chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Guillian Barre; This is a spontaneous report from a contactable pharmacist. This report was received via a sales representative.   A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for immunisation.  The patient's medical history and concomitant medications was not reported. The patient admitted for suspected Guillian Barre, 1 week after receiving the Prevnar vaccine.  The outcome of event was unknown.   No follow up attempts are possible. Information about Lot/batch number cannot be obtained.; Sender's Comments: Aside from the time association, there is no biological plausibility that the suspected Guillian Barre is causally attributed to PREVNAR 13 use.  More immunological and neurological data would be needed to explore the etiology for the event onset.  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
4 hours of rapid heart rate 14 hours of irregular heart beat 24 hours of diarrhea elevated blood pressure (continuing) Saw my PCP to evaluate reactions and advise whether to get second vaccine dose)
Pt noted to have tachycardia - HRs in 130-150s at home and seen in the ED with tachycardia to 130s
Reported nausea, vomiting, with diarrhea, dizziness for 6 days now. Tdap vaccine administered 10/8/13. Spoke to pt's husband 10/14/13 pt feels better but continues to be dizzy and vomits at night.
Secondary transfer of vaccinia virus, exposure to smallpox vaccination site (primary) between 09/07 to 09/10. Large pustule with crusting on chin and smaller pustule above upper lip.
13SEP96 pt notified office-site of DT very red-size of palm of hand, was very warm to touch;the first few days - now pink in color;18SEP96 inj site, pink very large-covers whole upper arm itches & swollen;
Information has been received from a registered nurse, concerning a 1 month infant of unknown gender. On an unspecified date, the patient was vaccinated intramuscularly with a dose of GARDASIL (dose was not reported) (Lot # and expiration date were not reported). It was reported that the patient was to have received the first dose of RECOMBIVAX HB, but instead was administered GARDASIL. No product confusion was discovered, just a medication error. It was reported that the patient did receive the first dose of RECOMBIVAX HB on 03-JAN-2013 (dose and route were not reported) (Lot # and expiration date were not reported). There were no adverse effects. Additional information has been requested.
Felt like a headache right in the middle of head; Uncomfortableness; Face felt funny on the left side / It felt funny, it was not hurting, it feels kind of something's there, it wasn't numb or anything; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient received bnt162b2 (BNT162B2), administration date 04Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing), notes: Verbatim: Diabetes. Concomitant medication included: METFORMIN taken for diabetes mellitus. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunisation, reaction: "my arm was sore".  The following information was reported: FEELING ABNORMAL (non-serious) with onset Mar2021, outcome "recovered", described as "Face felt funny on the left side / It felt funny, it was not hurting, it feels kind of something's there, it wasn't numb or anything"; HEADACHE (non-serious) with onset 07Mar2021, outcome "recovered", described as "Felt like a headache right in the middle of head"; DISCOMFORT (non-serious) with onset 07Mar2021, outcome "recovered", described as "Uncomfortableness". Therapeutic measures were taken as a result of feeling abnormal, headache, discomfort.  Additional Information: The patient have taken the second shot last Thursday. On the patient's way home, her face felt funny on the left side, it was not hurting, it feels kind of something's there, it wasn't numb or anything but it felt funny. And then, it lasted a few minutes and by the time she got home, she felt it no more. But on Sunday afternoon, she got up and felt like a headache right in the middle of her head and after that she felt the same thing on face and this time, it lasted a little longer, it was just uncomfortableness for about maybe 30 minutes or so and it went away. The patient did not have lab works. The patient stated that she just had aspirin and took one aspirin each time.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021274396 Same patient and product, different dose and event
Dizziness on the day of injection. Followed by extreme fatigue, fever (101.4), headaches starting 24 hours after injection and lasting 48 hours. Sense of smell began to return after 36hrs after injection  (lost smell and taste in August 2020 due to COVID-19 and it has not returned).
Significant pain at the injection site during administration; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Significant pain at the injection site during administration) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Significant pain at the injection site during administration). At the time of the report, VACCINATION SITE PAIN (Significant pain at the injection site during administration) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. Treatment medication was not provided by the reporter.
The patient was administered a COVID-19 Moderna Bivalent Vaccine prior to receiving her primary series. No adverse effects were reported by the patient.
herpes zoster in dermatomes; This case was reported by a physician via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced shingles. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The reporting physician was the patient's husband. The reporter and the patient were both on the phone with medical information and both shared details for this report. The age at vaccination was not reported. The patient received Shingrix about two years before the date of reporting. Six to 8 months after receiving 1st dose of Shingrix, the patient developed herpes zoster in dermatomes which was treated with Acyclovir but reoccurred.  Till the time of reporting, the patient did not receive the 2nd dose of the Shingrix series due to the occurrence of herpes zoster. No further details were shared at time of call. The consent to follow up was granted since the contact details of the healthcare professional were available.
Low grade fever of 100.4 F the morning following vaccination. Was tired enough to lay down. Took one  200 mg ibupofen tablet.   Within an hour, temperature was down to 99.3.  The following hour was back to normal at 98.6. Regained energy and felt fine the rest of the afternoon and evening. Time of tiredness lasted about 3 hours, and energy was regained once temp was back to normal.
significant, extreme hives all over patient's body; Fatigue; Weak/unable to get out of bed or care for themselves; This spontaneous case was reported by a physician and describes the occurrence of URTICARIA (significant, extreme hives all over patient's body), FATIGUE (Fatigue) and ASTHENIA (Weak/unable to get out of bed or care for themselves) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 029K20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 and Hyperlipidemia (since 20 years) since an unknown date. Concurrent medical conditions included Sulfonamide allergy (years ago, rash, no hives or shortness of breath) and Osteoporosis. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) from an unknown date to 15-Nov-2020.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (significant, extreme hives all over patient's body), FATIGUE (Fatigue) and ASTHENIA (Weak/unable to get out of bed or care for themselves). At the time of the report, URTICARIA (significant, extreme hives all over patient's body) and ASTHENIA (Weak/unable to get out of bed or care for themselves) was resolving and FATIGUE (Fatigue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered URTICARIA (significant, extreme hives all over patient's body), FATIGUE (Fatigue) and ASTHENIA (Weak/unable to get out of bed or care for themselves) to be possibly related.    Treatment information not provided   This case was linked to US-MODERNATX, INC.-MOD-2021-037358 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2021: reporter contact details, patient demographic's and event outcome of the events, and reporter causality of all the events was updated.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-037358:
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 10-SEP-2015, the patient was inadvertently vaccinated with a dose of expired ZOSTAVAX lot # K000727, expiration date 30-JAN-2015 (dose and route of administration were not provided). No adverse effect was reported. Additional information has been requested.
Patient is an 79 year old male who had his 2nd Moderna vaccination in his dominant right arm Thursday afternoon.  Upon awakening Friday morning, he had difficulty walking.  His legs were strong enough to hold him, but he was unstable.  He also had some numbness on the palmar surfaces of some index and middle fingers of his left hand.  His speech was somewhat garbled, but when his wife would encourage him to repeat himself, he could enunciate more clearly.  He had some nonspecific difficulty swallowing.  He attributed this all to adverse reaction to the vaccination, which would pass...  Friday mid day his wife took him to the barber, and on return home he was briefly nauseated and vomited.  Later in the day on Friday they went for car ride, and on return home he was briefly nauseated and vomited.  He had no other episodes of nausea.  He had no fevers or chills.  He had no visual disturbances.  He had no other numbness or paresthesias.  He was aware of no clear weakness.  Finally today, the gait instability persisted and the numbness in the left hand, so he came to the ER for evaluation.   Patient is currently recovering in the hospital
Chronic shoulder pain, still unresolved 5 months after the injection. Was referred to neurologist who stated this is not nerve pathology but may be SIRVA (shoulder injury related to vaccine administration).
Patient was age 16 and given The Moderna Vaccine. Realized after the fact that Pizer is the only approved vaccine for 16
Information has been received from a pharmacist concerning a 70 year old male patient with no drug reactions/allergies who on 22-FEB-2007 was vaccinated SC with a 0.65 ml dose of ZOSTAVAX (Merck). On 05-FEB-2010 the patient was diagnosed with shingles. The patient went to the emergency room and was kept overnight for observation. At the time of report the patient's status was not recovered. Additional information has been requested.
Large red circle formed around injection sight that was hard and elevated and hot to the touch.  Lasted 4 days.
Discharge Provider: MD Primary Care Provider at Discharge: NP  Admission Date: 9/15/2022 Discharge Date: 9/18/2022  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Pulmonary embolism associated with COVID-19 [U07.1, I26.99]   HOSPITAL COURSE: Patient is a 70 y.o. female who presented with a history of GERD, GI bleed, common murmur.  Over the past day or 2 patient has had increased weakness and fell on Wednesday.  Patient waited until Thursday to come to the emergency department when she noticed her blood pressures were low.  EMS was called and noted patient to be hypotensive provided 1 L saline.  Upon arrival to the emergency department chest x-ray, x-ray of the spine were all negative acute process.  Lab work showed potassium level of 3.2, sodium level 128 BNP 337.  Initial troponin 24 with a repeat of 21 a delta of -3.  WBC 3.11.  COVID-19 PCR did detect virus.  D-dimer was 1710. UA was negative for infection and occult blood stool was negative.  EKG showed normal sinus rhythm  with possible atrial enlargement.  CTA thorax was ordered due to elevated D-dimer.  Imaging showed right lower lobe subsegmental pulmonary embolism.  No findings of right heart strain.  Patient was then started on heparin infusion.  Hospitalist services was contacted and accepted patient treatment of pulmonary embolism in the presence of COVID-19.   The patient was transitioned to Xarelto without issue, and the cost was verified as affordable with patient. The patient otherwise remained stable on room air, with a cough as her only bothersome symptom.  Echo was completed showing an EF of 75%, grade 1 diastolic dysfunction, mild LVH, severely increased left atrial volume, and moderate mitral stenosis. She was noted to be hypertensive while inpatient and blood pressure medications were titrated to achieve better control. She is recommended to have a sleep study outpatient.   PT and OT recommended SAR stay for further strengthening. The patient was concerned about finances and was only agreeable to placement. This was not possible due to covid status. She elected to go home with home health care, and services were arranged.  She was explicitly that she is at high risk of self harm is she continues to have multiple falls while on Xarelto. This did not persuade her; she expressed understanding of the risks, and knowledge of when she should seek medical care. She was discharge home in stable condition with HHC services, xarelto and blood pressure medications sent to desired pharmacy. She is recommended to follow up with her PCP for further management of PE, referral for sleep study, hypertension, and other chronic conditions. A BMP was ordered for 2 weeks as lisinopril was increased and hydrochlorothiazide were added, to check for electrolyte abnormalities.
"Normal" immediate post vaccine symptoms. Several months later I had acute kidney failure. I spent 7 days in the hospital and they have no idea what caused it and were suspicious it may be a chronic condition (auto-immune disease, cancer, etc). But after a kidney biopsy they determined it was just an acute kidney injury (AKI). Still no known-cause which is why I'm listing it here. I don't believe the vaccine is related but perhaps long-haul COVID symptoms? There was a recent study linking AKI and long-haul COVID symptoms
6/16/22 pt had a positive COVID test at Care Center; 6/19/22 pt brought to ED with dyspnea; O2 saturations in the 80s on RA; placed on O2 supplement; admitted; CXR showed moderate bilateral multifocal opacities and pleural effusions; A Fibrillation; dexamethasone; pneumothorax, chest tube placed; suffered cardiac arrest; CPR; transferred to CCU; treated with medications; ABX started for suspected sepsis; family decided to withdraw care; comfort care; pt expired in the hospital.
Painful swelling at injection site followed by limited mobility. Can't sleep on left side. Naproxen, heat/cold application, topical pain relievers all ineffective. Two weeks since TDAP injection and arm is still as sore as the first day. Saw a GP about it and she dismissed it as tendinitis, which I did NOT have prior to this vaccination. Normal tendinitis treatments have been ineffective. Anticipating physical therapy or cortisone next.
20 y/o basic trainee who developed urticarial eruptions with itching on his arms 2 minutes after receipt of IPV and Td; lesions ranged from penny to quarter size, 3 on right forearm, 1 on left forearm, and one on each elbow. There was no lip, tongue, or facial swelling; no throat tightness, cough, wheezing, or shortness of breath. He was treated with IM Benadryl and oral Loratadine. The eruptions resolved by day 3, and itching resolved completely by day 7. Urticaria Start: 08/10/2007 End: 08/13/2007 Pruritus Start: 08/10/2007 End: 08/17/2007
congestive heart failure; rashes; shortness of breath; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 13-AUG-2012, the patient was vaccinated (inoculated) with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by a provider for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: rashes, shortness of breath (dyspnea), and congestive heart failure (cardiac failure congestive). The patient claimed damages as result of injury to themselves, and economic losses.The outcome of the events was not provided. Therefore, the causality for the events was related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of cardiac failure congestive was considered to be medically significant.
29MAY96 RN called RE: another matter dad reported pt having welts on legs (esp thigh) & arms;welts were described as flat red & the size of a fifty cent piece
This is a spontaneous report received from a contactable consumer or other non-HCP (parent), for a Pfizer sponsored program (005570). An infant female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced projectile vomiting, somnolence (drowsiness) and exposure via breast milk (vaccine exposure via breast milk), with outcome of unknown. Additional information: Patient's mother reported for patient (daughter). She wanted to report adverse effects in her infant from the 1st Pfizer shot. She is a nursing mom. Her daughter had drowsiness and projectile vomiting. She was willing to take surveys, submit breastmilk samples and etc. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected. Sender's comments: Linked report: US-PFIZER INC-202101150168 same reporter/drug, different patient/event (mother/baby case).
09/13/22 presents to EC ED for "fatigue". PMHx of "chronic A. fib on Eliquis, UTI, CHF"
after the first shot I was just tired for quite number of days; This is a spontaneous report from a contactable consumer (patient). An 80-years-old female patient received bnt162b2, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included primary biliary sycosis (liver disease), high blood pressure, stomach ulcers and breast cancer. The patient had liver disease, she had primary biliary cirrhosis, she also had 3 different times stomach ulcers in the past and 25 years she had breast cancer ( she didn't remember when she was diagnosed with that, it's been at least 15 years). Concomitant medications included ursodeoxycholic acid (URSODIOL) taken for primary biliary cirrhosis; metoprolol taken for high blood pressure and amlodipine taken for high blood pressure. After the first shot, she was just tired for quite number of days on an unspecified date. No treatment was received for the event. The outcome of the event was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Whelps/ Urticaria on the nape of the neck and upper center back and on my rightarm, near wrist.  I started itching immediately following with minor discomfort but it was noticeably worse within 30 minutes.  I wasn?t sure if it was a reaction until later.  The irritations on my wrists didn?t start for hours later.  A burning sensation that happens on and off.
Developed Tachy-Brady Syndrome about a week after my second Moderna shot. Never had any symptoms before.
Received Td on 9/8/03. On 9/9/03 BP increased (143/107), pulse 135 for 2.5 hours. BP dropped. On no medication, but stuffy nose 9/8/03. BP now 114/82, pulse 72.
Pruritic rash at the local site of injection developed a week after the first dose. Symptoms improved after two days. Took diphenhydramine at bedtime prn for sleep aid which might have helped.
had a bad reaction/rash; This spontaneous report was received from a physician via Pfizer referring to a female patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  On an unknown date in 2009, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dosage schedule, route, anatomical location, lot number and expiration date were not reported) for prophylaxis.         On an unknown date in 2009, the patient experienced a bad reaction characterized by rash after the vaccine was administered (allergy to vaccine).  The outcome of allergy to vaccine was unknown.     The reporter considered allergy to vaccine to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23).