chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a Licensed Practical Nurse refers to a 15 month old patient of unknown gender. No pertinent medical history, concurrent conditions, drug reactions, allergies or concomitant therapies  were provided. On 09-JUL-2018, the patient was vaccinated with an improperly stored dose of PEDVAXHIB lot # R001085, expiration date on 30-SEP-2020,  for prophylaxis (dosage schedule, route and anatomical location were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 0 to 1 (1.4) degrees Celsius for 3 hours. Digital Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA004691: US-009507513-1807USA012290: US-009507513-1807USA012291: US-009507513-1807USA012292: US-009507513-1807USA012304: US-009507513-1807USA012294: US-009507513-1807USA012295: US-009507513-1807USA012296: US-009507513-1807USA012297: US-009507513-1807USA012298: US-009507513-1807USA012299: US-009507513-1807USA012300: US-009507513-1807USA012301: US-009507513-1807USA012303: US-009507513-1807USA012289: US-009507513-1807USA012288: US-009507513-1807USA012287: US-009507513-1807USA012286: US-009507513-1807USA012293.
After  couple of days of the  4th dose.  I had a headache  which lasted   2- 3 days and then  in few days I  felt  severe  pain on my neck . I couldn't move or turn my head around. I took ibuprofen  for 2 day then I stopped taking it because  I didn't want to take too much medication.  My pain is persistent if I move I feel  the pain. The pain is less now but I still have it. I didn't see a doctor yet.   I feel like pain is going  down on my back from the neck.
Began vomiting and was followed by diarrhea. Continued randomly for 3 weeks followed by hives all over body every time she was exposed to egg products. Vomiting has subsided hives are ongoing with egg exposure. No previous allergies existed.
SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer via a company representative concerned an 84 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: 21-SEP-2021) dose was not reported, 1 total, administered on 07-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced covid-19 (suspected covid-19 infection and suspected clinical vaccination failure). On an unspecified date in 2021, the patient died from covid-19. It was unspecified, if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of suspected covid-19 infection on 2021, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Death, and Other Medically Important Condition). This report was associated with product quality complaint: 90000194804.; Sender's Comments: V0:20210952702-COVID-19 VACCINE AD26.COV2.S-Suspected covid-19 infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210952702-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS; Reported Cause(s) of Death: COVID-19
Onset of diarrhea - Sept 4, 2012. Very loose frequent stools vaccinated on 8/28/12 DAPTACEL & IPV stools are returning to normal on 9/10/12. Used probiotic.
Expired dose of Havrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 21-year-old female patient who received HAV (Havrix) (batch number 75C45, expiry date 19th August 2022) for prophylaxis.   On 26th August 2022, the patient received the 1st dose of Havrix. On 26th August 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK Receipt Date: 26-AUG-2022 Reporter's Comments: The office Manager reported that the patient was administered 1st dose of Havrix on 26th August 2022, which had an expiration date of 19th August 2022.  At the time of reporting, the dose had not been repeated.  The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. Additional Supportive Information: The patient received expired dose of Havrix, which led to expired vaccine used.
Patient presented to our booster clinic on 03/26/22 stating that he wanted to receive his Moderna booster vaccine.  He presented his COVID vaccination card, which showed that he received his first dose of Janssen on 03/15/2021.  No other vaccinations were listed on the presented card.  He completed our registration and screening paperwork, which asks about vaccination history, and patient was verbally asked when his last COVID dose was, which he replied, "03/15/2021."  Patient received his Moderna booster dose (0.25 mL) at our clinic, was observed for 15 minutes, and then released.  Upon entering the vaccination, it was realized that the patient already received two other doses of Moderna (10/03/21 & 12/03/21).  Patient was contacted today, 03/28/22, to follow up.  Patient admitted that he purposely withheld that information/vaccine history as he still "did not feel safe" and is "all for vaccines."  Patient denies any adverse effects/reactions, and states that he feels great with no issues.  He apologized for withholding his vaccine history and is advised to seek medical assistance if he has any concerns.
Persisting headache from day after vaccine 4 March 2009 to 12 March 2009.  Accompanied by fever (101 deg), chills, burning eyes, cough, sore throat, joint pain stiffness, minor neck pain.  No loss of appetite.  Drank lots of fluids.
Fever, chills, diarrhea, headache, muscle aches lasting 5 days. Symptomatic treatment.
Patient had just received required immunizations of Anthrax and Typhoid in Right deltoid, then immediately following injection of TwinRix (HepA with HepB in one) in Left deltoid, patient stated "I'm starting to not feel so good after those first two shots", and was immediately noted to have facial and bilateral full arm erythema, with lips slightly bluish tinged and decreasing LOC.  Code Blue was called immediately, and prior to the swift arrival of Code Blue staff, patient immediately aroused with the ammonia wafted beneath her nose. Awake and alert, color pale, but erythema dissipating rapidly, and lips pale pink, saying "oh my goodness, what just happened?". No hives, no angioedema.  Just a few  seconds later, she again appeared to have decreasing LOC, and developed tonic-clonic type movements X4 along with decorticate type posturing noted of her upper extremeties. Aroused again and seizing/posturing stopped concurrent with ammonia pledget wafting again. No urinary incontinence. No post ictal phase. Drs. along with Code Blue staff here at chairside.  V/S taken and recorded on Code Blue sheet, IV started in Left AC, and O2 given via blow -by then nasal cannula. NAS FW Fire Department arrived. 09:58 Contacted patient's husband at her request, and she spoke with him briefly.  Then, he was given information on location of ED of patient's choosing. 10:01Report called to Emergency Department . Spoke with RN. Transported by Ambulance to hospital, awake, alert, oriented, conversing, skin only slightly pale now, eupneic respirations. No further seizure activity.  Code Blue Record Sheet: Oct, 5 2011. 0952 32 yo well developed, well nurished female reported feeling weak after receiving 3 immunization shots. (Anthrax, Typhoid and Twin rx) 0953 A Code Blue was called by Rn in Imms. Drs., RNs responded to Code. Along with several corp men.  The Crash cart was brought to Imms. 0953 Pt started to have a seizure, she passed out, unresponsive, pale and clammy. She was layed back in the chair and was out for 5 seconds. Attempts were made to arouse her successfully. 0954 O2 was started via Nasal Cannula. 0954 RN began to start an IV. and other RN Spiked LR and primed the tubing. 0956 RR=20, HR= 59, BP=71/38, 0958 RN confirmed placement of a #18g iv to the left FA, secured with tegaderm. Good blood return noted. She then started 1 liter of Lactated Ringers solution wide open. 0958  EMS arrived, pt was Alert and Orientated x4, she was still pale and clammy. She was assisted to a standing position and walked to the EMS stretcher. 1000 HR=59 Bp 74/34 , pt left the clinic via stretcher with EMS staff.
A day or 2 after shot - numbness & burning in hand shooting pain - unable to raise arm above head cannot grasp with and pain.
12/20/96-Discoloration around eyes and bluish mark on bridge of nose. 2/12/99-hypotonia throughout extremities and trunk. 7/1/99-Speech, hearing, in-toeing and poor eye contact concerns. 8/11/99-Autism and significant delay in speech. At 2 months of age, pt had right eye discharge, post vax of 1st , Polio (+) DTP (+) Hib.
Day of vaccine c/o (R) hand pain. Day after vaccine c/o achey, weak, light headed, fever 100-102.
Vial opened 1/19 at 430pm, a dose was given 1/20 at 10am; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial opened 1/19 at 430pm, a dose was given 1/20 at 10am) 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 20-Jan-2022 at 10:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial opened 1/19 at 430pm, a dose was given 1/20 at 10am). On 20-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Vial opened 1/19 at 430pm, a dose was given 1/20 at 10am) had resolved.        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 did not allow further contact
Around 0800 the patient got her vaccination. During the registration process, she was seen by An Employee (Pharmacy) and associate stated that she never had any allergic reactions in the past and filled in both forms that she does not have any allergic reactions to either the vaccine components, food, and medication. She was then escorted to the Observation room for 15 minutes where she felt dizzy at first. The observation nurse and pharmacy was also present at site. After a few minutes, associate complained of more dizziness, some tightening of the jaw but was still able to speak and swallow.  Associate was then given Benadryl around 0804 and connected to the vitals machine for continuous monitoring. Around 0806 patient was feeling worst and Observation RN took her vitals and her HR went down to the 30?s associate was given epinephrine and hence the CODE BLUE was called on 0807. During the CODE BLUE, ED was notified, and a gurney was sent to the Observation Room. Patient was then transported to ED for further evaluation and observation.
Initially the recipient felt tightness in her throat, which she relates is similar to past episodes of anaphylaxis .
Fever of 100.1, chills, aches, joint pain, abdominal pain, nausea, light headed, lethargic, increased heart rate of 98
Almost two weeks after 2nd dose(1st dose 12/17/20) woke up to minor itching on upper arms and hips which over the course of the proceeding days increased in size and intensity to include arms, back, and upper legs/thighs. As of 1/27/21 skin shows signs of very dry and peeling skin at biceps, upper shoulders, back and upper legs with less intensity of itching.
Immunization given 8/14/02. On morning of 8/15/02 started having arm and leg jerks with stiffness lasting 45 seconds, then grunting for about 10 seconds then started crying for 5 minutes then acted drowsy on evening of 8/14/02 listless.
edema in face, pain, edema lt arm;fever n/v, gen aching/malaise, h/a;
This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patients were inadvertently administered doses of RECOMBIVAX HB (lot number J004700 and expiration date 26-NOV-2015, lot number L010595 and expiration date 12-NOV-2016, dose and route of administration were not reported) that had been improperly stored. Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient received FLUARIX 10/23/16. Mother reported on 10/26/16 that he had fever the next day after receiving vaccine and now has swelling, warmth, and redness of site. Patient seen in our office 10/26/16, no fever, irregular shaped erythema, warm but not tender on left arm measuring 5 x 3 cm on left arm. Diagnosed with cellulitis and started on cephalexin 250 mg/5 ml, 11 mL TID for 10 days.
I have been getting fever blisters about every other week since getting the vaccine. I never had one before. My doctor gave me Rx of valacyclovir HCL (1 gram).
RECEIVED BOTH PFIZER COVID VACCINES ON 01/27/21 & 02/14/21. WENT TO ER ON 02/28/21 WITH COMPLAINT OF URINARY FREQUENCY, ALTERED MENTAL STATUS, AND FATIGUE. DIAGNOSED WITH ALTERED MENTAL STATUS, UNSPECIFIED ALTERED MENTAL STATUS, ACUTE UTI, TACHYCARDIA, AND SINUSITIS. ADMITTED TO HOSPITAL.
Redness on right thigh, no fever, warm to touch, mother administered TYLENOL night of reaction. No other symptoms. Mother was advised to administer BENADRYL every 6 hours for 1-2 days, Ibuprofen tid for 1-2 days. Signs of alarm given (high fever, increased redness, induration).
My skin under my bra strap just completely became extremely irritated and infected. I have not been able to wear a traditional bra since. It is still scarred 2 months hence. The Doctor said that she had never seen any skin condition like this before. It was so irritated I could not even apply the prescribed medicine. It was just raw. I've never had anything like this so I'm reporting in case this is a condition that you have seen before. I do not understand the blanks in the question above so real quick, I had two Pfizer vaccines starting in march and again the second one on time. Right before Thanksgiving I had the Moderna booster. I have never had a skin reaction like this one and the Dr. Dermatologist had not seen anything like it, the skin just was raw. I still cannot wear a normal/traditional bra.
Urticarial reaction that had onset several hours after receiving the Hep A and pneumococcal vaccines.  Rash has been coming and going for last 3 days and is still present.  They did not seek medical care until today.  Zyrtec was prescribed today.  No wheezing, fever, angioedema, difficulty swallowing or other systemic symptoms.  Normal PO intake and activity level.
Provider summary "84 YO male with history of hypertension, Alzheimer's, BPH, recent diagnosis of atrial fibrillation presented to the hospital after fall from stairs   Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures)  found to have COVID pneumonia, acute respiratory failure overnight, has acute T2 fracture and nondisplaced left rib 5th and 7th fractures, had AFib with RVR"
Received vaccine 9/10/13 and stopped by 9/12/13 with swelling to her left arm (also red and tender to touch).
At 2 am 6/10/10 noted to have red, swollen (morning following vaccine administration) (at least 14 hr), left upper arm, fever T100 (oral). Seen 6/11/10 approx 2 pm-19 x 12 cm erythematous, warm patch on left upper arm anterolateral arm- T 97.9 ax.
Mild headache 1 week after, subsided. About a month after the second dose, had issues with depression, body aches, joint pain down neck and spine. Spoke with doctor, no longer taking symbastatin to see if symptoms go away.
Red, swollen, tender 5-6" around injection site. Heat. No nausea, vomiting, diarrhea. Currently still having symptoms.
Temperature dropped in the freezer where vaccines were stored; Vaccine administered after temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT QUALITY ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Temperature dropped in the freezer where vaccines were stored) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No medical history was reported.     On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT QUALITY ISSUE (Vaccine administered after temperature excursion). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Temperature dropped in the freezer where vaccines were stored). On 02-Apr-2021, PRODUCT QUALITY ISSUE (Vaccine administered after temperature excursion) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Temperature dropped in the freezer where vaccines were stored) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On an unknown date, there was temperature drop to -13.79C in the freezer for 47 min while 12C in the refrigerator for 59 min which contained vials. Doses were given to 63 patients. No Concomitant  information was  provided. No Treatment information was  provided.    This case was linked to MOD-2021-066578 (Patient Link).
couldn't go work scared/not feeling like himself; Feeling very dizzy; didn't sleep well last night after receiving second dose of Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (didn't sleep well last night after receiving second dose of Moderna vaccine), FEELING ABNORMAL (couldn't go work scared/not feeling like himself) and DIZZINESS (Feeling very dizzy) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jun-2021, the patient experienced INSOMNIA (didn't sleep well last night after receiving second dose of Moderna vaccine). On 07-Jun-2021, the patient experienced FEELING ABNORMAL (couldn't go work scared/not feeling like himself) and DIZZINESS (Feeling very dizzy). At the time of the report, INSOMNIA (didn't sleep well last night after receiving second dose of Moderna vaccine), FEELING ABNORMAL (couldn't go work scared/not feeling like himself) and DIZZINESS (Feeling very dizzy) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  No concomitant medications reported. No treatment reported
Eye pain and mild swelling for 2 days and then day 3 diplopia and maltracking of the eye x 7 days. Diagnosed with Browns Syndrome. Course of prednisone improved within 10-12 days total
Patient administered first dose of Pfizer-BioNTech Covid-19 Vaccine on 05Sep2021 and second dose on 07Sep2021; sleeping a lot; has not been opening his eyes; has not been much responsive; This is a spontaneous report from a contactable consumer or other non-health care professional. A 68-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FD0809, NDC and UPC number: unknown) dose 1 via an unspecified route of administration on 05Sep2021 (at the age of 68 years old) as dose 1, single and dose 2 via an unspecified route of administration on 07Sep2021 (Lot Number: FF2589) as dose 2, single for COVID-19 immunization at hospital. Vaccine was not administered at military facility. Medical history included urinary tract infection but prior to these events the patient was admitted to the hospital on 01Sep2021 for a urinary tract infection and was discharged home on 08Sep2021. Concomitant medication(s) included atorvastatin calcium; docusate; ferrous sulphate; midodrine; milk of magnesia; pantoprazole; quetiapine; dutasteride accord; fludrocortisone acetate; levetiracetam; venlafaxine; spiriva handihaler (tiotropium bromide monohydrate); cholecalciferol; acetaminophen; montelukast sodium; senna glycosides; amoxicillin taken from 08Sep2021 and. Investigation assessment was reported as unknown. He has other unspecified medications that are prescribed only as needed and have not been taken in the 2 weeks prior to onset of events. On an unspecified date the patient experienced patient administered first dose of pfizer-BioNTech covid-19 vaccine on 05sep2021 and second dose on 07sep2021. On 08Sep2021 sleeping a lot, has not been opening his eyes, has not been much responsive. Reporter stated that these doses were administered while the patient was hospitalized for unrelated reason. The clinical outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected
Patient was given 1 dose of Pfizer/BioNTech Covid vaccine intended for ages 12 years old and up. Patient's mother was present at time of event and expressed verbally the understanding of error. The patient's mother brought patient to clinic to be vaccinated for COVID-19 for the first time, minutes after hearing public news stating that it was approved COVID-19 vaccinations for ages 5-11 years old. Patient's age at time of administration was below minimum required age of 12 years old. After vaccine was administered, adverse event was identified and informed patient and mother immediately on-site. Patient was monitored on-site for 30 minutes prior to vaccination and no adverse reactions were seen or noted during that time. Clinic contact information was given to patients mother in case of emergent issues arising after leaving clinic. Clinic nurse manager obtained and verified contact information for the patient's mother in the event that they will need to be contacted in the future for further actions or information.
Positive Covid Test after negative test; Positive Covid Test after negative test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Apr2021 as dose 1, single (Lot number: EW0170), in left arm and on 12May2021 as dose 2, single (Lot number: ER8736) at the age of 45 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 23Nov2021 as dose 3 (booster), single (Lot number: 012F21A), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LESSINA; MELATONIN; L-THEANINE; MAGNESIUM. Past drug history included: Azithromycin, reaction(s): "known allergy: Azithromycin". The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovered" and all described as "Positive Covid Test after negative test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (11May2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible. No further information is expected.