chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I am still kind of bad/ Not feeling good; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 24Mar2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (First dose), for COVID-19 immunisation. The following information was reported: MALAISE (non-serious) with onset Mar2021, outcome "not recovered", described as "I am still kind of bad/ Not feeling good".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt with increased bruising - presented to ED - admitted to the hospital - continued workup and pt with BM results aplastic anemia.
Approximately 24 hour low grade fever, general malaise. Injection site reaction, redness, soreness, pain localized on arm. Patient had improved (no fever) when calling pharmacy (9-30-09 1:30).
bump where shot was; very large red area and very itchy; very large red area and very itchy; This is a spontaneous report from a contactable consumer (patient herself). A 69-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 11Mar2021 at 16:00 (at the age of 69-years-old) as a dose 1, single for covid-19 immunisation. The patient medical history included high blood pressure from an unknown date and unknown if ongoing. Concomitant medications received in two weeks of vaccination included blood pressure medicine (unspecified). The patient had no known allergies. No other vaccine was received in four weeks of vaccination. Patient did not have covid prior vaccination and has not tested for covid post vaccination. On 11Mar2021 at 17:00, the patient experienced bump where shot was, very large red area and very itchy. The patient reported that, she had very large red area and very itchy and it was still very red and itchy today which is 4 days after the shot. Also, a bump where shot was. No treatment was received for the event. Outcome of all the events were not resolved.  No follow up attempts are possible. Information about Lot/Batch number cannot be obtained.
Contracted Shingles about 9 months after receiving Zostavax vaccine.                   SX:  (3) 2" shingles lesions - pain at sites -    Duration: Appx 2 months
Received 2nd dose on 4/10. On 4/11, lymph nodes under left arm felt swollen and tender, plus pain flared up in the left armpit region. Currently (4/14) symptoms are milder but persist.
This case was reported by a other health professional and described the occurrence of inappropriate route of vaccination in a female patient who received ENGERIX B adult (batch number 15MN2, expiry date 2nd September 2016). On an unknown date, the patient received ENGERIX B adult (intravenous). On an unknown date, an unknown time after receiving ENGERIX B adult, the patient experienced inappropriate route of vaccination. On an unknown date, the outcome of the inappropriate route of vaccination was unknown. Additional information received: ENGERIX B 40mcg dose was administered via IV route to a patient on dialysis. No AE reported.
2 days after receiving vaccine, patient began with non-bloody, watery diarrhea, up to 6 times daily, with 2 episodes of vomiting.  Was seen in the ED 2/26/21 and diagnosed with 1. Acute prerenal azotemia, 2. Abdominal pain, vomiting and diarrhea, 3. Dehydration, 4. Covid ruled out.  Stool studies were negative for c.dif, stool cultures were not completed due to communication problem with patient.  Diarrhea continued and was seen in PCP's office 3/1/21.  Additional labs were ordered, as well as the previous incomplete stool studies.  Lab were nonremarkable, unable to process repeated stool studies as contents leaked out of containers and patient refused to repeat.  Diarrhea continued through 3/6/21 and has gradually resolved, although patient stating she still feels weak.
Left arm redness and swelling 9.5 cm by 9 cm swollen tender slightly cellulitic.  Given amoxicillin & ORAPRED on 5/26/10.
Child began fever in evening. The following morning increased to Tmax 104.1 degrees Fahrenheit. Irritable and arching back.
In August I was diagnosed with Afib in which my doctor checked my heart with an EKG and my heart was fine.  I was put on Metroprolol 50 mg.  The medication appears to be working keeping my blood pressure down.
Cellulitis, 48 hours after injection.  Treatment was keflex 250mg  tid.
Significant impairment/ extreme exhaustion consisting of substantial disruption of the ability to conduct daily normal life functions. I was to the point where I could not walk due to severe exhaustion accompanied with some achyness in muscles.  This has NEVER happened to me.  Very concerning to me. Next day I was fine.
Vomiting, nausea, vitals wnl. Advised to drink plenty of water.
Information has been received from a physician concerning a 77 year old male who on 16-JAN-2008 was vaccinated with Zostavax (Oka/Merck). Concomitant therapy included VASOTEC, nadolol and NORVASC. The physician reported that "the patient had shingles after he was given Zostavax (Oka/Merck)". Unspecified medical attention was sought. There was no product quality complaint. At the time of reporting the patient's status was unknown. Additional information has been requested.
PT mother presented with immunization card and said she was sent from school to get her kindergarden shots.  Saw on form blanks for Dtap #5, Polio #4, MMR #2, .  NCIR was not operating at that time. Did not realize pt was too old to need 5th Dtap.  No adverse reaction from pt.
pt recvd vax & exp elevated liver function tests (elevated SGOT, LDH, & GGT) which have not subsided;
HEADACHE; This spontaneous report received from a parent concerned a male of unspecified age. 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: 1805022 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache was not reported. This report was non-serious.
might have administered/lyophilized vial without the adjuvant/not sure about it yet and did not mention any other diluent; might have administered/lyophilized vial without the adjuvant/not sure about it yet and did not mention any other diluent; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported on a voicemail that they might have administered Shingrix lyophilized vial without the adjuvant, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered, they were not sure about it yet and did not mention any other diluent either. The reporter consented to follow up.
Metallic taste in her mouth, swollen lips and cheeks, slight difficulty breathing, thought to be d/t anxiety Narrative:  Employee reported anaphylactic reaction to previous vaccination but apparently denied this in ED. Has allergy to penicillin, receives weekly iron infusions. Given Benadryl and sent home in stable condition.
Extreme nausea; Diarrhea; Complete loss of appetite; This is a spontaneous report from a contactable nurse, the patient. A 44-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in right arm on 25Mar2021 at 15:30 (44-year-old at the time of vaccination) as a single dose for COVID-19 immunisation. Medical history included PCOS (polycystic ovarian syndrome), hashimotos disease and GERD (Gastro-oesophageal reflux disease). Concomitant medication included pantoprazole sodium sesquihydrate (PROTONIX), levothyroxine (MANUFACTURER UNKNOWN), dulaglutide (TRULICITY), levocetirizine dihydrochloride (XYZAL) all started since an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in right arm on 04Mar2021 at 15:30 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021, the patient experienced extreme nausea, diarrhoea and complete loss of appetite. The patient did not receive any treatment for the reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events extreme nausea, diarrhoea, and complete loss of appetite was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Hours after getting Hep A shot he got hives on both legs and red sheet of hives on left thigh.
It has been getting worse; It's at a point where she can't lift left arm/It is very hard to raise her left upper arm down to the elbow; Pain at left arm is internal throbbing pain; Her left shoulder started getting sore at injection site; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (It has been getting worse), VACCINATION SITE MOVEMENT IMPAIRMENT (It's at a point where she can't lift left arm/It is very hard to raise her left upper arm down to the elbow), PAIN IN EXTREMITY (Pain at left arm is internal throbbing pain) and VACCINATION SITE PAIN (Her left shoulder started getting sore at injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. FC031B2RA and 026A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN and HYDROCHLOROTHIAZIDE for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Her left shoulder started getting sore at injection site). On an unknown date, the patient experienced CONDITION AGGRAVATED (It has been getting worse), VACCINATION SITE MOVEMENT IMPAIRMENT (It's at a point where she can't lift left arm/It is very hard to raise her left upper arm down to the elbow) and PAIN IN EXTREMITY (Pain at left arm is internal throbbing pain). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency. At the time of the report, CONDITION AGGRAVATED (It has been getting worse), VACCINATION SITE MOVEMENT IMPAIRMENT (It's at a point where she can't lift left arm/It is very hard to raise her left upper arm down to the elbow), PAIN IN EXTREMITY (Pain at left arm is internal throbbing pain) and VACCINATION SITE PAIN (Her left shoulder started getting sore at injection site) had not resolved.
Rash on front of abdomen, severe aching of right arm alternating with a heavy, dead, numb feeling in that arm. It has been 6 weeks since the shot and my arm still feels heavy and aches.
Blurry vision on right peripheral; This is a spontaneous report from a non-contactable consumer, the patient. A 15-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 04Jun2021 at 09:15 (at the age of 15-years-old), as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient did not have any allergies to medications, food, or other products. Concomitant medications were not reported. 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 04Jun2021 at 09:30, the patient experienced blurry vision on right peripheral. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event blurry vision on right peripheral was recovered on 04Jun2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Bright red rash, approximately 2"x4" on upper left arm, around injection site.  Warm to touch, no other symptoms.
1st dose: could not lift left arm after vxn for 2 days due to pain in arm and had sinus issues. 2nd dose: Had arm pain for 3 days past having vaccine, have sweats, trouble breathing, chest pain, white lips, headache, subcutaneous itching under skin, felt feverish, fatigue, muscle pain, weakness, dizziness, vomiting, and disorientation.
All symptoms on the list were experienced, I didn?t realize how big the swelling was until i removed the band aid the following day.  Day 4, the swelling at the injection site is still there. Bigger than the size of a quarter.  Warm to touch and itches occasionally.  Pain to touch as well, too.  Day 5, size is slightly smaller but still itchy , swollen and painful.
Nurse called to report temperature excursion for VARIVAX; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 02-NOV-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, lot number S035125, expiration date 04-NOV-2021 (route of administration) for prophylaxis and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) 1 dosage form (Route of administration, lot number and expiration date were not provided) for prophylaxis.  The vaccines were exposed to the following temperature excursions: -13.9 degrees Celsius (°C) to 14.7°C; -14 to -10°, with an average of -13.9°C for 30 minutes. -14°C to -10°C, with an average of -14.2°C for 15 minutes; -14°C to -10°C, with an average of -14.7°C for 20 minutes and -14°C to -10°C, with an average of -14.6°C for 5 minutes. There were no previous temperature excursions. The call was due to digital data logger.
Patient came in on 8/14/19 after receiving vaccine on 7/28/19. The injection site was red with a small bruise to the left of it. The patient complained of still having a knot from the injection and that her arm was still very sore to touch. She also complained of numbness around the site.
Chills from 10:30am-1pm, 4/8/21.  Low grade fever, body aches & tiredness 8pm 4/8/21  - 5pm 4/9/21.
tingling feeling in her calves and ankles; headache; muscle pain in her legs from her thighs down to her ankles; Getting out of bed hurts, it's debilitating; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for herself). A 61-year-old female patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 11Aug2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 for COVID-19 immunization. On an unspecified date in Aug2021, the patient experienced tingling feeling in her calves and ankles, headache, muscle pain in her legs from her thighs down to her ankles, getting out of bed hurts, it's debilitating. Patient is a 61 y/o female. Patient reports receiving her second Comirnaty vaccine on 11Aug2021. Patient had a mild headache following the vaccine and approximately 1 week after the vaccine dose patient began to experience muscle pain in her legs from her thighs down to her ankles and a tingling feeling in her calves and ankles. Patient reports that the pain and tingling move around and is debilitating to the point where she wants to cry. Patient reports feeling these sensations 70% in her legs and 30% in her hands. Getting out of bed hurts, it's debilitating, my life is devastated. It's been going on for weeks now. Patient wants to know if we have information on this side effect and will it ever go away. Outcome of the events tingling feeling in her calves and ankles, muscle pain in her legs from her thighs down to her ankles, getting out of bed hurts, it's debilitating was not recovered and headache was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.  Follow-up attempts are completed. No further information is expected.
Patient experienced an arthritis flare after the 1st dose, and this became much more intense after the 2nd dose. She had increased weakness, abdominal pain, loss of appetite (not eating/drinking much), falls, and failure to thrive x3 weeks after the second dose which all ultimately got her admitted to the hospital (4/6/21). Upon admission, her blood counts were found to be dangerously low.
Patient received Jassen vaccine 4/10/21.  4/11/21 began with symptoms of fever, headache, chills, nausea, vomiting, and diarrhea, loss of taste and smell.  4/15/21 he presented to ED with symptoms of fever, chest pain and pressure, shortness o breath, myalgias, headache, tachypnea, tachycardia, hypoxia.  Was given IV Decadron, DuoNeb and albuerol in ED.  Inprovment seen, but patient continued with tachypnea and difficulty breathing.  He was admitted to ED with a diagnosis of COVID 19 ,  asthma exacerbation and elevated Troponin  at 31.52 (Ref Range 19)  . During admission, glucose levels were labile, requiring adjustment to routine insulin regimen and Glucovance for hypoglycemia. An Echocardiogram was ordered due to elevated Troponin levels on admission.  Echocardiogram  4/19/21 showed a density in the right atrium.   Cardiology recommended a cardiac MRI.  Patient was transfered to Hospital 4/19/21 for elevated care and evaluation, with diagnosis of
Patient is a 64 y.o. male with PMH of COPD on 3-4L home O2, HFpEF, DM2, lung adenocarcinoma s/p chemoradiation 2018, rheumatoid arthritis who presented on 1/28/2023 with worsening LE edema, pain, numbness with worsening SOB.  COVID positive. Patient started on BiPAP and was admitted to ICU, transferred out on 1/30/2023     Acute on chronic hypoxic hypercapnic respiratory failure -On 3-4L O2 at home with h/o COPD and CHF.  -Acute exacerbation in setting of COVID, CAP, Hx of lung adenocarcinoma.  -CTA negative for PE and doppler US negative for DVT. -Required BiPAP on admission and weaned to O2 of 3-4L which is his baseline   COVID-19 infection  - Presented with: worsening SOB  - Symptom onset: unclear  - Positive COVID-19: 1/29 - Vaccination status: Vaccinated with Moderna with last dose 3/4//2021 - CT Chest on admission showed Right middle lobe pneumonia with bronchiolitis and pneumonitis in the right upper lobe and right lower lobe - Decadron: Yes. Expected end date 2/8   Pneumonia  - CXR shows Right lower lung haziness may suggest atelectasis or developing infiltrate - CTA chest RLL PNA with bronchiolitis and pneumonitis in the RUL and RLL - Possible viral PNA with COVID infection -Patient will need repeat CT chest 2 to 3 months after hospitalization for lymphadenopathy and right middle lobe opacification   COPD  -in the setting of continued smoking with a 105 pack year smoking  -Possible mild exacerbation in setting of COVD and PNA on admission -Home regimen including  albuterol Proventil nebulizer, albuterol ventolin,  Symbicort, Spiriva Respimat.  -We will complete Decadron for COVID after discharge  Hx of lung adenocarcinoma -s/p chemoradiation 2018. -Not currently receiving treatment.    Suspected metabolic alkalosis with compensatory respiratory acidosis, resolved -Per patient, had been discharged on lasix 60 mg BID and was supposed to transition back to his home 40 mg BID but did not. -Lasix initially held, now resumed   HFpEF -Per history. Follows with Dr.   -TTE 12/31/22 showed LVEF 63%, abnormal diastolic dysfunction indicative of elevated L atrial pressure. - BNP 1891 on admission, was 785 on 12/30  Lower extremity Dopplers negative for DVT -Lasix resumed at 40 mg twice daily   BLE edema -Acute on chronic problem related to CHF and venous stasis -Doppler US BI LE negative for DVT. ABI R 1.02, L 0.72, unchanged from 12/2022. -Keep leg elevated. Compression stocking if tolerated -Lasix resumed     DM2 -Hgb A1c 7.8  -A1c was 7% 1 year ago; will have patient carb restrict his diet and follow-up with PCP   CAD -Per history. Follows with Dr. -S/p recent PCI for OM1 and in-stent restenosis of mid RCA. -Continue at home Plavix 75 mg BID and ASA 81 mg.    Essential HTN -Continue home Toprol 25 mg.    HLD - Prescribed atorvastatin but nooncomplaint     GERD -Continue at home Protonix 40 mg daily.    RA -Per history. -Doesn't currently take anything.    Tobacco use disorder -Current smoker, 1 ppd with year smoking history. -Encourage cessation.
Initial information received on 29-Jun-2018 regarding an unsolicited valid non-serious case received from a pharmacist via phone. This case involves a 06 month old patient who received 0.5 ml injection of PENTACEL (frequency one dose, batch number, expiry date was not reported) intramuscularly in left thigh on 29 June 2018. It was a case of actual medication error due to Inappropriate reconstitution technique as PENTACEL injection given without the diluent being reconstituted. It was unknown if any Adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.