chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I got them 3 year ago and still got them / suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I got them 3 year ago and still got them / suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 12-JUN-2023 This case was reported by the patient via interactive digital media.  The reporter reported that he/she got them 3 years ago and still got them. They would not go away. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Upon arising next morning after immunization.  Noted swelling of both parotid glands & (slightly) face.  Confirmed on physical examination today.  No other abnormal physical findings other than swelling RIF. RMF.
Woke up on the morning of September 8 and was not feeling well. Both of my eyes were almost swollen shut. I had some chest pressure, headache, eyes burning, eyes watering, very fatigued, congestion and all over body aches.
received her 2nd Pfizer dose approximately 12 days too early due to rescheduling the first dose but not reschedule the second dose.
Child began acting fussy and like he was hurting, began running a fever as well. He continued to act ill, then the next day developed a disseminated rash all over from head to toe.
developing a headache; This is a spontaneous report from a contactable consumer (patient, self-reporting). A female patient (Age: 69; unit: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date as single dose for an COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. A patient experienced PMH of headaches and calling to see if she can take Excedrin migraine. She thinks she may be developing a headache. Outcome of the events was unknown.   Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Patient received a Flu vaccine on 11/05/2020, did not experience any immediate discomfort or adverse events. Patient presented back at the pharmacy on 11/7/2020 with the following symptoms Diarrhea that started on the night of 11/6, painful, red, warm to touch rash at the site of administration that was noticed on the morning of 11/7.  I examined the rash, it was well defined and localized to the deltoid region. Patient also reported that the rash was itchy. Patient was asked to update the pharmacy within 24 hours.
Onset of symptoms occurred approximately 12 hours post vaccines. Symptoms include vomiting, nausea, extreme body aches, fever, chills, fatigue, and dizziness.  Received a shot of Toradol and Zofran. Currently, at 48 hours post vaccines, nausea and vomiting are not present. Fever and chills comes and goes. Body aches have lightened in severity, (not crying due to pain anymore)  but are still present. Fatigue and dizziness are still present./
24 hours post pneumococcal vaccine injection (L) deltoid reddened, raised, warm to the touch. Red rash on back, legs and abdomen.
pt recvd vax & started falling towards the ground;noted was contractures to all 4 limbs, unresponsive to verbal stimuli, eyes rolled towards left, snoring noise noted x 30seconds;VS-BP 100/50, P52;pale;pt responsive to voices rested & sent
This spontaneous report was received from a registered nurse and refers to unspecified number of patients of unknown age and gender. No medical histories, current conditions and concomitant therapies were reported for them. On an unknown date, the patients were vaccinated with doses of improperly stored (Merck) VARIVAX lot # K015946, expiration date 23-SEP-2016, dose 0.5 ml, subcutaneously. No adverse effects were reported. Additional information has been requested.
Approximately a 1?x2? knot below & to the inner right of injection site on day 2 after injection (1/8/21)  Developed itching in area where the knot had been 1 week after injection (1/14/21)  On 1/14/21 also woke up with very sore neck, left side along top of shoulder  radiating to back of left shoulder. Noticed swelling in that area. On 1/15/21,  still swelling in upper & back of left shoulder. Large red, slightly raised area in area where knot had been on 1/15/21.
15SEP95 reddened raised warm area 4x5inches # inj site;later in day had extended to lower arm as well as ax area; afeb; given DPH; given pred & Keflex; c/o lightheadedness & gen felt lousy
I experienced a "rash" on my left arm that grew in size over a few days. It is still growing as I make this report. It is painful to the touch and very hot to the touch.
Red / raised/ warm / hard area at injection site (1 1/2 mo) Muscle aches/pains/spasms (1 1/2 mo) Headache 1 month tried cold compresses, tylenol, ibuprofen, tramadol, methocarbamol to relieve s/s
pt recv vax; devel gen rash which was specifically noted at inject site;reporter felt the rash related to vax;
Vaccine, pediarix, given was expired. Per manufacturer potency of vaccine is good for 30 days. Per CDC recommendations repeat as soon as possible.
From initial information received on 10/30/2002 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a four year old male patient received FLUZONE SV '2003-'2004 USP, lot number U1268AA, administered intramuscularly in the left arm on 10/27/2003. Two days later, on 10/29/2003, the patient's entire left arm was swollen, red and itchy. The patient was seen by a physician. At the time of this report, the patient had not recovered from these adverse events. From additional information received on 02/12/2004 from the reporting physician, a correction to the patient's name was provided, as well as his address, birth weight and number of siblings. Per the physician there is no additional information for this case. No further information is anticipated, this case is considered closed.
really bothered me/ I can still feel where I was injected; This case was reported by a consumer via  interactive digital media and described the occurrence of discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a month after receiving Shingles vaccine, the patient experienced discomfort. On an unknown date, the outcome of the discomfort was not recovered/not resolved.   It was unknown if the reporter considered the discomfort to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated, 1st Shingles shot really bothered. At the time of reporting the patient could still feel where it was injected after almost three or four weeks. The follow-up would not possible as no contact details were available.
no adverse event; 16 patients were administered pediatric monovalent vaccines instead of bivalent boosters; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (16 patients were administered pediatric monovalent vaccines instead of bivalent boosters) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 21-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (16 patients were administered pediatric monovalent vaccines instead of bivalent boosters). On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (16 patients were administered pediatric monovalent vaccines instead of bivalent boosters) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (16 patients were administered pediatric monovalent vaccines instead of bivalent boosters).    This case contains information for the 7 of 16 adult patients described by the reporter No concomitant information was reported. Patient was administered pediatric monovalent vaccine instead of bivalent booster on 21DEC2022. No symptoms reported. No treatment information was reported.   This case was linked to MODERNATX, INC.-MOD-2022-692175 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-692175:Master
Pt was given vaccine 10/12/21 and recently reported that he still has intermittent pain down his arm. He explained that he has seen 2 different doctors for this issue and both doctors told him it is likely related to nerve pain. When asked during the interview if he has pain at this time, he stated no but explained that the pain is intermittent.
Dizziness, fatigue, body aches, light headedness, very high blood pressure, mild abdominal pain. Symptoms started day after and worsened. Required an office visit by 1 week after vaccine
Cellulitis at vaccine site. Seen at ER. Given 10 days of Keflex.
the patient involved did not report any symptoms or medical concerns related to the administration of the expired PNEUMOVAX 23.; Medical Assistant calling to report expired administration of PNEUMOVAX 23.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 13-NOV-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) injection (0.5 mL / once, lot#: W015900, expiration date: 20-OCT-2023; strength and route of administration were not reported) by a health professional for prophylaxis (expired product administered). The patient was aware the expired problem told by the physician. The patient involved did not report any symptoms or medical concerns related to the administration of the expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23). No additional information provided regarding this adverse event (no adverse event).
No adverse event; First dose was given on 30-Mar-2021 and second dose on 21-Apr-2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was given on 30-Mar-2021 and second dose on 21-Apr-2021) and NO ADVERSE EVENT (No adverse event) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 055F22B, 071f21a, 002C21A and 016B21A) for COVID-19 prophylaxis.     The patient's past medical history included Generalized anxiety disorder. Concomitant products included SERTRALINE from 09-Feb-2018 to 26-Nov-2022 for an unknown indication.   On 30-Mar-2021 at 6:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021 at 6:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021 at 2:30 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Sep-2022 at 3:00 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was given on 30-Mar-2021 and second dose on 21-Apr-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was given on 30-Mar-2021 and second dose on 21-Apr-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            The patient had Paxlovid for the treatment of COVID-19 from 16-Nov-2022 to 20-Nov-2022 and had COVID-19 rebound on 26-Nov-2022. Rebound COVID on day 11 of isolation after successfully completing a round of Paxlovid taken days 2-6. All symptoms originally went away by day 8, and tested negative 3 times on rapid tests until symptoms returned day 11, confirmed with 2 positive rapid tests and positive PCR.  No treatment medication was reported.
This initial report was received from a medical assistant concerning unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9, lot number reported as L040459 with expiration date 06-APR-2017 (dose, strength, route of administration and anatomical location were not reported). According to reporter, the vaccine experienced temperature excursion of up to 45.5 F for 362 hours and 12 minutes. No adverse effects were reported in any patients. This is one of several reports from the same source (1611USA012963 and 1611USA012962). Additional information is not expected since reporter did not give consent for follow up.
S/P 24 hrs: 5x5 cm local erythema and induration L deltoid. Apparent migration of erythema down contralateral side of L arm with L wrist pain. No decrease in strength or ROM. No paresthesia, hypesthesia. 50mg Benadryl IM administered. PT instructed to RTC tomorrow for f/u.
10/23/15 - Dizziness, flush, increased heart rate, difficulty breathing, tightness in chest within 5 minutes after vaccine being administered. 10/24/15 - experienced fatigue, body aches and pains, headache throughout day. 10/25/15 - hives developed on chest, neck and back.
had stiff upper neck with no pain near base of skull on day of vaccination (8/27/21).  stiffness continued for 3 days and resolved with no intervention.   On 9/2/21, woke up dizzy, head spinning, and nauseous @ 7AM.   one session of unproductive vomiting around 8AM.  The dizzy feeling resolved to mild virtigo within 3 hours.  completely resolved by the following day.
severe pain and swelling in my left shoulder The pain was so severe that I thought my collarbone was broken.  The swelling was also affecting my breathing as it was pushing on my lungs.  I was fine on Friday after getting the shot and all day Saturday.  I woke up on Sunday morning with pain thinking I had slept wrong.  The pain and swelling got worse during the day.  It spread up my neck and down into by back and chest.
Patient had pain in right arm the day of shot which improved. The next day she was having stiffness in the (R) neck and tingling from neck to ear on right side.
Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Shakiness-Mild;
urinary tract infection; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (urinary tract infection) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included LISINOPRIL, AMLODIPINE and LOSARTAN for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URINARY TRACT INFECTION (urinary tract infection). At the time of the report, URINARY TRACT INFECTION (urinary tract infection) outcome was unknown.            The patient was prescribed unspecified antibiotics as treatment for the event.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Dosing details of first dose was added. This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Mar-2021. The most recent information was received on 07-Jul-2021 and was forwarded to Moderna on 28-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (urinary tract infection) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included LISINOPRIL, AMLODIPINE and LOSARTAN for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URINARY TRACT INFECTION (urinary tract infection). At the time of the report, URINARY TRACT INFECTION (urinary tract infection) outcome was unknown.            The patient was prescribed unspecified antibiotics as treatment for the event.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Dosing details of first dose was added.
States that woke up next am and arm was so sore that she could not hardly move it. This went on for several days. Had to schedule appt with doctor on 5/9/13 to be evaluated. Trial Flexeril 5 mg QHS prn.  Motrin 800 mg Q 8 hrs prn.  Tylenol 1 g Q 8 hrs prn OTC.
A report was received from a health professional on 1/15/01 concerning a 64 year old patient who experienced a bitter taste after receiving Fluvirin on 10/18/01. The patient was receiving human insulin, isophane, losartan potassium, furosemide, acetylsalicylic acid, atenolol, ranitidine hydrochloride, gabapentin and amitryptiline concomitantly. The patient has a previous medical history of hypertension, gastroparesis, diabetes, diabetic retinopathy, diabetic neuropathy, osteoarthritis, esophageal spasm, hiatal hernia, chronic pain, chronic cough, melanosis of colon, chronic palpitations, poor dentition, and nephrolithiasis. On 10/27/01, the patient complained of a bitter taste in her mouth that developed one week after receiving the influenza vaccine. The patient was reported as having no complaints of dysphagia, odynophagia or any other adverse events. At the time of reporting, the adverse event was not resolved. The reporter assessed the causality as unclassifiable.
Per patient's daughter, the patient told her that she "passed out" while she was on the toilet the day following vaccination. States she felt weak.   Per daughter the patient is doing fine now.
Injection site for days; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Injection site for days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced INJECTION SITE PAIN (Injection site for days). At the time of the report, INJECTION SITE PAIN (Injection site for days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
This spontaneous report as received from a registered nurse refers to a 73 years old patient of unkonwn gender. On 17-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX lot # K003600, expiration date verified as 10-MAR-2015 (also reported as 19-MAR-2015) 0.65 ml dose once, subcutaneous (dose number was not reported), that was exposed to 19.5 F for 9 hours (supported). No adverse effects were reported. No product quality complaint (PQC) involved. This is one of the several reports from the same source. Additional information has been requested.
vaccine was given with a diluent  other than what is provided with it; vaccine was given with a diluent  other than what is provided with it; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) for prophylaxis.   On 20th August 2021, the patient received Hiberix. On 20th August 2021, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The age at vaccination was not reported. Health care professional reported, Hiberix vaccine was given with a diluent (MMR diluent) other than what was provided with it, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.  The reporter did not consent to follow-up.
Dizziness; This is a spontaneous report from a contactable other healthcare professional, the patient. A 66-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the right arm on 06Apr2021 at 11:30 (at the age of 66-years-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 14Mar2021 at 17:00 (at the age of 66-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 12:00, the patient experienced dizziness. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event dizziness was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Raised, erythematous, itchy (L) lateral aspect of (L) arm apply ice.
High fever 102-104 times 2 days of fine, pinpoint, erythematous rash on truck and neck.
pt recvd vax; 5 hrs later, devel rhinorrhea, nasal congestion & irritability; no rash; low grade fever; similar sxs, devel w/ 2 mo immun;