chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dry mouth shortly after the 1st shot and is still present; Weak arm- inability to carry and grip things roughly 5+ pounds in same arm the shot was administered.; Weak arm- inability to carry and grip things roughly 5+ pounds in same arm the shot was administered.; Also shaking of the arm and hand when carrying things for longer than 1-2 minutes.; This is a spontaneous report from a non-contactable consumer, the patient. A 26-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 30Aug2021 at 14:30 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Aug2021 at 15:00, shortly after the 1st shot, the patient experienced dry mouth and which was still present and weak arm- inability to carry and grip things roughly 5+ pounds in same arm the shot was administered and also shaking of the arm and hand when carrying things for longer than 1-2 minutes. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event dry mouth, weak arm- inability to carry and grip things roughly 5+ pounds in same arm the shot was administered and also shaking of the arm and hand when carrying things for longer than 1-2 minutes was not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Redness swelling and warmth at injection site Body aches treated with ibuprofen and aleve
Diarrhea - around 4:15 - off and on all night of 9/16/08.  Vomiting - vomited x 1 time late evening 9/16/08.  Nausea - nausea throughout evening of 9/16/08.  High fever - around 4:15 - all night 9/16/08; treated with Tylenol, Motrin alternated.  Shortness of breath - late evening of 9/16/08/ sat up in bed.
Note - this was a booster dose   I developed mastitis in my left breast. My left deltoid began to get red, swollen, & painful later the same day as the vaccination. By the next day, lymphnodes in my axilla, above the clavicle, and my neck were swollen and tender. My left breast was also sore and tender and has persisted for a month. On 1/6/2022 I visited my PCP. She performed an exam and diagnosed mastitis.
expired second dose of Havrix was given; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 58-year-old female patient who received HAV (Havrix) (batch number D94MK, expiry date 5th July 2021) for prophylaxis.   On 26th July 2021, the patient received the 2nd dose of Havrix. On 26th July 2021, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were reported as follows: The patient received an expired dose of Havrix and was later discovered, which led to expired vaccine used. The reporter consented to follow up.
an allergic reaction/ get one on her first dose with the Pfizer-BioNTech COVID-19 Vaccine; the injection site was really itchy and red like a mosquito bit it; the injection site was really itchy and red like a mosquito bit it; This is a spontaneous report from a contactable consumer or other non healthcare professional. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 23Jul2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced an allergic reaction get one on her first dose with the pfizer-biontech covid-19 vaccine on 2021 with outcome of unknown, the injection site was really itchy and red like a mosquito bit it causing injection site pruritus and injection site erythema on 2021 with outcome of unknown.    Follow-up (16Aug2021): This is a follow-up spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient) reported for herself that: she is scheduled for the second dose of the Pfizer Covid-19 vaccine on 13Aug2021,.said that she was not able to get the second dose on 13Aug2021. She mentioned that she took the first dose on 23Jul2021. is asking if there is a grace period or timeframe for her to reschedule her second dose.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unspecified date in 2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to inoculation, the pt was treated for shingles. The pt had and would continue suffering ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. At the time of the report, the outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
approx 2 hrs p/vax given started running fever & rt leg swelling; given APAP-fever reduced; will not let anyone touch leg-limping; 10PM took to ER t104.5 R;
Received vaccine 5:10/pm, developed at 6:00/pm headache, dizzy, tingling sensation in hands and feet.
pt recv vax & w/in 48hr of vax pt devel redness @ inj site;it persisted 4 or 5 days post vax so pt contacted the MD who prescribed a steroid;pt recovered;
This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified were vaccinated with VARIVAX (Merck) Injection, (strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARIVAX (Merck) was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information has been received from the license practical nurse providing information VARIVAX (Merck) temperature excursion such as affected lot numbers, expiration dates and patient ID. A patient was vaccinated on an unknown date with a dose of VARIVAX (Merck) Injection, (strength, dose, frequency, route of administration and indication were not provided) (lot # J008652, exp date: 10-JUL-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports from the same source. Additional information has been requested.
No adverse reaction. MMR II given 1wk after VARIVAX (3/23/09).
30 second nonepeleptic seizure , loss of blood pressure and extreme dizziness along with nausea
THIS 14 YEAR OLD WAS GIVEN MODERNA BRAND COVID VACCINE WHICH IS NOT INDICATED FOR THIS AGE GROUP. THE MA SHOULD HAVE GIVEN THE PFIZER BRAND. NO ADVERSE EFFECT OR SIDE EFFECT NOTED. PARENT NOTIFIED.
Pounding headache every morning since the vaccine; This is a spontaneous report from a contactable healthcare professional. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8733) via intramuscular route of administration in the left arm on 07Apr2021 at 11:30 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6205) via intramuscular route of administration in the left arm on 17Mar2021 at 11:30 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. On 08Apr2021, the patient experienced  pounding headache. The patient described that  "from the top" goes away after taking Tylenol, but there was a pounding headache, every morning since the vaccination. It had been going on for at least a week. 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 patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pounding headache every morning since the vaccine was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Information has been received from a registered nurse concerning a 22 year old female with no medical history and allergy to KEFLEX, who on 02-OCT-2008 was vaccinated with a 0.5ml first dose of GARDASIL (lot# 660612/0229X), intramuscularly. On 4-OCT-2008 the patient developed a raised, "gum ball sized", itchy, burning area at the injection site. The reaction resolved without treatment. On 11-Dec-2008 the patient received the deltoid muscle of the right arm and later that night developed itchiness and swelling of both hands. The patient contacted the office by phone on 12-Dec-2008 and was prescribed BENADRYL. There were no laboratory diagnostics performed. The patient had not recovered for the itchiness and swelling of both hands. The patient sought medical attention through a phone call to the doctor's office. Additional information has been requested.
Received shot 1/21/2021.  Sore arm that evening.  Progressively got very sore, muscle pain until 1/24/2021. Diarrhea 1/22 and 1/23/2021.  So very tired, felt like I didn?t want to wake up.
Client went to E. R. ER records obtained. Several phone calls and certified letter sent. Father signed for certified letter. No response back from the parents.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around July 2016, the patient was inoculated at a pharmacy with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine adult health maintenance and the intended purpose of the long-term prevention of shingles and zoster-related injuries. The ZOSTAVAX did not prevent shingles and zoster-related injuries as intended. In or around October 2016, the patient was treated by a physician for shingles and zoster related injuries. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long term prevention of shingles and zoster-related injuries, 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, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
After the needle was withdrawn, a few drops dripped out and flowed down my arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of UNDERDOSE (After the needle was withdrawn, a few drops dripped out and flowed down my arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (After the needle was withdrawn, a few drops dripped out and flowed down my arm). At the time of the report, UNDERDOSE (After the needle was withdrawn, a few drops dripped out and flowed down my arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicines were reported. No treatment information were reported.
A physician reported that a female child received Prevnar vaccine and subsequently, developed a positive blood culture. Additional vaccines received included DTP and Poliomyelitis vaccine inactivated. The child was admitted to the hospital. The physician stated that the child was treated with an injection of ceftriaxone sodium (Rocephin) in their office. No additional information was available as of the date of this report.
My arm was sore at the injection site; I was tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (My arm was sore at the injection site) and FATIGUE (I was tired) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 016C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced VACCINATION SITE PAIN (My arm was sore at the injection site) and FATIGUE (I was tired). At the time of the report, VACCINATION SITE PAIN (My arm was sore at the injection site) and FATIGUE (I was tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-264191 (Patient Link).
Pain or burning during urination.  Frequent urination, but very little urine was passed.
wheezing, chest tightness.  Hx of asthma.  Epi-pen, albuterol inhalers.  Pt sent to Urgent Care, then ER
pt recvd vax 27SEP93 & mom states 10OCT started w/cough; treated by MD; dx pertussis 3NOV93;
came with her father for the Pfizer vaccine around 8pm Thursday evening.  After the vaccine she stood up and walked to a different chair while I was giving her father his vaccine.  While giving his vaccine the divider between the chairs was knocked over and when we looked over noticed that   was on the floor.  She sat up slowly, stated that her vision was blurry and  felt disoriented.  I helped her sit in the chair and checked her blood pressure which was 60/43 and PR 66.  Her father stated that she has SVT and takes atenolol to help control it.  I called EMT.  Pt was alert, answered questions, felt clammy and sweaty and vision was improving.  EMT arrived @ 8:20pm and BP was 121/78.  They hooked her up to EKG in the ambulance and looked good.  Dad later came to tell me that she was brought home and they would check with cardiologist on Friday.
t105 soon p/vax 48 hrs p/t104 then would come down to 101 w/APAP; red legs swelling from knee to hip w/eccymosis of both legs; vomiting for 48hrs; crying as if in pain for 48 hrs;
product was mixed with another diluent instead of the saline that it comes with no reported adverse event; product was mixed with another diluent instead of the saline that it comes with no reported adverse event; Initial information received on 20-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and gender patient and it was reported HIB (PRP/T) vaccine [ACT-HIB] was mixed with another diluent instead of the saline that it comes with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, it was reported HIB (PRP/T) vaccine [ACT-HIB] Powder and solvent for solution for injection (batch/lot number, expiry date, strength, route: not reported) was mixed with another diluent instead of the saline that it comes and administered in an unknown administration site for prophylactic vaccination (immunization) with no reported adverse event (product preparation error; latency: unknown) (incorrect product formulation administered; latency: same day).  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the 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 the guidelines. 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.
Around 12:30 pm, Abdominal cramps, pain approx 45 minutes after shot; 9 AM following day:  9 bouts of diarrhea before 3PM.   No food after 8 AM; 3 Immodium tablets (packages advises no more than 4 per day).
Received TD 5/2/06. on 5/4/06 had pain across entire back. ON 5/6/06 had pain in thighs. On 5/9/06 had severe nausea.
Patient reported that she has white patches all over... red itchy bumps (hive like) all over... patient does have eczema
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing), notes: COPD; "Sleep Apnea" (unspecified if ongoing), notes: Sleep Apnea; "Bronchiectasis" (unspecified if ongoing); "Controlled Hypertension" (unspecified if ongoing), notes: Controlled Hypertension. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Postive, notes: COVID 19 Treatment; (08Feb2023) Postive, notes: positive antigen test 7 days post last dose. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Vaccine was received and other medication taken in 2 weeks. Anti-viral Paxlovid taken for COVID 19 Treatment, treatment started from 28Jan2023 to 01Feb2023. No known allergies reported. Other medication in 2weeks product was Amlodipine. Symptomatic rebound and positive antigen test 7 days post last dose.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back trouble after all 3 doses), PROCTALGIA (Prostate problems of aching in the rectum area after the 2nd dose & booster dose), VISION BLURRED (Had water in eyes, blurred vision, and extreme headaches with all 3 doses but they were real bad after the 1st dose), FEELING ABNORMAL (It feels like a vise squeezing the base of his neck) and LACRIMATION INCREASED (Had water in eyes, blurred vision, and extreme headaches with all 3 doses but they were real bad after the 1st dose) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066P21A or 066F21A, 008B21A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Back pain (He has a history of back trouble.), Prostate infection (He had the same prostate trouble (prostate infection ) when he was 35 but hasn't had it since.), Rectal pain (He had aching in the rectum.) and Bladder infection.On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BACK PAIN (back trouble after all 3 doses), PROCTALGIA (Prostate problems of aching in the rectum area after the 2nd dose & booster dose), VISION BLURRED (Had water in eyes, blurred vision, and extreme headaches with all 3 doses but they were real bad after the 1st dose), FEELING ABNORMAL (It feels like a vise squeezing the base of his neck), LACRIMATION INCREASED (Had water in eyes, blurred vision, and extreme headaches with all 3 doses but they were real bad after the 1st dose) and HEADACHE (Severe headache on the right side of the back of his head down into his brain stem with all 3 doses/extreme headaches with all 3 doses/ It feels like a vise squeezing the base of his neck). At the time of the report, BACK PAIN (back trouble after all 3 doses), PROCTALGIA (Prostate problems of aching in the rectum area after the 2nd dose & booster dose), VISION BLURRED (Had water in eyes, blurred vision, and extreme headaches with all 3 doses but they were real bad after the 1st dose), FEELING ABNORMAL (It feels like a vise squeezing the base of his neck), LACRIMATION INCREASED (Had water in eyes, blurred vision, and extreme headaches with all 3 doses but they were real bad after the 1st dose) and HEADACHE (Severe headache on the right side of the back of his head down into his brain stem with all 3 doses/extreme headaches with all 3 doses/ It feels like a vise squeezing the base of his neck) outcome was unknown. Sitting in hot water helped the patient with the rectum aching.No  concomitant medications were provided. This case was linked to MOD-2021-416043, MOD-2021-035354 (Patient Link).