chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient has achiness; fatigue; headache; This spontaneous case was reported by a patient and describes the occurrence of PAIN (The patient has achiness), FATIGUE (fatigue) and HEADACHE (headache) in an elderly male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. A43834B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (The patient has achiness), FATIGUE (fatigue) and HEADACHE (headache). At the time of the report, PAIN (The patient has achiness), FATIGUE (fatigue) and HEADACHE (headache) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Reportedly, the patient received his first Moderna COVID-19 vaccine on 15-Jan-2021 with lot number 026L20A. Patient received in his left arm. The patient had no adverse reactions or side effects to 1st dose.  The patient received his second Moderna COVID-19 vaccine on 02-Feb-2021 with lot number 029K20A. Patient received in his left arm. The patient had no adverse reactions or side effects to 2nd dose.  The patient received his first booster dose of Moderna COVID-19 vaccine on 24-Aug-2021 with lot number 002F21A. Patient received in his left arm. The patient had no adverse reactions or side effects to first booster dose.  The patient received his second booster dose of Moderna COVID-19 vaccine on 03-Mar-2022 with lot number 045L21A. Patient received in his left arm. The patient had no adverse reactions or side effects to second booster dose.  The patient received his third booster dose of Moderna COVID-19 vaccine on 07-Sep-2022 with lot number AS7144B. Patient received in his left arm. The patient had no adverse reactions or side effects to third booster dose.  In Feb-2023 the patient had a very mild case of COVID-19, the patient tested positive and had the sniffles for one day.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-744675 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-744675:Case for Bivalent dose
Pt recvd 1 dose of Engerix-B & following dose 1 2 pts devel rash;
Significant swelling, redness, bogginess of left arm from deltoid and up to 2 inches above elbow noted a day after KINRIX was given. Symptoms resolved 4 days later.
Patient presented 2 days after vaccine administration with area of swelling, redness, and itching that was warm to the touch. Area was about 4" in diameter below the injection site.
Redness all over patient's left shoulder, not at injection site. from collar bone to chest area. Red and inflamed, but not itchy or rash.
RIGHT DELTOID WHERE IMMUNIZATION GIVEN HAS 3CM WIDE ABCESS WITH PUS DRAINING
sore arm; This is a spontaneous report from a contactable consumer (patient) received. A 75 (unit not specified) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 22Feb2021 (Batch/Lot number: not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history included diabetes (notes "sugar spike") and atrial fibrillation (reported as AFIB). Concomitant medications included apixaban (ELIQUIS) taken for AFIB. On an unspecified date in 2021, the patient experienced a sore arm. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No adverse event took place, a miscommunication between pharmacy and clinic led to patient receiving the primary series Regular Pfizer appropriate for her age, but was intended to receive the Bivalent Pfizer Booster. Pt mother informed.
Adverse Event: Severe swelling of skin, hives, redness, severe itching. Treatment: Topical Steroids, Wet wraps, salt baths, bleach baths.
Fever of 101F first two days.  Injection site erythema, swelling, pain, pruritus slowly improving over 5 days. Reduced appetite with resulting dizziness.
Got the gardasil shot on a friday, sunday night my body was itchy. Monday I was covered in hives. Tuesday my foot and hand is swollen and still breaking out in hives.
p/recv vax pt devel a low grade fever, diarrhea; hyporeactive hypotonic episode, described as went limp, eyes closed & pt passed out; pt hosp;
Patient received covid booster and instructed to stay near the pharmacy for approximately 15 minutes. Patient acknowledged and then stood up and ambulated out of vaccination area with parent.  This nurse was approached by parent stating  "My daughter is having a reactions and she is on the floor". This nurse found patient crouched down on the floor on her bilateral knees.  Patient noted to be  Red, Diaphoretic, & Clammy. This nurse assisted patient to her feet and ambulated back to vaccination area with this nurse to be watched for 30 minutes.  Upon entering vaccination area, patients BLE were elevated, fluids offered, and BP taken. BP 149/87 HR 94.  Color improved drastically within 60 seconds.  Patient was calm and alert throughout event.  After 30 minutes BP  113/78 HR 87.  Patient stated she felt 100% better. Patient and parent instructed to follow up with PCP.
Around 10 minutes after receiving the first dose, I started feeling woozy, hot, and just very unwell. I was still at the treatment sight, and the pharmacist just had me sit and wait a few mins. My face was all red like I had a sunburn. They took my Blood pressure and it was really high. So I waited over an hour, and they called the ambulance and they redid by BP, it was a little lower but still high. After a couple of hours I went back home and I was okay. I had a virtual visit with my Dr. after a week later, for, I felt better but still felt bad. I started getting twitches in my belly and left side of my head. The Dr. said he didn't think the vaccine had anything to do with it and that I could go ahead and get my second dose. But after two weeks, I was feeling like I was trembling, and still had muscle twitches. I physically went to the Dr. after these symptoms came back and he recommend that I do NOT get the second dose. So I didn't get it. I told the pharmacist about my reactions etc. I'm still not fully recovered.
Narrative: Reports receiving vaccine on 1/28 and later having muscle pain and headache; 1/29 had muscle pain; 1/30 lips slightly swollen; 1/31, swelling to right cheek, lips, chin. His daughter, a nurse, accompanied him to the ER on 1/31. Patient was given an unknown dose of solumedrol and a unknown dose of benadryl. Do not have access to notes from non clinic ER.
I'm itchy from scalp to toes, and it's not just a slight itch, it's so intense i'm literally tearing at my skin. I end up with welts and wheals, and sometimes what feels like a rash at the site i scratch at. I"m still itchy I've taken some antihistamine and that helps mask the itch but I can still feel it, just not as badly without the antihistamine
11/3 flu vaccine (L) arm. 11/5 required emergency visit for marked soft tissue swelling with splotchy areas of erythema extending up over the shoulder and down to the AC joint.
12/02/2010 LEFT ARM SWOLLEN, ERYTHEMA, WARM TO TOUCH. MEASURING 15X15CM. INSTRUCTED PARENT TO ADMINISTER TYLENOL AND BENADRYL ONT. COOL COMPRESSORS
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: pt reported swelling / redness and itching at injection site
Moderna given to client under the age of 18 at time of administration.  No adverse events noted.
patient presented to emergency room with severe headache and blurry vision. diagnosed with cavernous sinus thrombosis
Pt was pale and light headed.  Syncopal event- caught by staff (did not fall).  Hx of syncopal events with other vaccinations. Pt did not eat breakfast. BP 98/49, HR 65, RR 18 -- > 94/48, 83, 18 -- > 93/58 -- > 106/60.  Pt laid down with feet elevated. Pt given crackers and juice.  Pt improved, stable, and released from the vaccination site.  Recommended patient eat and drink prior to next dose.
tingling; pain in ankle and hands; pain in ankle and hands; not able to move due to muscle spasm; not able to move due to muscle spasm; didn't sleep and never felt sleepy; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 06Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (dose 1, manufacturer unknown), for COVID-19 immunisation, reaction: "no adverse effect"; COVID-19 vaccine (dose 2, manufacturer unknown), for COVID-19 immunisation, reaction: "no adverse effect". The following information was reported: INSOMNIA (non-serious) with onset 07Oct2021, outcome "unknown", described as "didn't sleep and never felt sleepy"; PARAESTHESIA (non-serious) with onset 08Oct2021, outcome "unknown", described as "tingling"; ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 08Oct2021, outcome "unknown" and all described as "pain in ankle and hands"; MUSCLE SPASMS (non-serious), MOBILITY DECREASED (non-serious) all with onset 08Oct2021, outcome "unknown" and all described as "not able to move due to muscle spasm".  Additional information: The patient stated that this was the foreign medicine in the patient's body. The patient never had any reactions to needles to inoculation but this was the first time the patient ever had any kind of a reaction from inoculation.  Follow-up attempts completed; information about lot/batch number cannot be obtained. No further information is expected.
I had chills and a fever and sinus congestion, and my body hurt and slept for 24 hours.
Initial misuse report received from a healthcare professional on 01 April 2014. A patient (no other information was provided regarding patient) had received the dose of Tet Tox instead of Td vaccine an unspecified date. i.e. wrong vaccine administered. No adverse event was reported. List of documents held by sender: none.
Had a sore arm by the afternoon of the first shot, it was fine by Monday 3-15-21 3-16-21 Tuesday morning developed a rash on the front and right side of my neck.  I used Aquaphor on it twice daily and it was gone by Friday (3-19-21) 3-20-21-Woke up Saturday morning with a rash on my stomach (left side). Raised bumps.  It was gone by the next morning. Wednesday 3-17-21, developed a rash in my belly button. Raised bumps and itchy.  It's Friday at approximately 4:15pm and I still have the same symptoms. I don't feel bad or anything.  Just rashes developing in areas and I don't usually have those.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2013, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2015, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
A serious spontaneous report of jaundice has been received from a health professional/mother concerning her newborn baby daughter, subsequent to H1N1, Intranasal. This case is linked with MEDI-0009558. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient did not received the H1N1, Intranasal. On 05-Nov-2009, the patient's mother received the H1N1. The patient was perfectly healthy at the time of birth. On 28-Jun-2010, the patient was admitted overnight for jaundice and put under bili lights and discharged on 29-Jun-2010. The patient was fine since she discharged from the hospital. The outcome of the event jaundice was considered resolved.
Initial report received on 06 November 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a 21-month-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had received 3 doses of PENTACEL; lot number C3603AA received on 01 March 2011, lot number C3782AA received on 19 May 2011 and lot number C3816AB received on 11 August 2011 (route and sites of administration not reported). The subject developed a cough on 08 October 2012, approximately 14 months after the last dose, and paroxysmal cough on 09 October 2012 with a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 10 October 2012. Chest x-ray findings were positive for pneumonia. Corrective treatments consisted of azithromycin starting on 10 October 2012 for 5 days. The subject was hospitalized for 4 days. At the time of final contact on 31 October 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 23 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
2nd dose Pfizer given 3/7/21.  Hospitalized 8/18/21
Vaccine administred to 17 year old; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administred to 17 year old) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administred to 17 year old). On 02-Feb-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administred to 17 year old) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  Treatment medications were not provided.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old male) for mRNA-1273 (lot number 012M20A) with no associated AEs reported.
weakness; feeling of worn down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 26Feb2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ASTHENIA (non-serious), outcome "unknown", described as "weakness"; FATIGUE (non-serious), outcome "unknown", described as "feeling of worn down".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After the flu vaccine was given approx. 8 minutes she started to go look for item in store (drug), walked approx. 15 feet & fainted, required stitches under chin (#11) & chipped tooth; she came to & taken to ER immediately .
A non-serious, spontaneous report of four-year-old received FLUMIST two weeks after flushot was received from a registered Pharmacist concerning a four-year-old of unknown gender. The patient's medical history included twin birth. The patient had received a flu shot two weeks before FLUMIST vaccination. On 28-Oct-2010, the patient received FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
SLIGHT HEADACHE, FEVER 102 IN THE EVENING, SORE ARM, NAUSEA
pt dx w/HIB meningitis 31MAR93; presented w/abdo pain & GI bleed; hospitalized recovered w/no hearing loss; pt recvd 2 doses 1st dose-lot # M160HF; 2nd dose M660HH; pt did not receive subsequent immun;
The patient was fine for 15 minutes after taking the shot. However, After 25 minutes the patient fell on the chair and started calling for help. He was feeling dizzy and fainting. He was saying that he is feeling like throw up. He was feeling nauseous, had a sore arm, swelling, redness, and pain at injection site. Tiredness, muscle pain, and chills was also reported.
At 9:48am after taking the vaccine pt reported that she was unable to use her voice. Her voice became very raspy and she could only say 4 to 5 words. It progressed to where she couldn't speak at all. She was sent to Hospital for further evaluation.
Patient reports bad chills, shaking, headache, but no fever starting 7 hours post administration of COVID-19 vaccine. Symptoms resolved within 36 hours. Patient had new onset of nausea/diarrhea 48 hours post administration. Patient advised to hydrate and monitor GI symptoms, and call provider if symptoms last more than 24 hours.
ACUTE RESPIRATORY FAILURE 3/26/2023 SEPSIS WO ACUTE ORGAN DYSFUNCTION ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/26/2023 SEPSIS WO ACUTE ORGAN DYSFUNCTION
I was infected with Covid seven weeks after my 5th vaccine.  CDC called me and instructed me to fill out this form.
Ii got he vaccinator on 3/5 and went home.  the first night around 9p, I started to feel chills, Had a really big temporal headache.  I thought it was a reaction to vaccination, I took Tylenol PM, layer down and woke up in the middle of the night, in a full body sweat.  I went strait into chills, changed my clothes.  Layed back own and awoke the next morning, with chills and temp of 101.  I had body ache but proceeded with my day.  I continued to have chills, I went out to my elderly parents, took them food and had dinner.  Upon arrival home, had high fever 103...no Tylenol.  Awoke still w/ chills and high fever and this was Sunday.  Stayed in Sunday then the afternoon, felt like I needed to seek help.  I went to get a rapid test at Medical Center and it came back Neg.  Went back home, I could now sense that my taste was altered.  I then continued to have a high fever but they would only come at night.  Body sweat, aches, chills cont'd on Sunday.  Monday still had same s/s and Tuesday, I thought that I should seek more medical attention.  I went to an Urgent Care 3/9/21.  They then did a nose swab and felt that it would come back Neg.  I went home and on Thursday 3/11/2021 I got a call that I was positive.  Did isolate.  But from 3/5 to 3/11 then I lost taste/smell.  Came out of isolation 3/20 and on 3/21 my whole left side of fact, shoulder and leg went numb for approx 1hr.  Then my wife said that I was talking a little slow in my response.  Next morning my left shoulder was hurting and I had pain.  The Urgent care provider wanted to r/o TIA  so he sent me to ER for full work up and that doctor said he saw nothing.  He didi say that it could be Covid related and/or possible TIA.  "I am feeling good today"  There is no residual but because of the left shoulder pain I did go back to Urgent Care.  Got cortisone inject and MRI.  My PCP then told me that I had a partial "tear" in my left shoulder but I do exercise every day and could have done it then.
Symptoms: fatigue, low-grade fever (100.6), body pain (could not walk), extreme chills, severe headache, swollen lymph nodes in both sides of neck,, weakness  Time Course: fatigue began at 6 pm on January 5th. On January 6th at 2:30 PM extreme chills began that lasted until morning of January 7th followed by sweating until 1pm. Could not walk until 11:30 am on the 7th.  Headache persists  Treatment: Tylenol two regular doses (too weak to sit up and take more)
This prospective pregnancy case was reported by a healthcare professional and described the occurrence of plagiocephaly in a newborn female subject who was exposed to BOOSTRIX (GlaxoSmithKline) which her mother received. Co-suspect medication included clobestasol received topically by the mother (dates and details unknown). The neonate was also exposed to MVI and ALLEGRA which the mother took concurrently. On 25 May 2011 at 10:30 the subject's mother received a dose of BOOSTRIX (.5 ml). The neonate was exposed to BOOSTRIX during the second trimester of the pregnancy. On 16 September 2011, 114 days after exposure to BOOSTRIX and an unknown time after exposure to clobestasol, the neonate was delivered by cesarian section and weighed 3.6 kg. and was 51 cm. long. APGAR scores were 8 and 9 at 1 and 5 minutes, respectively. A birth defect of mild right plagiocephaly (occipital deformation) was noted. This defect was not evident from any prenatal testing. At the time of reporting, the outcome of the event was unknown. The event was considered to be a congenital anomaly. Please see report A0929221A for details regarding the mother case.
Constant dull headache, pain behind eyes,  ( for three weeks to-date)and on eye balls not relieved by over the counter medication
After high intensity exercise, patient collapsed onto a closet door mirror bending the frame of the door in a twisting motion resulting in a open wound.
patient had little bit of bleeding out of his bandage. Patient was fine in the pharmacy while waiting post vaccination. His wife called and informed pharmacy about the incident. Bleeding  was contained in the bandage and came out after removing bandage.
Gave injection in the left deltoid. Patient tolerated the injection well even commented on how the HPV hurts. Patient then turned very pale and mom started calling her name. Patient then slumped over and was sliding down the chair. I placed my body in between her to stop her from sliding to the floor. After about 5 mins and having her smell the smelling salts, cold washcloth she started to respond and stated it was blurry but she could see and hear.