chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pts mom reported pt to have redness, warmth and swelling to Right deltoid events was reported on 09/30/2005 via phone. NP ordered pts mom to give pt Benadryl, Tylenol and ice instructed to follow up with MD if symptoms continue or worsen. This was the 6th dose of DTaP D/T the 5th dose of DTaP was given at another providers office on 01/16/2003.
Patient was seen for cough on 11/28/17 after exposure to pertussis at school. He had a pertussis PCR done and was placed on BACTRIM. He was subjectively warm but no documented fever. He received a Tdap on 11/28/2017 as well. On 11/29/2017 his entire left arm from shoulder to wrist developed redness, warmth and swelling with tender left armpit. BENADRYL was given with cold compress with benefit. Mom states he had fever to 101 F x 2 days.
This spontaneous report as received from a pharmacist refers to a 69 years old female patient with no pertinent medical history and no drug reactions/allergies. The patient was intramuscularly vaccinated at right arm with 0.5 ml of PNEUMOVAX 23 (Lot# reported as H009826 Exp date 11-FEB-2014) on 15-OCT-2012. Concomitant medications included FLUVIRIN, simvastatin (manufacturer unknown), metformin, JANUVIA and low dose aspirin. Subsequently the patient developed swelling and blotchy redness on her right arm from the injection site and down to her wrist in October 2012 after receiving PNEUMOVAX23. The patient has sought medical attention via coming back to the pharmacy. No lab diagnostics studies was performed. No treatment was given for the event. The outcome was reported as not recovered/not resolved. Additional information has been requested.
Itchy; Swelling arm; Pyrexia; This spontaneous case was reported by a physician and describes the occurrence of PRURITUS (Itchy), PERIPHERAL SWELLING (Swelling arm) and PYREXIA (Pyrexia) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PRURITUS (Itchy), PERIPHERAL SWELLING (Swelling arm) and PYREXIA (Pyrexia). At the time of the report, PRURITUS (Itchy), PERIPHERAL SWELLING (Swelling arm) and PYREXIA (Pyrexia) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-101963, MOD-2021-101963 (Patient Link).
chills, fever up to 103.4, headache, muscle aches, tiredness, nausea and vomiting
Pain in my left arm, continuous ache, worse when I move it. So far it has not stopped hurting.
Local erythema of forearm within 48 hours, vaccine inadvertently administered as if it were PPD in error, Topical treatment.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 17-NOV-2015 at time- 06:22, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 4.1 and 2.9 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
suspected vaccination failure; shingles; shot was not available /Product supply issue; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, 274 days after receiving Shingrix and 61 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and product supply issue. The patient was treated with antivirals nos, antivirals nos, antivirals nos, antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the vaccination failure, shingles and product supply issue were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were received as follows: The reporter was the concerned patient. The age at vaccination was not reported. The patient received 2nd dose of Shingrix 7 months after the 1st dose, because the demand for shot was greater than the supply.  At the time of reporting, 2 months after vaccination with 2nd dose the patient experienced shingles. The reporter contacted GlaxoSmithKline (GSK) when shot was not available and asked if the patient should start the series over. The patient was assured that the patient should not restart, as the patient received 2nd dose within 12 months after 1st dose. The patient was seen by the primary care physician (PCP) and had been given antiviral prescription. The patient asked if this was occurring due to delay in getting the 2nd dose. This case was considered as suspected vaccination failure since confirmatory laboratory test were unknown at the time reporting.
Itchiness all over body about 2 and a half hours later.  I took a benadryl and I'm still itchy.  Slight rash on arm.
Flu shot didn't stop it. Got flu anyway; Initial information received on 27-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and gender patient who reported flu shot didn't stop it. got flu anyway after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (lot number, form, strength, expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event of flu shot didn't stop it. got flu anyway (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event (Flu shot didn't stop it. Got flu anyway).  At time of reporting, the outcome was Unknown for the event flu shot didn't stop it. got flu anyway.
Approximately 3 weeks post vax, the pt developed flu-like symptoms characterized by myalgia with low-grade fever. On 3/30/99, the pt developed herpes zoster. The pt went to physician's office on 4/5/99 and was treated with Famvir.
Pt received Pfizer x2.  Pt tested COVID + on 9/22/21 and admitted to hospital for COVID on 9/22/2021. Pt receiving remdesivir and dexamethasone.
a possible untoward reaction to a flu vaccine; Based on information received on 23-May-2019, the report previously considered as non-case became valid due to specific adverse reaction.  Initial information received on 10-May-2019 regarding an unsolicited valid non-serious case received from a nurse by phone and aaitional information was received on 23-May-2019.  This case involves a 7 months old patient (gender not reported) who experienced a possible untoward reaction to a flu vaccine, while he/she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number, expiry date, dose and dose in series not reported) via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious a possible untoward reaction to a flu vaccine (adverse reaction) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  No Lab data was reported.  Final diagnosis was a possible untoward reaction to a flu vaccine.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for a possible untoward reaction to a flu vaccine.  Information on batch number requested.  Documents held by the sender: none.
An improperly stored dose of VARIVAX was administered to the patient on 19 FEB 2022; This spontaneous report has been received from a medical assistant referring to a patient of unspecified age and gender. The patient's pertinent medical history, concomitant medications, previous drug reactions or allergies and concurrent conditions were not reported.   On 19-FEB-2022, the patient was vaccinated with an improperly store dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliters (ml) (route of administration, anatomical site of vaccination, and vaccine scheme were not reported; lot number U008181 has been verified to be valid, expiration date reported and established as 08-FEB-2023) as prophylaxis.   The vaccine was exposed to a temperature excursion of 9 degrees Fahrenheit (F) during a time frame of 293 hours and 14 minutes (product storage error). No previous temperature excursion was reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2202USA008282: US-009507513-2202USA007938: US-009507513-2202USA008270:
This patient was given an MMR along with Varivax, IPV, and Prevnar on 02/20/01. He came into the clinic on 02/28/01 with a rash on his face and his chest, that developed the day before. The patient was on an antibiotic 5 days ago from the ER.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 31 years 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) and as dose 3 (booster), single (Batch/Lot number: unknown) 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), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative; Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti-viral details: Product: COVID 19 Treatment, treatment was started on 31Oct2022 and stopped on 04Nov2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vision went very blurry; Things became very distant in hearing; Hard to focus; Felt like was burning up; Sweating; This is a spontaneous report from a contactable consumer, the patient. An 18-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 13May2021 at 17:00 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had known allergies to lactose (slightly lactose intolerant) and sever Acetaminophen allergy. The patient did not receive any other concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 13May2021 at 17:00, shortly after having the vaccination, the patient vision went very blurry and things became very distant in hearing, these side effects were hard to focus on however as he started sweating and felt like he was burned up. These effects lasted around 10 minutes. No therapeutic measures were taken as a result of reported events. The clinical outcome of the events vision went very blurry, things became very distant in hearing, hard to focus, felt like he was burned up and sweating were resolved on 13May2021 at 17:10 (after the duration of 10 minutes).   No follow-up attempts are needed. No further information is expected.
2 days after the Shingles vaccine I experienced  severe shooting nerve pain in my left arm and left ribs. My left hand felt numb and tingly. This pain lasted 1 week and returned 3 weeks later during coughing episode. The pain lasted 20 hours after the cough ing
8/26 RT shoulder pain at site, went back to pharmacy. 9/12 Orthopedic appt (R) shoulder pain and bil hand numb/tingle, swollen 3 fingers ea hand, cannot make a fist. Prescribed MEDROL DOSEPAK and high dose NEURONTIN. 9/16 Doctor appt whole body pain, feels on fire, muscle tightness/hand swelling, arthralgia, joint swelling, pain Kw/standing possible rxn to NEURONTIN, stop meds, use BENADRYL prn. Doctor appt 9/20 excessive sweat, muscle pain, weak all over, all 4 extremities, diaphoresis, fatigue, trouble swallowing, temperature intolerant, arthralgia, gait problem, myalgia, weakness, numbness, sensory deficit bilateral lower extremities, abnormal muscle tone all 4 extremities unable to walk. Direct admit to hospital. 9/21 Admission hospital GBS following vaccination. 9/22 Lumbar puncture, CSF protein elevated. Neurology Dr confirmed diagnosis.
body aches, fever, nausea and vomiting, headache, fatigue lasted 36hours
Patient received Pfizer Bivalent vaccine at around 12:30 p.m. administered by RN. After the injection the Nurse instructed the patient to self-monitor for 15 minutes.  Patient left immediately after the vaccine.  RN reported to administrator that sister of the patient, called and reported that her sister had an allergic reaction to the vaccine she received today. Nurse contacted the sister to determine what occurred.  Per patient's sister, patient had contacted her around 1:04 pm with swollen throat and garbled speech requesting that she call 911. Patient ended up driving herself to local Memorial Hospital and was found in her vehicle by Hospital staff.
pt recv vax 19FEB99 & that noc devel temp of 105.5, crankiness, poor appetite & had local reaction of swelling, erythema, tenderness;had no prev reaction;tx w/med;
Myalgia, Arthralgia, CoughWheeze, Syncope, Body pain,throat dry, sore left arm, feels cold, coughing Narrative:
administered vaccine that was "not stored properly"/"room temperature since Monday"/syringes that were kept in non-sterile conditions without termperature or other controls; administered vaccine that was "not stored properly"/"room temperature since Monday"/incorrectly been given injections of an expired Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered vaccine that was "not stored properly"/"room temperature since Monday"/incorrectly been given injections of an expired Moderna vaccine) and PRODUCT STORAGE ERROR (administered vaccine that was "not stored properly"/"room temperature since Monday"/syringes that were kept in non-sterile conditions without termperature or other controls) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CELECOXIB (CELEBREX) from 01-Jan-2010 to an unknown date for an unknown indication.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered vaccine that was "not stored properly"/"room temperature since Monday"/incorrectly been given injections of an expired Moderna vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (administered vaccine that was "not stored properly"/"room temperature since Monday"/syringes that were kept in non-sterile conditions without termperature or other controls). On 05-May-2021, EXPIRED PRODUCT ADMINISTERED (administered vaccine that was "not stored properly"/"room temperature since Monday"/incorrectly been given injections of an expired Moderna vaccine) and PRODUCT STORAGE ERROR (administered vaccine that was "not stored properly"/"room temperature since Monday"/syringes that were kept in non-sterile conditions without termperature or other controls) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products included CELECOXIB (CELEBREX)  No treatment medication included.   This case was linked to MOD21-084222, MOD21-084255 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Significant follow up received, patient demographics updated, out come of the event updated from unknown to recovered.; Sender's Comments:  MOD21-084222:cross linked id MOD21-084255:cross linked id
Within about 24-hours from receiving  Dose 2 of Pfizer COVID-19 vaccine, started having headaches, diarrhea, muscle aches, chills, and fever that went up to around 100.4 degrees.  The symptoms reduced after two days, taking Tylenol to help with fever reduction and headaches during that time.  As of 8AM on 8/13/2021, only a mild headache remains with no other symptoms.
nodules back of neck w/soreness 25JUL went to personal MD 26JUL prescribed ATB;29JUL sore joints, flushed to ER-prescribed anti-inflammatory;CBC-sed rate-chem panel (sed rate elevated);
Moderately sore arm (a little more sore than with the flu shot), minor-moderate fatigue/low-energy, moderate headache (but note that I have chronic headaches, so hard to connect this to the vaccine). All in all, this was no problem at all: I simply took it easy for a while. I'm only reporting because I know the CDC is trying to get a full picture. After dose 1, I had only a sore arm, and the soreness was much less than for dose 2 (and less than for the flu shot.
Limited range of motion with pain across clavicle, across right shoulder - shoulder blade and down right arm extremity to hand.
pt devel severe muscle pain from inj site extending to shoulder since recv vax in early AUG95;pt has no evidence of muscle wasting or neuro damage;no further details known as of the date of this report;
Right eye/eyebrow spasms (twitching) intermittently for 24 hours.   Previous ASE from 1st vaccination on 12/28/20 was right eye/eyebrow spasms (twitching) intermittently for 1 hour
PATIENT FAINTED ABOUT 5 MINUTES AFTER VACCINE ADMINISTRATION AND PROCEEDED TO HAVE A SEIZURE. PATIENT HAD 3 SEIZURE EPISODES. 911 WAS CALLED AND PARAMEDICS ARRIVED. PATIENT WAS ASSESSED FOR BLOOD SUGAR AND BLOOD PRESSURE. BLOOD PRESSURE WAS LOW. PATIENT DECLINED FURTHER TREATMENT AT A HOSPITAL OR URGENT CARE DESPITE EMT ENCOURAGEMENT
Severe rt quadrant abdominal pain with fever 99.9 lasting 5 days abdominal ultrasound no results as of 11/05/2013.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19; This spontaneous report received from a patient concerned a 58 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number and expiry was not reported) dose was not reported, 1 total administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported. On SEP-2021, the patient felt like head cold. On 17 Sep 2021, the patient experienced Covid-19 (suspected covid-19, suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with adalimumab was withdrawn. The outcome of the suspected covid-19 and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with product compliant.; Sender's Comments: V0: 20211010186-Covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
I received the Pfizer vaccine on 8/14/21. On 8/27/27, I began to bleed from my uterus. I called my gynecologists to report the problem and I was requested to have a pelvic and transvaginal ultrasound that will lead to surgery - hysteroscopy and D&C. Prior to the vaccine I had not had any problems with bleeding. I am a 62-year-old healthy woman and have gone through menopause. I have not bled in over 15 years nor ever experienced abnormal bleeding. Yet, after two weeks after the Pfizer shot, I began to experience bleeding as if I am having a menstrual period. I am not suggesting that the vaccine caused the outcome of ultrasound, however, I strongly believe that some component of the Pfizer vaccine caused a chemical change in my body that triggered the abnormal bleeding.