chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt. developed soreness from legs - lower extremities to upper extremities and weakness on 12/30/13 and 12/31/13. On 1/2/14 pt. flown to hospital.
Poor quality vaccine administered; No adverse event; HCP states that the excursion occurred on 31MAY2023 and the vaccine was administered to 4 patients post excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (HCP states that the excursion occurred on 31MAY2023 and the vaccine was administered to 4 patients post excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in a 77-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 022H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-May-2023, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 31-May-2023, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (HCP states that the excursion occurred on 31MAY2023 and the vaccine was administered to 4 patients post excursion). On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (HCP states that the excursion occurred on 31MAY2023 and the vaccine was administered to 4 patients post excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (HCP states that the excursion occurred on 31MAY2023 and the vaccine was administered to 4 patients post excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    No relevant concomitant medications were reported.  Ten doses of Moderna, go out of range (46.6 F degrees) for 5 minutes on 31-May-2023.   HCP states that the excursion occurred on 31-May-2023 and the vaccine was administered to 4 patients post excursion.  HCP stated that the vials were stored in a cooler. They were thawed vials and were stored in the refrigerated temperature range in the cooler.  No treatment medications reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-727913 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 06-Jun-2023: Patient, vaccine and narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727913:Master case
Red swelling itchy  hard lump around injection site  Lasted 4 days. Accompanied by lymph node swelling a few days prior and during  Went away on its own after 4 days
Information has been received from a physician concerning an 18 year old single female who was vaccinated on 23-Jan-2007 with the first dose of GARDASIL (Lot # 655165/1425F), on 23-Mar-2007 was vaccinated with the second dose of GARDASIL (Lot # 655165/1425F) and on 23-Jul-2007 was vaccinated with the first dose of GARDASIL (Lot # "0389U"). The patient has an abnormal PAP test since receiving the vaccination and needed a colposcopy. The patient did not have positive PAP test prior to receiving the vaccination. Medical attention was sought in the office. Patient outcome was unknown. No product quality complaint was involved. Additional information has been requested. 02/17/2010 Follow up information was received from a physician indicating that the patient had the first abnormal PAP in July 2007 (ASCUS with diagnosis of HPV) and in January 2008 underwent colposcopy which was bening. The patient is still being treated. Follow up information was received from a physician indicating that she does not have any additional information at this time and in re-reviewing the chart, the doctor wishes to withdral the report. This report is realted to report WAES # 0902USA04152, 0803USA01379, 0803USA01380 with the same source. No further information is available.
Vial was first punctured on 10-AUG-2022 10:45 AM and administered on 11-AUG-2022 09:05 AM; No adverse event; Dose administered more than 12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours post puncture), PRODUCT STORAGE ERROR (Vial was first punctured on 10-AUG-2022 10:45 AM and administered on 11-AUG-2022 09:05 AM) 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. 060A22A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Aug-2022 at 9:05 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Aug-2022 at 9:05 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 10-AUG-2022 10:45 AM and administered on 11-AUG-2022 09:05 AM) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours post puncture), PRODUCT STORAGE ERROR (Vial was first punctured on 10-AUG-2022 10:45 AM and administered on 11-AUG-2022 09:05 AM) 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 (Dose administered more than 12 hours post puncture) and PRODUCT STORAGE ERROR (Vial was first punctured on 10-AUG-2022 10:45 AM and administered on 11-AUG-2022 09:05 AM).    This case contains information for the 2nd of two adult patients as described by the reporter.   No concomitant medications were reported. Number of doses/vial were 2 doses/1vial.  On 03-Aug-2022 the vial was initially stored in refrigerator. Vials was stored in fridge post puncture.  Vials did not undergo any temperature excursions.  Total amount of time the vial was exposed to room temperature range (8 to 25 degree Celsius = 46 to 77 degree Fahrenheit) was 30 minutes.  No treatment medications were reported.    This case was linked to US-MODERNATX, INC.-MOD-2022-628728 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-628728:Case for adult Patient 1 of 2
After 4 days, heart palpitations, racing heart, lightheaded, chest discomfort.  After 3 weeks, saw doctor.  Diagnosed with very high blood pressure and likely heart inflammation.
Noticed itching to site PPV given within 1 hour. Within 3 hours noticed red ring and local swelling approx. 4in in diameter. Erythema and swelling continued throughout  the day. Maximun swelling included erythema from lower deltoid down to elbow around diameter of right arm. Some improvement within 20 hours.
On first day I had headache within 4 hours and chills.  Later that day I started having fatigue.  The fatigue has basically continued .  About 3-4 weeks in my left arm started tingling then on or about May 10th I started having back pain and joints hurting which I had lifted a case of water and moved a piece of furniture ever so slightly and I normally recover from something like that next day - I have been on anti inflammatory and other meds without relief.  Went to a chiropractor which  made things worse.  I've had on and off episodes of fever/sweating and joints and back have continued to hurt.  Doctor did a UA test to rule out any kidney or bladder problems (history of) and my WBC was high for me - course of antibiotics and I still dont feel well.  I'm usually pretty pain tolerant , not a complainer but I have felt not myself since the vaccine.
grunting noise while apparently sleeping, fixed stare, unresponsive, pale, then emesis x2;took to ER;no fever, no known infect;will see neurologist 16SEP96;
On 11/26 at 1000 having burning and tingling in her lip on left side of face, blisters occurred and the blisters spread down to lower jaw area about nickel size. Later throughout day jaw, then down neck and shoulder were tender and felt swollen. Had dime size blistering under her left ear and lower on clavicle. Had fever of 100.1. Fever and tenderness lasted 3 days, the blistering lasted for 10 days. After 10 days symptoms were resolved. States on February 2/17 developed fever blisters on the left side of her lip and slowly spread from inner lip to corner of lip. Has taken Valtrex since 2/21 that was her moms, her mom gets recurring cold sores so she had the medication. Still has blisters.
Upper respiratory problems, severe congestion, having trouble breathing, trouble sleeping, elevated heart rate.  Follow up: Prescription not known.  Mother failed to report incident till august.
- Mild arm muscle pain about 5 min after the vaccine (second dose).  - 6-30 hours - progressive myalgias and arthralgias, fatigue   - 24 hours max temp 99.9, chills, sweats  - Symptoms all resolved by 36 hours after vaccine
Narrative: Patient with COVID breakthrough despite full vaccination likely due to underlying immunocompromise 2/2 ibrutinib use. Death likely due to disease progression
Inadvertently gave hepatitis A to soon. No S/S at time of vaccination. Attempted  to contact parents 6 times, no success.
Pt states she had tightness in her chest 48 hours after receiving Td. States,  couldnt get a full breath- used Benadryl and Primatene Mist- Notified us today of RX.
got the shot and broke out with shingles/suspected vaccination failure; shingles; blisters all over his arms; was in terrible pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male 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), shingles, blister and pain. On an unknown date, the outcome of the vaccination failure, shingles and blister were unknown and the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, blister and pain to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient's wife. The age at vaccination was not reported. The patient's wife reported that her husband never had shingles before. The doctor told the patient to take shingles vaccine and the patient broke out with shingles. The patient had blisters all over his arms. The patient was in terrible pain for 2 months. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Fever within a couple of hours. Crushing muscle aches and pain. (rating 9/10) Disorientation. Headache. Nausea. Extremely severe fatigue. Difficulty breathing (wheezing, a corset 6x too tight around torso and elephant sized weights on shoulders). Worst from hours 26-68.  Fatigue still lingers at a moderate level. Severe depression (without immediate previous prior indication) started after the 3 days of severe illness.  Depression still at a moderate to severe level.  Medical attention sought and anti-depressants prescribed. Ineffective.  Labs post injection showed a nearly 3x increase in hsCRP from prior to injection as well as ANA titer pattern change.
Approx 6 hours after vaccination pt experienced body aches and pains.  Approx 7 hours after vaccination pt experienced chills and 102 fever.  Fever stopped by the third day.
Pfizer-BioNTech COVID-19 Vaccine EUA: one day after vaccination patient presents to emergency department (ED) with myalgias, nausea, and fever. Denies chest pain, diarrhea, weakness, and shortness of breath. Oxygen saturation 88% on room air, rest of vital signs within normal ranges including temperature of 36.4 degress Celsius. Administered intravenous fluids, oxygen, antiemetics, acetaminophen, and NSAIDs. Patient's symptoms improved, oxygen saturation maintained within normal range on room air, and patient discharged to home stable.
The first few days it was extreme muscle pain in my shoulder and arm. My arm was swollen for about 3 days, I couldn?t move my arm for almost a whole week. My muscles were very weak in the arm and hurt to put pressure on it and couldn?t lift my arm. It has gotten better but it has now been 3 weeks and I am still experiencing some muscle pain and weakness in my left shoulder. The shit was administered in my left arm  directly below my shoulder bone.  I still can?t move my arm to shoulder height or higher with feeling pain and weakness in the muscle.
Received 1st anthrax vaccine, with the meningococcal vaccine, on 01/13/2003. Hours after receiving the vaccine, pt felt feverish, nauseated, and experienced 2 episodes of vomiting and diarrhea. He also reports new onset headaches. That evening, he lay flat on a cool floor, and when he awoke the next morning, all symptoms, except for the headache, had resolved. He denies a local reaction at either of the vaccination sites, except a little burning at the anthrax vaccine site. Pt describes the onset of his headaches as sudden. The location is described as frontal and bitemporal, without radiation. The quality of pain is described as sharp or stabbing, and the intensity was initially 10 of 10 on pain scale. The intensity of pain was usually less upon awakening, but would gradually increase during the day, with the range of pain intensity between 2-3 to 7-8. No precipitating factors could be identified. Increased activity aggravated headaches. Self-treatment with over-the-counter NSAIDs was not effective. After initially seeking evaluation for the headaches, it was thought they were related to allergies, and the pt was started on Allegra. He denies significant change in quality of headaches after Allegra initiated. He denies associated symptoms, except for initial episode accompanied by fever, vomiting and diarrhea. Headaches did not interfere with sleep pattern. He has no previous history of headaches. He denies a family history of headaches. He reports a very distant history of head trauma with a concussion as a child. Since the continuous headaches resolved at the end of February, he continues to experience less intense headaches, similar in character, once/week. The week of 01/19, pt developed palpitations, tachycardia and dyspnea on exertion. He had one episode, during a bike race on 2/16/03, where his heart rate was extremely elevated and he felt like he was going to black out. With some assistance, he sought medical evaluation in the ER. He was told his ECG was normal, and his heart rate was 78. Evaluation by this primary care provider included normal pulmonary function tests and labwork. A 24-hour Holter monitor revealed occasional PACs. He describes the palpitations as feeling like his heart is either racing or pounding really hard, a sensation he had not previously experienced. The sensation was worse after exertion, but no other precipitating or aggravating factors were identified. The episodes typically lasted 20 minutes. He is unable to identify relieving factors. He denies accompanying symptoms such as chest pain, nausea, or peripheral edema. The headaches, palpitations and dyspnea on exertion lasted approx 1 month and had completely resolved by the end of February. He is back to his baseline, except he feels he tires easier than he did in the past, and occasional mild headaches.
Red 5.5" x 2" area surroundings - not cellulitic - itchy rash - topical Ice/Zyrtec
Patient stated their arm was swollen, red, warm to the touch and itchy. When she came in on Sunday the arm was examined it looked fine. But she stated it was still warm to the touch.
9/24/21 at 6:00 am-Pt found on floor by nurse with complaints of headache and chest pain.  Taken to the hospital and admitted with chest pain and constipation.
Information has been received from a registered nurse concerning approximately eleven college-aged females who on unspecified dates, were vaccinated with the first, second and third doses of GARDASIL. Subsequently the patient's were experiencing abnormal pap smears since receiving GARDASIL. Prior to receiving the GARDASIL, the patient's had normal pap smears. The patient's sought unspecified medical attention. Follow up information from the registered nurse indicated that she has no medical records for these patients and that the girls live in three separate states. At the time of the report, the patient's outcomes were unknown. No product quality complaint was involved. No further information is available.
Pt experienced swollen and painful ankle joint. The pt was hospitalized. The physician suspected haemophilus type B and consequently vaccine failure. No further information is available.
This spontaneous report as received from a physician refers to an 12 year old patient of unknown gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 12-JUL-2017, the patient was vaccinated with an improperly stored GARDASIL 9 lot # M043731, expiry date 22-JUN-2019 (dose, route of administration were not provided). Data logger was not involved. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA007325: US-009507513-1709USA012766.
positive covid test; positive covid test; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16-year-old male patient received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 16 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergy to nuts" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13May2022, outcome "not recovered" and all described as "positive covid test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive; (unspecified date) Negative; (16May2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a registered nurse concerning a patient of unknown age and gender. On 11-MAR-2015, the patient received an unspecified dose of GARDASIL (0.5 ml, lot# were not reported) intramuscularly in the gluteal region (vaccine administered at inappropriate site). No adverse effects were reported. Additional information has been requested.
right arm pain; right shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (right arm pain) and ARTHRALGIA (right shoulder pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No medical history information was reported.  Concurrent medical conditions included Heart valve regurgitation, Depression, Anxiety, Dry eyes, Narcolepsy (Patient reported that she is a non-smoker, doesn't drive due to narcolepsy and is a small "thin" person.) since 2000, Low blood pressure and COPD. Concomitant products included DILTIAZEM HYDROCHLORIDE (CARDIZEM CD), PHENELZINE SULFATE (NARDIL), CLONAZEPAM, ZINC SULFATE (SOOTHEYE) and MINERALS NOS, VITAMINS NOS (CENTRUM PLUS) for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (right arm pain) and ARTHRALGIA (right shoulder pain). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Pain, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (right arm pain) and ARTHRALGIA (right shoulder pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-063790 (Patient Link).
General malaise; body aches; chills; severe headache; low grade temperature (100.0F).
Patient started itching  about 15 to 20 minutes after injection was given. She was immediately give diphenhydramine hcl capsule (25mg) but when the reaction continues, intramuscular diphenhydramine hcl 50mg/ml (0.5ml) was injected on her right deltoid muscle. The adverse effect stopped about 30 minutes after.
The pt developed a 3/4 inch hive at the site of the injection. There were no other symptoms. The pt sought unspecified medical attention. The pt's twin sister had a similar experience following exposure to varicella virus vaccine. Additional information has been requested.
Patient called clinic first thing Wednesday Morning 2/10/2021 and reports petechia above and below injection site.
Muscle aches started first on 9/30 pm then on 10/1 pm fever started, 10/1 6 pm chills (had to use 3 blankets and gloves to get relief).  Fever 100.3.  Fever at 100.0 at 1 a.m. 10/2 and fever broke before 5 a.m.  Started taking 2 acetaminophen tablets every 4 hours 10/1 - 10/2.  Today is 10/2 and just feel tired and nauseous. Had flu shot at same time but different arm.  Was unsure which flu vaccine to list above so just chose 1st one.
Pt received a 3rd vaccine of moderna. Had previously received 2 vaccines of Pfizer. No ( signs or symptoms) adverse reactions thus far.
Flu-like symptoms; muscle/joint aches, fever, chills, sweats for 2 days.
Received MMR and varicella vaccine at time of 1 year old check up. 2 days later developed 101 degree F temp for 24 hours, then unsteady gait suggested of acute mild ataxia.
After patient received his J&J COVID shot he told my technician who administered the shot that he was feeling woozey and would like some water...just after asking for the water he passed out...my technician was able to wake him but he was unaware that he passed out...911 was called and he was assessed...his blood pressure was low at 106/70 and heart rate was extremely low at 50 bpm...the EMTs assessed him for several minutes before feeling that his heart rate and blood pressure had stabilized and he was ok to leave.
Case number PHEH2013US019834 is an initial spontaneous report from the nurse received on 18 Sep 2013. This report refers to an 18-year-old female patient. Her medical history, concomitant medications and vaccination history were not reported. The patient received second dose of RABAVERT (batch number: 525011A, expiry date: 20 Sep 2016) at a dose of 1 ml via intramuscular route, on 10 Sep 2013. On the same date, after vaccination the patient had complaints of trouble walking which was reported as "gait problem was the worst" and mental impairment with foggy thinking. The patient went to the emergency room at a local hospital and then transferred to the regional hospital on 11 Sep 2013, due to the severity of events for 2 days. The patient underwent several tests (like MRI) and all were normal. The patient was discharged with diagnosis of Guillain-Barre-like syndrome. The outcome of the events reported as improving since hospitalization. The causality of the events was not reported.