chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 64-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Reporter stated that there had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of December-2021, January-2022, and February-2022. They were filling out a temperature excursion assessment with the State currently. Also reported that no adverse reactions were experienced by any patients.
Night that she got Tdap she developed pain in index finger of left arm. The pain worsened overnight and felt like she had to rub to straighten 2nd finger. Now with pain>paresthesias 2nd finger (L) hand.
Both tops of feet swelled badly and remained swollen 4-5 days, then continued to swell daily to a worse degree on the left. This lasted about 14-17 days. Lots of anxiety also. Historically,  I already experienced brief single partial days of swelling rarely. Years ago following PE in 2014 and DVT, i experienced swelling that was not so specific to the tops of feet.
pt recvd vax; dec feeding, crying moaning 9sep94;3 hrs p/ vax, lethargic,sleepy, starring,high pitched cry;to MD,stated this was nl response;v & all oth sxs cont until pt brought to Ped cardiologist 14sep94;
Chills and low grade fever evening and late morning after vaccines. Arm swelling and redness started late that night and lasted for 5 days. Patient also received Pfizer booster vaccine and flu shot on the same day.
10 min. after pt. received the vaccine she began to wheeze. She used her own Albuterol MDI. There was no improvement. She repeated the MDI 5 min. later. Her chest got tighter and wheezing increased. Pt. taken to treatment room and 911 called . Pt. given 25mg Benadryl by MD who is on site at vaccine clinic. At 0955, pt. given 0.3ml epi. in right upper arm. At 9:57 pt administered 2 more puff of Albuterol. On exam: HR 92, BP 138/82. EMS arrived 10:10, IV access obtained, dexamethasone pushed,  and albuterol neb started. On transfer BP 144/80, pulse 85 and o2 sat 100%. Pt. remained awake and alert. Wheezing improving on transport at 10:20.   Notes provided by Dr.
she got covid virus; she got covid virus; headaches,Kind of achy headaches; experienced weird sensation in right arm , right foot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Lot number: EL9261), on 21Feb2021 as dose 2, single (Lot number: EM9810) and on 04Oct2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "she got covid virus"; HEADACHE (non-serious), outcome "unknown", described as "headaches,Kind of achy headaches"; FEELING ABNORMAL (non-serious), outcome "not recovered", described as "experienced weird sensation in right arm , right foot".Patient reports that she had all of the vaccines, first two primary and one of booster doses. The sensation happened after the booster, not distinctly after, it's just happened, not immediate, not right away. All this is registered with my Doctors office. It's been in the last couple of months, happening about once a month for the last 3 months. It's a dragging of her right foot and dragging of her right arm. She is calling it like a gorilla thing. the foot is kind of like flapping, and arm is feeling like dragging. Foot and arm, it goes away and comes back. Patient had experiencing headaches, kind of achy headaches, never had that before either, she was not a headache kind of person. Just wants to report she was experiencing some weird symptoms. Was highly disappointed. She went to withheld and got COVID after 2.5 years of being protected. On three different occasions she has had a weird sensation in her right arm and right foot.  No follow-up attempts are possible. No further information is expected.
Development of Shingles rash on 9/30/2018. Patient seen in clinic on 10/3/2018 and treated with a 7-day course of valacyclovir.
Severe aching in left jaw, joint 11 hrs post vax. Persisted for about 12 hrs. Required a trip to ER in middle of night for pain.
diaphoresis, pallor, chest tightness Narrative:  Patient states that he started to feel unwell almost immediately after the vaccination. He became pale and diaphoretic. He was able to consume some bottled water prior to initial set of vitals being taken. He denied pruritus, swelling, dizziness, lightheadedness, SOB, nausea. +chest tightness and palpitations. Denies having any sort of prior similar reaction to vaccination and any known allergies to medications or other substances in the past. O: 1st set: BP 79/45, HR low 40s, RR 10, SpO2 97% on RA Exam significant for distress, pallor, diffuse diaphoresis (soaking through shirt/shorts), alert/oriented to person/place/time. CV: bradycardic, regular rhythm, no murmurs, b/l radial/pedal pulses 1+. PULM: CTAB, no wheezes/rhonchi. Neuro: no focal deficits. EMS was called 2/2 concerns for immediate allergic reaction. He notes he may have not eaten ecough today and politely declined CBG. Also politely declined IVF. He was able to slide safely to the floor and politely declined assistance (staff were ready in support), in Trendelenburg as much as possible with feet elevated on a  chair. 2nd set of vitals: T98.4, BP 121/64, RR 11, HR 50s, SpO2 95% on RA  Exam significant for: continued diaphoresis, improvement in pallor, continued A/O. Answers to questions linear and appropriate. No focal neurological deficits. Provided 2x rice crispy treats, which were consumed w/o issue. 3rd set of vitals: BP 144/82, HR 63, RR 10, SpO2 98% on RA Exam significant for: improved diaphoresis, vast improvement in pallor. Mental status/neuro exam unchanged. Fire arrived, repeat vitals reassuring (BP 131/77, HR 63 SpO2 100% on RA), EKG on monitor w/o arrhythmia and appeared to be NSR. A/P: 22 yo Veteran with immediate reaction to vaccination, concerning for immediate allergic reaction vs vasovagal reaction. Stabilized quickly with minimal intervention.
Moderna COVID-19 Vaccine EUA On the eighth day post vaccination, I developed an itchy rash and lump at the vaccination site (left arm).  Two days later,  the rash is still there but barely visible. Benadryl (topical) stopped the itchiness. The lump is still there. I have no other symptoms.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 24Sep2021 as dose 3 (booster), single (Lot number: EWO162) at the age of 72 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
Fever, ear infection and impetigo approx. 5 days. Taken to ER after eruption of "spots". ER physician diagnosed "chickenpox".
I started with a low-grade fever of 100 or 101. Some nasal congestion. I also had upper chest congestion and a cough. I had COVID-19 before that turn into pneumonia. Fatigue and chills I also had. I took a PCR test that conformed it was COVID-19. I did get a prescription to help with my symptoms.
Vaccine administered after more than 30 days in the refrigerator; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered after more than 30 days in the refrigerator) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 009C21A) for COVID-19 vaccination.     No medical history is provided by reporter.    On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered after more than 30 days in the refrigerator). At the time of the report, PRODUCT STORAGE ERROR (Vaccine administered after more than 30 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was administered vaccine which had been in the refrigerator for greater than 30 days. Patient did not experienced any symptoms after receiving the vaccine.
Eleven days after vaccine, full body internal itching and redness of hands and arms, also swelling of lips and tongue
Chills, muscle spasms, body aches, pain, throbbing feeling in legs are sharp stabbing pain in neck and back, abdominal cramping, bloating and gas.  heavy irregular vaginal bleeding  (uncommon for me) bleeding stopped 24 hours later . Skin sensitivity, like having sunburn, persistent headache, joint pain, specifically hands, knees and shin pain.
high pitch inconsolable crying onset 6 hrs p/vax, cried for 1 hrs than slept for 1 hr them woke up & high pitch cry for another 45 mins; t101-102 that evening;
i just felt terrible the next day i got the third booster; I got the third booster and the next day I threw up I was nauseous; I got the third booster and the next day I threw up I was nauseous; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 60 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for Covid-19 immunization, reaction(s): "sick"; Bnt162b2 (First Dose), for Covid-19 immunization, reaction(s): "body aches"; Bnt162b2 (Second Dose), for Covid-19 immunization, reaction(s): "sick", "not feeling good". The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "i just felt terrible the next day i got the third booster"; NAUSEA (non-serious), VOMITING (non-serious) all with onset 2021, outcome "unknown" and all described as "I got the third booster and the next day I threw up I was nauseous".  Additional information: The day after the covid vaccine Patient was sick and it happened that she had all three shots of Pfizer after the first shot she was sick the next day with body aches and pains and same with and just not feeling good the same with after the second shot she just felt terrible the next day she got the third booster and the next day she threw up and was nauseous when she woke up she was nauseous.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Blisters appeared on legs and fingers. Appeared as blood blisters that erupted. They then started to dry. They have emerged over several days.
pt recv vax 31OCT96 & 8NOV96 pt devel measles w/a high fever of 105, parotitis, gen maculopapular rash on torso, face, & extremities coryza & lethargy;pt fever lasted for 3 days;16NOV96 pt recovered from exp;
There was confusion regarding the expiration date of the Vaccine.  The vaccine was given on 01/24/2022 and the expiration date of the product was 1/23/2022
Information has been received from a nurse concerning a 23 year old female who in April 2007, was vaccinated with a first dose of Gardasil. On 22-JUN-2007, the patient received her second dose of Gardasil (Lot# 656371/0181U). On 25-JUN-2007, the patient developed red streaks moving away from the injection site area. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Developed rash, hives, fussiness, crying within 3 days of vaccination. Developed dry cough at night 2-3 days prior to visit. Wheezing. In office hives noted, no resp symptoms are found, otherwise normal exam. TX Benadryl, albuterol PRN Q 4 hrs.
My injection site is very swollen as week as the arm pit the same side as the injection  Very painful
1.5-2 HOURS AFTER VACCINE- VOMIT, DIARRHEA, COULD NOT BREATHE.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical history, concomitant therapy and concurrent conditions were not reported. In August 2016 (also reported as 22-AUG-2016 until 30-AUG-2016), the patients were vaccinated with RECOMBIVAX HB (route of administration not reported) and ROTATEQ via oral (Lot number, expiration date, concentration, dose, frequency for both vaccines were not provided), which were improperly stored, this excursion was detected due to a digital data logger. No adverse effect were reported. It was also reported that RECOMBIVAX HB and ROTATEQ were exposed to a temperature of 35 Fahrenheit degrees for 56 hours. Additional information has been requested.
three patients that had clots after the covid vaccine; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "three patients that had clots after the covid vaccine". Therapeutic measures were taken as a result of thrombosis.  Clinical course: Reported as, 3 patients not one- Reporter works in Cardiology - hospital also). Reporter stated "I am vaccinated myself with the bivalent and booster. I believe in the vaccine, however I got recently three patients that had clots after the covid vaccine and they had to be in heparin for 6 months. I would like studies about this problem from the scientific point." The adverse event took place after Pfizer product use. Date Reported: Sunday, 12Feb2013 at 4:15 pm mst (yes, I confirm the visit actually took place on Sunday at a Urgent care facility).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information and close temporal association, a possible causal relationship cannot be excluded between the suspect vaccine BNT162b2 NOS and the reported event thrombosis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202300028560 Different patients, Same reporter, drug, event.;US-PFIZER INC-202300067081 Different patients, Same reporter, drug, event.;
Severe myalgia, arthralgia, fever 102 F, chills, fatigue, nausea  Lasted about 48 hrs
Was shot with compressing gun; arm swelled up, can't move it or lift it up. Black not was  raising underneath bandages; severe muscle pain, entire body ache and was on fire. Came home was suck to stomach. Lay down and fell a sleep and when I woke up, my left side have busted and the skin was missing in serval places. Assure Wireless phone would not work because after phone phone; they findly to me the towel does not reach my location, for they had switch to Tmobile
REDNESS AT THE SITE OF PNEUMOVAX SPREADED DOWN TOWARD THE ELBOW. RED AND INFLAMED.
This spontaneous report was received from an office manager/medical assistant refers to an unknown number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies were reported. Since 03-DEC-2014 doses of RECOMBIVAX HB, which underwent supported temperature excursions, have been administered to unknown number of patients (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No adverse effects were reported. No concomitant therapies were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Yellow discoloration, like a bruise, over a week after the vaccine. No pain.; Yellow discoloration, like a bruise, over a week after the vaccine. No pain.; This is a spontaneous report from a contactable 23-year-old male consumer (patient himself). A 23-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0185) via an unspecified route of administration in left arm on 14May2021 13:30 as 2nd dose single and had previously received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER8729) via an unspecified route of administration in left arm on 23Apr2021 13:30 as 1st single dose for COVID-19 immunization. Patient was 23-years-old at the time of vaccination. Patient medical history and concomitant medications were not reported. Patient was not diagnosed with COVID-19, prior to vaccination. Patient has not been tested for COVID-19, since the vaccination. Facility where the most recent COVID-19 vaccine was administered was reported as Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23May2021 at 09:00, the patient experienced yellow discoloration, like a bruise, over a week after the vaccine with no pain. Patient did not receive any treatment for the adverse events. The outcome of the event was recovering.
Pt recently recvd Engerix-B & exp redness & swelling (site unspecified) right p/inject; Reporter states heard pt was allergic to Themosal;
nausea; Swollen lymph nodes; chills; fatigue; muscle aches; This is a spontaneous report from a contactable consumer (Patient). A 65-year-old female patient not pregnant received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Right on 02Mar2021 12:00 (Lot number was not reported) as SINGLE DOSE (at age of 65-year-old) for covid-19 immunisation. Medical history was not reported. Patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was reported that patient received concomitant medications within two weeks of vaccination, no details reported. On 04Mar2021 13:15 patient experienced nausea, swollen lymph nodes, chills, fatigue, muscle aches. No treatment was received for the events. Patient did not have COVID prior vaccination and also patient was not tested for COVID post vaccination. Patient had not recovered from the events. No follow-up attempts are possible; information about batch number cannot be obtained.
18MAY93 reddness noted along w/induration approx 1" area from inject site; area warm to touch; 19MAY93 t96.8 ax called MD advised to watch 430PM came to clinic; measured 22mm x 20mm warm to touch; 20MAY93 reddness & induration subsiding;
Red patches, bumps, blisters, pustules and intense itching-1 TRIANCINOLONE 0.1%-HYDROXYZINE 10mg began within hours of injection-began to ease up after 19 days-still a problem on 10-18-09
No adverse event; Dose 1 administered on 23JUN2021, and dose 2 was administered on 12AUG2022, which is greater than 35 days; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 23JUN2021, and dose 2 was administered on 12AUG2022, which is greater than 35 days) and NO ADVERSE EVENT (No adverse event) in a 66-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 056M21A and 047B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 23-Jun-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Aug-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 12-Aug-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 23JUN2021, and dose 2 was administered on 12AUG2022, which is greater than 35 days). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 23JUN2021, and dose 2 was administered on 12AUG2022, which is greater than 35 days) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 23JUN2021, and dose 2 was administered on 12AUG2022, which is greater than 35 days).    No concomitant medications were reported.  Patient didn't receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-707984 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-707984:Bivalent dose case
Self reported rapid heart rate, headache, feeling light-headed, "flushing feeling going to head", "tension feeling"