chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain at the site of injection; Received a double dose (1mL); A spontaneous report was received from a consumer who was an 29-year-old, male patient who was participating in the mRNA-1273 Emergency Use Program and received a double dose (1ml) and the patient experienced pain at the site of injection.    The patient's medical history was not provided. No concomitant medications were reported.  On 13-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On the same day, the patient stated that he received a double dose (1ml) and experienced pain at the site of injection.   No treatment was administered.   Action taken with mRNA-1273 in response to the events was not provided.  The event, received a double dose (1ml), was considered resolved on 13-Jan-2021. The outcome for the event, pain at the site of injection was not resolved.; Reporter's Comments: This case concerns a 29-year-old, male patient, who experienced a non-serious, unexpected event of extra dose administered and a non-serious expected event of injection site pain. There were no reported AEs associated with this case of extra dose administered. However, the event of injection site pain occurred same day after the first dose of mRNA-1273 (Lot number: 041L20A) administration. The event of extra dose administered was assessed as not-applicable. Based on the current available information and temporal association between the use of the product and the start date of the event  injection site pain, a causal relationship cannot be excluded.
This spontaneous report was received from an office manager referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medication and drug reactions or allergies was not provided. On an unspecified date in April 2021, the reporter had a delivery of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) that did not arrive for more than 5 days (product distribution issue), when the product was received it was supposed to be returned to the wholesaler, instead it was placed in the refrigerator. Information about the temperature storage or a time frame was unknown by the reporter. There wasn't a previous temperature excursion. On 15-JUN-2021, the patient was vaccinated with a bad dose  HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe, 1 time dose as prophylaxis (lot number T026168 has been verified to be valid, expiration date reported and validated as 04-DEC-2022) (vaccination scheme frequency, route and anatomical location of administration were not provided) (product storage error) (poor quality product administered). No additional adverse events occurred. This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T026168; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2106USA005004: US-009507513-2106USA005005: US-009507513-2106USA005047: US-009507513-2106USA005081: US-009507513-2106USA005150:
patient received vaccine on december 18, had fever of 102F on december 24 and first chicken pox were noted on january 3.
Received HPV vaccine on January 15.  Aunt called on Jan. 16 and reported that her niece had swelling and redness from site of injection to her elbow.  Area was warm to touch.  Told to put ice on area and take Tylenol and call her Doctor.  This is her 2nd HPV dose.
weakness, chills, tightness in chest, diarrhea, vomiting, headache
Patient had her vaccine on 9/22 at 3:02pm. By the next day, she came home from school and had mosquito and quarter size hives all over her upper body, and was itching. I took her into where she had her vaccine done, and they couldn?t tell me if it was a directly related to the vaccine. Told me to give her Benadryl and apply hydro cortisone cream.  By early morning (9/24), her hives had spread all the way down her legs, and the hives were raised and  severely spread all across her back and stomach. I took her to the emergency room, and they said the rash matched that of her left arm where she received her vaccine. They prescribed her Cetirizine & presnizolone, along with a prescription to take home. The next morning (9/25), she had hives again (not as severe), and we have her the prescribed medication and she was better a few hours later. We have been continuing  to take the prescribed medicine.
It's been nine days since my shot and my arm is still a tad sore from the elbow to the shoulder.  It's not too bad and does not prevent me from doing anything.  It's just like a sore muscle and I notice I still can't move it or pick up things like with my right arm (the non shot arm).  It's mostly sore around the shoulder and underarm area.  Since it has been over a week and doesn't seem to be going away, I thought it best to report it.  If it persists, I will call my doctor.
Was in office today 9-14-17. Had large swelling of left upper and forearm. Mom stated had similar but milder reaction after flu shot 9-10-16.
Chills, fever, headache, muscle pain, sinus congestion, weakness x 48 hours
Patient is recent immigrant. Catch-up vaccine schedule instituted. DTaP was given mistakenly despite patients age.
slightly loose stools; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (slightly loose stools) 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 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced DIARRHOEA (slightly loose stools). At the time of the report, DIARRHOEA (slightly loose stools) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment details were not provided.
Adverse symptoms occurred after I had gone to bed and were noticed when I got up to use the bathroom.  I had a temperature, chills, and had difficulty walking, felt unstable. Also had erratic tremors in my jaw and hands that I couldn't control.
11MAY93 pt recvd vax & 12MAY93 called & reported rash on face, nausea, dizziness, tingling arms & legs, very tired; denies fever; 14MAY pt reports feeling better; sx subsiding; rested all day 13MAY;
I am working and I was feeling well, and they took me to the hospital. When they ran test, and my transonic levels were up, and I was having a heart attack. I have to take several medications. I have notice some limitations to what I am use to doing.
Delirium for 6 months. Described as slamming doors, screaming, sitting in shower for >6 hours. Started on day vaccine was administered.
I received the vaccination on the afternoon of May 21, 2021.  I felt a hard, aching pain during the injection, which gradually subsided over the next 1-2 hours. Beginning the next day (May 22), my left upper arm felt generalized soreness, similar to the reaction following a flu vaccine.  By May 24, the generalized soreness was fading, but by May 25, I began to feel an exquisite and localized pain and tenderness near the injection site.  The pain felt like a very deep, painful bruise and was exacerbated by touch or pressure at the site and by certain arm motions (e.g., reaching up, or across my body to my right) and positions (unable to lay on my left side).  The pain continued to increase and intensify over the next few days (May 26-28). On the morning of May 28, with the pain still intensifying, I noticed a slightly raised, reddened, silver dollar sized area of skin near the injection site.  The reddened area was warm to the touch and extremely tender to touch.  No itching or exudate noted.  At approximately noon the same day (May 28), I took some Tylenol and cetirizine 10 mg.  (I also took some photos of my left arm on May 28). Today (May 29), the reddened area on my left arm is still present and my arm is still painful.  However, the pain is currently stable and does not seem to be intensifying at this time. (I obtained the vaccine info in Item 17 from my  medical record).
Patient stated that five hours after dose felt like she had the flu, shaking, shivers, and nausea, and lasted few days
Not sure when it started, as I slept most of Sunday, but Monday morning noticed a rash (non-itchy) over nearly 50% of torso - reported to my physician, who said it certainly looked like a drug reaction- said I could take Zyrtec or something similar for itching if needed - but I took nothing as it did not itch.  Went away on its own within 48 hours.
Slight sore arm; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 01Apr2021 at 11:15 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications included dietary supplements (MANUFATURER UNKNOWN) from unknown date for unspecified indication. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 01Apr2021 the patient experienced slight sore arm. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown if the patient received any treatment for the event. The clinical outcome of the pain in arm was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient presented to ED with constipation and near syncope. Patient sustained a left radial fracture after slipping on the ice a few weeks ago, and was prescribed oxycodone before and after surgery. Patient's constipation was treated with repeat enemas and stool softeners with resolution and patient is to be discharged today with daily miralax.
Immediately really hurt upon jab and felt the liquid spread in my arm, Burnt and very painful. The pharmoassured me this was normal. It was really bad for 3 weeks, still very achy and less range of motion with pain and hand grip weakness. The 2nd shot was placed much higher and I had zero pain or reaction ( except the on going from first vaccine.
Itchy circular reddened area at injection site 8 days after injection.  My private doctor is aware and monitoring at this time for any spreading of the affected area.
Patient reported feeling extremely flushed, slight sensation of throat closing/swelling, and chest tightness. Also reported numbness of lips. These reported events occurred approximately 10 minutes after the vaccine was administered
Pt. lost consciousness for approximately 30 seconds in chair immediately after receiving flu vaccine. Eyes open, pupils dilated, nonresponsive. Her blood pressure was taken and dropped from initial reading of 73/41 to 45/38. She was given a juice and moved to recliner where her feet were elevated above her head. She was diaphoretic, pale and nauseated. Repeated blood pressures increased to 92/66, and pt. was slowly sat up until upright, given crackers and juice. BP standing was 100/78 which she stated was back to her normal blood perssure. Pt. was able to return to work.
PATIENT HAD PAIN IN HER ARM AND A HEADACHE A COUPLE HOURS AFTER RECEIVING THE VACCINE. SHE LATER HAD TROUBLE SLEEPING AND HAD A RED AND SWOLLEN AREA ON HER ARM. SHE WENT TO THE EMERGENCY ROOM AS HER DR WAS UNABLE TO GET HER IN TO THE OFFICE THE NEXT DAY. THE ER TOLD HER SHE HAD AN INFECTION AND PRESCRIBED KEFLEX AND PREDNISONE.
A non-serious spontaneous report of "brought home H1N1 vaccine and gave it to six-month-old (sic) niece" was received from a registered nurse concerning a six-month-old female. On 13-Oct-2009, the patient received H1N1, Intranasal. The patient had no medical history and no concomitant medication taken by the patient. There was no adverse event associated with this vaccination error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved. Additional information was received on 09-Nov-2009 and incorporated into the narrative: event term was changed from "brought home H1N1 vaccine and gave it to 20-month-old nephew" to "brought home H1N1 vaccine and gave it to six-month-old niece" and statement regarding medical history and concomitant medication was included.
Developed bad stomach ache and then rash on Dermatone T10. Diagnoses as Herpes Zooster Which I have had before. Lasted for 3 weeks with significant pain and fatigue.
3hrs post vax pt exp nausea, vomiting & fever of 100-101 in a pt who recvd flu vax on 20OCT93; pt recovered;
Information has been received from a physician concerning an approximately 2 month old patient who was vaccinated PO with his first 2.0 ml dose of Rotateq (no lot# provided). The patient was diagnosed with enterovirus 48 hours after vaccination. The patient also experienced diarrhea and horrible diaper rash 48 hours after the diagnosis. The patient sought unspecified medical attention. Subsequently, the patient recovered. There was no product quality complaint. Additional information has been requested.
Narrative: Patient died of unknown cause, had multiple underlying conditions. Patient outside of hospital. Patient was in our facility with multiple underlying conditions.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 23-Jul-2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 23-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 51-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 23-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 23-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 23-Jul-2022).    No concomitant product use was reported.  Patient received half dose.  On 04-Jun-2022 the vials were initially stored in the refrigerator.  Vial did not undergone any temperature excursions.  No treatment information was provided.
EXTREME PAIN IN ARM FROM ELBOW TO SHOULDER, ARMPIT AREA AND PECTORAL MUSCLE AREA.  JOINT PAIN ALL OVER BODY, FEVER, CHILLS, LUNG TIGHTNESS AND ALL OVER MALAISE FEELING.
This is a spontaneous report from a contactable consumer (patient). A 48-year-old (non-pregnant)  female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# ER8733), at the age of 48, via an unspecified route of administration, left arm, on Apr 13, 2021, at 09:30, single dose, for COVID-19 immunisation. Medical history: none. The patient has known allergies to Phenergan (promethazine). Prior to the vaccination, patient was not diagnosed with COVID-19. Concomitant medications included Vitamin D3 (cholecalciferol), fish oil, potassium chloride, aluminum hydroxide, magnesium hydroxide and probiotic; all from unknown dates, for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Apr 13, 2021, at 22:00, patient experienced very tender breasts. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures taken as a result of the event. Since the vaccination, patient has not tested for COVID-19. The outcome of very tender breasts: not recovered (at the time of this report). No follow-up attempts needed. No further information expected.
loss of voice; bronchitis; coughing that was not going away; shortness of breath; cold; had chills; This spontaneous case was reported by a consumer and describes the occurrence of APHONIA (loss of voice), BRONCHITIS (bronchitis), COUGH (coughing that was not going away), DYSPNOEA (shortness of breath) and NASOPHARYNGITIS (cold) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced APHONIA (loss of voice), BRONCHITIS (bronchitis), COUGH (coughing that was not going away), DYSPNOEA (shortness of breath), NASOPHARYNGITIS (cold) and CHILLS (had chills). The patient was treated with GUAIFENESIN (MUCINEX) for Cough, at an unspecified dose and frequency. At the time of the report, APHONIA (loss of voice), BRONCHITIS (bronchitis), COUGH (coughing that was not going away), DYSPNOEA (shortness of breath), NASOPHARYNGITIS (cold) and CHILLS (had chills) outcome was unknown.            Concomitant medications were not provided. Mucinex for the cough but it seems not to be helping a lot. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 22-May-2021: Indication added for suspect drug, Partial onset date added for all events.
This spontaneous report as received from a nurse refers to a patient of unknown age. No concomitant were reported. On an unknown date, the patient was vaccinated with ROTATEQ INJ, lot K001715, expiration date 14-NOV-2015 (dose, frequency, route of administration and indication were not provided)) that was exposed to 8.8C for 10 days. No adverse effects reported. No product quality complaint (PQC) was involved. The outcome of events was unknown. On 02-JUN-2014 a phone call was placed to reporter. The receptionist stated they do not have any one by that name employed at this facility. No further information is available at this time. This report in linked to 1405USA013915 and 1405USA013916, 1405USA013915, 1406USA004908, 1406USA004909, 1406USA004913, 1406USA004914, 1406USA004915, 1406USA004874, 1406USA004881, 1406USA004891, 1406USA004896, 1406USA004897, 1406USA004900, 1406USA004901, 1406USA004814, 1406USA004830, 1406USA004831, 1406USA004832, 1406USA004833, 1406USA004835, 1406USA004837 by the same reporter link.
Entire shoulder swollen; Underarm glands swollen all the way down to breast area, collarbone gland swelling; All areas affected are hot; All areas affected are itchy. All on left arm. Still swollen after 48 hrs; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: ER8737) via an unspecified route of administration in the left arm on 06Apr2021 at 13:00 (at the age of 44-year-old) as a single dose for COVID-19 immunization. Medical history included hypertension and allergies to food. Concomitant medications included losartan and zolpidem. The patient previously took sulfa and experienced sulfonamide allergy and Keflex and experienced drug allergy to Keflex. Historical vaccine included first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EN6208) via an unspecified route of administration in the left arm on 16Mar2021 at 13:00 (at the age of 44-year-old) as a single dose for COVID-19 immunisation and experienced large hive/welt the size of a fist over the vaccine site in her left arm for two plus weeks. It was hot and itchy. She had large lump underneath. It left a mark which may be permanent. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021 after the second vaccine, the patient experienced entire shoulder swollen, underarm glands swollen all the way down to breast area and collarbone gland swelling. All areas affected were hot and itchy. All on left arm. It was still swollen after 48 hours. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. The clinical outcome of the events after the second vaccine, entire shoulder was swollen, underarm glands swollen all the way down to breast area, collarbone gland swelling, all areas affected were hot and itchy, all on left arm and it was still swollen after 48 hours was not resolved at the time of report.   No follow-up attempts are needed. No further information is expected.
12/23/2004 noticed dull pain associated with lump at injection site. Lump resolved but pain persists when arm hyper extended. Second shot in other did not produce same pain. Third shot in right arm did not make pain worse or improve. As of 6/17/2005 the arm shoulder pain has dissipated on its own.
Patient reported rash on left wrist approximately 10 minutes after receiving vaccine. Also reported pruritus at site of redness. Patient was monitored by provider and throughout duration of monitoring developed rash on wrist, neck, and left forearm with pruritus at all sites. Patient given 50mg of Benadryl PO approximately 25 mins after reaction. Within 30 mins of administering medication redness and pruritus had resolved and patient left clinic in stable condition.
Called supervisor 11/12 stated would not be in due to headache and fever. Patient questioned if R/T flu vaccine??