chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm, on 18Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 06Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 18Jan2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "IgA deficiency" (unspecified if ongoing); "Mixed connective tissue d/o nos" (unspecified if ongoing), notes: Mixed connective tissue d/o nos. The patient took concomitant medications. Past drug history included: Known allergies: keflex, reaction(s): "Known allergies: Keflex", notes: Known allergies: Keflex; Known allergies: terbinafine, reaction(s): "Known allergies: Terbinafine", notes: Known allergies: Terbinafine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Apr2022, outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Ae treatment: Dexamethasone.  Clinical course: Other medical history was reported. Patient received Other medication in 2weeks. Anti viral details reported as patient took Paxlovid orally for COVID 19 Treatment, Treatment start date: 15Apr2022, Treatment stop date: 20Apr2022. Adverse event: Took Paxlovid. Felt better next day. Then on day 11 of covid course which was 4-5 days after stopping Paxlovid symptoms rebounded. Event onset date, outcome and treatment was reported.   The information on the batch/lot number for (BNT162B2), has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events Vaccination failure and COVID-19 which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available.
pt states about 5 minutes after getting the vaccine her head felt strange.  She started seeing brown specs.  The next day her eyes were hurting so bad that she did not want to open them.  When she did finally open them she still saw specs.  When she woke up the day after her eyes were still blurred but she no longer saw specs.  The blurriness lasted about 2 or 3 days.  She no longer has these symptoms.
Administered DTaP on 03/19/2002. Mother reported "dime size" swelling on 03/26/2002 relates child as "cranky" temp 98.7 and notes swelling increased in site over weekend.
This spontaneous report was received from an immunization official referring to 68 patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unspecified dates, 20 patients were vaccinated with improperly stored PROQUAD lot # L040414 expiration date 13-APR-2017 (strength, dose and administration route were not reported). On an unspecified dates, 20 patients were vaccinated with improperly stored PROQUAD lot # L031600 expiration date 18-FEB-2017 (strength, dose and administration route were not reported). On an unspecified dates, 20 patients were vaccinated with improperly stored PROQUAD lot # L010143 expiration date 24-SEP-2016 (strength, dose, administration route were not reported. On an unspecified dates, 8 patients were vaccinated with improperly stored PROQUAD lot # L006390 expiration date 25-AUG-2016 (strength, dose and administration route were not reported). No adverse events were reported and no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Blurred vision, severe dizziness (unable to stand or walk without assistance) unable to form words and sentences clearly.
A vial of Pfizer covid vaccine was drawn up incorrectly by mistake by one of the nurses in our practice, RN.  In turn, this patient was mistakenly given the incorrect dose of the Pfizer covid vaccine by this same RN.   Patient was administered 0.25ml instead of appropriate 0.3ml dose.  After discussing this with the manufacturer,  gave patient repeat full dose as soon as possible, as recommended.    Patient was notified of error and agreed to receiving additional full dose, given on 1/26/21 at 3:16pm.
back itching; This is a spontaneous report from a contactable consumer (patient).   A 71-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: 18262), via an unspecified route of administration in Right arm on 12Feb2021 at 11:15 am (at the age of 71-years-old) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included known allergy to sulfa. Concomitant medications included digoxin (DIGOXIN), lisinopril (LISINOPRIL), montelukast (MONTELUKAST) and dicyclomine (DICYCLOMINE) taken for an unspecified indication on an unspecified date received in two weeks of vaccination. The patient previously took microbid and experienced drug allergy. The patient did not receive other vaccine in four weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. On 26Feb2021 at 07:00, the patient experienced back itching and resulted in Doctor or other healthcare professional office/clinic visit. Treatment for adverse event included Hydroxyzine HCL 50mg and hydrocortison-E 2.5%. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Patient developed what appears to be localized untreated rash with some mild induration about 12 days after vaccines. Exactly around injection site.
On 13 Feb2021 I got tested for covid and on 14Feb2021 result came covid Positive; A spontaneous report was received from a consumer concerning a 66-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and on 13 Feb 2021 I got tested for covid and on 14 Feb 2021 result came covid positive,  The patient's medical history was not provided. Concomitant medications reported were Rosuvastatin, Synthroid, Viagra(as needed), Vitamins for drug use for unknown indication.  On 5 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 039K209) intramuscularly for prophylaxis of COVID-19 infection.  On 14 Feb 2021, the patient experienced covid positive.  Treatment details included infusion of Bamlanivimab and Saline to flush lines in Emergency Room.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event was unknown.
swollen, hard & hot @ inject site on leg; 3 days later seen by MD w/cold sx which did not go away; By 30 days, cough so bad that pt required pulmonary nebulizer w/ventalin; now has PDD (autism) sx; constant ear infect started 30 days p/vax
5-6 varicella type vesicles noted (5/3/03) on body, had varicella vaccine on 4/16/03.
Potential Absence Seizure duration 5-10minutes,  vomiting at conclusion.  Episode occured roughly 40 minutes post vaccination.  Patient returned to her  baseline following episode.  EMS called and patient evaluated in ED and returned to facility with no lasting effects.
This spontaneous report was received from a nurse and refers to an unspecified patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 24-JAN-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot # M005974, expiration date 02-FEB-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine were exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because all information was obtained.; Sender's Comments: US-009507513-1611USA004113:
Employee presented to COVID 19 vaccination clinic and received 1st dose of COVID 19 @ 13:48. Patient proceeded to wait in the waiting area 15 minutes and was about to leave to return to work when the contracted employee reported she developed a cough and flushed face. VSS @ 2:04 BP 172/105 HR 111, she was A&O, Employee was moved to stretcher, given water to drink unable to drink, she stated "it feels funny", VSS retaken BP 151/97, HR 91. She continues with intermittent non productive cough and C/O she was unable to clear throat and felt throat tightness. Within minutes, her face flushed, coughing worsened, difficulty swallowing, and she became diaphoretic. Solumedrol 125 mg IM Given to right arm. Patient reported she felt heaviness throughout her body, and was unable to move her Left arm as easy as before, with bilateral numbness to tingling to upper extremities and decrease strength to left arm. Patient crying out, stated she felt as if she could not breath, no hives present, no angioedema. Anxious, crying out that she felt "heavyness on her chest". VSS 2:19 158/108 HR 78. This writer attempted to call ED RN several times through operator: NO answer to each call. I left personal message with Unit secretary of COVID 19 reaction and needed to speak with RC or ED MD. I attempted to to call ED MD, no answer. Epinephrine 0.5mg IM given to right deltoid at 14:20 patient was taken to ED triage area, patient taken to room. Report given to RN and ED MD.
April 10 and 11th had extreme headache and muscle soreness on ribcage/torso, that subsided . On April 12th and 13th had a rash on my torso, then that went away
Approximately 2 days after receiving the vaccine, the patient developed a rash on her left upper arm.  She also experienced dizziness.  The injection site was the left deltoid.
inadvertently being administered a 2nd dose of prevnar 13; pain; redness; swelling that extended from elbow to shoulder; This is a spontaneous report from a contactable other HCP via Pfizer sales representative. A 72-year-old female patient  received a second dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of pneumococcal 13-val conj vac (dipht crm197 protein) about four months ago for immunization. On an unspecified date, the patient experienced pain, redness, and swelling that extended from elbow to shoulder after inadvertently being administered a 2nd dose of pneumococcal 13-val conj vac (dipht crm197 protein). The outcome of the events was unknown.   No follow-up attempts are possible, information about batch number cannot be obtained.
Large size of  a  Orange,  reddish in color, warm to touch.  Went to local Urgent Care last night my husband noticed it had gotten larger with more color than the day before, they gave me 7 days of  Cephalexin 500mg, 3 times a day for 7 days.  They told me to take Benadryl when needed and Claritan   daily.
Patient woke in the middle of the night following vaccination with a fever, pain in arm and drenched in sweat. Patient got out of bed and experienced extreme dizziness and nausea, very weak followed by clamminess, chills and diarrhea. Patient also experienced nausea but no vomiting, sore throat and restlessness. Patient took aspirin which temporarily relieved fever but quickly wore off. Symptoms  continued for approximately 3 days. Arm redness, soreness and warm to touch had delayed development and is still present currently.
Pt given immunizations on L upper arm. Positive redness, swelling and firmness around immunizations and circumference of arm - Treated with BENADRYL.
Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Numbness in left arm and left side of face/throat. not severe. numbess in arm faded after 10 minutes face/throat not completed faded at 30min mark
little chills, and minor soreness; little chills, and minor soreness; got both the Pfizer and Moderna Covid-19 Vaccines; got both the Pfizer and Moderna Covid-19 Vaccines; This is a spontaneous report from a Contactable Consumer. A 77-Year-old male consumer reported that: Patient received (Pfizer-Biontech Covid-19 Vaccine, Formulation, solution for injection, Batch/lot number: Unknown, Expiry Date of Covid-19 Vaccine: Unknown) via unspecified route of administration in left arm on 20Feb2021 as dose 2, single (age at vaccination 77 years )for COVID-19 vaccination. The patient medical history and concomitant medication were not reported. Historical vaccine included Moderna Covid-19 Vaccine Batch/lot number: Unknown, Expiry Date of Covid-19 Vaccine: Unknown) on 30Jan2021 for COVID-19 vaccination. Patient received the 1st dose of the Moderna vaccine on 30Jan2021 and received the 2nd dose is from Pfizer on 20Feb2021. It was reported that patient was not experiencing side effects other than little chills, and minor soreness. Patient was asking if there had been reports about my situation and any potential side effects. The outcome of events were unknown  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Extreme nerve pain/reduction in range of motion that began shortly after administration. Patient went to PCP the following day and received prednisone and lidocaine patches. Patient contacted us four days after injection and at that time the pain was almost gone and she was beginning to regain her full range of motion.
Extremely high blood pressure - 255/150, flushed face. BP was checked 35 minutes after administering the vaccine. It took 4 hours to come down to 175/90 and I was sent home from ER. After 14.5 hours, BP came down to 135/78. I was given 1 pill of Benadryl in the ER.
Numerous pox vesicles, widespread DX chickenpox 03/01/2006, post vaccination 05/05/1998, TX Acyclovir.
Extreme body aches, headaches, disorientation, fatigue, chills & fever. Occurred for roughly 22 hours.
Vaccine given on 9/28/21 with expiration date of 9/21/21. Janssen notified/consulted;inquiry#0259438. Dr notified/consulted. Patient notified-suggested antibody testing be done 2 weeks after receiving vaccine.
about 3x4 in  itchy, raised, and hard, and hot to the touch area at injection site
Vomiting; joint pain; muscle pain; nausea; feeling unwell; tiredness; kidney and lung pain; kidney and lung pain; This is a spontaneous report received from a contactable consumer (patient). A 56-year-old female patient received the second dose of BNT162B2 (lot number: EW0107), via an unspecified route of administration in right arm on 30Apr2021 13:15 at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included estrogens conjugated (ESTROCON), colecalciferol (VITAMIN D), oenothera biennis oil (EVENING PRIMROSE), and fish oil (O3 OMEGA 3). The patient previously received the first dose of BNT162B2 (lot number: EW0158) in left arm on 09Apr2021 13:15 for COVID-19 immunisation. The most recent COVID-19 vaccine was administered in workplace clinic. Patient experienced vomiting, joint pain, muscle pain, nausea, feeling unwell, tiredness, kidney and lung pain on 01May2021 01:00. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received for these events. Outcome of the events was not resolved.  No follow-up attempts are needed. No further information is expected.
The patient received her flu shot on Tuesday 11/9 and stated that it was injected high up in there shoulder bone. Patient stated that she was unable to move her arm and that she has lost some range of motion. Patient stated that the injection was given 1-2mm below the bone and that it should have been given lower. The patient stated that she experienced muscle soreness and lost the ability to move her arm after receiving the flu shot. She reports current limited range of motion and is unable to lift items.
Started having low level headache 2 days after injection. Headache has lasted up until the present day. Headache is almost none-existent when I wake up in the morning. Then over the course of the day the pain increases from about a 2 or 3 to about a 7. That was early in the headache. Now it increases to about a 4 or 5. Pain is located on left side of my head behind the left eye. No history of headaches lasting more than 2 days. Pain/pressure increases if I cough, sneeze or strain in any way or when bending over. Pain can also increase after looking at computer or phone screens or when wearing glasses for an extended period of time.
Varivax on 10/18/2000. Had chicken pox on 5/11/04.
General malaise, diarrhea, elevated temp 99.8, pallor. Started S/S early am of 7/18. Ibuprofen 600mg given at approx 1300. S/S resolved at 1600.
Localized rash appeared around injection site within 4 hours of administration for both doses  2nd Dose administration 02/19/2021: site appeared red, it was itchy and sore, tender to the touch?dissipated within 7 days; body aches and pains, low grade fever?eased with oral antipyretics and pain reliever, dissipated within 3 days  Booster administration 11/15/2021: site appears red; it is sore and tender to touch and movement; minimal body aches and pains; onset of cervical aching and a headache ranking 6/10 apps 10 hrs following administration, eased with oral pain reliever
Eczematous Dermatitis- Information has been received from a registered nurse concerning a 12 month Asian female, who on 12 Jan 2001, was vaccinated with measles virus vaccine live (+) mumps virus vacine live (+) rubella virus vaccine live second generation lot 1276 invalid.  subcutaneously in the right thigh.  At the time of vaccination the patient has otitis media and was treated with hydrocortisone (+) neomycin sulfate (+) polymxin B sulfate cortisporin otic solution.  On 12 Jan 2001, the patient also was vaccinated with hepatitis b vaccine manufacturer unknown.  On 19 Jan 2001, while at day care. the patient developed a mild rash on the back of her neck.  The child was sent home due to possible contagiousness.  The patient was seen by her physician who diagnosed eczema.  The nurses reported she received information that this was not likely contagious.  The patient recovered from the eczema.  No further information is expected.
Patient received a TETANUS shot (decavac) and FLUZONE shot in opposite arms. Pt fainted about 2-3 minutes after shot was given. Pt was very afraid of getting shots.
8:00 pm 10/24/09 Saturday started having body aches all over. 8:00 am 10/25/09 Sunday started when breath chest hurts, tired. 10/26/09 report situation to employee health. No fever at any time
newborn was given Adacel by mistake instead of hepatitis B vaccine when in the hospital at birth and Adacel was intended for the mother; newborn was given Adacel by mistake instead of hepatitis B vaccine when in the hospital at birth; Initial information received on 14-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a  new born female patient who received vaccines DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of HEPATITIS B VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant vaccines were given.  The patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (formulation: unknown, lot: 33T42) via unknown route in unknown administration site instead of HEPATITIS B VACCINE (formulation: unknown).  It was an actual mediaction error due to Inappropriate age at vaccine administration (newborn was given adacel by mistake instead of hepatitis B vaccine when in the hospital at birth and adacel was intended for the mother) and wrong vaccine administered (newborn was given Adacel by mistake instead of hepatitis B vaccine when in the hospital at birth)  It was unknown whether the patient had any adverse event.  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.  List of documents held by sender: none.
Pneumococcal bacteremia 08/27/2001. Febrile seizure.
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 (BNT162B2), administered in left shoulder (deltoid), administration date 04Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. On 04Sep2021, the patient was given the 1st dose of the Pfizer COVID -19 Vaccine. The following day the patient had the following side effects: Unable to walk for 24 hours, Dizziness, Light-headedness, Vomiting, and Could not respond to other people. At 4:30 a.m. on 05Sep2021 the patient woke up because the left foot was on fire. Then fire went to left ear and then to left nostril. The patient stated mind was not clear. On Monday, 06Sep2021, the patient had extreme fatigue, no energy.  The patient also had headache for 12 days.  The patient decided not to get the second dose as the patient could not put the body through this again. The patient had an extreme violent allergic reaction according to the CDC, whom called, and the doctor, who the patient visited.  The following information was reported: HYPERSENSITIVITY (medically significant) with onset 05Sep2021, outcome "unknown", described as "extreme violent allergic reaction "; INTELLECTUAL DISABILITY (medically significant) with onset 05Sep2021, outcome "unknown", described as "Mind not clear"; GAIT INABILITY (non-serious) with onset 05Sep2021, outcome "recovered" (Sep2021), described as "unable to walk for 24 hours"; DIZZINESS (non-serious) with onset 05Sep2021, outcome "unknown", described as "Dizziness / light-headedness"; VOMITING (non-serious) with onset 05Sep2021, outcome "unknown", described as "vomiting"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 05Sep2021, outcome "unknown", described as "could not respond to other people"; BURNING SENSATION (non-serious) with onset 05Sep2021 04:30, outcome "unknown", EAR DISCOMFORT (non-serious), NASAL DISCOMFORT (non-serious) all with onset 05Sep2021, outcome "unknown" and all described as "left foot on fire, then fire went to left ear and then to left nostril"; FATIGUE (non-serious) with onset 06Sep2021, outcome "unknown", described as "extreme fatigue"; ASTHENIA (non-serious) with onset 06Sep2021, outcome "unknown", described as "no energy"; HEADACHE (non-serious) with onset 05Sep2021, outcome "recovered" (16Sep2021), described as "headache for 12 days".   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
This vaccine clinic was held at the Center in  on 1/23/21 and hosted by the Hospital.. Vaccine administered at 1340 by   LPN. Patient with immediate c/o of feeling light headed, hot all over, flushed. Patient stated she felt better but at 1357 c/o of itching all over body and tongue swelling. Epinephrine pen administered at 1358 by LPN.  Emergency services contacted. Patient transported to  ER at approximately 1410.