chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I've been vaccinated but still had a bad case while on vacation / Suspected vaccination failure; I've been vaccinated but still had a bad cas while on vacation; 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've been vaccinated but still had a bad case while on vacation / Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I've been vaccinated but still had a bad cas while on vacation). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolving.   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: 26-JUN-2023 This serious case was reported by the patient via interactive digital media. The patient had been recovering from Shingles since April 2023. The patient stated it was what it was. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Patient experienced egg-like bump at injection site. Area around injection site and below became hot to touch and a red thick band around the arm for an appearance. Patient also experienced a tightness in her throat.
pt recvd vax & had inc t; redness & soreness; to er. tx w/ apap, dph, motrin, augmentin;
Pt stated swelling, itching over torso waist up to head left side (large area) redness at injection site and shoulder to elbow. Tender to touch 5-28 and 5-29. Took BENADRYL to set side affects to reduce.
their arm was sored; slight headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (their arm was sored) and HEADACHE (slight headache) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (their arm was sored) and HEADACHE (slight headache). At the time of the report, PAIN IN EXTREMITY (their arm was sored) and HEADACHE (slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   No treatment medications were reported
Chills, body aches, headache lasting approx. 9 hours the day after the injection.
Intense, debilitating abdominal pain and cramping starting 12 hours after first oral dose.    Intermittent at first then intensifying and becoming continual  Nausea, loss of appetite. Given Bentyl for spasms.
patient presents to the ER complaining of nausea, vomiting, diarrhea on 3/1 @ 0134 AM.  She states the symptoms occurred gradually on 2/28.  She is admitted to the hospital with a diagnosis of noninfective gastroenteritis.  She states the symptoms are aggravated by food and alleviated by remaining still.  She states she has not experienced similar symptoms in the past.  The patient and the hospitalist, Dr., attributes her symptoms to the Moderna Vaccine.  Patient is given IV fluids (NS), protonix, and Zofran for her symtpoms.
extremely upset; crying; clumps of hair started to coming out, scalp is healthy, healthy person.; same rash which was worse; This spontaneous case was reported by a consumer and describes the occurrence of RASH (same rash which was worse), ALOPECIA (clumps of hair started to coming out, scalp is healthy, healthy person.), FEELING ABNORMAL (extremely upset) and CRYING (crying) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M70) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced RASH (same rash which was worse). On 07-Apr-2021, the patient experienced ALOPECIA (clumps of hair started to coming out, scalp is healthy, healthy person.). On 21-Apr-2021, the patient experienced FEELING ABNORMAL (extremely upset) and CRYING (crying). At the time of the report, RASH (same rash which was worse), ALOPECIA (clumps of hair started to coming out, scalp is healthy, healthy person.), FEELING ABNORMAL (extremely upset) and CRYING (crying) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medicine and medical history were not provided. Treatment medicine were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-083025 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow up document contains No New Information; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-083025:1st dose vaccine
I began to have pain and cramping in my stomach during the week of Monday, November 16, 2009.  The pain and cramping increased on Sunday, November 22, 2009.  I had bleeding and cramps on Wednesday, November 25, 2009.  I called my doctor and he told me to come in that morning.  I had a sonogram after which I was told that I miscarried my baby.  I was about 4 weeks pregnant. 11/30/2009 OB-GYN records and MR for 11/25/2009. Dx Missed abortion  OB records note patient pregnant with EDC 6/17/2010. on 11/25/2009 had D&C, c/o' uterine cramping, US verified non viable fetus.
was very tired.; she experienced dizziness; imbalance "my balance was off"; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 88-year-old female patient received bnt162b2 (BNT162B2), administration date 17Feb2021 (Batch/Lot number: unknown) as single dose for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: fatigue with onset 17Feb2021, outcome "unknown", described as "was very tired."; dizziness with onset 17Feb2021, outcome "unknown", described as "she experienced dizziness"; balance disorder with onset 17Feb2021, outcome "unknown", described as "imbalance "my balance was off""; headache with onset 17Feb2021, outcome "unknown", described as "headache".  Additional information: consumer agreed to be contacted later, if possible after 5:00 PM, declined to file a report online on website name) 2 hours after the 1st COVID-19 vaccine, she experienced dizziness, imbalance "my balance was off", headache and was very tired. I was that way for 2 or 3 days. Patient is 88-years old. The first dose was administered 12 days ago, her next vaccination is scheduled for 11Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Twenty minutes after injection mental fog, then onset of headache which became debilitating, requiring 5mg of Oxycodon every four hours for five days to be functional. Woke up every night after four hours, from pain, took meds, an hour later able to sleep again. Stabbing knifelike pain over right eye, Able to transition to naprosyn, Advil and Tylenol after five days, but still in constant pain eight days later, even with meds.  No sensitivity to light, some mild nausea for first few days.
confused; weak; fatigued; This spontaneous case was reported by an other caregiver and describes the occurrence of CONFUSIONAL STATE (confused), ASTHENIA (weak) and FATIGUE (fatigued) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced CONFUSIONAL STATE (confused), ASTHENIA (weak) and FATIGUE (fatigued). At the time of the report, CONFUSIONAL STATE (confused), ASTHENIA (weak) and FATIGUE (fatigued) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment of these events were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Follow up received on 15APR2021 included no new information.
Information has been received from a medical assistant concerning a premature baby who was born at 22 weeks gestation. The mother was a 26 year old female patient with no pertinent medical history, who on unspecified dates were vaccinated with two doses of GARDASIL (lot# not reported). The mother's Last Menstrual Period was 17-SEP-2009 and expected date of delivery was 24-JUN-2010 (also reported as 23-FEB-2010). The mother was referred to a "high risk physician" because she received GARDASIL during pregnancy. The medical assistant informed that the mother had a "normal healthy delivery" on 23-FEB-2010 (22 weeks from LMP). The medical assistant reported that their office had no information on the health of the baby. It was unspecified if the patient sought medical assistant. Upon internal review, the baby was born by 22 weeks from LMP was determined to be an other important medical event. The mother's experience has been captured in WAES 0911USA02681. Additional information is not expected.
Information has been received from a physician concerning a patient who was vaccinated with an initial PO dose of Rotateq. Subsequently the patient developed bloody stools. It was described as dark in color. It was not reported if medical attention was sought. The patients outcome was not reported. There was no product quality complaint involved. The patients bloody stool was considered to be an other important medical event. Additional information has been requested.
Pfizer Dose 1 1/7/21 (EL0142); Pfizer Dose 2 10/13/21 (FD0809); COVID Positive 2/14/22. 2/14/22: 81-year-old male patient with a history of type 2 diabetes, depression, COPD, CAD, BPH, hypertension lives at a local nursing home where he was moved recently from another nursing home.  Over the last couple of days, the patient was visited by his family members who noticed slurred speech becoming worse this morning.  When the family spoke with him on 02/13 over the phone, they noticed some difference in his communication and the nursing staff at the nursing home mentioned that the patient could be having some infection and is daily reassess.  But this morning when the patient was seen by the family, he had significant slurred speech which concerned them and hence he was brought to the hospital for further evaluation.  The noticed that his left-sided facial droop which became more evident this morning.  Patient is also scheduled for a neuro psychological evaluation at the Administration in May of this year as the family wanted clear diagnoses for his cognitive dysfunction. Neurology consultation was obtained from the emergency room for evaluation of his slurred speech.  CT of the head was negative and the patient is admitted for further evaluation and treatment. A Foley catheter was placed in the emergency room which is draining the noon tinged with blood.  The patient denies any abdominal pain.  He does have urinary incontinence and wears depends but the family has not noticed any blood in the urine and the nursing staff at the nursing home did not inform them of any new onset of hematuria. 2/24/22: 2019 novel coronavirus detected. Acute cerebrovascular accident (CVA), Acute cerebrovascular accident (CVA). Dysarthria, Dysarthria
02/20/21 5 days later after shot started reporting complaints. Hospital Visit with chest pains and confusion.   03/07-03/14 2021 hospital stay with encephalopathy, delirium?s, confusion.    03/20/-03/29 2021 hospital stay with hallucinations , staring and continued decline in health.
on 4/16/2021 @ 4:42AM I woke up with severe pain in my finger tips; swelling and burning (at the time no redness).  Today, 4/17/2021, my finger tips have painful red blisters on them (feels like they are on fire).  Ring and Pinky fingers on my left hand are numb at the finger tips down to the second knuckle (on each finger).  I have taken (1) 81mg children chewable aspirin this morning at 8:00AM; at 12:00PM I took (1) 500mg pill of Tylenol and repeated the Tylenol at 4:00PM & 10:00PM.  They haven't worked at all with the fiery pain, swelling, nor the blistering redness on my finger tips.
Four minutes after vaccine administration, severe burning chest pain, lightheadedness, dizziness, scratchy throat, metallic taste in mouth was experienced. The next day, a pruritic rash appeared on my right forearm and bilateral thighs. Two days after vaccine numbness to right leg that lasted about 24 hours.
fatigue;  could not work more than 2 hours the next day;  had trouble staying awake driving home;  had to continuously pinch myself to stay awake while driving.    Went to a "urgent care"  (walk-in) doctor facility to have a doctor see if I had  something seriously wrong with me  later that day. shivering;  it was 78 degrees in the lab where I worked the 2 hours that morning, and I was shivering the whole time.
Pt was here to receive his Covid vaccine. He was given the 6mo-11yr formulation of the Moderna vaccine accidentally. The error was caught before the pt left. CDC recommendation for lower than authorized dose was looked up and found to be to repeat vaccination with correct dosage immediately (no minimum interval). Error was explained to patient and family and they agreed to be vaccinated with correct dosage. The invalid dose was Moderna 6mo-11yr, lot #AU5509B, NDC 80777-0287-07, exp date 5/19/24. Administered in right deltoid. Correct vaccine given; see Covid checklist; patient was advised to wait 15 minutes after vaccine before leaving.
The primary reporter for this case is the patient. Pt explained that during her vaccination with MMR II vaccine on 10/17/2012 she had a urine pregnancy test that came back negative. On 10/21/2012 she took a second urine pregnancy test that came back positive. No Further AE information was provided. This is an amended report. The gender was entered as female, the pregnancy field was marked as, prospective was checked as report type and unknown was added as pregnancy outcome.
Refridgeration excursions identified; No Adverse Event; Poor quality vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No Adverse Event) in a 20-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.         For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    No concomitant medications were reported.   Dose 4 vaccine administered through deltoid.  It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation. No adverse reactions reported for any of these patients.  The Nurse reports a temperature excursion that has occurred in a refrigerator at her clinic containing both monovalent and bivalent Moderna Covid-19 vaccines. The Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients.   The Nurse was now calling about Moderna Monovalent and Bivalent vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022.   No information was available on that patients at this time.   It was unknown that the patient ever been diagnosed with/ tested positive for COVID-19.  The patient had received moderna vaccine doses 1, 2, and 3 intramuscularly and at the deltoid site of the body.  No treatment medications were reported.
Around 3:30am, I woke up out of sleep with a severe migraine headache the next day following taking the 2nd dose of Pfizer shot. It continued to hurt through out the day. Around 1pm after taking a short nap, my  body began to ache. Around 4:00pm decided to take 2 alleve over the counter pain pills. They did not work. Overall, symptoms have been severe throbbing headaches, body aches and fatigue.
Nausea/vomiting, diarrhea, severe abdominal cramps, body aches, headache, fever, diaphoretic, pale, manifestation s/s over 8 hour period. Pt experienced altered mental status, SOB. Primary Tx: Fluids, Tylenol, Benadryl. Sent to ER.
pt recvd vax; c/o low grade t since fri; rash since sun; irritable & dec appetite;had enlarged, red, rt tonsil which had some white exudate;Lt TM red;pink macular rash on chest,back & abdo;viral cause which led to bacterial Lt otitis per MD
Had a real serious side effect, not a side effect but a reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had a real serious side effect, not a side effect but a reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Had a real serious side effect, not a side effect but a reaction). At the time of the report, VACCINATION COMPLICATION (Had a real serious side effect, not a side effect but a reaction) outcome was unknown.            No concomitant medications were provided. No treatment medications were reported.
Patient received monovalent Pfizer vaccination instead of bivalent Pfizer. Patient was instructed to come back in 2 months to receive the correct bivalent pfizer vaccine.
Chills; Staggering at times; Could not get out of bed for some time; Lack of sex drive; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization; leuprorelin acetate (ELIGARD), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 7.5 mg for an unspecified indication. The patient medical history and concomitant medications were not reported. On unspecified date the patient experienced chills, staggering at times, could not get out of bed for some time, and also stated, the patient had all of the side effects (including lack of sex drive). The patient did not feel the vaccine was related to side effects. The outcome of all events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Initial and follow-up information has been received from an office manager concerning a 46 year old female with a history of breast cancer and an allergy to VICODIN, who on 20-SEP-2007 at 14:06 was vaccinated SC in the right arm with a 0.5 ml first dose of PNEUMOVAX 23 (lot #657525/0554U). Concomitant vaccinations included influenza virus vaccine (unspecified) (Lot# 79897) administered intramuscularly in the right deltoid. There were no illnesses at the time of the vaccination. On 21-SEP-2007 the patient developed cellulitis at the injection site. On 21-SEP-2007 the patient called and was seen in the physician's office. The patient was treated with KEFLEX. No laboratory diagnostics were performed. The patient recovered on an unspecified date. The office manager is requesting a lot check. A standard and enhanced lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the government and was released. The physician considered the cellulitis at the injection site to be an other important medical event. Additional information is not expected.
Began to have redness and swelling at injection site.  By Sunday Morning stated that arm was red and swollen from elbow to shoulder. Pt stated it took until Tuesday until the swelling went away.
Sickness; Had no energy; I was shivering, feeling so cold felt like ice in my veins/I felt frozen, had no energy/The chills come and go still in episodes; I had the worst headache of my life/ feeling headache; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (Sickness), ASTHENIA (Had no energy), FEELING COLD (I was shivering, feeling so cold felt like ice in my veins/I felt frozen, had no energy/The chills come and go still in episodes) and HEADACHE (I had the worst headache of my life/ feeling headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 018B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), VITAMIN B12 [VITAMIN B12 NOS], SUCRALFATE (CARAFATE), VERAPAMIL HYDROCHLORIDE (CALAN [VERAPAMIL HYDROCHLORIDE]) and MECLOZINE HYDROCHLORIDE (ANTIVERT [MECLOZINE HYDROCHLORIDE]) for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sickness), ASTHENIA (Had no energy), FEELING COLD (I was shivering, feeling so cold felt like ice in my veins/I felt frozen, had no energy/The chills come and go still in episodes) and HEADACHE (I had the worst headache of my life/ feeling headache). At the time of the report, ILLNESS (Sickness), ASTHENIA (Had no energy) and HEADACHE (I had the worst headache of my life/ feeling headache) had resolved and FEELING COLD (I was shivering, feeling so cold felt like ice in my veins/I felt frozen, had no energy/The chills come and go still in episodes) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-358790 (Patient Link).