chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm, slightly red at injection site. The shot hurt more than the first one. Had small waves of stomach upset, headache, chills, lethargy but none lasted longer than an hour. All symptoms are gone now, 3 days later.
hoarseness; throat tightness; flushing; This is a spontaneous report from a contactable consumer. An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunisation. Medical history was none. Concomitant medications were not reported. On 23Dec2020, the patient experienced hoarseness, throat tightness and flushing. Therapeutic measures were taken as a result of the events that included epinephrine, steroid, and Benadryl. Clinical outcome of hoarseness was recovering, while for the other events was unknown.  Information on the lot/batch number has been requested.
This spontaneous report was received from a physician refers to an infant patient of unknown age. On an unknown date, the patient was inadvertently vaccinated with adult dose of RECOMBIVAX HB (10 MCG/ML) (dose, route and frequency were not reported). No adverse effect reported. No further information was provided. Follow up information has been received from the physician refers to a 6 month old male patient. On 25-JUL-2014 at 12:00 PM the patient was vaccinated with the first dose of RECOMBIVAX HB (lot# H010965, expire date 01-JUN-2014) in the right arm (dose and route not reported). Concomitant therapies included PREVNAR 13 and PENTACEL. No adverse events. Additional information is not expected.
This case was reported by a pharmacist via call center representative and described the occurrence of tingling in a elderly male patient who received SHINGRIX (batch number HM3NC, expiry date 13th April 2021) for prophylaxis. In December 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced tingling. On an unknown date, the outcome of the tingling was unknown. It was unknown if the reporter considered the tingling to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported but it could be 71 or 72 years old. After vaccination, the patient experienced tingling on one side of the head. The reporter consented to follow up.
Sore arm with first injection on September 14, 2020. Sore arm, shivering, body aches, back and neck muscle soreness, fatigue and nausea with second injection on November 27, 2020. Symptoms for second injection started about 12-13 hours after the injection and continued through 48 hour period. Arm soreness still lingers, but diminishing.
Itchy rash; arm swell; Diagnosed with cellulitis; Fever; Over all feeling bad; sore arm; This case was reported by a consumer via call center representative and described the occurrence of cellulitis in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th July 2020, the patient received the 1st dose of Shingrix. On 30th July 2020, 5 hrs after receiving Shingrix, the patient experienced cellulitis (serious criteria GSK medically significant), fever, feeling bad and pain in arm. On an unknown date, the patient experienced itchy rash and extensive swelling of vaccinated limb. The patient was treated with benadryl (nos) (Benadryl) and cefalexin (Cephalexin). On an unknown date, the outcome of the cellulitis, fever, feeling bad, pain in arm, itchy rash and extensive swelling of vaccinated limb were recovered/resolved.   It was unknown if the reporter considered the cellulitis, fever, feeling bad, pain in arm, itchy rash and extensive swelling of vaccinated limb to be related to Shingrix.  Additional details were provided as follows: It was reported that the symptoms of fever, sore arm and over all feeling bad presented 5 hours after the vaccination. The symptoms lasted 3 days. Four to five days later the arm swell and a itchy rash appeared. It was spread from the injection site all the way around the arm down to the elbow.  The patient was treated in the emergency room with Benadryl and Cephalexin. The patient was diagnosed with cellulitis.  The reporter consented to follow up.
Appendicitis.  Onset on Friday Sept 17.  Pain continued to increase.  Low grade fever.  Went to ER on Saturday after speaking with primary care doctor.  CT scan showed an enlarged, inflamed appendix.  Transferred to a different hospital to have appendix removed on Sunday.
vaccine was left at room temperature for / 3 hours, prior to reconstitution / clinic / administered the vaccine; This case was reported by a consumer and described the occurrence of incorrect storage of drug in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details was reported as follows: The case was reported by patient's daughter. The age at vaccination was not reported. The reporter was concerned about efficacy of vaccine, after clinic administered the vaccine to the patient that was left at room temperature for approximately 3 hours, prior to reconstitution, which led to incorrect storage of drug. The reporter did not consented to follow up.
REDNESS AROUND THE AREA OF ADMINISTRATION. SWELLING SPREAD FROM ELBOW TO SHOULDER.
IMZ GIVEN APPROX 1" FROM BURSA. PATIENT HAD A GOOD AMOUNT OF BLEEDING AFTER IMZ. NOW, SEVERAL HOURS LATER, HAVING A HARD TIME MOVING ARM AND VERY DECREASED RANGE OF MOTION. MAY HAVE HIT BURSA AND CAUSED BURSITIS. TOLD PATIENT TO TAKE TYLENOL, IBUPROFEN, AND USE A COLD PACK FOR 15 MINUTES TO HELP WITH PAIN AND INFLAMMATION. INSTRUCTED PATIENT TO F/U WITH PCP IN AM
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A 89 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 07Apr2021 13:00 (Lot number: EW0158) at the age of 88 years as dose 1, single and intramuscular, administration date 29Apr2021 13:00 (Lot number: EW0173) as dose 2, single for covid-19 immunisation. Relevant medical history included: "pneumonia" (unspecified if ongoing), notes: I had pneumonia earlier in the year aspiration you hear of that it had nothing to do with anything you know; "Bad birth" (unspecified if ongoing), notes: when I was 28 you know from bad birth; "aspiration" (unspecified if ongoing), notes: I had pneumonia earlier in the year aspiration you hear of that it had nothing to do with anything you know. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Jan2022, outcome "unknown" and all described as "I did get Covid 15Jan, very mild symptoms"; NASAL DISCOMFORT (non-serious), outcome "unknown", described as "I didn't get the booster yet but I had the other two cause I'm fighting this I don't know this post nasal drip or something and I didn't wanna get the booster till I kind of got this cleared up"; GASTROOESOPHAGEAL REFLUX DISEASE (non-serious), outcome "unknown", described as "I didn't get the booster yet but I had the other two cause I'm fighting this I don't know this post nasal drip or something and I think its acid reflux".  Patient called in to check on the status of their enrollment in the program for the medication Toviaz. During the call patient stated she read the brochure on the internet kind of sort cause her eyes were bad. Her eyes see worse since she started taking this, but she did not know if it had any effect on them or not she talked to her Retinologist and he didn't think it would. It's probably just a matter of her getting older she was 89 you know what she meant Patient later stated on the call. She was just old and tired Its so difficult for her to do anything she was losing her eyesight and her hearing. Her bladder was shot when she was 28 you know from bad birth. She was doing ok, little by little starting to wear overnight pads during the day. She didn't get the booster yet, but she had the other two cause she was fighting this she did not know this post nasal drip or something and she didn't wanna get the booster till she kind of got this cleared up. Cause she had pneumonia earlier in the year aspiration you hear of that it had nothing to do with anything you know she had the 2 first shots they were absolutely nothing didn't even feel the prick. I didn't get the booster yet, but she had the other two cause she was fighting this she did not know this post nasal drip or something and she think its acid reflux. She did get Covid 15Jan, very mild symptoms.  No follow-up attempts are possible. No further information is expected.
CDC reports: 5 yo developed "Knot" @ inject site lt thigh & unable to walk following DTP/OPV/HIB immun, lasted 3 days, warm compresses applied.
First off, I had soreness in my arm and secondary thing that came on in a couple weeks was an inability to exercise at an elevated heart rate. I also had a breakthrough case of COVID on 09/15/2021 between 2nd dose and booster. My symptoms with COVID were mild muscle aches, fever, and a runny nose. The fever lasted 2 days and the runny nose lasted several weeks. I also had slight nausea and loss of appetite.
maybe you had a stroke; didn't feel good the other night; vertigo; urinary tract infection; I feel so much sicker; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old patient received BNT162b2 (BNT162B2), as dose number unknown, 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: CEREBROVASCULAR ACCIDENT (hospitalization, medically significant), outcome "unknown", described as "maybe you had a stroke"; MALAISE (hospitalization), outcome "unknown", described as "didn't feel good the other night"; VERTIGO (hospitalization), outcome "unknown"; URINARY TRACT INFECTION (hospitalization), outcome "unknown"; ILLNESS (hospitalization), outcome "unknown", described as "I feel so much sicker". The events "maybe you had a stroke", "didn't feel good the other night", "vertigo", "urinary tract infection" and "i feel so much sicker" required emergency room visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram: maybe you had a stroke. Pfizer-BioNTech COVID-19 Vaccine was reported to be a suspect product. Clinical course: Patient called in to find out if an order for their medications Diflucan, and Premarin vaginal cream had been shipped out to them. During the call patient stated that patient was in the hospital. Patient just didn't feel good the other night and went to the ER. They did a cat scan they said maybe patient had a stroke. Patient said that he/she didn't have a stroke. Patient have vertigo and have urinary tract infection (UTI). Patient stated that hopefully they send the patient home tomorrow. Patient later stated on the call, "Nobody know's about the Accupril? The quinapril's really not holding me. I have to take more quinapril' than I have to do Accupril. I still have to get my booster shot. A lot of people have been getting it and they've said they haven't been feeling well. It's not just Pfizer and Moderna it's all of them. The booster contains all 3 of the viruses so it's a hell of a lot stronger and a lot of people are saying why did I get this I feel so much sicker."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
PT presented 3 days after vaccination c/o 1 day l/o redness, swelling, pain surrounding injection site. Warm, indurated. Cellulitis diagnosed and treated with antibiotics.
doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 2:09 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported as 72.74 No concomitant medication was provided. It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.   No treatment medication was provided.
Bump at injection site; Little itchy at injection site; Swelling at injection site; Pink-red at injection site; Slight soreness in arm; A spontaneous report was received from a consumer concerning an 83-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bump at injection site (vaccination site mass), swelling at injection site (vaccination site swelling), pink-red at injection site (vaccination site erythema), little itchy at injection site (vaccination site pruritus) and slight soreness in arm (vaccination site pain).  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included pravastatin and esomeprazole magnesium.  On 26 Jan 2021, prior to the onset of the events, the patient received their planned dose of mRNA-1273 (Batch Number: G29L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 26 Jan 2021, after the vaccination, patient's left arm was little sore. On 03 Feb 2021, 8 days later, patient experienced bump at injection site, swelling at injection site, pink red at injection site and little itchy at injection site. Treatment information cortisone and paracetamol.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, bump at injection site, swelling at injection site, pink red at injection site, little itchy at injection site and slight soreness in arm, was recovering at the time of this report.
Vaccine placed on the outer arm. Redness and swelling noted approximately 2.5 x 2 inches in size. . Employee complains of pain and burning in the affected area.
-Redness & swelling injection arm in elbow region & forearm -bruising in injection site.
fatigue, headache, muscle pain, chills, joint pain, fever, nausea, feeling unwell, arm pain
was given adjuvant only / vaccine was not mixed with antigen; was given adjuvant only / vaccine was not mixed with antigen; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The age group was not reported but was captured as adult as per vaccine indication. The patient was given adjuvant only vaccine was not mixed with antigen prior to administering which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow up.
Late in the evening I had trouble sleeping as the arm was sore. Unable to do anything for about 2 weeks. I experienced extreme fatigue. I just slept close to 24 hours a day for 2 weeks. Arm was swollen. Back Pain flared up as well. Saw doctor and he gave me some prednisone, a topical cream, and something for diarrhea. Follow up with Doc, reupped the diarrhea medications and to come back in things get worse. Symptoms have become less, but I still have fatigue and brain fog.
5 minutes after receiving injection pt. became light headed, c/o blurry vision, nausea and pale. No LOC. PM Hx negative, NKA, taking no meds. On exam, pale, HR 60, BP 90/62, HeartS1, S2, RRR, Lungs CTA bilat. Post 15 min. BP 122/78, O2sat 98. A/P Vasovagal post vaccine.  Good response to supine position, cold room and water.  Pt.  left to home with friend. Informed  pt. to contact PCP.  Notes by doctor Low who examined pt. on site.
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report was received from a registered nurse refers to an unspecified patients of unknown age and gender. NO pertinent medical history was reported. On an unknown date, an unspecified patients were vaccinated with doses of (Oka/Merck) VARIVAX vial 1350 U (dose, route, lot # were not reported) which were exposed to temperatures outside of the recommended range. No adverse experience reported. No Product Quality Complaint (PQC) was involved. This is one of the two reports received from the same source. Additional information has been requested.
Limited mobility of shoulder joint. Initially had pain at site of injection. Experienced shoulder pain for approximately 2 months, then consulted PCP regarding continuous shoulder pain.
Patient reports developing itchy raised hives 4-5 days after receiving first dose of vaccination. Hives located on left arm, top of head and back. Improved spontaneously, now has slightly raised areas of skin where hives were located. No longer itchy.
pt recvd vax 15JUN94 & noted pain, redness & swelling 16JUN94; about 1" size; 13JUN93 3"x3" size;
I pretreated with zyrtec, pepside and benedryl. I had swelling on the second day in the left , my nose, cheeks that stayed for days.
04/05/21 sore arm for several days 04/08/21 tongue went numb for 3 days as well as entire arm started spasming 04/20/21 weakness quivering in legs for 4 day doctor visit weeks later all muscles in right arm froze base of skull at the neck froze( neck and arm immobile)  chiropractor
a dose of Engerix-B that had expired on 29/Apri/2023 was administered to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a female patient who received HBV (Engerix B) (batch number 7XY23, expiry date 29-APR-2023) for prophylaxis.   On 23-AUG-2023, the patient received the 3rd dose of Engerix B. On 23-AUG-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: a dose of Engerix-B that had expired on 29/Apri/2023 was administered to a patient).The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-AUG-2023 The reporter was a medical assistant. The reporter called to inform that earlier that day, a dose of Engerix-B that had expired and administered to a patient, which led to expired vaccine used.  The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter.
Fever of 102; Chills; Headache; Muscle aches; Nausea; Sweating; Pregnant : yes, gestational age 27 weeks; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old and 27 weeks pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 17Aug2021 at 10:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. 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. Concomitant medications included sertraline hydrochloride (ZOLOFT), cetirizine hydrochloride (ZYRTEC) and unspecified prenatals(MANUFACTURER UNKNOWN) all from an unknown date for an unknown indication and unknown if ongoing. The last menstrual period (LMP) of the patient was 08Feb2021. On 17Aug2021 at 11:00, the patient experienced maternal exposure during pregnancy second trimester, fever 102, chills, headache, muscle aches, nausea and sweating. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. On 17Aug2021 at 11:00, the patient underwent body temperature test and the result was found to be 102 (units unspecified). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event maternal exposure during pregnancy second trimester was unknown however the clinical outcome of the events fever 102, chills, headache, muscle aches, nausea and sweating were recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
General Itchiness, fatigue, joint inflammation, worsening hives on trunk and extremeties
Patient described feeling weak and out of breath (heavy feeling in chest) on Wednesday, April 7, 2021. On the morning of 4/8/2021, patient noticed a small nodule on right elbow (has a sore appearance to it). As the morning continued, she noticed raised red/purple bruising on right anterior forearm. When she presented to the pharmacy, she also had what appeared to be erythema spreading to posterior right forearm. She describes the "rash" as being itchy.