chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At around 0800 am on 2/27/2021, I started experience some slight itching around my right forearm. I proceeded to take my morning shower and in the shower the itchiness felt to have intensified. Within an hour of showering, I noticed the itchiness was so severe and I started developing generalized rash and hives. I took Benadryl 25 mg at around 0900am, contacted my doctor. During the break out, I was concerned that my airway might be affected, but thankfully I did not experience any throat itchiness or respiratory distress. After speaking with my doctor, I took another dose of 25mg Benadryl. I was instructed to take 50 mg of Bendaryl every 6 hours for the next 2-3 days. The rash completely resolved later in the day, around 1:00pm, but i continued to take benadryl for the next 2 days.
Fever, rash, red eyes, cough. Supportive care at home given. Symptoms 5-7 days.
This spontaneous report was received from a consumer refers to her 1 year old daughter. The patient's medical history included albuterol allergy. The patient was vaccinated with VARIVAX on 17-SEP-2012. Concomitant medications included IBUPROFEN. On 26-SEP-2012, the patient developed a rash at the injection site after she received VARIVAX. She was also coughing and congested and had a fever. She was also getting new teeth. The patient was seen at the physician's office on 01-OCT-2012 it was confirmed that she had experienced a mild case of chicken pox and a double ear infection after receiving the VARIVAX. While the patient's mother was waiting in the office, she also hear two other children had a similar experience. No treatment information was reported. No laboratory diagnostics was performed. The outcome of the adverse events was reported as not recovered. This is one of several reports received from the same reporter. Additional information has been requested.
Soreness in the arm; This is a spontaneous report from a non-contactable consumer or other non hcp. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced soreness in the arm on an unspecified date. On an unspecified date it was reported, Caller stated "but the first shot doesn't protect you, right. Offered to place on additional hold to provide additional resources, but caller states "oh no I have to go now, thank you and caller disconnected. Response: Not provided, caller disconnected before response could be given. Caller was a consumer (declined to provide last name and phone number). Caller was inquiring about additional information regarding side effects of the Pfizer Covid-19. Caller states "I gotta talk to you, what happened was 07Jul2021 I got first dose, people I know got the first shot before me and said expect soreness in the arm. Alright that doesn't sound bad but my arm was excruciating, the pain was unbearable. Caller's questioned was that normal. Caller asked what about nausea, what does it say about that. Caller states "so I'll actually be throwing up". Caller asked "does this, listen carefully this was important, were any of the side effects related to your eyes, could it effect vision. Caller stated "because shortly after they gave me the vaccine, my vision was getting blurry, but I do have cataracts in both eyes. Could it make it blurry because I have cataracts" Caller states "here's my crucial question. I had the first shot and I'm going back for the second shot anytime after 28Jul2021. was it true--my pharmacist told me this--was it true that after the second dose your side effects are worse" Caller stated that means my nausea and my arm will be even worse. Caller stated but the first shot doesn't protect you, right. DSU: e-transmitting potential duplicate AE data captured. Response: Confirmed Pfizer Covid-19 vaccine. Provided disclaimers and spoke from the attached document. Also spoke from the EUA Prescribing Information on page 21 in Table 1 under pain at the injection site with reports of severe pain (LAB-# Revised: 25Jun2021). Referred caller to her HCP. Survey not offered due to caller disconnecting. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Fever 101.6 treated with childrens tylenol Vomiting-1-2 days Fussiness-1 week Sleeping more-1 week Runny nose-3+weeks
No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) in a 33-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 13-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.).     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant drug was reported. No treatment drug was reported.
High feaver, aching body, general overall discomfort, still some feaver, now 2 days later. Red patch below injection site, about 3 inches square.
Patient developed swelling of his upper and lower lip on 4/11 and was given 25 mg benadryl at the care home.   Swelling subsequently worsened and 911 was called, with EMS noting SpO2 at 88%.   He was transported to the ER and found to have CHF/pulmonary edema and NSTEMI.   Comfort care measures were implemented and he died 4/15.
Information has been received from a licensed practical nurse concerning a 54 year-old male patient who on 16-NOV-2006 was vaccinated intramuscularly in the left thigh with a 0.5 mL dose of Pneumovax 23 (Lot #651406/0620F). On 16-NOV-2006 at 13:00, the patient's leg became very weak and "agony" started. The patient developed a temperature of 103 F, the left thigh was tender and warm to touch and a lacy pattern like rash developed from the thigh to below the knee. On an unspecified date, the patient complained injection site reactions. The patient sought unspecified medical attention. The patient was placed on MEDROL, ibuprofen and CLARITIN. At the time of this report, the patient was recovering from the injection site redness but the outcome of the other events was unknown. No product quality complaint involved. Additional information is not expected.
welt on the injection site the size of a silver dollar which was itchy; Itching at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE URTICARIA (welt on the injection site the size of a silver dollar which was itchy) and INJECTION SITE PRURITUS (Itching at injection site) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced INJECTION SITE URTICARIA (welt on the injection site the size of a silver dollar which was itchy) and INJECTION SITE PRURITUS (Itching at injection site). The patient was treated with STEROIDS CREAM (topical) on 07-Jan-2021 for Itching, at a dose of 1 dosage form. On 10-Jan-2021, INJECTION SITE URTICARIA (welt on the injection site the size of a silver dollar which was itchy) and INJECTION SITE PRURITUS (Itching at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Non significant follow up received. On 14-Apr-2021: Non-significant Follow-up appended: updated contact information, last name correction.
I had an itchy, painful shingles rash on the left side of my back and left torso. I started having bad nerve pain in my back. I also so had fatigue and loss of appetite. I went to the doctor, and I was diagnosed with shingles, and they prescribed me an antiviral. On the 10th I went to the urgent care because I had kidney stones, and they did a CAT scan to confirm.
Tested positive for Covid19 using Binax Now rapid test on 9/24/2021.  Confirmed with PCR on 9/28/2021.  Minimal Symptoms of slight congestion and runny nose.
no additional AEs; it was reported multiple temperature excursion 16-NOV-2022 and 09-DEC-2022 and were administered PEDVAXHIB, ROTATEQ and VAQTA; This spontaneous report was received from a medical assistant and refers to an unspecified group of patients of unknown age and gender. Their medical history, concurrent conditions and concomitant therapies were not reported.  On 16-NOV-2022 and 09-DEC-2022, the patients were vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) lot number: U029144 and expiration date: 31-MAR-2024; with Hepatitis A Vaccine, Inactivated (VAQTA) lot number: W015191 and expiration date: 27-OCT-2023; and with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot number: U038854 and expiration date: 20-APR-2023. The vaccines were administered only once for prophylaxis, but dosage regimens, route of administrations and anatomical locations were not reported.  It was reported that the vaccines were administered after multiple temperature excursions (product storage error). Temperature was above 47 Fahrenheit (F) degree (50.0 F) for 0 hours 12 minutes and 0 seconds on 16-NOV-2022 and above 47 F (47.6F) for 0 hours 15 minutes and 0 seconds. Time frame was total 27 minutes. Additionally, no previous temperature excursion was reported. No other adverse event was reported (no adverse event).  Follow-up information was received from the medical assistant on 28-DEC-2022. This report refers to a 19 month old patient who was vaccinated on 29-NOV-2022 with Hepatitis A Vaccine, Inactivated (VAQTA) lot number: W015191 and expiration date: 27-OCT-2023, intramuscular (IM). The primary thermometer displayed out of range temperature for less than 15 minutes. The back-up thermometer did not display max. that was out of range. Log was ran and the temperatures were within range. The primary thermometer was re-calibrated.  Patients' identifiers were missing in the previous report but have now been provided.
Parent noticed a red spot near injection site the night the vaccine was given.  Was also given Prevnar vaccine same day and same leg, however has tolerated prevnar well in the past with no reaction.
pt was dc'd from the hosp on 12/22/21 after being diagnosed with COVID on 12/19/21; was dc'd to home on RA; pt began to have SOB, weakness, headache, diarrhea and came to ED on 12/23/21; COVID pneumonia; EKG showed sinus tachycardia; O2 supplementation; admitted to ICU; started on steroids and ABX, heparin drip; continued to require increased levels of supplemental O2; pt and husband decided to make pt DNR/DNI and she passed away in the hospital
This spontaneous report was received from a registered nurse via a company representative referring to a 53 year old female patient. The patient's past medical history, concurrent conditions or concomitant medication were not provided. On 06-JUL-2017, the patient was inadvertently vaccinated with an expired dose of RECOMBIVAX HB, 10 mcg/1.0 mL, expiration date 15-APR-2017 (Lot #, dose number, and route of administration were not provided). No adverse effect reported. The nurse reported that the adverse event (NOS) had been previously reported and evaluated. No further information was provided. Additional information has been requested.
Information has been received from a nurse concerning a 16 year old female with a history of glomerulonephritis, idiopathic thrombocytopenic purpura, Raynaud's syndrome and possible lupus erythematosus, who in April 2007 was vaccinated with Gardasil vaccine. Concomitant therapy included Plaquenil. In June 2007, the patient experienced asthenia, paresthesia. The patient experienced pin-prick sensations along the right thigh and a crawling sensation in the middle of her back. It was reported that the patient sought unspecified medical attention. The patient's paresthesia and crawling like sensation in the middle of her back persisted. The patient's asthenia has improved. Additional information has been requested.
first dose of Moderna Covid-19 on 31Mar2021, she received her second dose of Moderna covid-19 vaccine on 4Apr2021; lips were swollen; she felt like her throat was going to close; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of Moderna Covid-19 on 31Mar2021, she received her second dose of Moderna covid-19 vaccine on 4Apr2021), THROAT TIGHTNESS (she felt like her throat was going to close) and LIP SWELLING (lips were swollen) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Hypercholesterolemia. Concomitant products included ATORVASTATIN for Cholesterol, METFORMIN and GLIBENCLAMIDE (GLYBURIDE) for Diabetes.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 31-Mar-2021, the patient experienced THROAT TIGHTNESS (she felt like her throat was going to close). On 30-Apr-2021, the patient experienced LIP SWELLING (lips were swollen). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of Moderna Covid-19 on 31Mar2021, she received her second dose of Moderna covid-19 vaccine on 4Apr2021). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) for Swollen lips, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) (oral) for Throat swelling, at an unspecified dose and frequency. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of Moderna Covid-19 on 31Mar2021, she received her second dose of Moderna covid-19 vaccine on 4Apr2021) outcome was unknown and THROAT TIGHTNESS (she felt like her throat was going to close) and LIP SWELLING (lips were swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-149672 (E2B Linked Report). This case was linked to MOD-2021-149232 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-149672:Crosslink case for family member
p/vax pt had tingling over both shoulders 1 day; 25MAY93 recvd 2nd dose of vax tingling persisted x 2 wks no assoc weakness or other neurologic sxs;
Patient hospitalized Jan, 2011 for Guillain-Barre Syndrome. She was hospitalized for several months and required extensive rehabilitation. Required PEG tube placement. Received IVIG. Residual fatigue, neuropathic pain, gait change.
This spontaneous report as received from a pharmacist via the consumers husband refers to a 66 year old female patient with hypothyroidism. On 10-MAR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number was reported as H021711 and expiry date was 07-MAR-2014), 0.65 millimeter (ml), subcutaneous in the left arm. On 11-MAR-2013, the next day after vaccination patient experienced quarter size swelling at the injection site of the left arm, the site was firm, tender, has some warmth, but no pain and no rash. The patient had sought medical attention (the patients husband had called the pharmacy). The outcome of all the reported events was not recovered/not resolved. Additional information is not expected.
Patient received first dose on 1/22/21.  Earliest date patient could receive 2nd dose was 2/19/21.  Patient presented to vaccination clinic site on 2/9/21 in error.   Patients 2nd dose was administered on 2/9/19.  Patient denied any adverse reactions after vaccine administered.  Will continue to follow up with patient to monitor symptoms.
Rash at injection site, I did not have the rash for the first two doses. Also a slight fever and body aches.
I had vaccine on 1/10/2021. I did not have any symptom at the time of vaccination. I started feeling Fever with Chills on 1/15/21 evening and then I had headache, and next day I lost smell and taste. I thought these are all COVID symptoms and went for lab testing for SARS RT PCR testing on 1/18/ 21. The result was Detected. I am now feeling well. I went for another testing again for the same test and waiting for the result. Now my question is I have second dose scheduled at 2/7/2021. What if my second lab result comes Negative and What if my second lab result comes Positive? I want to know if i need to take a shot or not? I was isolated in my room at home for all these days and still isolated until I get my result.
PATIENT WAS GIVEN SECOND DOSE OF MODERNA AT ONLY A 20 DAY INTERVAL
Large, red, hot whelp at vaccine site on left arm, about the size of my palm. Tired, achy feeling for about 2 days. Low temperature 99+.
Within seconds of administration, the patients arm developed a welt at the area of injection.  As I sat in our immunization booth, it grew in size.  She said in our pharmacy area to monitor her.  After 15-20 minutes, it had swelled even more.  I gave her 10ml of diphenhydramine syrup for the allergic reaction.  Other than the local reaction, pt was ok
HIGH FEVER, UNCONTROLABLE CHILLS, BODY PAIN EVERYWHERE ALSO PAIN IN ARM. AFTER SEVERAL TYLENOLS WERE TAKEN FEVER WENT DOWN AND I COVERED MY SELF IN COLD SWEATS, VERY DIZZY AND EVEN WHEN FEVER WENT DOWN I CONTINUE WITH THE CHILLS AND BODY ACHES THIS LASTED ALMOST THREE DAYS.
Pt. came into the clinic for her influenza vaccine. During the screening portion, member reported history of allergic reaction to the flu shot, and the COVID vaccine. After speaking to the provider, pt. was cleared to receive the influenza vaccine, with recommendation of monitoring for 30 minutes post vaccination. Prior to receiving the vaccine, self-administered Claritin 10mg PO, and Advil 400mg PO. She received the Afluria Quadrivalent 0.5ml at 1130, and was brought to the training room for observation. While being monitored, at 1150 this writer found member sitting upright with her arms dropped to her side. Upon assessment, pt. was alert and verbal with eyes closed, and stated, "My face is burning up." Redness noted to face and neck. Assisted pt. to a supine position with legs elevated. She reports numbness and tingling to left arm. VS: BP 165/93, P 69, RR 18, SpO2 100%, T 98.0, A&Ox4, and responds appropriately. Dr. arrived on scene and continued assessment. Pt. reports, "Feels like something is standing on my chest." Lungs CTAB. Per provider order, O2 3L administered via NRB. At 1159, EMS was activated when started to dry heave. EMS arrived on site at 1211, and was updated with member's status by Dr.
Patient claims they have a bright red hives on face, neck, and chest, and that it was spreading.  Patient notated that the hives were not itchy.  Patient did say that they took Benadryl, but would seek medical attention if hives continued to spread.
Severe redness at site of injection (huge red spot the size of a hand); felt warm; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 86-year-old female patient who received Herpes zoster (Shingrix) (batch number K735H, expiry date 15th September 2022) for prophylaxis.   On 7th August 2020, the patient received the 1st dose of Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site erythema and injection site warmth were unknown.   It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient had developed a huge red spot at the site of injection. The red spot was the size of a hand and it felt warm.  The reporter was consented to follow up.
15 minutes after the vaccine was given, my son starting pouring out blood from his nose.   He bled profusely for 20 minutes before it stopped.  He has NEVER had a bloody nose in his life.   After we went home, he became extremely tired and fell asleep at 7pm (he usually goes to bed at 12am).   He was suffering from adrenal fatigue and I had to stress dose him steroids for the next 2 days.  I want him exempt from any further doses of this vaccine!
On 11/27/00, the pt experienced chickenpox. One week later, he developed over 50 generalized lesions. He was seen at a medical center, where he was treated with acyclovir. Subsequently the pt recovered.
mother said pt was 12 years old but acutually is shy of being 12  by 2 months pt did not have an adverse advent just got the shot early
Information has been received from a physician concerning a 15 year old female, who, on an unspecified date, was vaccinated with a first dose of Gardasil. Subsequently, the patient experienced significant arm pain at the injection site and then full body pain. The patient was taken to the emergency room of the local hospital. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Acute fainting episode during the night following the day of the vaccine.  Hit my head on the stone floor and was unconscious.  Taken to ER in ambulance.   All diagnostics were normal and after blood pressure returned to normal and getting 4 staples in my scalp I was released.  Since coming home I have been very ill with weakness, vertigo, nausea, and headache.
Chest pain. Shortness of breath. Pain in left arm. Pain in left rib cage. Rapid heart-rate and feeling of irregular palpitations. Swelling of upper left breast, chest area. Elevated D-Dimer level. Pain in left calf muscle
pt was admitted to hosp 24 hr post vax for apparent staring spells & crying paroxysms. Resolved about 48 hr later.  These events reoccurred 3 days after discharge & persisted.  Dx w/ colic. These were no sz