chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tetanus vaccine given 11/7/19 at 4:00pm right deltoid. Per patient day after (11/8/19) approximately around 12pm right deltoid became very red and swollen. Swelling and redness continued to get worse. 11/11/19 Patient called to be seen in office for redness and swelling at injections site. Denied fever, SOB, difficulty breathing/swallowing, difficulty w/right arm mobility, chest pain, or palpitations. Patient was treated in office
Patient was born a healthy 7 lb baby full term via a natural, vaginal birth. She was perfectly fine, very alert, held her head up, was tracking individuals with her eyes, latched onto the breast... until the Hep B vaccine. She went completely lethargic within hours and eventually had to be given a bottle because she was too tired to latch or do anything but sleep. She was hospitalized at 2 days old. Facility is only a birthing center so she had to be admitted into Hospital and was kept overnight. 6 individuals attempted to wake her up.
Patient had red welts around the injection site within 24 hours. She later developed within the next 2 to 3 days severe skin reactions on the insides of both elbows as well as rash/welts/peeling on both hands and inner thighs. The reaction started out moist and later turned to severe peeling due to dryness.
Shingles/ herpes zoster; This spontaneous report was received from a lawyer and refers to a patient of currently 81 year-old of unknown gender concerning a case in litigation. The patient's concurrent conditions, medical history, historical drugs and concomitant medications were not reported.  On or about 14-JUL-2009, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, lot number and expiration date were not reported) for long-term prevention of shingles and zoster-related conditions.  On an unknown date, the patient experienced shingles/herpes zoster and was treated with unspecified medications.  The outcome of herpes zoster was unknown.  The reporter considered herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).
AT 4:15am 1/4/2021 I was either dreaming or actually  massaging my left trapezius muscle which I was doing because it hurt and the pain was severe 9/10. Thinking it was because I was lying on my side, I sought to move onto my back. My wife was awake during the whole event.  Upon moving over to  my back I very quickly felt my legs jerking uncontrollably and could not open my mouth. This sensation last for about 10 seconds at which point my legs stopped jerking , and I was able to open my mouth. I felt a sudden rush of warmth, proceeded to throw off the covers, and was then followed not too soon after by intense chills and feeling cold.  Immediately after coming to, I noticed I felt nauseated which after a few minutes began to subside.  My wife mentioned she tried to gently rouse me but I was unresponsive by  touching and calling my name. After 5 seconds of jerking of the legs, she mentioned it sounded like I was trying to gasp for air but could not seem to get air in. This continued for another 5 seconds with the leg jerking. The episode ended as mentioned above.
17JUN93 pneumococcal vax site red & tender BP 88; P108 tx DPH & hot & cold packs to arm, 18JUN93 arm more swollen hot & tender; t102 on last noc; PAP taken for fever;
Acute cerebrovascular accident (CVA) due to embolism of left middle cerebral artery Patient is a 57 yo female with PMH of multiple CVAs on coumadin, cold agglutinin disease, HTN, DM type 1, who presented with right sided hemiparesis, global aphasia, left gaze deviation.  She is 10 days s/p initial COVID positive test but has been asymptomatic. She had recent admission at hospital where she required multiple transfusions.  Records have been requested but not yet obtained. In ER, workup revealed large vessel occlusion. INR was 1.0. She underwent successful M1 embolectomy by IR.  She was admitted to ICU post embolectomy.  She initially had improvement in NIH but this morning had sudden decline in neurologic status and NIHSS.  She was taken for stat CT head which revealed bleeding along left MCA distribution with ventricular compression and 5mm midline shift.  She was intubated and hyperventilated. Hypertonic saline initiated with target Na 150-155. Sodium prior to initiation of hypertonic saline was 133.  Facility was contacted regarding transfer for neurosurgical evaluation and accepted.  Pt the developed fever of 104.  She had no leukocytosis.  Blood cultures and procalcitonin have been ordered.  Fever may be related to ICH but Vanc and Rocephin have been administered pending results.  Pt also had significant anemia on presentation with Hgb <7.  She is being transfused pRBCs with blood warmer given cold agglutinin disease.  HH will need to be followed after transfer.  Pt will fly to facility, accepting physician
Shallow respirations, tightness of chest, loss of bladder control, rash at site, raised red welt at site after receiving #2 Anthrax Lot #FAV067.
had both shots and have shingles / suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient had both shots and had shingles 3 times since. This case was considered as suspected vaccination failure, as details regarding laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
I got am extreme headache right after receiving the shot, also alot of arm soreness.  The following morning I felt pretty good until 10:00 am and then it got bad for me. Very fatigued with headache, arm pain, nausea and diarrhea. It has continued till the present day. 9/5/2021.
Feeling pain in his legs; His back,he felt achy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 40 year-old male patient received bnt162b2 (BNT162B2), administration date 11Apr2021 (Batch/Lot number: unknown) at the age of 40 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 12Apr2021, outcome "not recovered", described as "Feeling pain in his legs"; BACK PAIN (non-serious) with onset 12Apr2021, outcome "not recovered", described as "His back,he felt achy".  Additional Information: The reporter reported that the patient got a Pfizer COVID vaccine on 11Apr2021, the next day he started feeling pain in his legs and his back, he felt achy, and he was still feeling achy, actually he has had them now for a while, the reporter enquired should it last this long. The reporter asked if the patient should get his 2nd dose on Sunday 02May2021, if he was still experiencing the AE.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient stated she had a rash on her neck that started about 1 week after vaccine was given. The rash lasted about 1 week.
This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 15Mar2021 at 12:00 hours (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included covid-19. Concomitant medications included kirkland aller-fex (MANUFACTURER UNKNOWN), glucosamine (MANUFACTURER UNKNOWN), both drugs started on an unknown date for unknown indication. Past medications were not reported. The patient had an allergy to contrast dye. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other medications or vaccines within four weeks prior to the vaccination. On 15Mar2021 at 12:50, the patient experienced the left side of the face went numb (numbness in the face). The patient took the vaccine at 12:00 hours and waited about 40 mins in the hospital. Then she noticed the left side of her face went numb about 10 mins after leaving the hospital. Lasted for 24 hours. The patient did not have any trouble breathing and did not seem like she needed to return. The patient did call hospital to notify of the reaction and also with the primary doctor office. The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the event numbness in the face was recovered on 16Mar2021, after the duration of 24 hours.  No follow-up attempts are possible. No further information is expected.
headache; arm soreness; muscle ache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), VACCINATION SITE PAIN (arm soreness), MYALGIA (muscle ache) and FATIGUE (fatigue) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included Chemotherapy (undergoing Chemotherapy once a month.) since an unknown date. Concurrent medical conditions included Multiple myeloma. Concomitant products included OXYCODONE for Back pain, AMLODIPINE BESILATE (AMLODIPINE BESYLATE 10) and LABETALOL HCL for Hypertension, MORPHINE HCL for Pain, FOLIC ACID for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced HEADACHE (headache), VACCINATION SITE PAIN (arm soreness), MYALGIA (muscle ache) and FATIGUE (fatigue). At the time of the report, HEADACHE (headache), VACCINATION SITE PAIN (arm soreness), MYALGIA (muscle ache) and FATIGUE (fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also included Potassium Hydrochloride as Supplements and Ranncol-Rite 100 mg for stool softener(constipation). No treatment medications were provided.
Patient started on GARDASIL series 5/15/2007- 2nd given 7/16/2007. Mom noticed in fall of 2007 that absence type seizures began.
PATIENT CONTRACTED COVID DESPITA BEING FULLY VACCINATED AT TIME OF EXPOSURE/POSITIVE COVID PCR TEST AND DIAGNOSIS. CURRENTLY ASYMPTOMATIC.
Is not feeling well/feeling sick right now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558) from a regulatory authority  A female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "Is not feeling well/feeling sick right now".  Additional Information: Caller (Withheld) and his wife (Withheld) had their first dose about two weeks ago and scheduled today 05May2021 for their second dose. (Withheld) mentioned that he just got back from town and his wife was not feeling well that's why they cannot get their dose today. He and his wife are scheduled for their second dose of the vaccine today, but they won't be able to go. His wife is feeling sick right now  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Migraine Headache - 6 hours, severe pain across skull and down face. Resolved on its own with sleep . Used heating pad for short period but did not help. Continue to have intermittent low grade headache Nausea- avoid foods that trigger nausea. Has not resolved,  continue  to have intermittent episodes of nausea  Itching & swelling at injection site. Itching continues  & have itching & intermittent rash on abdomen  treated with topical cortisone cream.  Muscle ache alone enter left arm. Manual Massage on arm heating pad and slight elevation of arm  helps However. Can trigger severe Neuropathy  pain in left hand .
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021 at 1:14 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Apr-2021 at 1:14 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 48.77 for dose administered on 27-Apr-2021.  No concomitant medications were reported.  Batch number 007C21A underwent temperature excursion on 27-Apr-2021 with temperature 35 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 19-Apr-2021 and beyond use date for the vial was reported as 19-May-2021. Product moved to clinic on 27-Apr-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.
"Negligible side effects" after all the doses, except for her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION ("Negligible side effects" after all the doses, except for her arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised (Immunocompromised), Blood pressure high (High Blood pressure) and Arthritis.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION ("Negligible side effects" after all the doses, except for her arm). At the time of the report, VACCINATION COMPLICATION ("Negligible side effects" after all the doses, except for her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient states that she used to take an immunosuppressant drug for a long time for her current conditions, but she stopped taking the drug after the pandemic started.  No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-325511, MOD-2021-325512 (Patient Link).
Pt felt lightheaded after vaccine administered.  She was placed on a gurney with legs elevated and monitored vital signs.  Pt improved and was discharged home.
HYPOTENSION IATROGENIC PULMONARY EMBOLISM W INFARCTION HYPOXIA
w/in 12 hrs p/DTP/OPV, pt exp a fever 103-104, lethargy, was dazed, difficulty swallowing & a lcoal rxn consisting of redness & swelling up to shoulder; Seen in MD office & later taken to ER; blood work up done to rule out illness;
typical arm swelling; headache; tiredness; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 17 patients. This is the eleventh (11th) of the seventeen (17) reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date were not provided) via an unspecified route of administration from an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that multiple friends (unspecified) had the regular side effect of soreness in the arm on an unknown date. They all got the vaccine shot in the village and all had the typical arm swelling, headache, and tiredness on an unspecified date. The outcome of the events was unknown.  Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018227 same reporter/drug/event, different patient
Information has been received from a registered nurse concerning a 6 year old female patient who on 04-Aug-1998 (also reported as 24-Aug-1998) was vaccinated with dose of varicella virus vaccine live (Lot #624781/0056H). On 18-Feb-2003, the patient developed a rash. On 19-Feb-2004, the patient was seen. The patient presented with a vesicular rash with approximately 20 lesions on the face and neck. The patient did not require additional treatment. On 20-Feb-2004, the patient was seen again in the office and the physician changed the diagnosis to impetigo and decided it was not chickenpox. A product quality complaint was not involved. Additional information has been requested. The patient was treated with Cephalexin (Keflex) and mupirocin (Bactroban). On 02/22/2004 the patient recovered. Additional information is not expected.
Pfizer Dose 1 4/7/21 (ER8734) Pfizer Dose 2 4/28/21 (EW0170) Pfizer Dose 3 12/13/21 (lot NA) COVID Positive 1/17/22  1/19/22: Patient is a pleasant 65-year-old gentleman with past medical history of renal transplant 2 years ago secondary to rapidly progressive glomerular nephritis, hypertension, history of DVT and PE in, arthritis, chronic back pain who presented to the emergency department this evening with a chief complaint of shortness of breath.  Patient reports that he has been feeling unwell for about 4-5 days, 2 days ago had a positive COVID test. Patient is fully vaccinated against COVID including receiving his booster.  Patient endorses shortness of breath, cough, chest pain with deep breathing, fevers and chills, decreased appetite.  Today he contacted his renal transplant team at the hospital and they advised him to cut his dose of mycophenolate and half due to his illness.  In the emergency department the patient was found to be febrile with a temperature of a 101.3° F, hypoxic requiring 4 L of supplemental oxygen via nasal cannula. Blood pressures were also noted to be soft.  Workup including CMP, CBC, VBG, lactate, troponin, proBNP, and coags was notable for lactate elevated at 2.2, platelets low at 110, sodium 128, BUN 40, creatinine 1.97 (baseline is around 1.3-1.40).  Chest x-ray showed bilateral pneumonia consistent with a viral pneumonia.  While in the emergency department the patient received 2 L of IV fluid, dexamethasone, azithromycin, and Rocephin.   Past medical history is as noted above.  Reviewed patient's home medications with him, he reports compliance. No recent surgeries, within the last year has had surgery on his neck and lumbar spine.  Home family history noncontributory.  Patient lives alone but his daughter does live nearby.  Patient works part-time.  Patient is a former smoker.  Denies use of alcohol or recreational drugs.  2/20/22: Patient is a 65-year-old male who presented on 01/19/2022 with chief complaint of shortness of breath.  He was COVID positive.  He was fully vaccinated, but was immunosuppressed due to history of renal transplant for rapidly progressive glomerular nephritis.  He did poorly. He was intubated 01/24/2022.  He failed to wean and was eventually trached and pegged on 02/09/2022.  He started spiking fevers again on 02/09/2022 and infectious disease was consulted.  His infectious workup was negative and he was placed on fluconazole, vancomycin, and meropenem empirically by Infectious Disease.  Antimicrobials were discontinued at time of discharge.  Nephrology aided and management as well due to his history of renal transplant. Patient was managed in ICU until an LTAC bed was available. He was discharged to LTAC at select Hospital to continue current cares on 02/20/2022..
3 days after the vaccine i passed out. I threw up several times. My husband called 911 and ambulance took me to ER.  Took blood work, urine sample, chest xray and ekg.  Everything came back normal.
Hoarse, Hives around eyes (bad), hair line, mouth, shoulders, neck and minor on his back.  Child got the hives on and off for three days (so far).  Would go away after shower, medicine and topical ointment, but would come back a few hours later.
erythema 8.5x5 cm on left thigh. Induration the size of olive. Prevnar was the only vaccine administered in the left thigh.
Patient became extremely dizzy and had to sit immediately on the floor.  A check of her blood pressure showed very low results.  Patient spoke of history of anxiety, but had never experienced dizziness/near fainting as a symptom.  EMS was called and took over caring for the patient.
Confusion, lasted 12 hours. Wheezing with deep breaths, lasted 14 days. Inconsolable crying, frequent night waking, outbursts of rage and inability to cope (not typical for child), lasted 19 days. Reported to physician, no treatment provided. Fully recovered.
This case was reported by a healthcare professional and described the occurrence of unspecified adverse experiences in at least three other subjects of unspecified ages and genders who were vaccinated with FLULAVAL (GlaxoSmithKline). On an unknown date, the subjects received 1st dose of FLULAVAL (unknown), and experienced unspecified adverse experiences. The nurse reported that at least three other subjects who were vaccinated at the same clinic reported having "similar problems", events were not specified. At the time of reporting the outcome of the occurrence of unspecified adverse experiences were unknown. This was one of two cases reported by this nurse; see case A0810774A for muscle pain and feeling terrible in a 63 year old female subject after FLULAVAL vaccination.
pt recvd vax in ER & devel diff breathing & had a petite mal sz per ER records;pt had hx of sz activity