chrisvoncsefalvay/vaers-outcomes huggingface dataset:
her whole face was very swollen with no pain and she had swollen glands on her face and her; something inside her mouth busted and she experience "the most horrible bitter taste"; bitter taste and a hard time breathing; her arm became swollen and she started to experience a bitter taste (like lemon) and chills 3 or 4; her arm became swollen and she started to experience a bitter taste (like lemon) and chills 3 or 4; her arm became swollen and she started to experience a bitter taste (like lemon) and chills 3 or 4; A spontaneous report was received from a consumer concerning a 65-year-old female patient  who experienced bitter taste, a hard time breathing/Dyspnoea, her whole face was very swollen with no pain and she had swollen glands on her face and her/Lymphadenopathy, something inside her mouth burst and she experienced "the most horrible bitter taste"/Oral discomfort , her arm became swollen/vaccination site welling,  she started to experience a bitter taste/dysgeusia, chills/chills.   On 23-Feb-2021, prior to the onset of the symptoms, the patient received their the patient received first of two planned doses of mRNA-1273 (Batch number:031L20A) for prophylaxis of COVID-19 infection.     The patient's past medical history included sinus infection. Concomitant product use was not unknown    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 23-Feb-2021, the patient experienced peripheral swelling (her arm became swollen dysgeusia (she started to experience a bitter taste (like lemon) and chills. On 27-Feb-2021, the patient experienced dyspnea (hard time breathing) (seriousness criterion medically significant). On 28-Feb-2021, the patient experienced lymphadenopathy (her whole face was very swollen with no pain and she had swollen glands on her face and her) and oral discomfort (something inside her mouth busted and she experience "the most horrible bitter taste"). At the time of the report, dyspnea outcome was unknown and lymphadenopathy (her whole face was very swollen with no pain and she had swollen glands on her face ), oral discomfort (something inside her mouth busted and she experience d "the most horrible bitter taste"), peripheral swelling (her arm became swollen) , dysgeusia (she started to experience a bitter taste (like lemon) and chills had not been resolved.     Treatment for the event included Ibuprofen.    The outcome of the events were not resolved.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
No adverse event; Poor quality product administered; Temperature excursion occurred; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 29-Nov-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred) 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 POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred).    No concomitant medications were reported.   No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-687690, US-MODERNATX, INC.-MOD-2022-687785, US-MODERNATX, INC.-MOD-2022-687787, US-MODERNATX, INC.-MOD-2022-687788 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-687690:Original case US-MODERNATX, INC.-MOD-2022-687785: US-MODERNATX, INC.-MOD-2022-687787: US-MODERNATX, INC.-MOD-2022-687788:
PRODUCT COMPLAINT; INTERFERED WITH HIS SLEEP; REMAINS TIRED; NAUSEA; This spontaneous report received from a parent concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the patient experienced interfered with his sleep, remains tired and nausea. On an unspecified date, the subject experienced product complaint. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from nausea, had not recovered from remains tired, and the outcome of interfered with his sleep and product complaint was not reported. This report was non-serious. This report was associated with a product quality compliant : 90000176058 This suspected product quality complaint has been confirmed to be void (does not meet criteria) based on PQC evaluation/investigation performed.
3 hrs p/vax pt was screaming in the car & vomited; a/pt vomited turned blue; appears limp; starting crying again p/brought back to the office; PE was nl;
9/26/06 client received TWINRIX in right deltoid. Received ADACEL in the left deltoid. Clint complained of "tingling" in right hand and some soreness in right deltoid. Resolution in 5 minutes. 10/9/06, c/o "chest pain" which turned halted 10/6/06. Referred to ER physician for f/u.
Plunger on Fluvirin prefilled syringe did not depress...regave shot in same arm.
i had no initial reaction to any of the shots which is why this is so strange. I had a reaction 6 months after shot 3 targeting the fillers in my face.
Received on 12/12/09 - on 12/15/09 - light headed not feeling well headache since 12/16/09 - sleeping most of the day - denies fever without vomiting - called FMD 12/17/09 - to go to doctor 12/21 if no change of symptoms. 12/21/09 per mother was in school on 12/21/09.
Tested NAAT positive for COVID 10/11/21 after being fully vaccinated.
No ADR, timing ERROR, 2nd dose given 43 days after 1st Narrative: No ADR, timing ERROR, 2nd dose given 43 days after 1st.
I'm not sure of exact dates... At 4 months of age I noticed patient not using his left hand.  We told pcp and was referred to a neurologist.  On January 17, 2009 we found out that patient had a severe right cerebral stroke.  The MRI showed the stroke occured around 2-3 months.  My husband and I began looking back at pictures and saw that before his vaccines patient could push with both hands and look to his left.  Pictures immediately after show a clinched left hand and a crooked smile.  Patient is now 2 1/2 diagnosed with left hemi-paresis, 50% visual field cut to the left, strabismus and developmentally behind.  He receives occupational therapy, physical therapy, speech therapy, a visual aid teacher, and orientation & mobility specialist and a chiropractor.  He sees his neurologist and opthamalogist regularly.  patient will be receiving surgery on his eye soon (just found out yesterday so I don't have a date yet).
Patient's arm swelled up immediately after injection. Became very tender, swollen, and hard in a one inch radius around the injection site. Patient did not feel dizzy, could breathe fine, and overall felt in general health. I had the patient sit in the sitting room for five minutes under observation, then in the waiting room for 15 minutes. After 15 minutes, I checked on the patient to monitor for changes, and the swelling and hardness had stopped progressing. He still felt "the way he usually feels", so I instructed his son to continue to monitor him and seek medical attention if he started to worsen or show signs of anaphylaxis.
This spontaneous report as received from a health professional, refers to unspecified number of patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, unspecified number of patients were vaccinated with improperly stored RECOMBIVAX HB injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaint (PQC) involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
My arm start hurting and upon looking at the injection site. It was given at the back of my left arm not at deltoid muscle.
Information has been received from an office manager concerning an approximately 18 year old male patient who on an unspecified date was vaccinated with a fourth dose of RECOMBIVAX HB (lot number unspecified). The office manager reported that after the three doses of RECOMBIVAX HB were given to the patient, all blood work (hepatitis B surface antibody) came back negative, not immune (lab was 5). The patient was administered at least one dose of RECOMBIVAX HB, lot #603895/0748V. The patient required a fourth dose of the vaccine. The hepatitis B surface antibody was repeated a month after the fourth dose was given to the patient and the result was greater than 1000. The patient did not develop hepatitis B. No other adverse experience was reported. At the time of the report the patient's outcome was unknown. It was unspecified if the patient sought medical attention. The office wanted to know if lot# 603895/0748V was associated with failed immunity. Follow up information has been received from the office manager who reported that on 30-SEP-1992 (approximately at the age of 23 weeks) the patient was vaccinated with a dose of RECOMBIVAX HB (lot number lot # 603895/0748V), (adult dose vaccine; actual dose not reported), as an infant. The office manager could not confirm if the vaccine was stored correctly back in 1992. A preliminary lot check investigation was performed. To date our investigation has found that this lot conformed to quality release parameters and the manufacturing was typical of a lot of RECOMBIVAX HB. Additional information will be provided upon finalization of this manufacturing investigation. Follow up information has been received from a physician who reported that a current 18 year old, no smoker with no pre-existing allergies, birth defects or medical conditions, that at the age of 23 week, on 24-AUG-1992 was vaccinated with a first dose of RECOMBIVAX HB in the left leg (route unspecified, lot number: 603897/0750V). On the same day the patient received a second dose of DTaP, poliovirus vaccine, Hib conj vaccine (unspecified carrier) (LEDERLE) in the right leg (route unspecified, lot number:318-908), second dose of poliovirus vaccine, Hib conj vaccine (unspecified carrier) (LEDERLE) in the right leg (lot number: 320-9320653A), orally and a second dose of hepatitis B vaccine, recomb (PRAXIS) (route unspecified, lot number:M130JB) in the right leg. On 30-SEP-1992, the patient was vaccinated with a second dose of RECOMBIVAX HB in the left leg (route unspecified, lot number: 603895/0748V) in the left leg. On 22-OCT-1993, the patient received the third dose (route unspecified, lot number: 607248/0451W). On 13-MAY-2010 the patient underwent a hepatitis B surface antibody which was <5 mIU/L (not have immunity to hepatitis B virus). On 02-JUN-2010, the patient received a fourth dose of RECOMBIVAX HB (manufacturer unknown). On 09-JUL-2010, the patient's hepatitis B surface antibody which was > 1000 mIU/L (immunity to hepatitis B virus). This is one of several reports received from the same source. In the AE screen the event of overdose was deleted. Additional information is not expected.
Information has been received from a health professional concerning a 7 year old white female who on 23-MAR-2007 was vaccinated intramuscularly into the leg with a booster varicella virus vaccine live (Oka/Merck) (Lot # 655071/1148F). On 23 MAR 2007 the patient experienced "local pain" which resolved in one day, 24 MAR 2007. It is unknown if medical attention was sought. There was no product quality complaint. Additional information is not expected.
pt recvd vax; pt exp mild pain in inject arm; when pt recvd 2nd dose, pt devel knot & exp pain at both of inject sites which progressed to difficulty of lifting arms;
Patient said this was her first covid vaccination, she received shot and during her 15 minute observation returned to the pharmacy counter with a vaccination record that showed she had received 2 doses of Pfizer (one in feb 2021 and one in march 2021). she said she was confused and thought she had not received yet
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient pertinent medical history included diabetes. Drug reactions/allergies were reported to be for HUMALOG, NOVOLOG, VICTOZ and SYMLIN. On 21-MAR-2014 the patient was vaccinated with ZOSTAVAX. Concomitant therapies included insulin (unspecified brand, unspecified manufacturer). On 21-MAR-2014 the patient received a dose of ZOSTAVAX and then approximately on an unknown date in March 2014, the patient experienced injection site reaction, injection site is red and swollen and injection site is red and swollen. The area involved had the circumference size of a tennis ball. There was no rash. The patient does not have any pain, itching or discomfort. The pharmacist told the patient to take BENADRYL and to apply hydrocortisone cream on the area. The outcome of injection site reaction and injection site is red and swollen was reported as not recovered/not resolved. The patient sought medical attention reported as called pharmacist on 26-MAR-2014. Action taken with the suspect product was unknown. The reporter causality was not provided. No product quality complaint was reported. Additional information has been requested.
Dose #1 given 1/15/2021  Dose #2 was given too early on 2/6/2021 (day 22)
Within an hour of receiving the vaccine, I began itching and breaking out everywhere. I suffered from extremely severe hives and itching, also with large whelps all over my body from my face all the way down to the top of my feet. Lasted 3 plus months duration in which I did not sleep well during the entire time due to the excessive itching. Was the most miserable 3 plus months of my life.
Copied and pasted triage note from call center: HAD DTAP/POLIO IN L ARM YESTERDAY. TODAY MOM NOTED AREA OF REDNESS AND SWELLING AT SITE. NOT C/O PAIN, BUT CHILD DOESN'T WANT HER TO TOUCH IT. FEELS HARD AT SITE. FELT WARM EARLIER, BUT DIDN'T TAKE TEMP. GAVE TYLENOL. CHILD PLAYING. Patient was seen in urgent care 05/8/10. Copied and pasted provider note: Reviewed intake note. SUBJECTIVE: Patient is a 4 yr old female who presents with erythema and tenderness.   Location: left upper arm   Onset: acute   Duration: 1 days and symptoms are worsening   Patient Active Problem List:   CLOSED FX FEMUR, SUPRACONDYLAR LESION SIZE/LOCATION: Left upper arm from tip of shoulder to just above elbow, in a circular area LESION DESCRIPTION: erythema and swelling    A/P:Cellulitis vs local reaction to immunisations. Will treat with Keflex and Benadryl as directed. To return PRN. Patient seen again by PCP on 5/8/10 for allergic reaction to Keflex Per PCP:LIKELY EXTREME LOCAL REACTION TO KINRIX (DAPT-POL), COULD BE TO VARICELLA
Information has been received from a health professional concerning a male who was vaccinated PO with a first dose of Rotateq. Subsequently the patient experienced diarrhea for seven days. The patient was also reported as being lethargic. Unspecified medical attention was sought. Subsequently, the patient recovered. Additional information has been requested.
After about 10 minutes I started feeling weird. I became light headed. Then I felt a burning sensation done both arms and my tounge. My heart was beating fast and I was struggling to get my breathing under control. My throat also got tight or warm and that feeling seem to go down through my chest. The monitor told me to take off my mask and gave me water. Shortly after I started to gag and almost vomited. The monitor checked my blood pressure and it was 180 over 120. I was admitted to the ER. I stayed there for about an 90 minutes as was released as the symptoms seemed to leave. While driving home many of the symptoms resurfaced. When I returned home I took a zyrtec and an anxiety medication. A day after I am light headed and a little nautilus but otherwise ok.
Fever, rash over face, stomach back, in hairline, partially on arms and legs and buttocks.  Some spots inside of mouth.
Headache; Fatigue; Muscle pain; Joint pain; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), FATIGUE (Fatigue), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and PYREXIA (Fever) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced HEADACHE (Headache), FATIGUE (Fatigue), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, HEADACHE (Headache), FATIGUE (Fatigue), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown. Not Provided          No relevant concomitant medications were reported.  No treatment information was provided.
some temporary diarrhea; felt tired; This is a spontaneous report from a contactable consumer. An 83-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247, expiry date: unknown), via an unspecified route of administration on 30Jan2021 (at the age of 83 years old) at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 on unspecified date at a single dose for covid-19 immunization. On unspecified date in 2021, the patient experienced some temporary diarrhea and felt tired for about 15 hours. Outcome of all the events was recovered on unspecified date in 2021.
vesicular outbreak and decreased immune symptoms; The vaccine did not prevent shingles as intended; vesicular outbreak and decreased immune symptoms which was then diagnosed as severe herpes zoster, or shingles; Information was received from a lawyer regarding a case in litigation concerning a male patient (pt) of unknown age. The pt's medical history, concurrent conditions, or concomitant medication were not provided. In an unspecified date in 2009, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided) at a medical center as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended (Vaccination failure), and the pt subsequently contracted a persistent strain of herpes zoster or shingles. In an unspecified date in 2011, the pt was treated for a severe vesicular outbreak and decreased immune symptoms (Decreased immune responsiveness), which was then diagnosed as herpes zoster, or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, and/or despite receiving the vaccine for long-term prevention of shingles, the pt suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the pt suffered and would continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of the events was not reported. The events were reported to be related to zoster vaccine live (ZOSTAVAX).
Information was received on 06-JAN-2017 from a medical assistant regarding a male patient (age not reported). Medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date the patient was vaccinated with VAQTA (lot # M052338 expiration date 31-MAY-2018)(dose not specified). The patient received the dose of VAQTA following a temperature excursion of 32-36F for 72 hours. No adverse effects were reported. The call was because of a "data logger". Additional information is not expected.
was unsure if the patient had COVID-19 virus; was unsure if the patient had COVID-19 virus; Inability to eat; Severe sweating; Stomach cramping/pain; Headaches that wouldn't go away; Diarrhea; A fever of of 100 degrees or more; Felt like his eyes were going to pop out; Stomach burning; This is a spontaneous report from a contactable consumer reporting on behalf of the patient via a Pfizer sponsored program. A male patient of unspecified age (husband) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation.  Medical history included headache. The patient's concomitant medications were not reported. The reporter stated her husband got his first dose on 09Apr2021, and she (the reporter) received her second dose on 12Apr2021. The reporter is concerned about the patient because he began having severe sweating, stomach cramping/pain, headaches that wouldn't go away, diarrhea, inability to eat, a fever of 100 degrees or more and felt like his eyes were going to pop out along with stomach burning after receiving the first dose of COVID-19 vaccine (in Apr2021). The reporter stated the patient had a headache before his first dose and was unsure if the patient had COVID-19 virus or if it is side effects after his first dose of COVID-19 vaccine. The reporter clarified side effects several times. The reporter also stated she had no side effects with the COVID-19 vaccine. The patient had not yet recovered from headache, while unknown outcome for the remaining events.   Information on the lot/batch number has been requested.