chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderate to Severe Muscle aches, Fever, Chills, Headaches.  Symptoms began 2 hours after second vaccination, lasted for ~36hours  Treated by NSAID
25 minutes status post the vaccine patient experienced head itchiness. Patient was brought to the triage room and had fine rash on chest. BP noted to be 190/90, HR 60, RR 16, sat 100%, and no SOB/difficulty breathing. Allergy on call was paged and patient was given zyrtec.  After given zyrtec patient was monitored for two hours. There was a redness on patient's neck which was continually lessened, HR, RR, and sat remained stable throughout. Sat remained between 150-170 for the next hour. After 2 hours the redness on neck has completely resolved and BP 153/79. Allergist on call notified. Plan was to have patient go to ER if she experienced SOB, chest pain, or headache.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with ROTATEQ, oral for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ. Additional information has been requested.
Irritation of skin and rash around injection site within a few hours of injection.; Irritation of skin and rash around injection site within a few hours of injection.; Flu-like symptoms later, much worse the next day; Body ache; sweating; chills; extreme fatigue; low fever (99-100); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female (not pregnant) patient received BNT162b2 (BNT162B2), on 24May2022 at 09:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Reflux" (unspecified if ongoing); "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Allergy"; Levaquin, reaction(s): "Allergy". Vaccination history included: BNT162b2 (Second dose), administration date: 23Mar2021, when the patient was 48-year-old, for COVID-19 immunization; BNT162b2 (Third dose), administration date: 16Nov2021, when the patient was 49-year-old, for COVID-19 immunization; BNT162b2 (First dose), administration date: 01Mar2021, when the patient was 48-year-old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 24May2022 at 12:00, outcome "recovering", described as "Body ache"; INFLUENZA LIKE ILLNESS (non-serious) with onset 24May2022 at 12:00, outcome "recovering", described as "Flu-like symptoms later, much worse the next day"; SKIN IRRITATION (non-serious), VACCINATION SITE RASH (non-serious) all with onset 24May2022 at 12:00, outcome "recovering" and all described as "Irritation of skin and rash around injection site within a few hours of injection."; CHILLS (non-serious) with onset 24May2022 at 12:00, outcome "recovering"; FATIGUE (non-serious) with onset 24May2022 at 12:00, outcome "recovering", described as "extreme fatigue"; PYREXIA (non-serious) with onset 24May2022 at 12:00, outcome "recovering", described as "low fever (99-100)"; HYPERHIDROSIS (non-serious) with onset 24May2022 at 12:00, outcome "recovering", described as "sweating". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of skin irritation, vaccination site rash, influenza like illness, pain, hyperhidrosis, chills, fatigue, pyrexia.  Additional information: Irritation of skin and rash around injection site within a few hours of injection. Flu-like symptoms later, much worse the next day. Body ache, sweating, chills, extreme fatigue, low fever (99-100). The patient was tested COVID-19 positive prior to vaccination.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a lawyer regarding a case in litigation concerning a 94 year old male patient. The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster related conditions. In October 2011 the patient was administered ZOSTAVAX by a pharmacist (lot# and route unknown).  On or about 06-FEB-2017, the patient was treated by a physician for shingles as a result of vaccination with ZOSTAVAX.  The outcome of the event was unknown. Additional information has been requested.
Redness, swelling, near injection site. Tx: cold compress and Ibuprofen.
Administered expired vaccine to the patient, after the manufacture date of expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration.) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Date the vial was initially stored in the refrigerator was unknown. The vial did not undergo any temperature excursions. Vaccine manufacture date of expiry reported was 09-Nov-2021.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live Follow-up document included non-significant information.
After the second shot on 8/26/21 I was sick with fever, diarrhea for 5 days, lost 15 pounds.....never felt quite right.....was healthy before the 2 vaccines- never had any health issues......then I kept getting short of breath, tightness in chest.  Went to my Dr. on 10/13/21 she ordered EKG, blood work and a chest xray....the next morning, 10/14/21 I was sent for a CAT scan- my d'dimer numbers were high.....they found 4 blood clots in my lungs...I was immediately admitted to the hospital and put on Heparin.....I spent 2 days in the hospital and was placed on Elaquis.   I never had any problems until after the 2nd shot.....I have never smoked and was a college basketball player - in excellent health!
Pt called on 5/7/19 to report that after having received vaccines in the morning he felt his (R) arm stiffen & by the evening it was swelled from deltoid to below elbow
4th Shot left arm 5th red, slight swelling, warm, slightly stiff (all expected and not worried) 8, 9th tired Here is where it gets weird Monday the 11th, lower back pain, limited movement (not concerned as it happens with some viruses for me), started APAP Overnight into Tuesday 12th, left arm at shot area, red hot, swollen, stiff up thru shoulder. Still have back pain. I started Benadryl.  Wed 13th continues as above Thursday 14th, arms continues, low back pain improved Friday 15th, today, back OK, arm still red and hot but better, stiffness improved. Still on APAP and Benedryl.
Approx. 10 min after vaccines were given, while in waiting period in lobby, pt attempted to approach pharmacy window,  pt faltered and fell. This happened at approx. 1:07 PM.  911 called, pt assisted on ground.  Eventually helped to sitting position in chair. Pt given water and monitored until EMS arrived.  EMS checked vitals/BP, and pt stable. Pt then declined EMS offer for further care/transport.  Pt requested transport by pt agent/friend, who arrive ~25 min after incident.  Pt states he has no PCP at this time.
heart rate went up to 190 according to my smart watch hours after second dose. I have not gotten my period since i received the vaccine
Patient has had fatigue, depression, and chronic allergies since the first shot. Patient says, "Something happened, and I don't feel like myself."
I started growing a small protruding horn-like thing out of my forehead. (Almost like a rhino horn, but covered in skin. It happened right after I got my vaccines and it's about 3 inches long today.
Rheumatoid arthritis flare up; Covid-19; Covid-19; This is a solicited report from a non-Pfizer sponsored program from a contactable consumer (patient), based on information received by Pfizer from Abbvie (manufacturer control number: 21K-163-3766578-00). Solicited report received by Abbvie from (unlisted country) by a consumer with events of non-serious. A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 Vaccination; and started to receive adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at Citrate Free for Moderate to severe Rheumatoid arthritis. The patient's medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. In Nov2020, the patient experienced covid-19. On an unspecified date, the patient experienced rheumatoid arthritis flare up. The action taken in response to the events for adalimumab was unknown. The outcome of the events was unknown. The reporter's causality for the events of adalimumab was not provided, while of bnt162b2 was Possible.  The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on the limited information provided the lack of efficacy of the vaccine, BNT162B2 and rheumatoid arthritis flare up with the usage of the vaccine cannot be completely excluded. The case will be reassessed once additional information is available. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Area of slight erythema, sl. elevated temp. noted at injection site 15 minutes after injection. Development of widespread erythema - no urticarial lesions. C/o pruritus, pain at site. Transient (less than 1 minute) tingling sensation reported along (L) arm. Vital signs stable Cetirizine 10mg po at 1105. Prednisone 20mg po at 1125.
patient is experiencing ringing of the ear that began 1 to 1.5 weeks after booster #1. The ringing was persistent and has increased in volume the past 2 months
Patient experienced nausea Following shot #2 - he  presented for physical & follow up of chronic medical issues on 10/13/2021 & was found to have anemia He has been more fatigued since taking 2nd shot
DIZZNESS; VOMITTING; DIARRHEA; CHILLS; NUASEA; FEVER; This spontaneous report received from a patient concerned a 46 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced dizziness. On 02-APR-2021, the subject experienced vomiting. On 02-APR-2021, the subject experienced diarrhea. On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced nausea. On 02-APR-2021, the subject experienced fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizziness, nausea, vomiting, fever, chills and diarrhea was not reported. This report was non-serious.
Patient experienced swelling/redness all down her arm into her hand along with dizziness and blurred vision for a period of 2-3 days.
Initial unsolicited report received from a nurse on 09 December 2015. This case involves an 11-year-old female patient who was vaccinated with a dose of MENACTRA (batch number-U5216AA) intramuscularly in right deltoid on 03 November 2015 in the morning. The patient's medical history was not reported. She was previously vaccinated with Tdap vaccine on July 2015 and had experienced arm pain but was less severe. The patient's concomitant medications were not reported. On 03 November 2015 in the evening, few hours following vaccination, the vaccination site was sore. On 04 November 2015, the event worsened and the patient was crying due to the arm pain. Her right anterior shoulder (larger (approximately 6x10cm) vertically oriented) area developed swelling/erythema/warmth/tenderness which extended downward from shot site (right deltoid). The patient had experienced itching. Laboratory data was not reported. The patient's corrective treatment included ice pack for swelling, Ibuprofen for pain and BENADRYL for itching. It was reported that it was not recommended to withhold the dose 2. The outcome of the events was not reported. List of documents held by sender: none.
56 adult patients received doses after its expiration date Jul 13, 2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 adult patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004m21a) for COVID-19 prophylaxis.     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 EXPIRED PRODUCT ADMINISTERED (56 adult patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 adult patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (56 adult patients received doses after its expiration date Jul 13, 2022).    No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Caller mentioned that "the CDC had just approved extended expiration dates" and wanted to know if it was extended. When asked the caller stated that there were no remaining vials unused of that lot number and agent reminded the caller that no patients should receive doses from expired vials. Dose was administered after 30-day Use by Date or after manufacturer date of expiry. Vial did not undergo any temperature excursions.  Treatment information was not provided.  This case belonged to patient 38 out of 56 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case
Per History and physical on 12/20/21: Patient is a 83 y.o. male with a PMH significant for NPH status post shunt in 2013, diabetes mellitus type 2, CKD stage III, CAD, HTN, HLD who presents to the ED due to cough with positive at home Covid testing today.  Patient lives with his daughter.  Today daughter who works in healthcare was routinely tested for Covid.  She tested positive, asymptomatic.  She returned home and tested both of her parents who live with her, patient and spouse both tested positive.  Patient reports a cough for the past couple of days.  He denies fever, fatigue, malaise, decreased appetite, nausea, vomiting, diarrhea, headache, loss of taste or smell, shortness of breath, chest pain, dysuria.   Hypoxia due to Covid 19 Pneumonia. --Satting 92% on room air, not on home oxygen.
Patient received a second dose of the Pfizer bivalent 3 months apart which is not recommended that this time.
15 hours after injection: high fever (x24 hours); general muscle aches; red rash began and advanced thru next day to include outer surface of upper arm from armpit to elbow; rash accompanied with pain, swelling, cherry red shiny skin, and feeling as if a rubber band was around lower part of rash tightening t/o the day. PCP contacted at 7:40 due to concern of increasing pain and advancement of red swollen area. PCP recc ER. Er visit 2/6
Hands and feet turn blue periodically and all extremities have a "cold" sensation at all times.  Dr appointment being made this week of Jan 25th and reported to HCP at healthcare facility.
Thursday, I got the vaccine - felt fine all day. On Friday, I was really tired and lethargic. I laid on the couch all day and probably took an Ibuprofen. Playing hockey, I twisted wrong. My whole back locked up and it was very painful. About a week after that happened, I had Sciatica in left leg. L5 S1 - Severely Herniated Disc was the diagnosis.  Treatment was Physical Therapy and Prednisone Steroid (6 day dose) and Muscle Relaxers. I'm getting there with recovery - still working on it though.
Got the shot and still got shingles/ Suspect vaccination failure; shingles; This case was reported by a consumer via  media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age group was not reported but was selected as adult as per vaccine indication. The age at vaccination was not reported. The patient got the shot and still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
The patient initially complained of chest pain, dyspnea, and palpitations that he apparently found extremely disconcerting, such that he sought medical attention at varied urgent care centers, emergency rooms, and doctors offices including, at least, that of a cardiologist (the current reporter), a pulmonologist , and an infectious disease specialist (name uncertain).  He later complained of head aches, for which he saw a neurologist / neurosurgeon.
Diarrhea. Red, hot, swollen/pain at injection site. Pain lasted 3 weeks after shot. (This was not reported to us until she came in for her second dose).
Approximately 12:30 PM on 2-12-21, about 1 hour 30 minutes after vaccination, I experienced severe diarrhea.  At about 1;30 PM on 2-12-21 I became severely dizzy, very high heart rate (115-120- heart rate was irregular), nauseated and experienced chest tightness.  Moderate shortness of breath.  I was unable to walk unassisted due to dizziness.  This lasted about 3 hours.  When I awoke on 2-13-12 the dizziness and shortness of breath was gone.  I experienced mild flu-like symptoms on 2-13-21 (general achiness, tiredness, slight fever - 99degrees- mild headache).  Symptoms were treated with Tylenol and had subsided by 2-14-12.
Thursday(5/30/19) had fever of 103, chest pain, chills headache, nausea, neck pain on left side, and joint pain.  ED admit on Thursday evening. Discharged to home on Saturday (6/1/19)
Patient already received the flu shot on 11/7/22 and another dose again on 12/7/22 by accident. He was observed for 15min in the office and no adverse events were noted.
The vial was initially stored in the refrigerator on 04-Apr-2022 and administrated on 18-Apr-2022; Expired vaccine administered to 155 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 04-Apr-2022 and administrated on 18-Apr-2022) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 18-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 04-Apr-2022 and administrated on 18-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 04-Apr-2022 and administrated on 18-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was initially stored in the refrigerator on 04-Apr-2022. The vial did not undergo any temperature excursions. It was reported that pharmacist thought that the vaccine was expired in Jun-2022, however it was expired on 01-Apr-2022.  No treatment information was reported.
Patient reports "passing out" in his bathroom after getting home from a gym workout.  He reports shortly loosing consciousness.  Patient recovered almost immediately other than being scared.
One week after receiving her first Moderna dose, pt noticed that she had a 4cm welt on her left arm. This went away after 48 hours.
This spontaneous report as received from a Licensed Practical Nurse who refers to a female patient of unknown age. The nurse reported that the patient of an unknown date reported as 9 months approximately was vaccinated with a first dose of GARDASIL (dose, route and lot# not reported). The second dose of GARDASIL (dose, route and lot# not reported) patient received on 05-SEP-2013. No adverse symptoms reported. The outcome and action taken were not reported. Additional information has been requested.
Pt recv'd Covid19 vaccine on 8/6/21, on 8/8/21 pain in both feet started. Pain radiated from knee to feet and felt like pins and needles. He also complained of pain when exhaled.
Warm to the touch, slightly raised and approximately 25mm redness. Continued to get worse. Pt brought back to HD where swelling and redness of Left arm was 75 X 80 mm, and itchy. Recommended Benadryl and cold compress per FNP. Advised to return if worsens.