chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients medical histories and concurrent conditions were not reported. On an unknown date, the patients received either VAQTA (Lot# L023232; expiration date 25-FEB-2017) or RECOMBIVAX HB (Lot# L033343; expiration date 13-SEP-2017) or ROTATEQ oral (Lot# L023870; expiration date 26-APR-2017) that were improperly stored on an temperature of 1.1C degrees for an hour and 5 minutes. No adverse effects reported. Additional information has been requested.
Rash on arms, abdomen, top of feet; very itchy; took Benadryl, then Doctor suggested Cetirizine, so am taking them. Would like to not take any more, but the longest I can go without is one day.
Within 30 minutes, emesis, flushed, itchy. Benadryl and Epinephrine administered.
c/o loss of consciousness, itching, nausea & vomiting which did not improve. Pt given Epi im x1 then transported to ED.
This spontaneous report as received from a registered nurse refers to a 42 year old female patient. On 18-NOV-2014, the 42 years female patient was vaccinated with a dose of GARDASIL, 0.5 ml, intramuscular (lot number not provided). No adverse effects reported. Additional information is not expected.
PAIN AND BODY ACHES; ABDOMINAL DISCOMFORT; LITTLE SORE ARM; FATIGUE; NAUSEA; This spontaneous report received from a consumer concerned a 62 year old male. 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: 1805029 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced pain and body aches. On 13-MAR-2021, the subject experienced abdominal discomfort. On 13-MAR-2021, the subject experienced little sore arm. On 13-MAR-2021, the subject experienced fatigue. On 13-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little sore arm on 15-MAR-2021, was recovering from pain and body aches, abdominal discomfort, and nausea, and had not recovered from fatigue. This report was non-serious.
Fever - which has passed pain swelling rash - not localized, spreading on left side spreading to neck and face on left side.
On 6/7/00, the pt experienced severe pain to left arm, extremely tight muscles on left shoulder. On 6/7 and 6/8, the pt's MD prescribed pain killers and muscle relaxers, with no response. On 6/9/00 a different meds were prescribed, this time some minor relief occurred. On 6/10/00, the pt's left thumb began feeling numb. On 6/12/00, the pt made an appt with a military facility.
Information has been received from a physician concerning a 32-year-old female who about 10 years ago, in approximately 1996, was vaccinated with a dose of Varivax. Subsequently, the patient recently underwent a titer that did not show seroconversion. Unspecified medical attention was sought. No outcome was reported. No product quality complaint was involved. Additional information has been requested.
Vaccine administered after after 4 temperature excursions; Vaccine administered after after 4 temperature excursions; No aderse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No aderse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions).    No concomitant medications were reported.   It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that vaccine was moved from freezer to refrigerator on 12/2/22 of the ten vials in question 43 injections were given and 7 doses were wasted. Vaccine administered after after 4 temperature excursions.  No treatment medication was provided.  This case contains information for the 12th of 43 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-689222 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-Dec-2022: Upon internal review on 20-Jan-2023, significant correction was performed to update the worldwide unique case identification number.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689222:
Patient received Pfizer vaccine and developed small red rash on left face, chest. Given Benadryl by medics began to feel dizzy and woozy transported to ED, given Decadron and Pepcid. Discharged in stable condition.
The first dose was very minimal symptoms, just arm injection site pain.  The second dose on February 24th, 2021 I experienced fever, chills, body aches and eye pain for approximately 24 hours.  I never felt like myself after this dose until May.  In April I went into the doctor due to Braycardia and had a  calcium Ct scan which concluded myocarditis
Tiredness. Rash - 2 days, so far diarrhea, headache.
Pt reported that subsequent to receiving vax, she developed Bell's Palsy. No further information was available at the date of this report.
Very tired. Slight headache. Some chills but do not know if I have a fever.
Mother was explain that moderna vaccine was not indicated for patients age group. She understands the CDC guideliness and agrees to proceed with second covid vaccine.  No adverse reaction reported
Debilitating migraine three days, Fever 101 two days. Caught Covid July 7, 2022 with mild symptoms, but lingering and worsening bronchitis-wheezing, semi productive cough, but mucous getting thicker with each day.
Headache; Nausea; Tired; Swollen lymph node in armpit; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0185) via an unspecified route of administration in the left arm on 29Jul2021 at 10:00 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. The medical history included bipolar 1, obsessive-compulsive disorder (OCD), sever depression and anxiety. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included beclometasone dipropionate (QVAR), valproate semisodium (DEPAKOTE), montelukast sodium (SINGULAIR), ropinirole hydrochloride (REQUIP), cariprazine hydrochloride (VRAYLAR) and albendazole (ALB), all from unknown dates and  for unspecified indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0164) via an unspecified route of administration in the left arm on 08Jul2021 at 10:15 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. On 31Jul2021 at 16:00, the patient experienced headache, nausea, tired and swollen lymph node in armpit. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, nausea, tired and swollen lymph node in armpit were not recovered at the time of this report.
2/25:  - 20 minutes after shot: slight discomfort in the throat and slight swelling of the tongue  - 5 p.m.: feeling dizzy and tired, headache  - 9 p.m.: fever, chills/sweats, really bad headache, flu-like symptoms begin  2/26:  - All day: flu-like symptoms, fever (~101dF), chills/sweats, body aches (shoulders, knees)  2/27:  - 9 a.m.: headache and lethargy (took DayQuil to help deal with flu-like symptoms, was able to go on a 30-min walk around the neighborhood at 5 p.m.)  - 5 p.m.: noticed some swelling of the lymph node in the left armpit and some redness of the left arm  2/28:  - 10 a.m.: noticed that left side of the neck is also swollen  3/1:  - 11 a.m.: swelling in the left side of the neck has gone down 80%  3/2:  - 10 a.m.: still noticing some swelling and redness of the arm and some swelling of the lymph node in the left armpit, swelling in the neck has gone done completely  3/4: 10 a.m.: all swelling and redness are gone
Pt/cg report onset of severe weakness, fall, ringing and change in hearing, confusion began one day after this shot, on 5/6/21. They made an office visit 5/19/21 complaining these were persisting, and now also c/o significantly reduced appetite. She was hospitalized 6/8/21 with Covid pneumonia. Pt experienced persistent symptoms and by 8/17/21, the patient remained less active/more weak, still c/o hearing changes and reduced mentation, and has lost 30lbs since her March office visit before the shots. Her weight went from 165 to 135lbs and in August was mostly chair/wheelchair bound.
Friday I started out with a scratchy dry throat, a little bit of dry cough. The following day I spiked a fever in 102 range. I had alot of nasal and sinus congestion and the worst headache I have ever had. On Sunday I spiked a fever of 104.4 and took Tylenol for fever. The Tylenol helped bring it down. Monday I still had the symptoms and I tested positive for Covid-19. On Tuesday I still had fever, chills, headache, sinus congestion, and my lungs felt clear. I isolated. My fever broke on the 9th day and I began improving. I used Sinumed to flush out my symptoms.
9/15 phone appt w/ PCP: " left arm- phizer, covid vaccine 2 weeks ago. 24 hours later, left arm pain and not able to use as well since. Starts at neck, getting worse. Is able to move arm.         Feels like heart skips a beat sometimes, with pain and SOB since then. Declines ER. Feels like a "guinea pig".         Vaccine required by pool hall, "if there's a fight, there's a fight. If there's blood, there's blood". Refusing getting vaccine #2.         Think he had delta variant for 3 weeks already 8/2021, declined testing at the time. " 9/16 Office visit FNP- "63 y.o. male c/o pain, n/v, and all covid symptoms, pt stated that he got the Covid Vaccine on 9/3/21 and has been experiencing severe L arm pain, loss of feeling in both hands, vomited for several hours on 9/11.        Pt states he received a dose of COVID vaccine and 3 weeks later received a 2nd dose. Pt states he became very ill after second dose. Voices no other concerns."...Received Toradol 30mg 0.5ml IM inj. Was prescribed  Albuterol Sulfate HFA Aerosol Solution, 108 (90 Base) MCG/ACT, 2 puff as needed, Inhalation, every 4-6 hrs as needed, 30 days, 1, Refills 3 Start Flovent HFA Aerosol, 110 MCG/ACT, 1 puff, Inhalation, Twice a day, 30 days, 1, Refills 2 Start predniSONE Tablet, 20 MG, 1 tablet, Orally, Once a day, 5 days, 5 Tablet.
This spontaneous report was received from a licensed practical nurse concerning a patient of unknown age and gender. On an unknown date in November 2011, the patient was vaccinated with the first dose of GARDASIL (lot number, expiry date, dose and route unspecified) and on 12-MAR-2013, the patient was in the office for the second dose of GARDASIL (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. The patient was not experiencing any known symptoms at the time of reporting. Additional information has been requested.
I20.9 ANGINA, UNSPECIFIED 3/22/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA
Felt lethargic with a headache coming on, stood up to go to kitchen to take Tylenol, started to feel dizziness as I took the Tylenol and getting flush feeling. Was able to take the Tylenol and intended to go back to sit/lay down and apparently passed out. Woke up on kitchen floor. Don't know how long passed out likely a couple of minutes. Came to and realized I was on the floor. Sat up and was sweating so took off sweatshirt. For about 5-10 minutes body was shaking, mostly in hands and arms like an electric shock type feeling, then started to feel a little better. Took my temperature and had a mild fever of 100.2. Ended up with sore ribs and hip apparently from the fall. Glad I didn't hit my head. Felt better the next day.
This spontaneous case, initially received from other health professional (nurse) on 04-Dec-2017, concerning a 64-year-old adult female patient. The patient had no medical history and she did not receive any concomitant medications. On 01-Dec-2017, the patient was administered with AFLURIA (TIV) (dose: 0.5 ml, route of administration; intramuscular, anatomical location: deltoid, batch number: XT30006 and expiry date: 07-Jun-2018) which underwent temperature excursion of maximum 55-degree Fahrenheit for 3.5 hours (explicitly coded as incorrect product storage and drug administration error). It was reported that, no adverse event was noted. The reporter assessed the events as non-serious. Non-significant follow up received on 03-Jan-2018: The reporter confirmed the age (64-year-old) of the patient and batch number (XT30006) of the vaccine.
she is still feeling very tired 4 days later; chills; headache; diarrhea; Initial information received on 11-Sep-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case involves a 85 years old female patient who experienced chills, headache, diarrhea and she is still feeling very tired 4 days later after receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included RSV Vaccine for Prophylactic vaccination (immunization) ; and dupilumab (Dupixent) for Dermatitis atopic.  On 07-Sep-2023, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer formulation, strength, dose, expiry date, lot number not reported via unknown route in unknown administration site for Prophylactic vaccination (immunization).Information on the batch number was requested.  On 07-SEP-2023 the patient developed chills, headache, diarrhea (diarrhoea) ln the same day following the administration of Influenza Vaccine. On an unknown date she is still feeling very tired 4 days later (fatigue) (unknown latency) following the administration of Influenza Vaccine.  Reportedly, The patient reported that she received vaccinations for both flu and RSV on 9/7/2023 and then later that night she had chills, headache, and diarrhea. The patient stated that these symptoms lasted for the next few days, but she is still feeling very tired 4 days later Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events chills, headache, diarrhea, she is still feeling very tired 4 days later.  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event chills, headache, diarrhea and was Not Recovered / Not Resolved for the event she is still feeling very tired 4 days later.
Swelling of face where a dermal filler was/is present (dermal filler injected under the eyes about 15 years ago). The swelling started on 02/06/2021 under the right eye and then, on 02/07/2021, under the left eye as well.
Discharge instructions per Dr. to have pt receive influenza vaccine today. RN spoke with mother, reviewed and completed and Influenza Vaccination Nursing Note prior to administration of Influenza Vaccine. 1555- influenza vaccine administered to left arm. 1605- mother noted prior to leaving clinic that pt's neck and facial cheeks appeared red and flushed. HR-100 RR-20 B/P 92/62. Pt given cool water to drink and crackers to ingest. 1612- redness to neck and facial cheeks subsiding, pt quiet, when asked states she feels dizzy- pt assisted to laying down on cot. 1620-Dr. informed. VS laying down HR-82 RR-20 B/P-110/64, then VS sitting up HR-88 RR-20 B/P-118/78. Lung sounds clear bilaterally per auscultation. Dr. in to assess pt. Pt states she continues to feel light headed. When asked, pt stated she would prefer to sit in chair (with armrests). Cool cloths to head and back of neck. Pt had few intermittent barky coughs. 1630- pt neck and facial cheeks red and flushed, states she continue to feel sick. 1650-frequency of cough increases, Dr. informed and in to assess pt. 1700- HR- 84 RR-20  B/P-124/84 O2 SAT=99%, Dr. in to assess pt. 911 Emergency Services Called. 1703- BENADRYL 50 mg oral medication given by RN - per Dr. 1705- Albuterol 2.5mg/3ml  nebulizer medication initiated by RN-per Dr. 1708-Epinephrine 0.3mg IM medication given to left thigh by RN per Dr. Pt coughing and had emesis of mucous X1. 1712- 911 Emergency Services arrived to take pt to Hospital Emergency Dept.
Initial report received from a healthcare professional on 22 October 2012. A 9-year-10-month-old male patient, who had no known allergies or illness at the time of vaccination and whose concomitant medications were not report, had received an intradermal dose 1 of FLUZONE ID (lot number: UT4470AA) in the left arm on 18 October 2012. It was reported that FLUZONE ID was given to a patient of 9 year 10 months of age, thus vaccine was administered at an inappropriate age. On 19 October 2012, 1 day after the vaccination, the patient developed swelling. Corrective treatment and laboratory investigations were not reported. At the time of this report, the swelling was decreasing and the patient had not recovered. List of documents held by sender: none.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. A 66-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "immunocompromised" (unspecified if ongoing). The patient's 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". Addition information: Caller would like to know if there's a second booster shot of the Pfizer-BioNTech Covid 19 Vaccine for group of 50 years old of age and older. Her husband is 66 years old and she was 64 years old and they received the first booster shot on 31Mar of this year and they did not notice that they had Covid when they received this shot. She also mentioned that both of them are immunocompromised and that they only received 2 doses of the primary series. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200765817 Same reporter/vaccine/event, different patient
Erythema Multiform -like rash with high fever, severe itching and malaise. Symptoms present after 48-72hrs of vaccines. Only treated with oral Tylenol and Benadryl and Hydrocortisone cream.
Rt arm swelling/tenderness in (R) arm & shoulder & warmth at site. Pt given ice packs & Ibuprofen. No LOC/change in behavior, pt is afebrile.
The pharmacist, injected it in my left arm. I could still move despite the painful arm. I got up after sleeping and it was 7pm. I had a little bit of fatigue and muscle joint pain but nothing like the first dose. In the car at 11pm, I could tell that my body felt achy and I got chills. After we got home which was around midnight I was having severe muscle and joint pain and the fever ran 101. I felt like this was a serious reaction but it is possible that my body hurt due to the fever. I took ibuprofen and got a cold rag to then went to bed and slept 13 hours consecutively. On the 25th, I was so itchy on my whole body everywhere and then I started noticing a rash all over my body like hives. My hand had a few red spots. Everything was itchy. This happened all day on Friday. My fever fluctuated to 99. Saturday, I woke up with a hive on my back and my mom suggested Benadryl cause I was super uncomfortable. The itching and fever made me feel uncomfortable. By Sunday morning, I had a very severe allergic reaction which I went to urgent care at 7am on Saturday. They gave me steroids ( Prednisone 10mg 2xday for 5 days) and take Benadryl around the clock. They seemed to help with the rash and I could tell I was getting itchy again when I would take a break. I have experienced abdominal pain for both doses. I woke up Thursday morning with severe cramps.
This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 14-JAN-2015 the patient was vaccinated with M-M-R II (route, dose, frequency and lot # not reported) which had undergone an temperature excursion. This is one of several reports from the same source. Additional information has been requested.
Patient diagnosed with Bells Palsy, mild case. Symptoms include numbness and pain on the left side of the patients face along the facial nerve. Patient also experienced left sided drooping of her cheek, lips and eye.
Patient reports an exacerbation of peripheral neuropathy after receiving first covid vaccination.   Patient has had in but reports this is worse that before   There has been no further medication intervention for this event
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Weakness-Mild, Additional Details: PATIENT FAINTED, FELL TO THE GROUND. CALLED 911. PT IS RESPONSIVE.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 22-JUN-2017 the patient was vaccinated with PNEUMOVAX 23 for prophylaxis. On JUN-2017 the patient experienced pyrexia and pain in extremity. The outcome of pain in extremity and pyrexia is unknown. The causality assessment was not provided. Additional information has been requested.
Pt was vaxed w/3rd dose of Hep B (Recomb) ID instead of IM; subsequently, pt devel a local rxn; no further details were provided;