medical history included Lyme disease from an unknown date. Pregnancy at time of Vaccination : No. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No, Prior to vaccination, was the patient diagnosed with COVID-19?: No, Since the vaccination, has the patient been tested for COVID-19?: No. The patient's concomitant medications were not reported. On Apr2021 patient experienced she has been experiencing "the most painful periods in her life" since april. The Outcome for the event was unknown.
fever; myalgia; body ache; fatigue; This is a spontaneous report from a non-contactable other healthcare professional (HCP). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number ek5730) intramuscular in the left arm on 20Dec2020 at single dose for COVID-19 immunisation.  Relevant medical history and concomitant medications were not reported. On 24Dec2020, the patient experienced fever, myalgia, body ache and fatigue. Prior to vaccination, the patient was not diagnosed with COVID-19. After the vaccination, on 26Dec2020, the patient was tested for COVID-19 with a nasal swab which resulted negative. At the time of the report, the outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Injection site redness, which spread below the injection site, localized in the deltoid area; Injection site redness, which spread below the injection site, localized in the deltoid area; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 19-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA055A, expiry date unknown) for prophylaxis.   On 23rd September 2019, the patient received the 1st dose of Menveo (intramuscular). On 24th September 2019, 1 days after receiving Menveo, the patient experienced injection site erythema and localized erythema. On an unknown date, the outcome of the injection site erythema and localized erythema were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema and localized erythema to be related to Menveo.  Additional case details were reported as follows: The patient received vaccine in right arm. The patient developed injection site redness, which spread below the injection site, localized in the deltoid area.  At the time of this report the event was reported as ongoing. The reporter consented to follow up. In the document outcome of event was reported as recovering, but in database its mentioned as not recovered, so kept as reported in database. As per sales data sheet reported batch number was changed from AMXA055A to AMVA055A.
Initial and follow up information has been received from a registered nurse concerning a 3 year old female with chronic ear infections and nasal congestion, and with no drug allergies, who, on an unspecified date, was vaccinated with the first two doses of PEDVAXHIB and then was vaccinated with two doses of ACTHIB.  Subsequently, the patient experienced low Haemophilus influenzae type b titer.  The patient's Haemophilus influenzae type b titer result was 0.96, and the lab's reference range was reported to be 1.00 and greater.  The patient was seen at the office.  At the time of the report, the outcome of the patient was unknown.  No product quality complaint was involved.  Additional information is not expected.
Blood pressure high; Blood sugar usually is between 115-130 and now last night it has been 168 and higher.; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK9231) via an unspecified route of administration in left arm on 21Jan2021 10:30 at single dose for COVID-19 immunisation, amlodipine besilate (manufacturer unknown) oral from an unspecified date and ongoing at 10 mg twice a day for high blood pressure, insulin human (NOVOLIN R) via an unspecified route of administration from an unspecified date and ongoing as needed (U-100, inject 5 units by sliding scale if blood sugar over 150) for diabetes, clonidine oral from an unspecified date and ongoing at 0.2mg daily, via an unspecified route of administration from an unspecified date to an unspecified date at 0.3 mg daily for high blood pressure, hydrazine oral from an unspecified date and ongoing at 200 mg two times a day (2 tablets by mouth in the morning, 2 tablets by mouth in the evening) for high blood pressure. Medical history included ongoing thyroid nodule and her thyroid was okay and her numbers okay for cholesterol, ongoing dialysis, high blood pressure. The patient's concomitant medications were not reported. Since taking the vaccine, the past 4-5 days the patient's blood pressure and blood sugar had been out of whack. The patient had said something to her doctors about this because something was going on because she has been having to use her sliding scale insulin when her sugar got to 150. Usually was under 150 and if she went over that she took a shot of insulin if necessary. She had used insulin human more in the past few days at least once a day. The patient had not had to use insulin human in past, it was still almost full. Again, the patient had taken more shots since this Covid than she had had in a whole year. The patient just talked to the kidney doctor and then she was going to the Endocrinologist on Thursday for the first time. They maintain her blood sugar records at dialysis center. Blood sugar usually was between 115-130 and now last night it had been 168 and higher. The patient knew something was not right and it had not been like that for so long. The patient spoke with the dialysis doctor on 01Feb2021 about her blood pressure and they adjusted her medication. The patient clarified her blood pressure had also been high. When she left 01Feb2021 her blood pressure was 168/79 and later that day was 189/70 which was very unusual for her. The other day when she went home it was 136/78. It was the Clonidine that was adjusted was taking 0.1mg, 2 tablets a day to now taking 3 a day. The action taken in response to the events for amlodipine besilate, insulin human, clonidine, hydrazine was dose not changed. The outcome of events was not recovered.  Pfizer is a marketing authorization holder of [Amlodipine Besilate] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [Amlodipine Besilate] has submitted the same report to the regulatory authorities.