chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax 18SEP96 & went home sicke & vomiting;pt visited MD who dx mononucleosis;24OCT96 pt is still sick but energy level is inc & no longer is home bound;
Information has been received from a healthcare worker concerning a 16 week old patient who on 17-AUG-2011, was vaccinated orally with a first dose of ROTATEQ (lot number and dose not reported) and today on 31-OCT-2011, was vaccinated orally with a second dose of ROTATEQ (lot number and dose not reported). No adverse effect was reported. Additional information has been requested.
Side effects recurring with same intensity and serverity as when vaccine first administered. Heart racing, dizziness, faint, chills, abdomen pain, vomiting, weakness
REDNESS/BRUISING. WARM TO TOUCH ACCORDING TO PATIENT BUT NOT AT THE TIME OF THIS REPORT. NO TREATMENT AT THE TIME OF REPORT. NO ITCHING. PER PATIENT, NOT ON BLOOD THINNERS OR ASPIRIN.
Patient came to clinic today to receive Janssen covid vaccine. This RN looked up patient is system and saw she had Pfizer dose on 08/27/2021. This RB educated and encouraged the completion of the Pfizer series. Patient reported she had a new employer that was recommending she now receive Janssen dose. This RN educated on the recommendations of boosters, and she would need a booster at 2 moths following the Janssen dose versus 6 months if she completed the Pfizer series. Patient declined the Pfizer dose and reported she only wanted Janssen. Patient educated about possible adverse effects and side effects. Patient verbalized understanding.
Itchiness at site, hardness, 4 inch radius red spot, tender to the touch
Redness and puffiness noted distal to injection site (Left Deltoid) Warm to touch. Tender. Bruising noted, of purple and red color. Two spots noted on each side of deltoid muscle. Client seen NP 10/12/2015, was given Bactrim but NP doesn't believe swelling and bruising is related to flu shot.
Muscle cramping; Twitching in legs and feet about 15-25 Times a day; period is very irregular (has always been regular); This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 20May2021 at 11:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to antibiotic. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22May2021, the patient experienced muscle cramping and twitching in her legs and feet about 15-25 times a day and period was very irregular (had always been regular). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events muscle cramping, twitching in legs and feet about 15-25 times a day and period was very irregular were not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Pt received Pfizer vaccine x1. Admitted into the hospital for COVID on 8/16/21. Pt is currently being treated with remdesivir and dexamethasone.
Patient complained of itchiness, rashes, shortness of breath and tightness in chest.
administered Pentacel without the HIB patient only received the liquid portion with no adverse event; Initial information received on 28-Mar-2023 regarding an unsolicited valid non-serious case received via medical assistant.   This case involves 4 months old female patient to whom Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (VERO)] was administered without the hib patient only received the liquid portion with no adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal Vaccine 13V (PNEUMOCOCCAL 13) for Prophylactic vaccination, and Rotavirus Vaccine for Immunization.  On 27-Mar-2023, the patient was administered suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine at dose 0.5ml once (lot: U7311AA, expiry date: 09-Sep-2023) via intramuscular route in the left thigh for prophylactic vaccination with administered Pentacel without the hib patient only received the liquid portion with no adverse event (single component of a two-component product administered) at same day latency.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event single component of a two-component product administered.     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.
Severe pain in arm, swelling in arm twice the size very red. I couldn't even move my arm it hurt so bad. 100.8 temp. It was in the right arm nurse said it was pneumococcal. Influenza shot was in left arm. Was better in 3 days, took Tylenol for pain.
Patient received a dose of his seasonal flu shot. Was fine that day but the next day noticed soreness, redness,and minor swelling. Patient saw on-site nurse and nurse felt that there was some possible "extravisation" of the vaccine into the skin. Felt that patient did not need medical attention.  Patient will just watch and wait to make sure does not get worse. He is using benadryl, ibuprofen for discomfort.
This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (Hoarse voice) and APHONIA (Lost his voice) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included PREDNISONE for an unknown indication. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPHONIA (Hoarse voice) and APHONIA (Lost his voice). At the time of the report, DYSPHONIA (Hoarse voice) and APHONIA (Lost his voice) outcome was unknown. No treatment information was provided. The caller stated that it has nothing to do with Moderna vaccine.
03/01/2008 Low grade fever and flu like sx.  No flu like sx at this time.  03/02/2008 Behavior change of "fussy", increased irritabilty, not sleeping much, "out of control".  Behavior changes unchaged as of today, 03/12/2008.  Has been seen by family physician times 2 since immunizations were given.
baby only received the Pentacel diluent and not the Pentacel powder; Initial information received on 16-Jul-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves patient who received dose of Pentacel diluent and not the Pentacel powder from DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (PENTACEL) (lot number and Expiry date unknown) via unknown route in unknown administration site.  The patients' medical history and concomitant medications were not reported.   It was a case of actual medication error due to inappropriate reconstitution technique. (it was reported that baby only received the Pentacel diluent and not the Pentacel powder)  It was unknown whether 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.  Information on the batch number was requested.  Documents held by sender: none
pt recv vax & MD took a look at red, hot site of Td 29MAR97 lt deltoid;pt home w/o tx told to return if worse;
Severe body aches almost immediately after the second shot, concentrated in joints.  Joint aches have continued randomly, symptoms are worse in the mornings.
Delivery Date: 10/5/2022  Delivery Time: 12:19 AM  Gestational Age(weeks days/7): 39 1/7      Method of Delivery: Vaginal, Spontaneous    Baby: girl
Chills; Fever; This is a spontaneous report from a program from a contactable consumer or other non hcp (patient).     A 34-years-old female patient received dose 1 of bnt162b2 (BNT162B2, Batch/Lot Number: ER8730; Expiration Date: 31Jul2021), via an unspecified route of administration, administered in arm Left on 30Mar2021 13:45 as dose 1, single and dose 2 bnt162b2 (BNT162B2, Batch/Lot Number: EW0167; Expiration Date: 31Aug2021) via an unspecified route of administration, administered in arm Left on 03May2021 11:30 as dose 2, single and for covid-19 immunisation (age at the vaccination 34 years old). Medical history included knee operation from an unknown date and unknown if ongoing. The patient tore the meniscus in her knee prior to the first dose of the vaccine, on an unspecified date in Jan2021. The patient's concomitant medications were not reported. The patient experienced chills and fever on 30Mar2021 18:00. The patient was not received the treatment. Outcome of events was recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Bullseye style rash at injection site. Rash spread over arm over the course of a week and then dissipated with the edge. Rash was raised and warm to the touch and covered upper arm
RACING HEART; HIVES; RASH ON CHEST/ RED DOTS ON BELLY; LOW GRADE FEVER; SORE ARM; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient never had a severe allergic reaction. The patient was previously treated with influenza vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Non-company suspect drugs included: diphenhydramine hydrochloride ( form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported. On 10-APR-2021, the subject experienced sore arm. On 11-APR-2021, the subject experienced racing heart. On 11-APR-2021, the subject experienced hives. On 11-APR-2021, the subject experienced rash on chest/ red dots on belly. On 11-APR-2021, the subject experienced low grade fever. On 12-APR-2021, Laboratory data included: Low platelets (NR: not provided) 118. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on chest/ red dots on belly, and the outcome of low grade fever, hives, racing heart and sore arm was not reported. This report was non-serious.
Baby received flu vaccine 0.25ml IM first time. 2 hours later, presents with vomiting, anorexia, fever. fussiness, cough lasted from 10/21/04 to 10/26/04. On 10/25/04, admitted to hospital for dehydration. Admission 24 hours and discharged home recovered after IV fluids. Medical Records received on 12/07/2004 states rash.
This case was reported by a physician via sales rep and described the occurrence of pleuritic pain in a 82-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. The patient's past medical history included neoplasm malignant and idiopathic thrombocytopenic purpura. In June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced pleuritic pain, herpes zoster and product supply issue. The patient was treated with VALTREX. On an unknown date, the outcome of the pleuritic pain, herpes zoster and product supply issue were unknown. It was unknown if the reporter considered the pleuritic pain and herpes zoster to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient history was malignancy and ITP. The patient was on an 8 hours plane flight and after landing developed pleuritic chest pain, no rash. Workup for pulmonary embolism is not conclusive, room air SA02 was normal. In June 2018, the patient had 1st dose of SHINGRIX. The Health care professional was considering herpes zoster in differential and considering starting VALTREX and requesting info on VE of 1st dose of SHINGRIX. The health care professional would like to give the patient a 2nd dose of SHINGRIX and given supply issues cannot locate a 2nd dose.
Extreme tingling on right side of body; Swelling in hand and foot; Dose number: 3; This is a spontaneous report from a non-contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 01Dec2021 (Lot number: unknown) at the age of 42 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Latex allergy" (unspecified if ongoing), notes: known allergies: Latex. Concomitant medications included unspecified BIRTH CONTROL medications. Past drug history included: Medrol, reaction: "Drug allergy", notes: known allergies: Medrol. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: Unknown, Anatomical site: left arm), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: Unknown, Anatomical site: left arm), for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021, outcome "unknown", described as "dose number: 3"; PARESTHESIA (non-serious) with onset 06Dec2021, outcome "not recovered", described as "Extreme tingling on right side of body"; PERIPHERAL SWELLING (non-serious) with onset 06Dec2021, outcome "not recovered", described as "swelling in hand and foot". The events "Extreme tingling on right side of body" and "swelling in hand and foot" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of paresthesia and peripheral swelling.   Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Per mom, client woke up this morning with a flat, red, splotchy rash on upper arms, chest and stomach. Rash not itchy or causing any discomfort. Denies fever and no other symptoms. No soreness or swelling at site of injection. Mom to monitor rash and if no improvement or symptoms worsen, will seek medical attention.
Sore arm; chest pain; body aches; This is a spontaneous report from a contactable consumer (patient). A 23-years-old non-pregnant female patient received bnt162b2 (Pfizer, Solution for injection, Lot Number: EL3248), dose 2 via an unspecified route of administration, administered in arm left on 02Feb2021 04:15 (at the time of 23-years-old) as second dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient had not covid. Post vaccination, the patient had not testet covid. No other vaccine received in four weeks. The patient previously took bnt162b2 (Pfizer, lot number: EL3248) on 14Jan2021 04:45 (at the time of 23-years-old) am in left arm dose 1 for covid-19 immunisation. The patient experienced sore arm, chest pain and body aches on 02Feb2021 12:00. The patient not received treatment for events. The outcome of events was recovering.  No follow-up attempts are needed. No further information is expected
patient who received only the diluent component of Menveo; patient who received only the diluent component of Menveo; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 14-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA436A, expiry date 30th September 2022) for prophylaxis.   On 5th April 2021, the patient received Menveo. On 5th April 2021, unknown after receiving Menveo, 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 reported as follows: The patient received only the diluent component of the Menveo vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up via email. The reported batch number AMXA436A for Menveo did not exist and was updated to AMVA436A as per the sales database.
MOM STATES BABY VOMITED LAST NIGHT(08-07-19) WHILE SLEEPING AND THIS A.M (08-08-2019) ; THIS A.M (08-08-19) TEMP WAS ELEVATED TO 100.1, GAVE OTC TYLENOL , RECHECKED TEMP 20 MINS LATER AND TEMP WAS 100.3
2 weeks after vax he got chills, shaking, sweaty, no sleep, couldnt eat, headaches, body aches, no energy
lethargic; pain which started to settle in lower back; could not bend over; did not feel like eating all day; arm became sore; terrible pain in shoulder; pain worked down the body down her ankles to legs; Temperature of 100.3 degrees Fahrenheit; itching; pain in joints and muscles; overwhelming pain in the body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), PAIN (pain in joints and muscles), PAIN (overwhelming pain in the body), LETHARGY (lethargic) and BACK PAIN (pain which started to settle in lower back) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LOSARTAN and PRAVASTATIN for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced PRURITUS (itching), PAIN (pain in joints and muscles), PAIN (overwhelming pain in the body), VACCINATION SITE PAIN (arm became sore), ARTHRALGIA (terrible pain in shoulder), ARTHRALGIA (pain worked down the body down her ankles to legs) and PYREXIA (Temperature of 100.3 degrees Fahrenheit). On 02-Mar-2021, the patient experienced LETHARGY (lethargic), BACK PAIN (pain which started to settle in lower back), BACK PAIN (could not bend over) and DECREASED APPETITE (did not feel like eating all day). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (itching), PAIN (pain in joints and muscles), PAIN (overwhelming pain in the body), LETHARGY (lethargic), BACK PAIN (pain which started to settle in lower back), BACK PAIN (could not bend over), DECREASED APPETITE (did not feel like eating all day), VACCINATION SITE PAIN (arm became sore), ARTHRALGIA (terrible pain in shoulder), ARTHRALGIA (pain worked down the body down her ankles to legs) and PYREXIA (Temperature of 100.3 degrees Fahrenheit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Temperature of 100.3 degrees Fahrenheit was reported on 01-MAR-2021   Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2021: Follow up information received on 11-AUG-2021. reporter first name and patient initials updated.
pt recv vax 24APR98 & 25APR98 flu-like sx, stomach upset;nausea/diarrhea;26APR98 back of rt knee tight & very swollen lasted through 24APR98;29APR98 bath feet & ankles swollen painful to step on;30APR98 feet & ankles sore;wrists painful;
Rundown, stomach discomfort - felt like someone sat on my chest for 2 days - By day 4 I was recovered - I don't have a spleen I could tell my body was fighting it off.
QUADRACEL was given to a 7 year-old. However, it is only indicated for 4-6 year old patients with no reported AE; Initial information received on 19-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 7 years old female patient who was given DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL]. however, it was only indicated for 4-6 year old patients with no reported ae(adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR).  On 30-Aug-2022, the patient received a 0.5ml once dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (strength, formulation was unknown, lot C6002BA and expiry date: 18-May-2024) via intramuscular route in the left lower thigh for Immunization.  On 30-Aug-2022 the patient developed a non-serious event of quadracel was given to a 7 year-old. however, it is only indicated for 4-6-year-old patients with no reported ae (product administered to patient of inappropriate age) (Latency: same day) following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  Action taken: not applicable.  Outcome: Unknown  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.
Narrative: 85yo pt died at the contract nursing home on Aug 2, 2021. Pt was admitted to hospice on 7/26/2021. Pt with history of chronic kidney disease stage 4 and abdominal mass with pain requiring oncology workup. Pt had refused oncology and pursued palliative care on 7/22/21 then hospice care on 7/26/21. Pt had received covid vaccinations on 2/5/21 & 3/9/21. Death not related to covid vaccines.
pt recv vax 19SEP97 11AM & 2 1/2hr post vax pt fever went up to 101.6 ax & was listless;mom had called in & talked w/RN about concerns;instructed to call MD if fever doses not go down w/APAP;
I have had NO significant adverse events or reactions to the Covid-19 vaccines or booster. I was contacted by CDC V-Safe Reg via phone and told that I responded to a survey that I had had an adverse event, I have not and do not recall indicating this on any of the V-Safe follow-up survey's I completed. The person that contacted me on the phone indicated that I should complete this form online to "close the loop" on this errant information.