chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suspected vaccination failure; Shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient got Shingles vaccine and experienced shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Pain in joints. Gradually increasing. Came into our office today (9-10-07). Was told by her doctor to come let us know about this.
This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. On an unknown date these unspecified patients were vaccinated with 4 doses of (Oka/Merck) PROQUAD (lot #, dose, route not reported) that had been improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter (other MARRS#1408USA006719). Additional information is not expected because the reporter did not want to be contacted.
had swelling, in the injection site which was red and hard, she also had soreness in the muscle and took a couple of days to go down; had swelling, in the injection site which was red and hard, she also had soreness in the muscle and took a couple of days to go down; had swelling, in the injection site which was red and hard, she also had soreness in the muscle and took a couple of days to go down; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (had swelling, in the injection site which was red and hard, she also had soreness in the muscle and took a couple of days to go down), INJECTION SITE ERYTHEMA (had swelling, in the injection site which was red and hard, she also had soreness in the muscle and took a couple of days to go down) and INJECTION SITE PAIN (had swelling, in the injection site which was red and hard, she also had soreness in the muscle and took a couple of days to go down) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A, 021B21A and 025D21A) for COVID-19 prophylaxis.     The patient's past medical history included Lymph node excision (Also had radiation) in 2021.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INJECTION SITE SWELLING (had swelling, in the injection site which was red and hard, she also had soreness in the muscle and took a couple of days to go down), INJECTION SITE ERYTHEMA (had swelling, in the injection site which was red and hard, she also had soreness in the muscle and took a couple of days to go down) and INJECTION SITE PAIN (had swelling, in the injection site which was red and hard, she also had soreness in the muscle and took a couple of days to go down). At the time of the report, INJECTION SITE SWELLING (had swelling, in the injection site which was red and hard, she also had soreness in the muscle and took a couple of days to go down), INJECTION SITE ERYTHEMA (had swelling, in the injection site which was red and hard, she also had soreness in the muscle and took a couple of days to go down) and INJECTION SITE PAIN (had swelling, in the injection site which was red and hard, she also had soreness in the muscle and took a couple of days to go down) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-744286 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-744286:Master case (SPIKEVAX 2023-2024 Formula)
Stiffening, followed by Shaking - at home ('several minutes') - no treatment; Followed by second event at 4am 10/21/2015.  Taken to ED noted by febrile 38.6.
Within approximately 10 minutes I started feeling my sinus tissue swelling along with facial pressure.  A few minutes later I had an itchy, scratchy throat along with excessive post nasal drip.   I normally have allergies all year long but this happened soon after the vaccine.  My allergies are somewhat controlled with all of the allergy medications I am currently taking and worsen during the spring and fall but usually do not happen with a suddenly onset.
Information has been received from a nurse concerning a 22 year old female who in April 2009, was vaccinated with her first dose of GARDASIL injection. In May 2009, the patient went to have her yearly Pap test done and her pap came back to the office today on 25-JUN-2009 to have a "colposcopy" done, and those results were not yet available. The patient's outcome was unknown. Additional information has been requested.
Student complained of ringing in the right ear.  Ringing lasted for about 10 minutes.  Monitored student for a hour for futher symptoms.
red rash back of the neck, back of the left shoulder, then the front of the right shoulder.  Muscles in these areas are sore.  Now in the second week of the rash.  Rash starts as a small red spot, enlarges to the size of a silver dollar.  Seems to form a granulated surface.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date; No adverse event; Administered the vaccine to the patient after the 30 days by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to the patient after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date) and NO ADVERSE EVENT (No adverse event) in a 65-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 30-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 30-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to the patient after the 30 days by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to the patient after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date) 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 the patient after the 30 days by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date).    No concomitant medications were reported.  No treatment medications were reported.  The patient received half dose of Moderna vaccine.  The vial had not undergone any temperature excursions.  The vial was initially stored in the refrigerator on 04-Jun-2022 and 35 vials were affected.
Became lightheaded and clammy after TST was placed and six of seven injections were given. Did not faint. Was given juice. Cool cloth applied to back of neck. Opened door and turned on fan in room. BP 84/50. Was able to give last injection after client felt better. Was monitored by PHN for 20 minutes before he was allowed to leave with his mom. Child was new to this country. No immunization records available from overseas.
CHRONIC HYPOTENSION 5/25/2021 ANEMIA DUE TO CKD CHRONIC HYPOTENSION 5/25/2021 ADRENAL INSUFFICIENCY, UNSPECIFIED
Excessive itching at injection site, pain, hard knot about 3-5" in diameter across injection site that lasted approximately 5 days.  Today is day 7.  Only slight knot remains; other symptoms subsided
3 weeks after 3 shot Patient started to experience more breathing issues, ended up with phenomena x2 and passed away
This spontaneous report has been received from a licensed practical nurse and refers to a 5 year 4 month old female patient. Upon examination, the patient was found to be pleasant, alert and oriented in no apparent distress, well developed and well-nourished, cooperative, normal speech, non-focal exam. patient had no known drug allergies. The patient had dry skin, dermatitis atopic/folliculitis proteinuria and fee dog bits on her right lower leg. The patient's family (brother and maternal uncle) had history of asthma, paternal grandfather had history of Type 2 Diabetes and mother had depression. On an unspecified date, between 29-AUG-2015 and 29-OCT-2015, the patient was vaccinated with improperly stored dose of (Oka/Merck) PROQUAD 0.5 ml (lot#K011311), on right vastus lateralis (incorrect product storage). Patient was concomitantly vaccinated with KINRIX 0.5 and PREVNAR 0.5 on left vastus lateralis. The patient's other medications included multi-vitamin gummy (1 gummy daily), fluoride, ivermectin topical and Ovide lotion. No adverse effect was reported. This is one of several reports from the same report. Additional information has been requested.
Mild reaction the following day including fever, fatigue, pain in joints. No treatment and symptoms went away in a few hours.  Tested positive for Covid 19 on March 19, 2021.
MILD FEVER; HEADACHE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a health care professional concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no medical history and no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, Laboratory data included: COVID-19 antibody test (NR: not provided) positive. On 09-APR-2021, the subject experienced suspected covid-19 infection. On an unspecified date, the subject experienced mild fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild fever, and headache, and had not recovered from suspected covid-19 infection. This report was non-serious. The suspected product quality complaint has been confirmed to be the patient received the vaccine on (03/15/2021) and had a positive . covid-19 test on (04/07/2021) with (23) days elapsed between vaccine and test. there was not sufficient time elapsed for the patient to achieve immunity therefore this report is not considered a lack of effect. this record was considered as void. based on the PQC evaluation/investigation performed.; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
SWOLLEN LEFT EYE, PATIENT RETURNED ONE HOUR POST VACCINATION. GIVEN OVER THE COUNTER BENADRYL.
The product was refrigerated on 04-Nov-2021 beyond expiration date 03-Oct-2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (The product was refrigerated on 04-Nov-2021 beyond expiration date 03-Oct-2021) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The product was refrigerated on 04-Nov-2021 beyond expiration date 03-Oct-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (The product was refrigerated on 04-Nov-2021 beyond expiration date 03-Oct-2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It mentioned that the vial was placed in the refrigerator on 04-Nov-2021, the vial did not undergo any temperature excursion and patient did not experienced any adverse events.  No treatment medications were reported.
Redness and swelling left upper arm at site of IPV and Dtap minimal warmth.
While waiting 15 minutes after the vaccine I had a brief tingling sensation run to my stomach but it went away and then three hours later my legs and toes became numb and tingly.  This feeling comes and goes.
DIARRHEA; FEELING PRESSURE ON BACK OF THE NECK; PRESSURE ON LEFT ARM; NOSE BLEEDS; ELEVATED BLOOD PRESSURE; This spontaneous report received from a patient concerned a 57 year old male. The patient's weight was 302 pounds, and height was 72 inches. The patient's past medical history included chronic obstructive pulmonary disease, dm type 2, and myasthenia gravis, and concurrent conditions included allergic to penicillin, non-alcoholic, and non-smoker, and other pre-existing medical conditions included no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with clarithromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced elevated blood pressure. On 10-APR-2021, the subject experienced nose bleeds. On an unspecified date, the subject experienced diarrhea, feeling pressure on back of the neck, and pressure on left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from elevated blood pressure, had not recovered from nose bleeds, and the outcome of pressure on left arm, diarrhea and feeling pressure on back of the neck was not reported. This report was non-serious.
This is third consecutive flu vaccination in which I have experienced vertigo, lightheadedness, fatigue and a general "mentally foggy" feeling after receiving the flu shot.  On all occassions, symptoms started about 3 weeks after vaccination.
This spontaneous report as received from a care coordinator refers to a 74 year old female patient without pertinent medical history, drug reactions or allergies. On an unknown date, the patient was vaccinated with pneumococcal vaccine, (manufacturer unknown) (dose, strength, route and lot number were not reported). Other suspect therapies included influenza virus vaccine (unspecified). Concomitant therapies were not reported. Care coordinator stated that she spoke with the patient on 31-JUL-2014, who stated she had an "allergic reaction" to an unspecified pneumococcal vaccine, (manufacturer unknown) and an unspecified influenza virus vaccine (unspecified). When asking the patient's present status the care coordinator stated the patient was fine. No lab diagnostics studies were performed. Additional information is not expected.
Patient received Rotateq vaccine 3/23/07. Developed 102 - 103F with yellow, mold watery diarrhea with no exposures - sx c/w  Rotavirus enteritis.
Patient reported a sore right arm since the flu shot on 11/4.  Has been seen by her family doctor and told that it was a local reaction and to ice it and use tylenol as needed.
Itching started immediately, throat tightness SOB in about 10 minutes with hives on chest
Swelling, pain, hives, redness, weakness in arm, warm to touch, and dizziness.
Pfizer Vaccine. 1st dose. Rash to chest area and slight difficulty swallowing; rash "hot" but not itchy; scratchy throat; occurred 2 min post dose; Diphenhydramine 50 mg IV, methylprednisolone 125 mg IV, NS 1000 mL; Discharged on medrol dose pack; approximate vaccine and adr time.
I had numbness to the left side of my face that lasted about 45 minutes after taking the moderna shot
Arm became red, mildly edematous, warm to touch. Used steroid cream and improved. 24 hours later with red circle at site of injection. No pain. It continues to itch. No PO medications used.
About ten days after I got the booster shot I developed a very itchy scalp which quickly spread over my entire body. Upon closer inspection, I have hives that develop with pressure (made worse by scratching). I haven't gotten tested for anything yet but my dad has identical symptoms and was diagnosed with urticaria and dermatographism. My particular symptoms seem to be relieved with antihistamines but never entirely go away. All of my lifestyle choices have remained consistent recently besides getting the shot, which led me to believe it is the cause.
For the past several weeks I have been experiencing terrible pain and stiffness in my shoulders and legs.  The X-Rays taken show mild arthritis, but I did not feel this discomfort until the past several weeks.  Just want to check if the vaccine could have caused it.
A spontaneous report was received from a consumer, a 57-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache, muscle pain/myalgia, fever/pyrexia and difficulty breathing/dyspnoea. The patient's medical history was not provided. Concomitant product use was not provided the reporter. On 17 Feb 2021, prior to the onset of the events, the patient received second of two planned doses of mRNA-1273 (lot/batch number: 016m20a) via unknown route for prophylaxis of COVID-19 infection. On 17 Feb 2021, a couple hours later the second dose of mRNA-1273, the patient experienced the events headache, muscle pain, fever with difficulty breathing. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events headache, muscle pain, fever with difficulty breathing was unknown.
Swollen lymph nodes began the day of vaccination (4/2/21) and have still not resolved as of today, 6/9/21. Client also reports ongoing intermittent pain in the arm where vaccination was administered (right arm). Has been working with primary care provider.
Initial report received from a healthcare professional on 16 October 2014. A patient, whose gender, age, medical history and concomitant medication was not reported, had received a dose of FLUZONE (batch number, dose, dose in series, route of administration and site of administration was not reported) on 15 October 2014. On 15 October 2014 after vaccination, the patient experienced vaccine reaction. Laboratory investigations and corrective treatment was not reported. At the time of this report the outcome of event was not reported. Documents held by sender: none.
Didn't experience that much of side effects as he would have expected for his second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Didn't experience that much of side effects as he would have expected for his second dose) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Didn't experience that much of side effects as he would have expected for his second dose). At the time of the report, VACCINATION COMPLICATION (Didn't experience that much of side effects as he would have expected for his second dose) had resolved.            No concomitant medications were provided. No treatment medications were provided.  Patient wanted to double-check that he received Moderna's vaccine or other. Patient still unsure if the vaccine was real Moderna's or not.
Stated  I got my flu shot during the flu clinic about 2 weeks ago and ever since then I have had very limited range of motion in my arm.  I gave it a couple days, since I usually have a sore arm for a couple days after getting vaccines, but it seems like the problem is getting worse rather than better. It really hurts to lift my left arm over my head or towards my midline.  At times, my little/ring finger goes to sleep.  I've tried icing/heating my shoulder and have been taking Ibuprofen and Tylenol as needed for the pain. It didn't hurt terribly when I got the shot, but progressively has gotten worse.  My only concern is that I had a hard time doing simple things at work, i.e. helping move someone up in bed, reaching for pillows on the top shelf, moving beds around.
Patient presented at drive-thru stating she needed her second dose and gave staff a record card that only had one documented dose on it, so a dose was administered.  Following the clinic it was discovered that she had already had a second dose administered on 2/19/2021.  Patient was contacted on 3/23/21 and she stated that she "forgot" that she'd already had her second dose.  Stated she was having no adverse reactions to the third vaccine and would voiced understanding that she should not have any additional doses at this time.
Left arm pain "after shot" - that radiated to left neck. "Cannot sleep - no fever had frontal headache. Can't take TYLENOL or ADVIL due to acid reflux. Ached all over. Couldn't pull bed covers up with left hand/arm. Had H1N1 vaccine last year. Was advised to call doctor if not improved by 10-12-10.
received 1st dose 7 months ago.; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine  (received 1st dose 7 months ago).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 23-Jul-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient received his/her 1st dose 7 months ago and asked that the series did need to be reset. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingles vaccine, which led to incomplete course of vaccination. The follow-up could not be possible as no contact details were available.