chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Still having pain in right arm a week after injection; Warmth/redness and hardness of injection site; Warmth/redness and hardness of injection site; Warmth/redness and hardness of injection site; This is a spontaneous report from a contactable nurse (patient). A 30-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 19Dec2020 19:15 at single dose on right arm for COVID-19 immunization in hospital. Medical history was reported as none and no known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced still having pain in right arm a week after injection, warmth/redness and hardness of injection site from 19Dec2020 19:15. No treatment received for the adverse events. The events outcome was not recovered. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. It was not reported as serious.  The information on the batch number has been requested.
Administered #2 dose of varicella too soon for age: previous dose of varicella given 02/04/2015 so this dose should have been given 05/04/2015 per CDC recommendations. Noted this when reviewing the records with client's mother. Let her know that it was given early but that it is still considered valid.
This case was reported by a consumer and described the occurrence of chest hot to touch in a 58-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included sulfa allergy. There were no concurrent medications. On 28 September 2010 at 12:00 the subject received 1st dose of FLULAVAL at 0.5 ml in the right arm. On 28 September 2010, an unspecified amount of time after vaccination with FLULAVAL, the subject experienced chest hot to touch, sores on chest (anything that touches the area causes sores), insomnia, skin sensitive to touch and sensitive skin on chest (nothing could be against the skin on her chest). At the time of reporting the events were unresolved.
scab formed over the injection site bruising; injection site had bruising; may have hit a blood vessel; This case was reported by a pharmacist via call center representative and described the occurrence of injection site scab in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 2ZN2D, expiry date 16th September 2022) for prophylaxis.   On 17th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 17th October 2020, unknown after receiving Shingrix, the patient experienced wrong injection technique. On 19th October 2020, the patient experienced injection site bruising. On 24th October 2020, the patient experienced injection site scab. On an unknown date, the outcome of the injection site scab and injection site bruising were recovered/resolved and the outcome of the wrong injection technique was unknown.   It was unknown if the reporter considered the injection site scab and injection site bruising to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix in the left arm. The pharmacist reports that upon injection, she might have hit a blood vessel.  Injection site had bruising 2 days after the injection, which appeared about 2 days post injection.  A scab formed over the injection site bruising at about 7 days post injection, and that had resolved.  The reporter consented to follow up.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent and historical conditions were not reported. On 11-MAR-2016, the patient was vaccinated an improperly stored dose of VARIVAX (Merck) (Lot number L035124, expiration date (exp) 14-SEP-2017), dose, route and anatomical location were not provided. The patient's concomitant medications were not reported. The reporting nurse stated that unspecified doses in VARIVAX (Merck) immunization series were improperly stored in a temperature of -5.9 degrees C, the time frame was 15 hours and 38 minutes. There was previous temperature excursion, data was cumulative since 04-MAR-2016. The vaccines involved included VARIVAX (Merck) private stock; L035124 exp 14-SEP-2017 and VARIVAX (Merck) VFC stock: L037563 exp 29-SEP-2017. No adverse effects were reported, no product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Full body rash. Slightly raised red blotches. Especially on underside of upper arms, top of thighs, stomach, and back of upper arms. Somewhat symmetrical. No fever.
About 12 hours after the 2nd dose was given, I woke up at 2:30am with a severe headache, uncontrollable chills, muscular discomfort, soreness at the injection site, and fatigue.  I took 2 Tylenol, the chills subsided about 15 minutes after they began, and the headache was better about 30 minutes after taking the Tylenol.  I was in and out of sleep on the couch until around 6am, and I took my temperature at that time.  It was 102 degrees.  I took a couple more Tylenol at 7am and contained to take 2 every 4 hours (last dose around 6pm that night).  My temperature reduced gradually, but it was still over 101 degrees around noon.  By 6-7pm my fever was gone and didn't return.  I called out of work sick, and I fell back asleep in bed from 8am-11:30am.  I woke up with significant muscle pain in my left theigh (I sleep on my left side, but the pain was much more pronounced than usual).  This lasted 3-4 hours.  Overall, less acute muscle soreness lasted the full length of pronounced reactivity (~2:30am to ~6:30pm on 02/09).  Fatigue was evident until a went to bed around 11:30pm and not noted when I woke up at 6:30am on 02/10 for work.  Soreness at the injection site (left arm) gradually decreased over about 3 days following the injection, but it never impaired my ability to engage in everyday tasks.
Symptoms started approximately 15 hours following the booster dose and included vomiting, fever up to 102.8F, and muscle aches. Symptoms were treated with ondansetron 4mg PO and acetaminophen 1000mg PO q4-6h PRN.
Information has been received from an RN concerning a retired 57 year old white female pt with no known allergies who on 03NOV2003 was vaccinated in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine. There was no concomitant medication. On 05NOV2003 the pt developed left arm redness and pain. The pt recovered form left arm redness and left arm pain on 07NOV2003. There was no lab or diagnostic studies performed. The pt was not ill at the time of vaccination. It was noted the pt did not have adverse evens following prior vaccinations. No additional info is expected. The RN nurse also reported three other pts who experienced similar reactions following vaccination with dose of pneumococcal 23v polysaccharide vaccine.
Shingles rash, headache, chills, body aches, couldn't get out of bed very tired
Patient felt light headed and passed out right after vaccine administration within few minutes. Patient was conscious and had pulse and breathing. pharmacist checked blood pressure and pulse every few minutes .Oxygen saturation was at 99.Initially blood pressure seemed to drop.so called emergency.first responder arrived and checked vitals which were normal by then.so patient chose not to go to the  hospital. she felt better and went home.
Gave a moderna vaccine that expired on 9/28 today; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave a moderna vaccine that expired on 9/28 today) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Gave a moderna vaccine that expired on 9/28 today). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Gave a moderna vaccine that expired on 9/28 today) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient was observed for side effects for 35 minutes following administration.  No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-Oct-2021: Patient age and gender added, suspect drug administration date, batch number updated.
Pfizer booster was administered one month too early. Patient received second dose of Pfizer COVID-19 vaccine on 5/29/21 and booster was administered on 10/28/21. Error was identified on 10/29/21. Patient confirmed dates of the first and second doses and was informed of the adverse event on 10/29/21. Patient did not express concern and verbalized feeling minor flu-like symptoms but otherwise is fine.
Information has been received from a pharmacist concerning a 70 year old female patient with penicillin allergy who on 20-MAR-2009 was vaccinated subcutaneously in the left arm with 0.65 ml of a dose of ZOSTAVAX (Merck) (Lot number 662857/1560X). On an unspecified date the patient experienced erythema at the injection site with induration after the administration of ZOSTAVAX (Merck). The area was tender, swollen, and warm and had a 1 inch red "pathway" radiating to the elbow. The patient sought medical attention with the pharmacist and no laboratory diagnostics studies had been performed. At the time of reporting, 13-MAR-2009, the outcome of the patient is not recovered. Additional information has been requested.
Fever of 101.7 chills, body aches, headaches, sweating , nausea
I test positive for COVID on 02May2022 with severe URI symptoms; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 50-year-old male patient received BNT162b2 (BNT162B2), in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history included: "Is the patient a smoker/former smoker? No" (unspecified if ongoing), notes: Is the patient a smoker/former smoker? No. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 01), administration date: Dec2020, when the patient was 49 years old, for COVID-19 immunization, reaction(s): "Covid-19"; Bnt162b2 (DOSE: 02), administration date: Jan2021, when the patient was 49 years old, for Covid-19 Immunization, reaction(s): "Covid-19". The following information was reported: UPPER RESPIRATORY TRACT INFECTION (non-serious), outcome "unknown", described as "I test positive for COVID on 02May2022 with severe URI symptoms".  Additional information: The patient did not have a positive test for SARS-CoV2. The patient have SARS-CoV2 antibodies at diagnosis. The patient was not hospitalized. Patient was not admitted to an Intensive Care Unit. The patient did not display clinical signs at rest indicative of severe systemic illness. The patient did not require supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation. The patient was not smoker/former smoker. The patient was not taking any medications routinely prior to the event being reported. The patient did not have pre-existing diseases worsened during the SARS-CoV2 infection (please specify). The patient had not been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. The patient think this was report worthy, as The patient Had clear documentation of negative tests, and subsequent days of positive testing with new symptoms occurring.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
client felt flushed 10 mins after vaccine client fainted fell face down received a laceration on the left side of the forehead  was pale and diaphoretic v/s 133/84 72 pox 96 r 20-22 after fall PATIENT WAS ALERT AND OX3 stated he felt ok legs were elevated . patient stated he had a similar episode after having a tattoo EMS was called vs 124/100 78 pox 96% RA patient refused to go to ER or urgent care offered water and rested for 30 mins left ambulatory without any c/o
The patient had breathing problems and came back to store. He is an MD, and said it was not anaphylaxis. He had another episode at store 20 minutes later. He took 2 BENADRYL and was symptom free for 40 minutes before he left the store.
Flu like symptoms; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported by the reporter No treatment medications was  provided by the reporter.
Patient reported a very sore arm and neck, such that she did not want to get out of bed. Recommended rest, ice packs, and Tylenol/Motrin. Upon follow up on 3/23/2021, the patient was fully recovered with no further sequalae.
1) Severe depression & anxiety. 2) Trembling in right arm - worsened.
Rash and itching ended up in hospital and was diagnosed with Cellulitis on injection site and is receiving antibiotics from PCP.
Pt did not seroconvert p/recvd Engerix-B; all injections were administered IM;
Neck pain: Beginning upon wakening on the morning following both injections, I had sharp neck pain running the length of my neck from my shoulder up to just under my ear on the side of my body of the injection.  The pain lasted for several minutes, and was off/on throughout the day.  the following day, the pain was faint and infrequent.  By the third day, there was no pain. No treatment was used. Breast pain: Beginning the first day after the injections, on the side of my body of the injection, I experienced pains in my breast for two weeks.  The pain was sharp the first day and was infrequent.  Throughout the two weeks following the injections, the pain resembled a pressure vs. a sharp pain.   Insomnia: Following both injections, for two weeks, although I was tired, I experienced insomnia; only sleeping about 5 hours/night. Brain: Pressure in the back of my head from my hairline to the top of my head, and sinus pressure.  Feeling of fogginess for the first few days after each injection.
Shingles reaggravating, mainly up the back and shoulders; itching; Inappropriate schedule of vaccine; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 88-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, several months after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles, pruritus and incomplete course of vaccination. On an unknown date, the outcome of the shingles and pruritus were not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles and pruritus to be related to Shingles vaccine.  Additional case details were provided as follows: The age at vaccination was not reported for 1st dose and not applicable for 2nd dose. The patient received dose of the shingles vaccine about a year and a half before day of reporting and after few months experienced shingles. Till the time of reporting, the patient did not receive the 2nd dose of shingles, which led to incomplete course of vaccination. The patient thought that it was the Shingrix, but patient was not sure. The patient stated that she just kept putting it off for the second dose. After the vaccination the patient had shingles, and they all came back to her. The patient currently stated that they were not real bad, but they were aggravating, mainly up the back and shoulders. The patient took aloe vera daily and uses a backscratcher for the itching, but the patient was tired of it. The patient consented for follow up.
Tingling sensation down arm of injection(felt like tiny robots in my arm) itchy throat, and numbness in left side of mouth/tongue.
presumed cardiac failure; This is a spontaneous report from a contactable nurse. An 89-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), intramuscular at arm left on 10Feb2021 (at the age of 89 years) at single dose for COVID-19 immunization. The patient medical history included congestive heart failure, coronary artery disease, hypertension, hyperlipidemia, osteoarthritis, presence of prosthetic heart valve and allergies, all from an unknown date and unknown if ongoing. The patient's concomitant medication included amlodipine besilate/benazepril hydrochloride, amlodipine, acetylsalicylic acid (ASPIRIN E.C.), atorvastatin, benazepril, carvedilol, ubidecarenone (COQ10), furosemide, acetaminophen and potassium chloride. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), intramuscular at arm left on 20Jan2021 at single dose for COVID-19 immunization. The patient experienced presumed cardiac failure on 12Feb2021 at 03:30 with fatal outcome. The patient died on 12Feb2021.  An autopsy was not performed.; Sender's Comments: Based on the current available information, the event Cardiac failure is most likely related to an intercurrent or underlying condition which is not related to the suspected drug BNT162B2. The patient medical history of congestive heart failure, coronary artery disease, hypertension, and hyperlipidemia provide plausible explanations for the event.  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: presumed cardiac failure
Information has been received from the patient's mother concerning a 13 year old female with no known medical history and no known drug reactions/allergies, who on 24-JUL-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast). There was no concomitant medication. On 24-JUL-2008, minutes after injection, the patient fainted and had sweating, tingling and heavy and weak limbs and had the same symptoms on 27-JUL-2008. Patient also reported feeling tired and her "feeling weird". The patient sought doctor medical attention. The patient was recovering from the adverse events. Additional information has been requested. 10/1/08 Reviewed PCP medical records of 7/12-9/23/2008. FINAL DX:Records reveal patient experienced usual state of good health on 7/12 when received Varivax, Menactra & TDaP.  Parent called PCP 7/14 w/local varicella  reaction of red, swollen, warm & indurated injection site.  RTC 7/24 for HPV #1.  Dizzy & fainted in office immediately after injection.  Observed & released.  Parent called office 7/29 after fainted again on 7/27 after having tingling in hands & cold sweat.  RTC 9/24 w/rash all over body, malaise, extreme fatigue, continued dizziness when standing, increased appetite, activities decreased, tingling hands, feeling hot, periods infrequent
very strange side effects; skin hot; the skin was swollen 2 inches below the site of injection shot; skin very red; skin hard; skin so painful; chest tightness ongoing; difficulty breathing ongoing; abnormal blood work: anemia; very sick; chills; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (chest tightness ongoing), DYSPNOEA (difficulty breathing ongoing), ILLNESS (very sick), ANAEMIA (abnormal blood work: anemia) and VACCINATION COMPLICATION (very strange side effects) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 023C21A and 042E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Nov-2021, the patient experienced ILLNESS (very sick), CHILLS (chills) and MYALGIA (Body ache). On 01-Dec-2021, the patient experienced CHEST DISCOMFORT (chest tightness ongoing), DYSPNOEA (difficulty breathing ongoing), ANAEMIA (abnormal blood work: anemia), VACCINATION SITE WARMTH (skin hot), VACCINATION SITE SWELLING (the skin was swollen 2 inches below the site of injection shot), VACCINATION SITE ERYTHEMA (skin very red), VACCINATION SITE INDURATION (skin hard) and VACCINATION SITE PAIN (skin so painful). On an unknown date, the patient experienced VACCINATION COMPLICATION (very strange side effects). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. On 30-Nov-2021, ILLNESS (very sick), CHILLS (chills) and MYALGIA (Body ache) was resolving. On 03-Dec-2021, ANAEMIA (abnormal blood work: anemia) had resolved. At the time of the report, CHEST DISCOMFORT (chest tightness ongoing) and DYSPNOEA (difficulty breathing ongoing) had not resolved and VACCINATION COMPLICATION (very strange side effects), VACCINATION SITE WARMTH (skin hot), VACCINATION SITE SWELLING (the skin was swollen 2 inches below the site of injection shot), VACCINATION SITE ERYTHEMA (skin very red), VACCINATION SITE INDURATION (skin hard) and VACCINATION SITE PAIN (skin so painful) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Dec-2021, Blood test: anemia (abnormal) anemia. On 01-Dec-2021, Electrocardiogram: abnormal (abnormal) slightly not normal, not particularly alarmed. On 01-Dec-2021, Troponin increased: 4 (High) 4. On 03-Dec-2021, Blood test: normal (normal) Normal. On 03-Dec-2021, Electrocardiogram: normal (normal) normal. On 03-Dec-2021, Troponin increased: 6 (High) 6. On 03-Dec-2021, X-ray: normal (normal) Normal.         No concomitant medication were provided Patient reported that she used ice pack after booster   This case was linked to MOD-2021-404409 (Patient Link).
My infant developed a cough after getting vaccinated. I have 2 other children in my home who are not sick. Only symptom for my newborn is a cough after vaccination.  In 1993 I developed pertussis as an infant after vaccination and the cough my newborn has is the same cough sound according to my mother. My infant now has a doctor appointment for Friday and will be speaking with his doctor and he will no longer receive tdap , he will only receive TD vaccine. I do not trust tdap vaccines any longer.