chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Potential AE due to doses administered from vials that may have been compromised; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; Administered vaccine from vials that may have been compromised; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Reporter stated that, they had a group of 13 pharmacies and had administered the Moderna vaccine. Their digital data loggers and freezers expired before they were re-calibrated. They were aware in some of the freezers there was a temperature excursion that their data logs showed. The vaccines had never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they had a paper-logs to monitor those temperatures. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log. The reporter was concerned that the vials had been compromised. Further reporter stated that, vaccines administered at their pharmacies that were stored in an unapproved freezer and thus, might have been compromised.  The beyond use date for vial was reported as 02-Feb-2022.  Moderna date ordered was reported as 03-Jan-2022.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-513803 (Patient Link).
Information has been received from a physician concerning five pediatric pts who on 8/25/99 were vaccinated with Haemophilus B, Hep B, DPT and poliovirus inactivated. On 8/25/99, following vaccination, all of the pts parents telephoned the clinic and reported that the pt's experienced injection site redness and warmth. It was indicated that all five pt's received Hib, Hep b, and polio in the opposite arm without reaction of that arm. The reporting physician felt that injection site redness and injection site warmth were not related to therapy with Hib and Hep b. Additional information has been requested.
Tingling which moved around in body, fatigue, minor headache right superior parietal area, some thought confusion lasting less than an hour
COVID-19 mRNA Vaccine-Associated Myocarditis; This is a literature report.  A 24-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccination (Dose 1, Manufacturer Unknown), for COVID-19 immunisation. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "COVID-19 mRNA Vaccine-Associated Myocarditis". The patient underwent the following laboratory tests and procedures: Angiocardiogram: normal; Angiogram: normal; Chest X-ray: normal; Echocardiogram: Normal; Ejection fraction: 55 %.; Sender's Comments: Based on the information provided in the narrative, a causal association between the event and the suspect drug cannot be completely excluded. 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.
MA called and advised that child received a COVID vaccine (5-11 orange cap) toady in the office out of an undiluted vial, unopened vial. The vaccine was not diluted with sterile diluent prior to administration. Child was given 0.2mL vaccine in the right arm. Child tolerated vaccine in the office and waited the appropriate wait time before leaving.
EHR was showing birthdate incorrectly as 1/9/15 when he was seen on 2/20/15. It was beleived that he was 6 weeks old at that time, and therefore, eligible for his first set of vaccines, which were given. Mother noticed today, that the birthdate in the EHR is not correct and that he was only 4 weeks old when the first set of vaccines was given. No harm done.
Upon injection, patient had a blank stare, froze, appeared to lose consciousness, started sweating, and became rigid. Patient stated it was his first time out after a knee replacement about a month ago and dressed to warmly. He has completely recovered upon phone call today.
PATIENT WENT HOME AND WAS FINE UNTIL THE EVENING WHEN SHE FELT HER TONGUE AND THROAT SWELLING. WENT TO EMERGENCY ROOM AND WAS TREATED FOR ANAPHYLAXIS. PATIENT HAD NO AIRWAY OBSTRUCTION OR WHEEZING IN THE PATIENT NOTE, BUT I WAS NOT THE TREATING PROVIDER AND DO NOT HAVE ALL OF THE DETAILS
c/o hot flash to head & dullness to lt occipital area; BP 124/70, HR 72 regular, resp 20 even labored, neg visual disturbance; neg swelling, no redness @ site;
Case number PHEH2014US003840 is an initial spontaneous report received from a nurse on 21 FEB 2014. This report refers to a 15-year-old patient of unknown gender who was inadvertently vaccinated with FLUCELVAX (batch number: unknown) on an undetermined date. The vaccine was reported to be from the 2013/2014 season. No adverse event was reported following this administration error (inappropriate age at vaccine administration).  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014: The BPI labeling of the event "inappropriate age at vaccine administration: changed from listed to unlisted and added second indication as Drug use in unapproved population.
stomach discomfort; diarrhea; This is a spontaneous report from a contactable consumer. A 53-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation:Solution for injection,Lot Number: EL3247) via an unspecified route of administration in Arm Right on 25Feb2021 14:15, as a single dose for COVID-19 immunisation. Medical history included asthma, bronchiectasis, anxiety. No allergies to medications, food, or other products. Concomitant medication included Propranolol, multivitamin, B complex, D3, Omega 3. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 26Feb2021 05:15, the patient experienced stomach discomfort (abdominal discomfort) and diarrhea. No treatment received for the adverse events. Serious reported as no. The outcome of the events was not recovered.
pt recvd vax & several hrs p/vax exp fever, chills, nausea; pt was fine the next day; several hrs p/vax exp fever, chills, nausea & vomiting;
12/15/2020My arm was really sore at first, and then my arm was worse the next day on 12/16/2020 as the morning went on my temperature felt like it was going up and down I felt body aches and felt really tired I had covid in June and it wasn't as bad as when I had it in June but it was still pretty bad, I also had a headache, I took tylenol and my fever broke but after a few hours my headache was worse and I started to take tylenol and ibuprofen. 12/17/2020 Under my left arm my lymph nodes are swollen but I feel much better and will go to work today 12/17/2020
9/25 Administered 1st Serie shot of the SHINGRIX vaccine. 2 days later I contracted shingles on left thigh and torso/hip are.
There were 4-5 individuals at the local clinic on 1/19/23 that received the 6 months to 5 years monovalent formulation due to a preparation error. Clinic is unable determine which 4-5 individuals out of 14 actually received the monovalent formulation instead of the intended bivalent product.  Moderna monovalent Lot number was AS1414B with manufacturer expiration date of 2/13/23.  No symptoms of adverse reaction
Hives from one shoulder to the other, down center of back, behind each ear, two on left side of face and several in scalp. 3" in diameter, raised, smooth, 1/4" red circumference. Itching. Dizziness. Continued until 25 mg BENADRYL taken at 17:05, second dose of 25 mg at 21:00. Next day, mild itching at just a few sites.
Vaginal bleeding and cramping began nine days after the second dose. Lasted three days the first time. Second round of bleeding for three days approximately one month later. Third round of bleeding lasting six days started July 19 until July 24, which was heavier and longer than previous two cycles. Went to primary physician approximately one week after initial bleeding.
Pain in injection sight; Tingling and bumps on tongue; Tingling and bumps on tongue; Tiredness/Fatigue; This is a spontaneous report from a contactable consumer (Patient) reporting herself. A 39-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: EN6199), dose 1 via an unspecified route of administration, administered in Arm Left on 08Mar2021 at 11:00 (39-years age at the time of vaccination) as single dose for covid-19 immunisation. Patient's medical history and concomitant medications were not reported. The patient had no known allergies. Patient did not receive other vaccine in four weeks. No other medications was received in two weeks. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. It was reported that, patient has experienced pain in injection sight, tiredness/fatigue, tingling and bumps on tongue. Patient was not received any treatment for the events. The outcome of events was recovering.  No follow-up attempts are possible, No further information is expected.
Vomitting greater than 24 hours Marked decreased appetite Lethargy Hospitalized w/ hematochezia Diagnosed intussusception Surgical reduction after failed enema (x 2) Did well after surgery
stiffness & jerking of both arms-slobbering from mouth, lasting only few minutes; arms, legs, feet & hands turned blue; face turned very white-seen by MD;
My arm was sore about an hour after the vaccine which I heard was normal but has continued to be extremely sore since then. When I went back for my second dose they gave me my shot in my other arm and with in 12 hours the pain subsided a good bit. Since then there is no pain in my arm where the second dose was injected but my arm (left) is still very sore where the first dose went in. I called my PCP and they told me along with vaccines there may be pain up to 6-8 weeks but this seems highly unusuall and is still very painful at times for me to move my arm and hurts as i type this email.
p/inj starting feeling bad;went home from work that day & laid down;awoke w/terrible h/a-lasted all noc & went to MD office next day;DPH inj given;area around inj site appeared w/rash;
Mother contacted clinic c/o child having fever, swelling and discoloration at vax sites, painful ambulation. Pt was seen at clinic the next day by staff provider for care. Pt was afebrile at the time, all vitals taken were within normal limits. Per provider, "Firm, edematous areas on bilateral thighs where vaccines were given ." "No rash noted. " Prescribed Tx included ice packs, MOTRIN.
Administered 1.0 mL of vaccine instead of 0.5 mL dose
Patient experienced a mild rash starting on the knuckles which spread to her elbows on 4/26. Patient went to Emergency room on 4/27 upon waking up and seeing that the rash spread to the rest of their body. The swelling/rash was painful to touch. Patient was given steroids. Exact times are unknown, but symptoms began 48 hours post vaccination per pt.
The patient was given a first dose Phizer on 3-24-21 and inadvertently given Moderna on 4-23-21 as his second dose; The patient has been notified and he denies any s/s of side effects from the vaccine. He stated " I never knew I had them"
August of 2021, approximately 7 months after the vaccination of dose #2, I began to notice pain on 08/04/2021 starting in my hand, and as days went on the pain continued up my arm. 6-7 days later I developed a rash on the palm of my hand that went all the way to my elbow. 8/11/2021 went to physician diagnosed me with shingles, prescribed Valtrex, and after about 5 days symptoms finally began to subside.
pt recvd vax 19MAR93 & did not feel well; appeared pale, skin clammy-alert & oriented-pulse 80-BP 90/60; coughed intermittently-vomited small amt; nose began to bleed; wants to go to sleep; poss vaso vagal;
Rapid heart rate. Colleague stated he was out to eat had 2 beers and was sitting down to eat when he noticed his heart beating fast. He states it was double the rate he usually runs. He did not have any other allergic type symptoms. He stated the next day he felt tired and run down and slept longer than usual.
Low grade fever 100.5, chills, body aches, fatigue, dry cough.
pt recvd vax; devel local rxn of redness, swelling at site (size of salad plate), anorexia & fever;
pt recvd vax;exp warmth from arm to chest & passed out immed p/ vax;20 mins later,exp chills,shaking,chest pain;BP rose to 150/100 mmHg & heart rate varied between 30-90;exp flushing & paleness;night sweats;pain in kidney area;adverse rxn;
Pfizer-BioNTech COVID-19 Vaccine EUA: six months after vaccination patient hospitalized for COVID-19 infection, acute hypoxic respiratory insufficiency, and acute kidney injury. Received steroids and antiviral agents and improved. Discharged to home medically stable.
Hospitalization for COVID-19 on dates 5/12/2022- 5/17/2022. Treated with dexamethasone, zinc, cholecalciferol, ascorbic acid
Widespread hives/rash in middle stomach and lower back, with accompanying burning sensation on contact. First noticed late Thursday but spread rapidly overnight, prompting doctor visit. Doctor prescribed Xyzal, famitodine and a topical cream. Hives have not responded to treatment and have continued spreading to neck.
We received from our license partner the information that in a local newspaper the following case was reported: A 50 year old male patient was admitted to a hospital in October 2002 and was administered Rabipur following exposure. Afterwards he was discharged from hospital. Following rabies symptoms he was readmitted to the same hospital. Following deterioration of his condition, he was moved to another hospital on 12/4/02, where he died on 12/8/02. We are awaiting further information.
Patient is a 81 y.o. female patient of local MD with history of  COPD, osteoporosis, squamous cell carcinoma of the tongue, arctic aneurysm, recent diagnosis of PE on Coumadin for anticoagulation is presenting with chief complaint of shortness of breath, cough with green sputum for about a week.     Covid-19 Virus Infection Date of onset of symptoms: A week ago was around 12/18.  Symptoms present on admission: Yes Date of covid positive test: 12/24 Vaccination status: vaccinated Imaging: CTPA?no acute PE with mild bilateral lower lung GGO which could reflect underlying mild pneumonitis.  Borderline prominent heart size with suspected mild pulmonary hypertension.  Extensive bilateral centrilobular and bullous emphysema with large hiatal hernia Oxygen requirements on admission: 3L patient is on 3 L oxygen chronically. Current oxygen requirements: 2-3 lit Medical therapy: Decadron started 12/27 given into no above home O2 demands. Remdesivir started 12/27 per HCP Consultants following: HCP Anticipated special isolation end date:  1/4/23 Breathing improving   Pneumonia- viral  CT pulmonary angiogram shows mild bilateral lower lung groundglass opacities at the right middle, bilateral lower lobes and left lingula.  Findings reflect underlying mild pneumonitis. Afebrile.  Vital stable.  Oxygen saturation 96% on 3 L oxygen. Lactic acid 2.7, WBC 3.8. She was initiated on Rocephin CAP. Procalcitonin <0.06. Stop Rocephin,  Check urine antigen- negative  BC negative at 48 hours Sputum culture normal flora after 24 hrs with heavy growth yeast. Discussed with HCP- likely a commensal mucinex Incentive spirometry/PEP Episode of hemoptysis 1/01- now resolved- likely due to recent pulmonary infection in the setting of AC use Pulmonary consulted. 1/02 CT chest demonstrated developing segmenta and subsegmental bronchial airway endobronchial density likely due to mucus plugging. Mild multifocal bilateral lower lung ground-glass opacities/pneumonitis have intervally decreased when compared to CT 12/24/2022.  Recent history of pulmonary embolism in November 2022 Hemoptysis. She is compliant with Coumadin, INR 2.7-- > 2.5 Patient reports specks of blood in the sputum for last 2 days prior to admission. Now ressolved CT chest as above. Continue Coumadin- dosing per pharmacy.   Given return, consult pulm for evaluation Increase mucinex to 1200mg BID   COPD Chronic respiratory failure She is on 3 L oxygen at baseline. Doxycycline- complete course Resume home inhalers.
Swelling and redness in the right arm where she had recieved the vaccine 9 days earlier. Also some itching and spasms in the right hand. Symptoms self resolved as of 1/20/21
Neck pain, similar to a pinched nerve or whiplash.  Started the day after and lasted 14 days.  Ibuprofen helped, but did not eradicate pain or increase movement.    Other more common side effects observed included chills (<24 hours), significant stomach/gas pain (30-36 hours post-injection), arm pain (five days duration beginning at day 1), arm rash at injection site (appeared on Day 9),
She stated that her arm got swollen and warm and tingled all down her arm with a huge itchy red area.
8/24/2021 - difficulty breathing - ongoing 10/20/2021 - listless, loss of appetite - ongoing 11/04/2021 - incoherent, incontinent, oxymeter dropped to 63 11/6/2021 - brought to ER by paramedics.   Tests showed signs of stroke and A-Fib. Currently still in the hospital.
Shortly after receiving the second dose I experienced projectile vomiting and I also had diarrhea. I also felt very fatigue and serve abdominal pain.
Significant swelling of injection site, roughly the size of a baseball. Also redness and itching of injection site. Sever Chills, joint pain, and fatigue.  Moderate nausea
Flushing, pruritis, heartburn, facial erythema, diaphoresis, chills.
Large local reaction, 4" X 3" area, red, hot, swollen and tender.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: Mom called to describe side effects pt was having.  Vaccine was administered at 11am 2/26/2022. Mom called about 545pm 2/26/2022 and said pt had rash all over and tightening in throat for the past hour. Mom said she had administed benadryl with out improvment in symptoms. I recommed taking pt to emergency room for further evaluation due to throat tightening and to call 911 if concerned breathing was rapidly becoming restricted
Patient developed body wide rash that's clearing up on 10/08/2015 to 10/23/2015.
4th dose (2nd booster) administered too soon. Patient is not yet 50, and is not immunocompromised, therefore not eligible for a 4th dose. Facility notified of error.
I started wheezing and that was strange enough that I took a puff of my albuterol inhaler. And normally I would take one puff and after 5 minutes it got worse so I took another puff. It kept getting worse and took a 3rd puff and 4th puff. I was really having trouble breathing and so we called the ambulance and they determined I wasn't breathing well. I breathed into a device in the ambulance and the breathing got better. I felt better after and I told them I could drive myself to the hospital but ended up not going. I followed up with my doctor the next day instead and my doctor noted I should've gone to the hospital. But I was fine the next day and they tested me and I was fine.
PATIENT HAD FLU SHOT AROUND 12:30PM. REMOVED BANDAID AROUND 8PM AND HAD NO APPARENT PROBLEM BUT SHORTLY THEREAFTER SHE EXPERIENCED ITCHING, PAIN, AND ARM WARM TO THE TOUCH. THEN SHE HAD REDNESS, SWELLING AND CHILLS,FEVER AND WEAKNESS. SHE SAID SHE HAD A ROUGH NIGHT AND IN THE MORNING HAD A RATHER LARGE RED AND SWOLLEN AREA IN THE DELTOID REGION, AND AROUND THE ARM AND AXILLA
Pt had some commonly reported side effects ("heavy head, sinus headache, body pains") within 24 hrs of the injection, which all have since subsided.  Pt reported large, red, warm circular rash around injection site that developed 2 days after injection. it did not itch or hurt and was still present at report.
Patient c/o dizziness, fever 105 degrees F, nervousness. Patient parent contacted us today 11-1-07 about the reaction patient was given unknown med at ER for reaction.
sore arms; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: unknown), via an unspecified route of administration on an unspecified date as dose 1, single and second dose of BNT162b2, (Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date, the patient experienced sore arm. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Syncope, dizziness, flushing/sweating. BPs 92/52, 94/58 (pulse 77), O2 sat 98%.
Hospitalized with COVID 19 pneumonia, fever and neutropenia received sotrovimab on 2/10 was found to be ill during infusion.  Worsening dyspnea.  Remdesivir x 5 days and dexamethasone 10 days.
Pfizer-BioNTech COVID-19 Vaccine EUA Systemic , severe hives began three days after shot. Did not go away with Benadryl. Got a prescription for Prednisone, and the hives went away within 48 hours.
Blood clot in R pointer finger 9 months later, onset 2/7/22. No prior history of clotting.