chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feeling a little down; Caught a cold; Scratchy throat; Coughing; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED MOOD (Feeling a little down), NASOPHARYNGITIS (Caught a cold), THROAT IRRITATION (Scratchy throat) and COUGH (Coughing) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEPRESSED MOOD (Feeling a little down), NASOPHARYNGITIS (Caught a cold), THROAT IRRITATION (Scratchy throat) and COUGH (Coughing). At the time of the report, DEPRESSED MOOD (Feeling a little down), NASOPHARYNGITIS (Caught a cold), THROAT IRRITATION (Scratchy throat) and COUGH (Coughing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient said that she took the second dose of Moderna vaccine and that she did not had any adverse reactions. The patient said that she was feeling fine.  No concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: No specific follow-up information recorded.
Vaccine given and within 5 minutes patient began to get very itchy, scratching at arm, neck and scalp.  No shortness breath.
4/12/19 AT 1700hrs, felt fatigued 4/13/19 @ 0700hrs began severe left arm pain and continued fatigue, by 1000hrs pt experienced redness, swelling, of left shoulder joint, unable to move left arm d/t pain, erythema and severe fatigue, fever of 101.6F. Fever broke 4/13/19 evening w/ Tylenol throughout the day. Sunday, 4/14/19 pt experienced progressing redness, swelling into upper left arm. Progression continued 4/15/19 and pt went to ER at 2330hrs. Per pt, diagnosed w/ left arm cellulitis by ER, started on Clindamycin 300mg four times a day, lactobacillus reuteri capsules.
no additional adverse events reported; dose of MMR II via intramuscular route instead of subcutaneous route.; This spontaneous report was received from a medical assistant referring to a 48 year old male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 01-MAR-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) 0.5 milliliter, intramuscular instead of subcutaneous route for prophylaxis (lot# reported as S035111 established as invalid lot #, expiration date on 03-MAY-2021). No further information was provided. No additional adverse events were reported. No product quality complaint.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 72 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 28Sep2021 10:30 (Lot number: FE3592) at the age of 72 years as dose 3 (booster), single for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1st, lot number: EN5318, Anatomical Location : Right Arm), administration date: 04Feb2021, when the patient was 71 years old, for COVID-19 immunization; Bnt162b2 (Dose: 2nd, lot number:  EN6201 , Anatomical Location : Right Arm), administration date: 25Feb2021, when the patient was 72 years old, for COVID-19 immunization. The following information was reported: HYPERSENSITIVITY (non-serious) with onset 28Sep2021 07:00, outcome "not recovered", described as "minor allergic reaction"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset 28Sep2021 07:00, outcome "not recovered" and all described as "she has heat around the site and it is pink and swollen and itchy". Therapeutic measures were not taken as a result of hypersensitivity, vaccination site erythema, vaccination site swelling, vaccination site pruritus, vaccination site warmth. Additional information: Patient stated that she thought it was just a minor allergic reaction, but patient wanted to know if she should just take an antihistamine, or what she should do. Patient stated that it was not huge, but it had been almost 2 days now and it doesn't look like hives, and it is not spreading, and she had no headache. Patient considered it as a minor allergic reaction. Much later in the day, arm hurt a little, but it was later in the evening at 7:00 p.m. It was reported that patient had not visited to the emergency room or the physician office because of any AE. There were no prior vaccinations (within 4 weeks) and no adverse events following prior vaccinations. Patient denied for any family medical history relevant to ae and for any relevant tests. Follow-up attempts are completed. No further information is expected.
Pt was admitted to the hospital on 3/31/21 and diagnosed with stroke.  Pt states that doctors told him it looked like the stroke may have occurred about one week prior to hospital admission.  Pt started experiencing daily headaches after receiving the vaccine, then a couple of days later started experiencing chest tightness, panicky feelings, feeling like he was going to pass out, and some tingling sensation in his hands.  Pt states that although he has been released from the hospital, he is still feeling like he is going to pass out multiple times a day and still experiencing tingling in his hands.  Pt states that he is still having minor headaches.
injection site redness; injection site soreness/injection site tenderness; Injection site itching; swelled up a little bit; This is a spontaneous report from a contactable consumer (patient). This 83-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL9263), via an unspecified route of administration on 27Jan2021 10:35 at single dose in the left arm for COVID-19 immunization. The patient's medical history included diabetes, thin blood, heart, kidneys, allergic to shellfish. Family history included heart and kidney problems. The patient's concomitant medications included metformin (GLUCOPHAGE) for diabetes for 25 years, metoprolol succinate for heart for 3 years, furosemide for 3 years, acetylsalicylic acid (ASPIRIN) for thin blood for five years, fenofibrate for heart for 3 years, colecalciferol (VITAMIN D) for kidneys for 3 years, and multivitamin to keep her healthy for a long time, all ongoing. Vaccination Facility Type was drive through. History of all previous immunization with the Pfizer vaccine considered as suspect: none. Additional vaccines administered on same date of the Pfizer suspect: none. The patient experienced injection site itching on 27Jan2021, injection site redness on 28Jan2021 and injection site tenderness on 28Jan2021. Clinical course reported as follow: patient had the first dose of the Pfizer BioNTech COVID-19 vaccine on 27Jan2021. On the night (27Jan2021) she got the first dose, she experienced injection site itching. Yesterday (28Jan2021), she experienced injection site redness. Last night (28Jan2021) at 20:00, she took a diphenhydramine hydrochloride (BENADRYL) and the itching stopped but she was still experiencing injection site redness and soreness. Clarified she received the first dose in the left arm. Added it was tender to touch. Patient was scheduled for the second dose on 17Feb2021 at 10:10. Patient stated when she got first shot she had some reaction to it, it wasn't that bad, it was itchy and it swelled up a little bit (Jan2021) and got real red. The adverse events did not require a visit to physician or ER. No prior vaccinations within 4 weeks. No relevant test. Outcome of injection site itching was recovered on 28Jan2021, outcome of injection site redness was not recovered, outcome of injection site soreness/injection site tenderness was recovering, outcome of other event was unknown. The report was assessed as non-serious.
Post COVID Vaccine injection  1639 numbness left lips, tingling in throat and feels tight BP 148/86 - HR 75 1643 Epi 0.3 via pen Right thigh Feeling shaking Medical emergency called  1645 Benadryl IM right arm. Feeling flushed  ED clinical staff here and transferred in own electric wh/chair. Husband with patient Allergy to CT Contrast - completely swollen shut
TASTE OF EGGS IN THE BACK OF THROAT. ON 11/7 SEVERAL BOUTS OF DIARRHEA.
pt recvd vax for prophylaxis; 24 hrs later exp stiff neck & vertigo which resolved;24 hrs p/ dose 2,exp stiff neck,vertigo,blurred vision,ha,n,nosebleed & axillary pain; outcome all sxs resolved w/in 48 hrs;
Hives pm 7/8/08 arms, leg.  Seen in office 7/9/08 late AM - Dx urticaria no facial swelling; BENADRYL 3/4 tsp given at 12:45/pm.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 4:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 4:00 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 39.13 for dose administered on 11-JAN-2021. No concomitant and treatment medications were reported. Batch number 041L20A underwent temperature excursion on 11-JAN-2021 with temperature 35 degrees Fahrenheit from 02:00 PM. This vial was moved to fridge on 08-JAN-2021 and beyond use date for the vial was reported as 07-FEB-2021. Product moved to clinic on 11-JAN-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.   This case was linked to MOD-2022-566976.
She felt dizzy and very anxious. Observed for 30 minutes before leaving the site. No action taken.
My arm became very itchy around 2 pm on 3/29/2021 and was also sore around the injection site later in the evening. At around 9 am on 3/30/21, I noticed my arm was even itchier than yesterday, warm to the touch and still sore. I have not done anything for it as of yet, but I may take a Benadryl later as per what I read on the CDC site and try some cortisone and ice.
Gave patient .25ml of Moderna blue cap with magenta border of the pediatric Moderna vial instead of the .25ml adult booster from the Moderna Red cap vial. s/s patient stated "I felt slightly achy for about a day and felt a bit of malaise but not too bad".
No PQC or additional AEs reported; PROQUAD administered after temperature excursion; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 29-MAR-2021, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) 0.5 milliliters (route of administration was not reported), lot # (T028296) rHA and expiration date (16-FEB-2022) administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of -10.6 degree celsius (C°) for 3 hours on an unknown date; no previous temperature excursions were reported.  The call was made due to a digital data logger. No adverse symptoms were reported.
Information has been received from a physician concerning a patient (age and gender unknown), who was vaccinated with a dose of Gardasil. Subsequently, the patient fainted. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested.
This spontaneous report has been received from a medical assistant, concerning a 65-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 27-NOV-2018, the patient was inadvertently administered a dose of GARDASIL 9 lot # R008164 and expiration date 12-NOV-2020 (dose, frequency and route were not provided) for prophylaxis instead of PNEUMOVAX 23 (dose, frequency, route, lot number and expiration date were not provided). No adverse effects reported.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). Concomitant medication(s) included: VUMERITY, start date: 01Mar2021. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 Immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 24Oct2023 to 29Oct2023. Clinical course: Patient had no known allergies  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-202300356700 same patient, different drug /event;
Patient reports vesicular rash on chest, back and inner thighs. No other disease signs/symptoms present. Patient seen by primary care provider, who advised her to treat the rashes with topical hydrocortisone and/or oral diphenhydramine. Upon follow-up approximately 15 days post-vaccination patient reports rash has improved significantly.
frist dose of the COVID vaccicne and then tested positive; received his first dose of the COVID vaccine and then tested positive, although with no symptoms; This is a spontaneous report received from a non-contactable physician (reporting for himself), via Pfizer from another company. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and Expiration date was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Patient's Medical history and concomitant medications were not reported. It was reported that patient was prescribed ILUMYA. He did not start the medication yet. Patient received his first dose of the COVID vaccine and then tested positive, although with no symptoms (per patient "I tested positive but I was never sick"). Patient asked if there's any risks with starting the medication after taking the vaccine and being infected. The outcome of the events was unknown.   Information about lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2  vaccine in this patient cannot be completely excluded.
Information has been received from a licensed practical nurse (LPN) concerning a 4 year old male with no known drug allergies who on 05/31/2002 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot #639986/1213L), diphtheria toxoid/pertussis vaccine/teta and poliovirus vaccine, at different injection sites. On 06/01/2002 the pt was seen and treated in the local ER due to the swelling at the injection site of the diphtheria toxoid/pertussis vaccine/teta vaccination. The pt was treated with prednisone dose pack, with a 4 day taper. The outcome of the pt's injection site swelling was unknown. Additional info has been requested.
Pt recvd Td vax & on 26OCT92 returned to ER c/o soreness & swelling & drainage of pus @ the site of inject;sinus cavity measuring about 2x2x2 cm;
pt recv vax;sharp pain in lt arm; pain in certain arm positions as crossing to opposite shoulder and reaching behind back; to MD for baby visit;
Pt recvd 3 doses of Engerix-B 1NOV90, 30NOV91 & 12MAY91 & 4SEP91 it was determined that pts titer was neg p/3 doses of Engerix-B;
1st Dose very painful going into arm; Stabbing pain at injection site; sleepy; nauseous; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 26Feb2021 15:15 (Lot number: EN6200) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "I think I have a Latex sensitivity (use latex free)" (unspecified if ongoing), notes: Known Allergies: I think I have a Latex, sensitivity; "AVN" (unspecified if ongoing), notes: Other medical history: AVN. Concomitant medication(s) included: PHENOBARB [PHENOBARBITAL]; SIMVASTATIN; ASPRIN; PLAVIX; TOPAMAX.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "1st Dose very painful going into arm"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Stabbing pain at injection site"; SOMNOLENCE (non-serious) with onset 2021, outcome "recovered" (2021), described as "sleepy"; NAUSEA (non-serious) with onset 2021, outcome "recovered" (2021), described as "nauseous".  Additional Information: Other medications in two weeks: Phenobarb, simvastatin, aspirin, Plavix, Topamax and 6 more. Adverse event: 1st dose very painful going into arm. Stabbing pain at injection site, sleepy and nauseous (All) for 2 days. Patient had no COVID prior vaccination and not tested for COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a pharmacist, concerning a 69 years old patient of an unknown gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On 21-FEB-2017, the patient was vaccinated with an incorrect storage dose of ZOSTAVAX (dose, frequency and route were not reported), lot # M033909 with expiration date of 17-OCT-2017, for prophylaxis. No adverse effects were reported. The temperature excursion of the ZOSTAVAX was greater than -10 °C but less than 8 °C (>14 °F but <46 °F), for a time frame of 17 hours. No previous temperature incursion was reported. No product quality complaint was involved (PQC). Data logger was involved. Additional information has been requested.
itchiness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchiness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness). On 02-Apr-2021, VACCINATION SITE PRURITUS (itchiness) had resolved.            Concomitant product use was not provided by the reporter.  No treatment information was provided. Action taken with mRNA-1273 in response to the events was not Applicable    This case was linked to US-MODERNATX, INC.-MOD-2021-044453 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-044453:
1st-Systemic itching  last 12 hours , sore arm, and fatigue for 3 days 2nd -systemic itching 24 hours, fever  and  fatigue, body aches x4 days, bloody nose., sore arm *3rd - sore arm but none of previous  symtoms. (Wrong vaccine?)
Starting 01/25/2022, I developed a sore throat and a cough, I was afraid due to my kidney transplant. I decided to go get tested for safety. It came back positive the following day, and my cough was worse that day as well. The sore throat went away fairly quickly after testing positive. I did a visit with my doctor who put an order in for monoclonal antibodies. However, due to availability I had to wait until the 6th day to get it (01/31/2022). The cough continued for longer than usual due to being a transplant patient. It lingered for about 3 weeks after the treatment. My mouth broke out around this time due to the strain on my immune system and I was given nystatin solution from my doctor.
Per mother recieved call from school stating child was complaining of arm pain.  Mother noted redness and swelling at injection site of Rt. arm at 8:00 PM.  Gave Tylenol for pain.  Today advised by provider to continue with Tylenol or ibuprofen for pain and to apply cool compresses.
Fully vaccinated with Pfizer x3. Tested positive for Covid 01/28/2022. Admitted to Medical Center on 01/28/2022. Expired on 02/12/2022 while still hospitalized.
Patient presented to ED and subsequently hospitalized within 6 weeks of receiving COVID vaccination. First hospitalization occurred 2/26/2021 for an endoscopy, second hospitalization 3/25/21 for four days, and third hospitalization 3/29/21. Patient has been hospitalized since 3/29/21.
Fully vaccinated at 21 years old, and contracted HP with LSIL on PAP in November 2020
Pain in fingers & arm, numbness, Swelling, redness, warm to touch. Went to ER. He said their diagnosis was an allergic reaction. He was given steriods, Benadryl, antibiotic, and pain relievers.
I have had multiple issues, back pain, chills, uncontrollably fall asleep, feel feverish with no fever, exhaustion, joint pain, weakness.
Patient recieved Varivax, Prevnar and Hepatitis A on 1/17/08.  On 1/20/08 mom noticed hard lumps under skin where injections were give.  Brought in to office on 1/29/08 and diagnosed wirh cellulitis/localized (hematoma).  Treated with Omnicef.
Myalgia, Tachycardia,  CHILLS, SWEATING Narrative:   Other Relevant History: