chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Six days post vaccination pt reported high fevers (peak 102.6) and red diffuse body rash. Reports fever persisted 5 days and was controlled by analgesia. Saw PCP and had blood work which per patient was normal. Pt continues to have rash, and general malaise, but no fevers. Says he has f/u with Infectious Disease Monday 8/3/15.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), on 15Oct2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 31 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jun2022) Positive, notes: Two at-home positive tests on 05Jun22; (05Jun2022) Positive, notes: Two at-home positive tests on 05Jun22; (unspecified date) Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Finished Paxlovid on 29May2022, started experiencing symptoms again on 03Jun2022. Two at-home positive tests on 05Jun2022.
Presented with CP and SOB.  Fully vaccinated and covid positive.  Treated with O2, steroids, vit c and zinc.
Severe flu like symptoms; Body aches; Migraines; severe fatigue; Feeling like my limbs are really heavy; Excessive sleeping; This is a spontaneous report from a contactable other HCP (nurse). A 41-years-old (reported as 40 years) patient of an unspecified gender received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number-UNKNOWN) via an unspecified route of administration on an unspecified date as dose 2, single (at the age of 40 years-old) for COVID-19 immunization. Patient medical history included asthma. The patient had taken concomitant medication in two weeks. The patient has known allergies. The patient experienced severe flu like symptoms, body aches, migraines, severe fatigue, feeling like my limbs are really heavy, excessive sleeping on 27Jan2021 04:00. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in Left arm on 06Jan2021 as dose 1, single (at the age of 40 years-old) for COVID-19 immunization. Patient did not receive any other vaccine in four weeks and patient received other medication in two weeks. Patient did not have COVID-19, prior to vaccination and was not tested for COVID-19, post vaccination. The patient visited Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 16Feb2021. The outcome of the events not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. Patients' pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On unknown dates in 2016 (reported as started on or after 06-JUL-2016), patients were vaccinated with improperly stored doses of VAQTA (lot # L015460 and expiration date 20-JUL-20107, lot # M017982 and expiration date 13-SEP-2017, dose and route of administration were not reported). The temperature of excursion was 31F and the time frame was 2 hours. There was no previous temperature excursion and the call was not due to a data logger. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Low fever on Friday 11/5, fever of 101 - 102 on Saturday 11/6, vomiting on Saturday 11/6 at 6:30 pm. Gave him Tylenol for fever and Zofran for vomiting.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. Information about concurrent conditions, concomitant mediation and medical history was not provided. On 06-OCT-2014 the patient was vaccinated with 0.5 ml single dose of PNEUMOVAX 23 (injection, lot # J014399, expiration date 20-NOV-2014) intramuscular for prevention of pneumonia. On 06-OCT-2014 the patient was vaccinated with 0.5ml single dose of PNEUMVOVAX 23 (injection, lot # J014399, expiration date 20-NOV-2014) intramuscularly for prevention of pneumonia. On 06-OCT-2014, the patient experienced swelling, redness and pain after receiving PNEUMOVAX 23. The patient sought medical attention by office visit on an unspecified date. Treatment included antibiotics (unspecified name, dose/frequency and manufacturer) was given for the adverse event. The pharmacist declined to request a LOT check. The outcome of the events was not provided. Additional information has been requested.
A physician reported that a 15 month old male received Prevnar, Hib-Titer and MMR (Merck) vaccines on 7/6/00. On 7/12/00, he developed an urticarial rash and joint swelling with decreased limb movement. He recovered. This is 1 of 2 pts from this facility who developed urticaria following receipt of Prevnar.
Early September weakness in left lowering extremities, motor skill also; fever reached 105; went to ER; 3 trips in 5 days; full body rash; DID work up for MIS-C; few elevated markers inconclusive; begin to resolve by it self; 10/28/2022  evaluated by physical therapy determined left hip had significant loss of range of motion referred to rheumatology 11/02/2022. 11/24/2022 high fever everyday until 12/27/2022. Admitted to hospital 12/27/2022.
MYALGIA, CHILLS, HEADACHES, MIGRAINE HEADACHE, SEVERE NAUSEA, VOMITING, (NO FEVER) FOR 10 DAYS  VISION DIFFICULTY WITH MIGRAINE HEADACHE
weakness; dizziness; nausea; fatigue; headache; chills; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ASTHENIA (weakness), DIZZINESS (dizziness), NAUSEA (nausea), FATIGUE (fatigue) and HEADACHE (headache) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced ASTHENIA (weakness), DIZZINESS (dizziness), NAUSEA (nausea), FATIGUE (fatigue), HEADACHE (headache) and CHILLS (chills). On 08-Mar-2021, ASTHENIA (weakness), DIZZINESS (dizziness), NAUSEA (nausea), FATIGUE (fatigue), HEADACHE (headache) and CHILLS (chills) 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.   No treatment information was provided.
Information has been received from a certified medical assistant (C.M.A) referring to a 4-year-old child with unknown gender. There was no pertinent medical history or drug allergies/drug reactions reported. The reporter stated that on 07-OCT-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) (lot # K007797 with expiration date 29-NOV-2015, dose and route were not provided). There was no concomitant medication reported. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
ITP, platelet count 1 on 3/5/21 (has petechia, purpura in mouth, and right sided nose bleed).  Admitted for steroid therapy.
13 min after receiving vaccine patient vomitted and complained of abdominal discomfort.  10 minutes after symptoms resolved
Six vaccines were administered today - the last of which was the GARDASIL. After administration of the GARDASIL the pt. passed out. Pt was observed in clinic for about one hour. Promethazine 12.5 mg was administered.
STIFFNESS OF JOINTS; STIFFNESS OF NECK DOWN; WORST HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. No adverse events reported post primary vaccination (Dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported 1 in total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced some bad reaction from the booster shot. Patient got the worst headache, stiffness of joints and stiffness of neck down (reported as single term: stiffness of joints and neck down, captured as two separate events) (Dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the worst headache, stiffness of joints and stiffness of neck down was not reported. This report was non-serious.
12/3/2021- Resident Passed away on Hospice services with comfort measures in place.
Right deltoid 3 inch redness, tenderness, swelling itching at injection site, warm compress Claritin 10 mg daily Recheck 9/15/06.
Sore arm, fatigue, inflammation on bottom of all toes causing serious redness (almost purple) and serious pain in right small toe. Painful to the touch.
Patient started to feel unwell the day after he received the shot. he experienced muscle weakness, lower back pain, shoulder and  spine hurts on bending to pick up stuff. has pain in hands when he tries to make a fist. has knee pain and has difficulty walking. reported on Sunday the 27th of October.
convulsions; This serious case was reported by a consumer via interactive digital media and described the occurrence of convulsion in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (The patient had shingles before).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced convulsion (Verbatim: convulsions) (serious criteria hospitalization and GSK medically significant). The outcome of the convulsion was not reported.   It was unknown if the reporter considered the convulsion to be related to Shingles vaccine.     It was unknown if the company considered the convulsion to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 20-JUN-2023. This case was reported by a patient via interactive digital media. After the second shot patient went into convulsions.  The patient went by ambulance to the hospital spent 2 weeks in the hospital 1 week in rehab and another 2 weeks with a home nurse.  The patient stated he/she had shingles before far less than what patient went through with the vaccine. The follow-up could not be possible as no contact details were available.
Info has been received from a consumer concerning her daughter, a 13 month old female with no known medical history or allergies who on 11/1/04 was vaccinated with a 0.5ml dose of varicella virus vaccine live. There was no concomitant medication. Two weeks after vaccination, on approximately 11/15/04, the pt developed a mild case of chickenpox. In early 12/04, the pt recovered. Unspecified medical attention was sought. No lab or diagnostic tests were performed. There was no product quality complaint involved. Additional info has been requested.
On 7OCT91, 7 days p/receiving immun  pt c/o vomiting & stomach ache in school sent home then taken to ER; ?fever; dx immun reaction;
fever; my arm felt like tetanus arm pain/It hurt just to touch it; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (fever) and VACCINATION SITE PAIN (my arm felt like tetanus arm pain/It hurt just to touch it) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2021, the patient experienced PYREXIA (fever) and VACCINATION SITE PAIN (my arm felt like tetanus arm pain/It hurt just to touch it). At the time of the report, PYREXIA (fever) and VACCINATION SITE PAIN (my arm felt like tetanus arm pain/It hurt just to touch it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information were reported by the reporter   This case was linked to MOD-2021-423233, MOD-2021-423238, MOD-2021-423238, MOD-2021-423238 (Patient Link).
Strong fatigue for 2 days. Strong joint aches for 2 days. Strong body aches for 2 days. Slightly enlarged supraclavicular lymph node on left side above collarbone. Still present. About the size of a pea. Mobile and painless.
Several hours after my H1N1 shot was given, I began to feel a tingling sensation trickle up and down my left arm, especially in my left hand. My left deltoid was the route of administration. Four hours have passed since I first started experiencing the tingling sensation and it still is occurring.
Information has been received from a physician concerning a 16 year old female patient who was vaccinated in left arm with a second dose of Gardasil lot #657006/0188U. Concomitant therapy included Yasmin. On 06-APR-2007 about one hour later receiving the second injection she developed "red blotches" on her left arm (injection site arm) and chest. Unspecified medical attention was sought by the patient. The reaction resolved spontaneously about 4 hours later. Additional information has been requested. This is in follow-up to report(s) previously submitted on 05/14/07. Initial and follow up information has been received from a physician and a health care professional concerning a 16 year old female student who on 05-APR-2007, PM was vaccinated IM in the left arm deltoid with a second dose of GARDASIL lot #657006/0188U. Concomitant therapy included YASMIN. On 06-APR-2007 about one hour later receiving the second injection she developed "red blotches" on her left arm (injection site arm) and chest. Unspecified medical attention was sought by the patient. The outcome was recovered. Follow up information indicated that within an hour of getting the second injection patient had erythematous macular rash on chest which progressed to abdomen and left arm (where injection was given) over next three hours. The reaction resolved spontaneously about 4 hours later. No association of chest pain or shortness of breath. Additional information is not expected.
One week after administration, developed area locally at injection site of redness, induration, itching and mild swelling. Also felt itching over rest of body but never developed rash. Lasted about 48 hours then disappeared.
urticarial rash  after  administration of vaccination; subsided on administration of benadryl in about 10 hours.
This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. This pharmacist reported similar event for 3 patients. This is 3rd of 3 reports. A female patient of an unspecified age received PREVNAR 13, (lot number and expiration date: Unknown), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The pharmacist reported that the patients complain of fever, severe lethargy, redness and soreness that lasts anywhere from 2 days to 7 days on an unspecified date. The outcome of the events was unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2018480203 same reporter/drug/event, different patient; US-PFIZER INC-2018480405 same reporter/drug/event, different patient.
About 1 month after her second dose of Moderna Covid vaccine she started noticing some shortness of breath with activity. She thought it was related to her subglottic stenosis that she gets dilated often.   A month after her symptoms started she was seen in clinic by ENT for the stenosis and was noted to have significant leg swelling and sent to ED where she was admitted for heart failure & significant PVC burden on telemetry (about 30%). She was diuresed & discharged with the plan to do a Holter monitor and decided if she was a candidate for ablation for PVCs.
Moderate to severe low back pain starting a few hours after vaccine was administered and continuing for one week. She is also having fatigue and tender axillary lymph nodes. She has missed school + has had no relief with ibuprofen.
Patient had been monitoring injection site after administration of Zostavax and had redness, swelling, and tenderness.  Four days after vaccination she noticed a vesicle, pock-like lesion about 1.5 inches below the injection site.  She came into the pharmacy to show us and it appears that it may be a localized shingles/chickenpox-like lesion or rash, which the potential for was discussed with the patient before vaccination.  I advised her to cover the area as a precaution.  She was interested in having the adverse event reported for the purpose of data collection.
No adverse effect; inadvertently received one dose of MMR II via the intramuscular route; This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. Concomitant therapy included sterile diluent. No information was provided regarding the patient's medical history and concurrent conditions.  On 19-APR-2019, the pharmacist reported that one patient received inadvertently one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), via the intramuscular route (incorrect route of product administration), lot # R019391 (expiration date: 05-JUL-2020), for prophylaxis (strength and frequency were not reported). No adverse effect was reported.
Within 5 minutes of the shot, I experienced abdominal discomfort and felt nauseous and then felt a warmth over my entire body. I also developed a very rapid heartbeat and palpitations. The pharmacist was notified of my condition. I waited 25 minutes before leaving. Over the next hour, I developed a headache and at about 5 PM another rapid heartbeat occurred. I took my BP. It was 171/94. 15 minutes later, my BP was 169/87. My normal BP is 120/72 and I do not have heart disease. I then decided to seek medical care at the ER.
This spontaneous report as received from a registered medical assistant refers to unknown number of patients of unknown age and gender. On an unknown date, the unknown number of patients were vaccinated with Meningococcal Protein Conjugate (manufacturer unknown). On an unknown date the patient may had received improperly stored Meningococcal Protein Conjugate (manufacturer unknown). No adverse effects reported. This is one of several reports from the same source. Additional information is not expected.
No patient adverse event. Notified patient that the vaccine used was drawn up for more thatn 12 hours.
The patient presented to this clinic with complaint of redness and tenderness at the site of a recent Tetanus vaccination on her right arm which she stated was given at Hospital last weekend. There is an area approximately 2 inches in diameter of firmness, erythema and warmth to touch. She stated she has had tetanus vaccine in the past with out any reaction. Dr. assessed the area and feels that this is a local reaction. The patient was told to apply a cool compress several times a day and she may use OTC Ibuprofen 2 tablets every 6 hours as needed for discomfort. The area will be marked and if the area of erythema is increasing the patient needs to come back in for further evaluation. The patient voiced understanding.
Pt complained of coughing, hives on arms, and swelling around the lower extremities around 15mins post vaccination. She was given Benadryl and water. Pt left at about an hour stating she felt better and the hives were diminishing. Coughing had stopped.
Right arm edema, hot to touch, pain + cough (mother is not sure if cough is related to injection) present X 3 days; pt's pcp ordered Benadryl and ibuprofen use prn; no further sx post 3 days
Got what looks like hives on legs after 11yr shot. Not itchy. Got 25 mg Benadryl & rash on legs went away. Was on both legs, both thighs and knee. No where else. Started to fade after Benadryl. No SOB or swelling
Injection site soreness; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the arm right on 19Feb2021 at 14:30 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included raised blood pressure and facial pain. The patient did not had allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included tramadol (MANUFACTURER UNKNOWN), irbesartan (MANUFACTURER UNKNOWN) and acetylsalicylic acid (ASPIRIN); all from an unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Feb2021 at 17:00, the patient experienced injection site soreness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event injection site soreness was recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.    Co-suspect product included non-company product PARACETAMOL (TYLENOL) for an unknown indication.    No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started PARACETAMOL (TYLENOL) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 25-Jan-2021, PAIN IN EXTREMITY (sore arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-068495 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068495:Second dose
Hospitalization for UTI on dates 8/15/2022- 8/20/2022.  Treated with no medications for COVID-19.