chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness of injection site; This is a spontaneous report received from a contactable healthcare professional. A 42-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN1206) via intramuscular route of administration in the left arm on 19Mar2021 at 07:15 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included lupus, mitral valve prolapse, thrombocytopenia and pulmonary fibrosis. The patient did not have any allergies to medications, food or other products. Concomitant medications included hydroxychloroquine (MANUFACTURER UNKNOWN), VASCEPA, XARELTO, folic acid (MANUFACTURER UNKNOWN), pantoprazole (MANUFACTURER UNKNOWN) and daily vit; all for unknown indications, from unknown date and unknown if ongoing. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 17Mar2021, the patient underwent saliva PCR test and had tested negative. On 19Mar2021 at 07:15, the patient experienced soreness of injection site. The adverse event resulted in doctor or other healthcare professional office or clinic visit. The patient did not receive any treatment for the event. The clinical outcome of the event soreness of injection site was resolved at the time of reporting. No follow-up attempts are needed. No further information is expected.
Initial report extracted from VAERS database via QSCAN report on 11 March 2009 (VAERS identification number 229204). A 76 year old male patient had received on 06 November 2004 an intramuscular injection of FLUZONE SV 2004-2005. "Ocularespiratory syndrome" patient experienced sinus congestion and eye drainage approximately 24 hours after receiving the FLUZONE vaccine that progressed to a cough with increased rhonchi, and catarrhal film over eyes. The patient was treated with pseudoephedrine, cefazolin 1 gm IVPB (times 2 or 3 doses) and levoflaxocin. Two days later on 08 November 2004, the eye secretions were cultured, a haemophilus influenza urine culture was done, and a Strep A glaciated (group B) blood culture was done. All cultures revealed no growth. The patient recovered (date not reported). The event of Oculorespiratory syndrome was reported by VAERS, but was not coded by VAERS. This case was coded as Ocular-Respiratory syndrome with symptoms that were coded by VAERS as rhinitis, conjunctivitis, cough and respiratory disorder as co-manifestation.
12/24/03: Temperature 100, felt bad. 12/27/03: Temperature 103.6, achy, whiney.  ER: Put on antibiotic, Tylenol, Ibuprophen.  12/29/2003: Saw MD, breathing treatments.  Prednisone. 01/09/04: Recheck MD, much better.
Lt arm swelling, redness, increased pain 2-3 days after vaccine given. Rx started 8/24/06.
I received the shot on a Friday and slept more than usual that weekend but that was not a big deal as I often will "fight" a virus off by sleeping. Starting a week after the shot I had an odd burning pain in my mid-back at the shoulder blades that awakened me every night for 3 nights in a row and then my mid-back started itching beyond relief and I scratched a lot using a back scratcher. After a week of these symptoms I look in the mirror and was shocked. I had a huge rash over my mid-back up to the neck and now my right breast is itching with a spreading rash from my armpit on the right into my mid chest. The back is still full of the rash and itching often with pain that comes and goes in these areas. It is a burning pain and I have self-diagnosed myself with shingles. I had chicken pox as a child and as an RN I have had patients with shingles and am familiar with what they look like. I have also verified it from pictures on the internet.
Narrative:  History of Present Illness Patient is a 94-year-old male with past medical history of CAD, CABG, hypertension, COPD on 4 L chronic O2 presenting to the emergency department today for evaluation of generalized weakness. Patient states that for the past 4 to 5 days, he has had generalized body aches and cough. He states that he had a home caregiver who recently tested positive for Covid just prior to onset of his own symptoms. He was tested 2 days ago and was positive. He states that he feels particularly fatigued and is unable to get around home to take care of himself due to the weakness and illness at this time. He denies any fevers. He states that he is not any more short of breath than normal and is most concerned about his weakness and fatigue. Does complain of generalized body aches. He has not taken anything for this. He has no complaints of any abdominal pain, nausea or vomiting. He has no other complaints at this time. Emergency department course: Patient came in for generalized weakness and fatigue in the setting of active COVID-19 infection. Initial vitals stable. On physical exam, he is in no significant distress. He does appear mildly tachypneic though states that he is not breathing any differently than normal. He has dry oral mucosa though otherwise exam is quite nonfocal. Patient was given IV fluids and Tylenol for complaints of body aches, which did improve slightly. Labs without significant leukocytosis or anemia. Electrolytes overall stable with only slight increase in his kidney function. Troponin negative. Chest x-ray and EKG performed and patient does have evidence of infiltrates consistent with COVID-19 infection. I discussed all findings with the patient as well as plan for disposition. As patiently currently lives in an independent living facility with home care, I did discuss the case with case management and unfortunately the patient's home care organization is unable to provide another worker for him. His facility is unable to provide any additional services otherwise. Patient's family is also unable to help with any of his care at this time and feel that he needs an increased level of care than he is currently getting. Based on this, I did discuss admission with the patient and he was agreeable. I discussed the case with hospitalist team, who accepted the patient for further care and management. As per 9/6/21 H&P Assessment and Plan Diagnosis: Acute COVID-19 (ICD10-CM U07.1, Working, Diagnosis). acute covid 19 infection chronic hypoxic respiratory failure hx COPD, BPH, bilateral carotid artery stenosis, hypertension, CAD status post CABG/PCI Order for monoclonal antibodies been placed in the emergency department Currently he does not meet criteria for prednisone or remdesivir therapy, his respiratory status is unchanged, he is on his baseline oxygen requirements and even saturating 93% on room air, he has no defined opacities on chest x-ray Continue supportive care with Tyelnol, albuterol as needed, home inhalers, and home medications Consult case management for placement options DVT prophylaxis with heparin subcu
ran fever 101 Saturday/Sunday/Monday;noticed knot under lt arm Friday evening 23OCT98; arm tender & sl red 23OCT98;By Saturday morning area inflamed, red, hot to touch & very tender;5 days p/vax 7" long 3-4" wide area;
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: En205), in right arm, on 26Mar2021 as dose 2, single (Lot number: Er8727), in right arm, on 26Oct2021 as dose 3 (booster), single (Lot number: 3203080), in right arm and on 01Apr2022 as dose 4 (booster), single (Lot number: Fj9943) at the age of 60 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: STATIN [ATORVASTATIN CALCIUM]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12May2022) negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course-After the 5 day treatment the patient felt fine.Tested negative on day 6. 5 days after the 5 day treatment have a head full, sinus, cough. Sore throat. It was reported that, the patient taking other medications within 2 weeks of starting COVID-19 treatment. The patient previously also received a COVID-19 Vaccine. Device Date: 12May2022  No follow-up attempts are needed. No further information is expected.
fainted; This is a spontaneous report from a contactable physician via Pfizer sales representative.   A 16-year-old female patient received first dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fainted on an unspecified date with outcome of unknown.    The information on the Lot / Batch number has been requested.; Sender's Comments: Based on the information provided and drug's safety profile, the event faint is possibly related to meningococcal group b rlp2086 administration. 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.
This was the booster shot. Adverse events: Extremely swollen lymph node at left armpit, which hurts to touch and move. Visibly swollen, looks like I was nailed in the armpit with a baseball. Even when I walk my lymph node throbs. Hard to sleep due to the pain. This is in addition to chills, fatigue, headache, body aches.
lt deltoid swollen, red area aprpox 3x3 inches; area itching; observed today 1 wk p/inject;
Body aches; Dizziness; Throbbing in joints; Headaches; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of PAIN (Body aches), DIZZINESS (Dizziness), ARTHRALGIA (Throbbing in joints) and HEADACHE (Headaches) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025a21a) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 11-Mar-2021, the patient experienced PAIN (Body aches), DIZZINESS (Dizziness), ARTHRALGIA (Throbbing in joints) and HEADACHE (Headaches). The delivery occurred  on 28-Feb-2021. For neonate 1, The outcome was reported as Delivered NOS. At the time of the report, PAIN (Body aches), DIZZINESS (Dizziness), ARTHRALGIA (Throbbing in joints) and HEADACHE (Headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Streptobacillus test positive: unknown (Positive) tested positive for strep B.    Action taken with mRNA-1273 in response to the event was not applicable.
Injection site redness and swelling day of for approximately 3-4days.  Ears red, swollen, & itchy day of through today 3/20.  Rashes on arms, neck, & face extremely itchy starting 4 days after vaccine & fluxuates in itchiness and severity.  Started taking benedril 50mg every 4h on day 4 & have continuously taken it since.  Legs also itchy at times but do not notice a rash.  Saw MD on 3/17 & they noted that it was a systemic reaction and to continue taking Benedril. Today, 3/20, woke up to injection site redness approximately 1.5-2? diameter.
The whites of one eyeball swelled up, almost like a blister on the eyeball; Sensations of pressure buildup; Minor swelling of the eyelid; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 07Apr2021 at 15:00 (at the age of 25-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no allergy to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive other medications within 2 weeks of vaccination. The patient previously received a single dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) in the left arm on 17Mar2021 at 15:00 for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08Apr2021 at 23:00, the patient reported that the whites of one eyeball swelled up, almost like a blister on the eyeball and sensations of pressure build-up and minor swelling of the eyelid. The patient did not had possible allergic stimuli. Therapeutic measures were not taken as a result of the events. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events eye disorder, sensation of pressure in eye and swelling of eyelid were recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
he noticed rash appearing all over his body, trunk, legs, hands, everywhere except his head and neck.; sore arm.; Caller states the rash is going away and it was a little itchy; booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 24Sep2021 (Lot number: FT8839) at the age of 79 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, Caller states he had the 1st dose of the Pfizer Covid vaccine on 26Jan2021 with lot EL9262 and expiry date 31May2021., he had the 1st and 2nd doses of the Pfizer COVID vaccine also and had no kind of reaction except for a sore arm), administration date: 26Jan2021, when the patient was 78 years old, for Covid-19 immunization, reaction(s): "sore arm"; Bnt162b2 (DOSE 2, the 2nd dose on 16Feb2021 with lot EL9267 and expiry date 31May2021., he had the 1st and 2nd doses of the Pfizer COVID vaccine also and had no kind of reaction except for a sore arm.), administration date: 16Feb2021, when the patient was 78 years old, for Covid-19 immunization, reaction(s): "Sore arm". The following information was reported: IMMUNISATION (non-serious) with onset 24Sep2021, outcome "unknown", described as "booster dose"; RASH (non-serious), outcome "recovered" (Nov2021), described as "he noticed rash appearing all over his body, trunk, legs, hands, everywhere except his head and neck."; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm."; PRURITUS (non-serious), outcome "unknown", described as "Caller states the rash is going away and it was a little itchy". The event "he noticed rash appearing all over his body, trunk, legs, hands, everywhere except his head and neck." was evaluated at the physician office visit.   Additional information: Consumer stated that, he was fine now and he had already consulted his dermatologist. Patient's Medical History reported as none. Family Medical History Relevant to AE(s) reported as none. Another vaccine was not administered on same day of Pfizer suspect. Consumer stated that a week later after the booster dose of the Pfizer vaccine, he also had the high dose flu shot on 01Oct2021 and had no name of the flu shot, manufacturer, or lot number to provide and states he is thinking the flu shot was administered to his right arm but does not remember and that is how good his memory is these days. He stated that he had soreness in his arm from that flu shot and also had arm soreness from the 1st, 2nd and booster dose of the Pfizer Covid vaccine also; states the arm soreness has resolved and went away pretty quickly.  Follow-up attempts are completed. No further information is expected.
C/O pains.......... at injection site (RT Del) few hours afterwards. Developed redness and swelling from............. to elbow by evening same day. Swelling and redness still present at 10/30 visit.
Info has been received from a health professional concerning a female, "in grades 3-5", who was vaccinated with a dose of varicella virus vaccine live. "Recently", since November 2005, the pt experienced a chickenpox outbreak. Unspecified medical attention was sought. No other info was provided. Additional info has been requested.
No adverse effects were reported; The HCP reported that she picked up PROQUAD instead of MMR II/ the caller said PROQUAD and VARIVAX was then administered to a 12 month old patient instead of VARIVAX and MMR II.; The HCP said she read MMR V and thought it was MMR II; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender.  The patient's medical history, concurrent conditions and allergies were not reported. The patient's concomitant medications included sterile diluent (manufacturer unknown) and an unspecified flu vaccine (manufacturer unknown).  On 11-NOV-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant human albumin) (PROQUAD) subcutaneous injection at dose 5 milliter (ml) once (lot number W024972 was verified to be a valid number, expiration reported and established as 05-FEB-2024) (strength, anatomical injection site, route of administration and vaccination scheme were not provided), instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (dose, strength, anatomical injection site, route of administration, lot number, expiration date and vaccination scheme were not provided) (wrong product administered). The HCP said she read MMR V and thought it was MMR II (product name confusion). On the same date, the patient also was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection at dose 5 ml once (strength, anatomical injection site, route of administration, lot number, expiration date and vaccination scheme were not provided). Both vaccines were administered for prophylaxis. No additional adverse events were reported.
Had a seizure at 4:30am the following morning less than 24 hours after his shots. Then he was vomiting and was admitted to the hospital.
Red, swollen and painful at site of vaccine. Required ER visit on 8/22/10 where Decadron and Ceftriaxone were administered.
Pt has allergies. Pt had vax in right thigh on 3/22/00. Pt developed hives on 3/23/00 and redness and swelling of the right thigh on 3/24/00.
Extreme exhaustion with episodes of chest pain radiating to jaw, back between scapulae, not responding to nitroglycerin or toradol.  Chest pain episodes since onset on 4/2/03 (there have been six of them) come and go; subside on their own after about an hour; not related to exertion or rest.  No h/o heart disease or of cardiac risk factors.  Admitted to Hospital.  Being evaluated for r/o ischemic heart disease, r/o myocarditis.
Right Bicep pain, swelling started about 3 weeks post vaccine. Diagnosed with Bracial DVT 5/26/21
Fever 101-102 at midnight 02/04/2005, treated with Tylenol, no fever 02/05/2005.  Rash on abdomen and trunk, onset 02/07/2005 21:15PM.   No fever.
Employee exhibited respiratory illness from 2/27 - runny nose, dry cough, afebrile, myalgia. No known exposures.
Ischemic stroke 03/09/21  (12 days Post Moderna #1 administration)
Blood Clot: Cerebral venous sinus thrombosis (CVST). This included a sudden onset of the worst and most painful headache at the center top of my skull that I have ever had in my life about 1-2 weeks after the 2nd Pfizer vaccination. The headache's high severity persisted for about a week or two. Then had recurring headaches at the same spot for about 5 months on and also a little to the right of the middle of the skull and also at the back middle of my skull. The severity decreased over time. It was a type of headache that I have never had before, which is scary and makes me feel like I have something wrong with me and that I need to go to the hospital. It is now 10 months later and I very rarely have the headache, probably only once a month. I use to never ever take advil, but now I do sometimes.   Also, Erectile Dysfunction, which was severe for 2 weeks immediately after vaccination, then gradually got back to normal at 5 months.
On 8/1/01, varicella shot given and on 8/5/01, pt started having diarrhea, lasting 2 days. On 8/15/01, pt's thigh was red and hot. On 8/22/01, pt had a bite-like rash over body (approx. 10-15 spots). Bites had hard knots with red halo, no pustules. No treatment needed. Rash if fading.
Pretty severe nausea began around 2/5/2021 at 9:00 PM and then I woke up on 2/6/2021 at 0300 with severe diarrhea.
No report of symptoms from patient; Nurse calling to report adverse event for improperly stored and administered PEDVAXHIB.  Nurse stated that the PEDVAXHIB had been stored in their freezer since 7/11/2023, and that the last time a PEDVAXHIB vaccine was administered was on that date of; This spontaneous report was received from a Nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.   On 11-JUL-2023, the patient was vaccinated with a haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 mL (lot # W015927, expiration date: 15-FEB-2025) 2 dose series (unknown which dose received) as prophylaxis, which was improperly stored in the freezer since this date. No reported symptoms from patient.
Pallor, Tremors, Fever 101.5, Attended by Paramedics @ home & subsqenquetly taken over to ER room. & D/C 21:30.
Still have a little bit of the nausea and the dizziness; Still have a little bit of the nausea and the dizziness; I had this confusion; 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 patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high " (unspecified if ongoing). Concomitant medication(s) included: ENALAPRIL; ATORVASTATIN; ASPIRIN 81; PROZAC; CARVEDILOL. The following information was reported: NAUSEA (non-serious), DIZZINESS (non-serious), outcome "unknown" and all described as "Still have a little bit of the nausea and the dizziness"; CONFUSIONAL STATE (non-serious), outcome "unknown", described as "I had this confusion".  Additional information: Event started about 4 to 12 hours after getting the vaccine. Consumer stated, "EW0153 on the first dose and the second dose LOT# is ER8735. When probed if the consumer is still experiencing the side effect, consumer stated, "A little bit but it's about to go away. I just want to say it's just mild after a week and its goes on milder as it going on, just wanted to report that.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.