chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE; Medical assistant calling to report expired vaccine was administered to patient. Vaccine did not experience any prior temperature excursions. Permission to follow-up with HCP. No additional AE information. No PQC.; This spontaneous report was received from a medical assistant and refers to a 4 year old female patient. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On 30-MAR-2022, the patient was vaccinated with an expired by 10 days dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 mL (lot # T032150, expiration date: 20-MAR-2022), subcutaneously in the right thigh, once, for prophylaxis.  No additional adverse event was reported.
First two days after injection injection site was sore and hands and wrists were achy.  1 week after injection, site was itching, red, swollen and warm to the touch.  Still some itching, redness, swollen and warm to the touch
70-year-old male known to us with past medical history significant for CAD s/p stenting, hyperlipidemia, complete heart block, hypertension, type 2 diabetes mellitus history of pacemaker, CHF with an EF of 35% was previously noted to have sustained V. tach on his pacemaker interrogation underwent an upgrade of his previous pacemaker to a biventricular ICD on September 27, 2021.Patient is COVID positive on 11/4/2021. He presented to the hospital due to shortness of breath and cough. In addition he had slightly elevated troponins and had been trending down. EKG was negative for ACS.  Hospital course:  remdesivir and dexamethasone for COVID.  Oxygen therapy, bronchodilator treatment, Lovenox for anticoagulation. Acute renal failure. Dialysis catheter placed. Set up HD as outpatient.  Pt discharged to home.
Systemic: Exhaustion/Lethargy-Mild, Systemic: Fainting/Unresponsive-Mild, Systemic: Weakness-Mild.
Fever and weakness firts 24 hours, pain in the arm and shaking all time 5 days ago
A non-serious spontaneous report of administered expired FLUMIST was received from a other health professional concerning a 21-year-old female. Neither medical history nor concomitant medications were provided. The product expired on 12-Dec-2010. On 13-Dec-2010, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. 14-Feb-2011: Follow up call was conducted on 14-Feb-2011, no adverse events were reported following administration of the expired FLUMIST.
redness that increased 3 times in size by now; This case was reported by a physician via call center representative and described the occurrence of erythema in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 4EB9Y, expiry date 21st February 2022) for prophylaxis.   On 18th February 2020, the patient received the 1st dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced erythema. On an unknown date, the outcome of the erythema was not recovered/not resolved.   It was unknown if the reporter considered the erythema to be related to Shingrix.  Additional details were provided as follows: The patient had local adverse reactions follwing the vaccination. At the time of reporting, the redness was increased 3 times in size. The reporter asked how long these adverse reactions going to last. The reporter consented to follow up.
life stopping migraine; tighten muscles around the back of my neck and shoulder muscles; VERY nauseated; small fever; be cold; chills; soaked in sweat; This is a spontaneous report from a contactable consumer(patient). A 42-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 13Mar2021 (Batch/Lot Number: F(E)N6208) as SINGLE DOSE for covid-19 immunisation. The patient was not pregnant. Medical history included Stroke, anorexia, gastroparesis, asthma, thyroid, low BP, hypotension, known allergies -Sulfa, Paxil, Demerol. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 09Feb2021 10:30 AM (Batch/Lot Number: EM9809 as SINGLE DOSE for covid-19 immunisation. Concomitant medications received within 2 weeks of vaccination included Fentanyl patch, seroquel, trazodone, ambien, baclofen. The patient previously took paxil and experienced known allergies-sulfa, demerol and experienced known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. No covid test post vaccination. No other vaccine in four weeks. On 14Mar2021 at 04:00, the patient experienced life stopping migraine, tighten muscles around the back of my neck and shoulder muscles, very nauseated, small fever, be cold, chills, soaked in sweat. The patient did not receive any treatment for the events. Outcome of all the events was recovered with sequelae.  Information on Lot/Batch number was available. Additional information has been requested.
9/10/18: ache/pain all the way down arm into wrist. 9/11/18: tired and increased pain, took TYLENOL, fever/chills started, stayed in bed all day. 9/12/18: fever went up to 102F, continued with TYLENOL, went to Dr. did blood work and xray which were normal eventually recovered on own.
Persistent to the point that they became swollen; Rash all over her body - arms, legs, chest and back; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Persistent to the point that they became swollen) and RASH (Rash all over her body - arms, legs, chest and back) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Nov-2021 at 1:30 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Nov-2021, the patient experienced SWELLING (Persistent to the point that they became swollen) and RASH (Rash all over her body - arms, legs, chest and back). On 03-Dec-2021, SWELLING (Persistent to the point that they became swollen) and RASH (Rash all over her body - arms, legs, chest and back) had resolved.            Concomitant product use was not provided by the reporter.  Treatment medications include steroids.
dead; Collapsed; bnt162b2 was given to patient with immunocompromised w/ reportable conditions; bnt162b2 was given to patient with immunocompromised w/ reportable conditions; This is a spontaneous report from a contactable nurse. A 40-year-old male patient receive first dose of bnt162b2 (Lot number: EK9231, Brand: Pfizer), intramuscular in left arm on 21Jan2021 15:15 at single dose for COVID-19 immunization. Medical history included immunocompromised w/ reportable conditions from an unknown date and unknown if ongoing, positive for Covid in September from Sep2020 to an unknown date. The patient's concomitant medications were not reported. The patient experienced dead, collapsed on 26Jan2021. Therapeutic measures were taken as a result of collapsed. The outcome of collapsed was unknown. The patient died on 26Jan2021. It was not reported if an autopsy was performed. Received Covid vaccine here on 21Jan2021, was at work on 26Jan2021 and collapsed, no known complaints at the time, CPR (cardiopulmonary resuscitation) was initiated immediately, transported to ER (Emergency room) and pronounced dead. Unknown if other vaccine in four weeks. The patient had COVID prior vaccination. Unknown If COVID tested post vaccination.; Sender's Comments: Based on the information currently provided, the patient was immunocompromised and had prior COVID infection.  The death and syncope more likely are associated with the patient underlying medical conditions.  More information such medical history, concomitant medications, treatment indication and event term details especially death cause and autopsy results are needed for fully medical assessment.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Dead
Muscle pain in neck and back, swollen and blistered uvula, sore throat, persistent headache.
Patients have been administered from vaccines that experienced a Temperature excursion; Patients have been administered from vaccines that experienced a Temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a Temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a Temperature excursion) in a 22-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 15-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a Temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a Temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a Temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a Temperature excursion) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported that the storage condition at the time of excursion was refrigerator.   Max Temperature reached to 64 F.  Reporter mentioned that the excursion duration was 7 hours instead 5 min.  They were returned to the refrigerator after administration.   Tran date was reported as 15-Mar-2022.  It was reported that the patient did not experienced any adverse event.  Treatment medications were not provided.
Mother describes after recurring 1st and 2nd DTAP - uncontrollable screaming for more than 4 hours.  This happened after 1st DTAP, but we were not notified after 2nd DTAP - child was taken to doctor.  Doctor did find ulcers - mouth, so we are not sure if DTAP was the entire problem.
Maculopapular rash, itching, tender on hands and fingers swollen, scattered rash on arms, legs, knees,top and bottom of feet. Injection site large (2 1/2 x 5 in) red  swollen. Skin started peeling 2/12/21. Zyrtec 10 mg twice a day, Clobatesol cream.
I had heavy menstrual bleeding very suddenly, about 2 weeks before my period should have started. It started very suddenly. No pain. It lasted about 6 or 8 hours, then stopped. My cycle is typically very regular and nothing like this had ever happened before. No indication of permanent irregularities but as it hasn't been very long I can't say for certain.
Narrative: This event may or may not be attributed to his booster dose being given earlier than indicated. However, the patient did voice concern that these events were related to his last dose of COVID-19 vaccine.
patient had severe headache, felt extremely tired, her face was very pale. she said she had some cereal in the am and that she was a little tired even before the shot, gave her some orange juice. she said she is going to wait a little bit till she feels better. she get worse, her chest was heavy but she was still talking normally. called 911, EMS came and transported her to the hospital
I got the Moderna Booster.  The day after, I started to feel ill, with racing heart, increased palpitations , felt tired, and almost passed out during work - I rested on the floor, then went to the ED at Hospital.  I had bloodwork - CBC, CMP, troponin and D-Dimer.  EKG  results were "tachycardia  and bi-atrial enlargement."   Doctor said I had an arrhythmia   but it was not dangerous,   I was sent home.   I am not sure what caused me to almost pass out.  I Subsequently had ECHO on Nov. 15th, and findings were normal - atria were not enlarged, everything normal size.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of M-M-R II (lot M004063 exp 25-JAN-2018, lot M035935 exp 09-AUG-2018) exposed to 47°F to 77°F for 20 hours. No adverse event was reported. No data logger was involved. Additional information has been requested.; Sender's Comments: US-009507513-1706USA002111:
4/28/19 3 pm Febrile seizure, temp 104°F rectal      seen in ER; rapid flu (-), UA normal, CXR normal  Initially had fever after Imms 4/12 - 4/14/19. Then new fever started      4/27/19 to 104°F. No other symptoms.   4/29/19 Clinic visit for ongoing fever to 104°F, labs drawn,      ceftriaxone 50mg/kg IM given x2 (24hrs apart)
Moderna vaccine.  Nausea, and chills after two hours of injection.  Nausea, light headed and dizzy lasting four days.  On 4/18 feeling nausea is better still exhausted and weak.
pt recv vax in rt thigh almost immed devel a macular erythematous rash proximal to inj site & onto RLQ of abdomen;no further rxn noted;
Tenderness, swelling over left deltoid. Numbness in 2 of her fingers, thumb and index finger.
Guillain Barre from flu shot. Per follow up report received on 07/19/2005:  Patient has numbness and tingling feet.  Let and arm muscle weakness, 90%. Information from medical records states ataxia, parethesis, low back pain.. Information from Discharge summary states decreased reflexes, msv Per follow up report-Still have no reflexes-fatigue, depression, spasms, numbness and patients feeling is not correct. Cannot wear flip flops they fall off.
positive for COVID this Sunday after being fully vaccinated 3 months; sick and having breathing problems and is now sick with covid; This is a spontaneous report from a contactable consumer (Reporter's friend of a friend) Follow-up information received on 13Apr2021 was processed together with initial information. A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient tested positive for COVID this Sunday after being fully vaccinated 3 months ago with the Pfizer COVID Vaccine. He is afraid of this unfortunate event and is wondering if the vaccine even still offers protection against COVID 19. Patient mentioned they had a cough and were not necessarily hospitalized a friend of his had a friend who got tested positive for COVID even after completing the 2-dose series of the PFIZER-BIONTECH COVID-19 VACCINE. Patient mentioned that this friend actually tested positive last Sunday and it has been 3 months ago since he completed the vaccination series. The patient experienced positive for covid this Sunday after being fully vaccinated 3 months on an unspecified date with outcome of unknown, positive for covid this Sunday after being fully vaccinated 3 months, cough, was sick, having breathing problems. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of event is Unknown.
Patient presented with fever, myalgias, decreased appetite, arthralgias and was tested positive for COVID. He was given decadron and remdesivir.
My arm was very sore and 3 weeks later my left arm is STILL very tender at injection site. I was very tired for about a week w ? brain fog? very scattered pertaining to staying on task. I see a neurologist in for headaches and administers Botox for that. I am concerned if I get a headache from the vaccine the Botox will mask it. I did have a bad headache yesterday which is unusual given I get Botox for headaches
just achy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Kidney transplant" (unspecified if ongoing); "immunocompromised" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "just achy". Additional information: the patient had his COVID vaccine and he is immunocompromised and his reaction was not so much of a reaction. He was just achy and that was it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
SORE ARM; This spontaneous report received from a consumer concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: 23-JUN-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, treatment medications included: paracetamol. On 09-APR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm. This report was non-serious.
30 mins p/inject pt felt dizzy & hot (flushed), later in day began to feel achey; like was getting the flu; missed next 3 days of work because ached all over; no fever or other sx;
Patient was seen with a 3 inch erythema around vaccination sight and circumfercial rash around chest, shoulders, and back. No shortness of breath or difficult swallowing. Weight based dose of diphenhydramine at 30mg PO Liquid administered with relief.
Warm, itchy red skin at the site of injection. Noticeable at 9 pm two days after the vaccine. The skin around the injection looks inflamed and slightly bubbly. Skin hurts, with a burning-like pain, when touched.
feeling some pain in the injection site like it throbbes where he got the shot; no energy; feel sick/felt very sick; pain/pains were worse; headaches; aches/ache all over; quizzy; like a severe case of the flu, dry heat for like 6 hours; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (like a severe case of the flu, dry heat for like 6 hours), ASTHENIA (no energy), MALAISE (feel sick/felt very sick), PAIN (pain/pains were worse) and HEADACHE (headaches) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A, 041L20A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroiditis, MONTELUKAST SODIUM (SINGULAIR), OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC), FAMOTIDINE and COLECALCIFEROL (VITAMIN D3) for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Sep-2021, the patient experienced INFLUENZA LIKE ILLNESS (like a severe case of the flu, dry heat for like 6 hours). On 19-Sep-2021, the patient experienced PAIN (pain/pains were worse), HEADACHE (headaches), MYALGIA (aches/ache all over) and NAUSEA (quizzy). On 21-Sep-2021, the patient experienced ASTHENIA (no energy) and MALAISE (feel sick/felt very sick). On 22-Sep-2021, the patient experienced VACCINATION SITE PAIN (feeling some pain in the injection site like it throbbes where he got the shot). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (like a severe case of the flu, dry heat for like 6 hours), ASTHENIA (no energy), MALAISE (feel sick/felt very sick), PAIN (pain/pains were worse), HEADACHE (headaches) and VACCINATION SITE PAIN (feeling some pain in the injection site like it throbbes where he got the shot) was resolving and MYALGIA (aches/ache all over) and NAUSEA (quizzy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Sep-2021, Body temperature: 100.6 (High) Degrees Fahrenheit. On 20-Sep-2021, Body temperature: 101.4 (High) Degrees Fahrenheit.         Patient  got the booster dose because he is travelling in October and that requires for them to get a booster shot.   This case was linked to MOD-2021-328256, MOD-2021-328226 (Patient Link).
Headaches & dizziness a few times on 1st & 2nd days.  Soaked bed from sweating all night on 1st & 2nd days.  Off-balance and dizziness on & off since 3-2-21.  Blurry vision/ can't focus, which bothers me more than the other adverse events.
This case was reported by a nurse and described the occurrence of worsening cough in a 2 month old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis absorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis. The subjects medical history was notable for reflux and cough. The cough began on Jan 5 2006. A polymerase chain reaction for pertussis was negative on 1/17/2006. On 1/27/2006 the subject received 1st dose of Pediarix (lot AC21B047AA). On 02/01/2006, 5 days after vaccination with Pediarix, the subject was admitted to the hospital with coughing and reflux. A polymerase chain reaction for pertussis was positive on 2/2/2006. The nurse considered the events to be clinically significant (or requiring intervention) (OMIC). The outcome of the events was not reported.
debilitating migraine; severe headache; nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (debilitating migraine), HEADACHE (severe headache), NAUSEA (nausea) and VOMITING (vomiting) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MIGRAINE (debilitating migraine), HEADACHE (severe headache), NAUSEA (nausea) and VOMITING (vomiting). At the time of the report, MIGRAINE (debilitating migraine), HEADACHE (severe headache), NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment medication reported.
Notified indicated client had received a prior Pfizer COVID-19 vaccination on 4/28/2021 which the client did not disclose and responded on the pre-vaccination screening tool that they had no received a previous COVID-19 vaccine, ever.   Janssen COVID-19 vaccination provided to the client on 5/13/21 with no reported issues.