chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Woke up with low grade fever; Headache; felt achy and sore and injection site very sore by this point.; very tired and achy/sore; My sugar numbers were 10-20 points higher than usual for every meal (breakfast is always the exact same food, lunch is very similar food).; Sore arm at injection site started 12 hours after injection; Pregnant at the time of vaccination?: Yes; This is a spontaneous report from a contactable consumer (patient). A 36-year-old pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was EP6955 and expiration date was not reported), dose 2 via an unspecified route of administration, administered in arm left on 15Apr2021 at 09:30 as dose 2, single (at the age of 36-year-old) for COVID-19 immunization. Medical history included gestational diabetes during this twin pregnancy and did not have known allergies. The patient was 28 weeks pregnant and due date was on 04Jul2021. Concomitant medications included insulin human injection, isophane (HUMULIN 30/70); minerals NOS, vitamins NOS (PRENATAL VITAMINS); folic acid and docusate sodium (COLACE), all concomitant medications taken for an unspecified indication. The patient did not have COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was pregnant at the time of vaccination. The patient previously took first dose of BNT162B2 (lot number: EP6955, pregnant at time of vaccination) on 25Mar2021 at 13:15 administered in left arm (at the age of 36-year-old) for COVID-19 immunization. The clinical course of the events was reported as: on 16Apr2021, the patient woke up with low grade fever and headache (100.6F) at 2:30, took 1 Extra strength Tylenol. She felt achy and sore and injection site very sore by this point. Sore arm at injection site started 12 hours after injection. She woke up at 5:30, very tired and achy/sore. Low grade fever again around 11:30 on 16Apr2021. Took another extra strength Tylenol. General very tired for the rest of the day. By 6pm she was feeling less fatigue. She had gestational diabetes and manage by diet and exercise except for night time fasting which was controlled by 20 units at night of Humulin insulin injection. Her sugar numbers were 10-20 points higher than usual for every meal (breakfast is always the exact same food, lunch was very similar food). On 17Apr2021, she woke up with no more side effects. The patient was not COVID tested post vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient received treatment with Tylenol for the events low grade fever and headache and did not receive treatment for the other events. The reporter assessed the events as non-serious. The outcome of the event "Vaccine exposure during pregnancy" was unknown and patient recovered from all other events on 17Apr2021.  Additional information has been requested.
She had tested positive for COVID this summer; She had tested positive for COVID this summer; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received second dose of bnt162b2 (Pfizer-bioNtech covid-19 vaccine, Solution for injection), via an unspecified route on an unspecified date in Feb2021 (age at vaccination: 71-year-old), as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (Pfizer-bioNtech covid-19 vaccine, Solution for injection), via an unspecified route on an unspecified date as a single dose for covid-19 immunization. On an unknown date, patient had tested positive for covid this summer and had an antibody therapy on 10Aug2021. Patient wants to know the timing on when she can have the booster dose of the vaccine. She wants to confirm if she needs to wait 90 days or 8 months from the time, she had her infusion before she can have the booster dose. She mentioned if you had antibody in the past you can wait for 8 months. COVID-19 vaccine can safely be given to persons with a history of a prior COVID-19 infection. The vaccine should be offered even if you had symptoms or no symptoms of COVID-19 infection. These interim considerations state mRNA vaccines, including the Pfizer BioNTech COVID-19 vaccine, can safely be given to persons with a history of a prior COVID-19 infection. The vaccine should be offered even if you had symptoms or no symptoms of COVID-19 infection. Patient mentioned that you were not able to answer my question whether she should wait 90 days or 8 months before she can have the booster dose. The patient underwent lab test and procedure which included SARS-CoV-2 test positive. The clinical outcome of the event was unknown.  Information on the lot/batch number has been requested.
Patient said vaccine was administered too high into the shoulder on 9/23/2021.  Patient is now experiencing numbness and tingling down her left arm.
On the morning of 1/27/2021 patient noted redness and swelling at the injection site.  Area is approximately 2"x2" is red and warm to touch.  Discomfort is also reported.  No other symptoms are reported.  No pain in neck area.
Pt vaccinated with TD developed temp of 102 X 2-3 days, pain, swelling, lump, numbness, warmth, rash lt arm x 2-3 days. Pt slept a lot; vomiting.
A non-serious spontaneous report of inadvertent administration of expired H1N1 from a registered nurse/health professional concerning a 37-month-old male out of eight patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine was expired on 15-Jan-2010. On 25-Jan-2010, the patient received the expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments were not applicable, and the event was considered resolved.
4/8 3:30pm chills, fever, and severe headache started 4/8 8pm fever 102.7, severe headache, left foot and knee swollen, ringing/muffled sound in left ear 4/8 11pm unable to sleep due to headache 4/9 severe headache, fever all day. Unable to sleep 4/10 fever, severe headache, yellow bruising on shin left leg, back pain between should blades. 4/11 fever, severe headache, back pain between shoulder blades.  4/12 low grade fever, headache  4/13 thru currently, random severe headaches (debilitating - need to close eyes, limit light and noise, headache worse when walking)
Tested positive for Covid with mild cold like symptoms.; Tested positive for Covid with mild cold like symptoms.; Tested positive for Covid with mild cold like symptoms.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult male patient received bnt162b2 (BNT162B2), administration date 10Nov2021 16:45 (Lot number: FF8841) as dose 3 (booster), single, administration date 10Feb2021 (Lot number: EL3247) as dose 2, single and administration date 20Jan2021 (Lot number: EL3247) 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), NASOPHARYNGITIS (non-serious) all with onset 05Mar2022, outcome "recovered" and all described as "Tested positive for Covid with mild cold like symptoms.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Mar2022) positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19, nasopharyngitis. The patient did not had covid prior vaccination.  No follow-up attempts are possible. No further information is expected.
Extreme tiredness/fatigue 24hrs after injection lasting for 48hrs and a headache requiring doctors prescription.
Patient did not tell Healthcare team he had received an MMR on Monday 3-20-23 and he had request the varicella vaccine and mmr again from us today. Patient received the Varicella vaccine 2 days after receiving the mmr. Patient had received multiple other vaccines from the health department a few days prior as well, which was not communicated until after varicella immunization.
Moderna COVID-19 Vaccine EUA - Pain on left lymph node (same side where injection was given) at 7am the following day.  Pain subsided within 6 hours.
heart fluttered within a 2-3 days of 2nd vaccine. it did it for less than a minute, a total of one or two times in that period. just learned it was vax related this week and reporting late. Did nor report or treat at the time.  Just told my dr of it now as it was in news yesterday and I am looking at getting 3rd vx shot soon.
This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a female patient of unknown age.  Medical history and concomitant medications were not provided.  On or about 22-NOV-2014, the patient was vaccinated with ZOSTAVAX at a hospital  as recommended for routine adult health maintenance for the prevention of shingles (route and lot # not provided).  The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster.  On or about 09-FEB-2015, the patient was treated by a physician for a vesicular outbreak that was diagnosed as severe shingles.  She was prescribed  acyclovir  and oxycodone/paracetamol  for management of her painful symptoms.  As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
booster; Sore underarm (lymph node); Chills; Fever; Body ache; This is a spontaneous report received from a non-contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received bnt162b2 (BNT162B2, solution for injection) (Lot number: FH8030) as dose 3 (booster), single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8732), for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8732), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; LYMPH NODE PAIN (non-serious), outcome "recovered", described as "Sore underarm (lymph node)"; CHILLS (non-serious), outcome "recovered", described as "Chills"; PYREXIA (non-serious), outcome "recovered", described as "Fever"; PAIN (non-serious), outcome "recovered", described as "Body ache". Therapeutic measures were not taken as a result of lymph node pain, chills, pyrexia, pain.  Additional information: The patient was neither diagnosed with COVID-19 Prior to vaccination, nor been tested for COVID-19 Since the vaccination.  No follow-up attempts are possible. No further information is expected.
Has multiple bumps on her chest, Painful to the touch; Bumps begin to appear at the center of her right breast/Has multiple bumps on her chest; Had enlarged lymph node near armpit near injection site/ spread to left, and bottom of right breast/ right side of left breast/ right leg, inner side, about six inches above knee; Hypersensitivity reaction; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Hypersensitivity reaction), PAIN (Has multiple bumps on her chest, Painful to the touch), RASH (Bumps begin to appear at the center of her right breast/Has multiple bumps on her chest) and LYMPHADENOPATHY (Had enlarged lymph node near armpit near injection site/ spread to left, and bottom of right breast/ right side of left breast/ right leg, inner side, about six inches above knee) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002b21a and 026a21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Anaphylaxis in 1979 and Migraine. Concurrent medical conditions included Mite allergy (had desensitization injections for dust mites) and Bee sting. Concomitant products included CICLOSPORIN (RESTASIS) for Dry eyes, TOPIRAMATE (TOPAMAX) from an unknown date to 30-Jun-2021 and SUMATRIPTAN (IMITREX [SUMATRIPTAN]) for Migraine.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction) and LYMPHADENOPATHY (Had enlarged lymph node near armpit near injection site/ spread to left, and bottom of right breast/ right side of left breast/ right leg, inner side, about six inches above knee). On an unknown date, the patient experienced PAIN (Has multiple bumps on her chest, Painful to the touch) and RASH (Bumps begin to appear at the center of her right breast/Has multiple bumps on her chest). At the time of the report, HYPERSENSITIVITY (Hypersensitivity reaction), PAIN (Has multiple bumps on her chest, Painful to the touch), RASH (Bumps begin to appear at the center of her right breast/Has multiple bumps on her chest) and LYMPHADENOPATHY (Had enlarged lymph node near armpit near injection site/ spread to left, and bottom of right breast/ right side of left breast/ right leg, inner side, about six inches above knee) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Mammogram: (normal) Does not show cancer.         Laboratory test performed included ultrasound scan and no results were provided. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Follow-up was received and added first dose info, patient demographics, medical history, concomitant medicines, event update,event outcome and causality.
Patient started with hives aprox 5 mins after receiving vaccines on face and neck symptoms resolved 15 mins after given 12.5 mg BENADRYL. No respiratory symptoms.
Symptoms: nausea; dizziness; SOB, hx of COPD and cardiac problems, taking meds frequently, had to take more often last night, unknown if SOB is worse than baseline currently; pt feeling better; fever, no thermometer
expired dose of Twinrix was administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a male patient who received HAB (Twinrix) (batch number unknown, expiry date 7th August 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th August 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 11th August 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-AUG-2022 Reporter's Comments: A Pharmacist stated that an expired dose of Twinrix was administered to a patient.  The reporter consented to follow up. The healthcare professional did not have the lot number at the time of the call and declined to provide the initials or DOB for the patient. He also did not know what dose number this was for the patient.  Additional supportive information: Patient received a dose of Twinrix on 11th August 2022 which was expired on 7th August 2022, which led to expired vaccine used.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and drug reactions/allergies were not reported. On an unknown date, the multiple patients were vaccinated with improperly stored doses of VARIVAX lot # M005971, expiration date 02-FEB-2018, (Concentration, dose and route were not reported). The multiple patients' concomitant therapy was not reported. No adverse effects were reported. A product quality complaint (PQC) was not involved. Additional information has been requested.
Notice swelling in clavical area on left side Saturday. Hurts to touch. Swelling at vaccine site of left deltoid.
Fever (103), body aches, headaches started about 24 hours after vaccines; swelling and redness to both deltoids; presented to ER - blood work, spinal tap performed - all normal.
Hives 48 hrs after shots. Shot site red ? which one. Still off and on hives on 7/9/18.
I am the epidemiologist reporting on behalf of patient who tested positive for COVID-19 via PCR on 5/15/21 after the completion of a full Pfizer vaccine series (Dose 1 on 2/8 and Dose 2 on 3/1). The patient later died on 5/28/21. Cause of Death is listed as ?Acute hypoxemic respiratory failure Pneumonia COVID-19?. Pre-existing conditions listed as: CARDIOVASCULAR DISEASE, DIABETES MELLITUS, CHRONIC LUNG DISEASE (ASTHMA/EMPHYSEMA/COPD)
Information has been received from a nurse via a field representative referring to a 17 year old female patient who had no pertinent medical history or drug reactions/allergies. The patient's concomitant medication included pantoprazole sodium (PROTONIX). On 22-JAN-2018 the patient received the first dose of her human papillomavirus (HPV) vaccination series with GARDASIL 9 (intramuscular, strength, dose, frequency, batch/lot # and expiration date were not reported) for HPV vaccination. On 25-APR-2018 the same patient received the second dose of her HPV vaccination series with GARDASIL 9 (intramuscular, strength, dose, frequency, batch/lot # and expiration date were not reported). On 29-AUG-2018 the same patient returned to the physician's office for medical attention and reported that she had a lump in her arm that itched. The start date, extent, and duration of swelling were unspecified. No lab diagnostics/studies were performed. The treatment given for the events was unknown. There was no intervention to prevent serious criteria. The outcome of the events was unknown. The causality between the events and GARDASIL 9 was unknown.
Watery eyes sore/ticklish throat, feverish, aches, immediate almost at 5:30ish pm - chills overnight.
After vaccination, patient experienced light and dizziness to a point where she had to kneel on to the ground.  Patient was suggested to lied down and remove her mask since complained about difficulty in breathing.   EMS was called, breathing improved but dizziness continued through the whole ordeal.   At one point she complained of tingling sensation in her mouth and feet.  Patient recovered after EMS checked her out and was walked to her car by EMS.
Initial information received on 27-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 44 years old female patient who was vaccinated with a 0.5 ml once dose of FLUZONE HIGH DOSE (Batch number: UJ006AA and expiry date: 14-Apr-2019) in the left deltoid (dose in series and route of administration were not reported) on an unknown date. The patient's past medical history included Female sterilization on an unspecified date of 2004. The patient's past medical treatment(s), vaccination(s) and family history were not provided. No concomitant vaccines given. It was a case of actual medication error due to inappropriate age at vaccine administration. It was unknown if any adverse event occurred or not following the vaccination. 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.
This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6201; Expiration date: 30Jun2021) on 27Feb2021 (14:27) as a single dose on the right arm, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included broken right shoulder; dizziness (not ongoing); and "sugar diabetes". There were no concomitant medications. The patient previously took meclizine HCl for dizziness, and was not working; paracetamol (TYLENOL), and reported he would be feeling good, and then his symptoms would hit him again; and the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9581; Expiration date: 31May2021) on 06Feb2021 for COVID-19 immunization. On an unspecified date in 2021, the patient was "feeling dementia"; had diverticulitis; pancreatitis; could not stop hiccupping; and had gastroesophageal reflux disease (GERD). On 09Mar2021, the patient had nausea; stomach was upset; had vomited in quantities (described as "had filled up two containers of trash"); was sick as a dog as/sick all day; did not sleep at night; and had lost weight (lost 30 lbs.). On 10Mar2021, the patient had dizziness. The patient clarified that the dizziness reported was a different dizziness from what he had before. The patient had taken meclizine as treatment for dizziness; and paracetamol (TYLENOL) as treatment for the upset stomach and nausea. The outcome of the events was unknown for 'feeling dementia', 'diverticulitis', 'pancreatitis', 'could not stop hiccupping', 'gastroesophageal reflux disease (GERD)' and 'did not sleep at night'; was recovering for 'nausea', 'dizziness', 'vomited in quantities' and 'sick as a dog/sick all day'; and was not recovered for 'stomach was upset' and 'lost weight'.
Upon waking the morning of 1/16/21, I noticed red, itchy lesions at the following locations:  - Between second and third digits of R hand  - Lateral aspect of R hand  - L forearm     The next day, I had a more extensive outbreak of possible hives on the R side of my neck and on both flanks. I also noted at least one lesion on my lower L leg.      Lesions were red and very itchy for 2-3 days then began to improve steadily.       Saw PCP on 1/21/21 with visit to dermatologist scheduled for 1/27/16.
Gave a HD Flu shot to a patient under the age of 65 instead of the Flucelevax
client stated that on Wednesday (vaccination done on Monday) rash noticed on forearms, legs (behind knees), and groin.  "Tiny, little rashed spots similar to poison ivy"  Stated had not been outside and had not changed detergent/household cleaning products.  Denies food allergies.  Rash is itchy and has been applying Caladryl lotion--which helps. No other symptoms.