chrisvoncsefalvay/vaers-outcomes huggingface dataset:
infection; left leg was swollen; left leg was sore; (sore leg) it woke her up a couple of times throughout the night; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (left leg was sore), PERIPHERAL SWELLING (left leg was swollen), INFECTION (infection) and INSOMNIA ((sore leg) it woke her up a couple of times throughout the night) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No medication history information was reported .  Concomitant products included HYDROXYCARBAMIDE (HYDREA) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (left leg was sore) and INSOMNIA ((sore leg) it woke her up a couple of times throughout the night). On 13-Feb-2021, the patient experienced PERIPHERAL SWELLING (left leg was swollen). On 15-Feb-2021, the patient experienced INFECTION (infection). At the time of the report, PAIN IN EXTREMITY (left leg was sore), PERIPHERAL SWELLING (left leg was swollen), INFECTION (infection) and INSOMNIA ((sore leg) it woke her up a couple of times throughout the night) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication include supplements. Treatment medication include antibiotics.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow up received on 23-Jul-2021 and contains no new information.
WHEN THE TECHNICIAN GAVE THE PATIENT THE  VACCINE AND PRESSED DOWN ON THE PLUNGER THE SYRINGE DETACHED FROM THE NEEDLE AND VACCINE LIQUID CAME OUT AND NEVER MADE IT INTO PATIENT ARMS. THE PHARMACIST READMINSTERED THE VACCINE BUT ONLY 0.4MLS JUST IN CASE THE PATIENT RECEIVED A SMALL AMOUNT OF VACCINE.
Moderate swelling at injection site with associated cellulitis and allergic reaction- angioedema.
Temp 102.2 the following morning (20 hours post-injection) with myalgia, fatigue. These symptoms resolved by 36 hours post-injection. Painful, red, swollen arm (injection site) then itching. These symptoms have improved but have not resolved completely (nearly 2 weeks post-injection)
Pt c/o weakness in hands & lack or coordination x 4-5 days. Rash on rt arm & behind neck. Swollen gland in neck. MD visit inconclusive. Recovered.
GBS is reported in a pt who recvd flu vax; 12 days p/inject, pt had sudden paralysis & became paraplegic w/loss of motor & sensory neurological function below the level of T12; pt hospitalized & tx w/meds; MD expect recovery;
severe bloating, then diarrhea; 23SEP92 f/u sx lasted 1 wk, unk recovery status;
A physician reported that several children over 2 years of age received a second dose of Pnu-Imune 23 and subsequently experienced unspecified adverse events. At the date of this report, no further information was available. The reporter was unable to specify the number of pts involved.
headache; aches all over my body similar to how you feel with the flu; aches all over my body similar to how you feel with the flu; very tired for 2 days; One week after the second shot I felt dizzy on two occasions; This is a spontaneous report from a contactable nurse (patient). This 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 at single dose on the left arm for COVID-19 immunization. The patient's medical history included hypertension, anxiety, degenerative arthritis and allergies: sulfa. The patient's concomitant medications were none. The patient previously took the first dose of BNT162B2 on 22Dec2020 09:30 at right arm for COVID-19 immunization and experienced headache and mild arm soreness. No other vaccine received in four weeks. Facility type vaccine was workplace clinic. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. After the second shot by 12:00, patient had a headache, in the middle of the night on 05Jan2021 patient started with aches all over her body similar to how you feel with the flu. The aches lasted for 2 days. Patient was also very tired for 2 days. One week after the second shot she felt dizzy on two occasions. No treatment received. Outcome of the events was recovered in Jan2021.  Information about lot/batch has been requested.
Patient complaining of severe pain at injection site, complaining that she is unable to move her arm,  no redness, warmth, or swelling at the site, no sign of infection. Patient advised to use hot compresses, take acetaminophen 1000 mg QID, advised to also take take ibuprofen 600 mg QID or 800 mg TID with food. Patient encouraged to follow-up if symptoms persist or worsen.
When I woke up the following morning after dose five of my COVID-19 I had muscle aches and headaches. I work at a hospital and at about nine or ten AM that morning my vision diminished rapidly. At around ten AM as I was driving home, I called all my doctors. My eye doctor was the only doctor I heard back from on Wednesday November seventh 2022 and he scheduled an appointment for today Friday December ninth 2022. The vision loss has improved although still present as of today. I learned today I have an infarcted retinal artery.
Required a booster dose and was administered a full dose (.5ml) Moderna vaccine. He was notified of the error and denied any side effects at that time.  He was advised to call the health department with any questions or concerns.
Approx 8 hrs p/immun very irritable for 4 or 5 hrs; better next 24 hrs, then apparent inc lethargy; exp sz; pt admitted to hosp dx encephalopathy unk etiology; abn head CT & MRI-encephalomalacia, abn neurologic findings;
delayed cutaneous hypersensitivity reaction  Narrative: onset 5 days post first dose. Duration 3 days.
The patient walked in to the office today 10 minutes after receiving TWINRIX vaccine here as ordered. She c/o throat tightness. NO wheezing, coughing, or sob. No hx of adverse vaccine reactions in the past. She did start the VIVOTIF Rx last night, tolerated that well.
1. 8 to 9 hours after administration:severe chills and body shaking, hands turned blue. 2.  1 hour later, severe nausea, stomach cramps 3.  1 hour later, tingling of hands
mom came in for 2nd set of shots; reported p/1st set of shots pt ran t101 & cried in a inc  pitch for hrs; called MD who told her to give APAP & put a cool clont on pt; mom states this cry was different
Received 1st shot at 10:52, departed at 11:05am at 11:08am I noticed an odd taste in my mouth.  Somewhat like a metal taste (not as bad as using a inhaler).  At 11:10am I had a tingling in my head that lasted approx 20 seconds.  The taste in my mouth was coming and going while driving home.  Approx 3 hours later I noticed I had no taste at all.  Tried eating different things to see if I could taste anything.  I had a slight taste with lemondade, Swiss cheese and hot sauce.   This morning 9 Apr 2021, taste is still off and cannot taste.
I had significant pain at site of injection starting about 1 day after initial injection.  From that time unitl now I experienced shoulder and muscular pain intermittently around the injection site and throughout my left shoulder region.  Sharp pains occurred with certain movements and at unexpected time.  On 3/18/21 I experienced serious pain at the injection site and radiating down my left arm.  I was unable to move my arm due to the pain. The pain was so severe (10 out of 10) that I couldn't sleep and I was concern it might be a heart attack.  I went to an urgent care center, They did an EKG and assuerd me that it wasn't a heart attack. The physican diagnosed a frozen shoulder and asked about the timing of my Covid vaccine.  I followed up the next day with my primary care physician and he suggested I report this as possibly related to vaccination.  The pain today is still centered right at the injection site.
patient younger than 4yo got Kinrix; 3rd dose of dtap and polio; the patient received kinrix on thigh; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-month-old female patient who received DTPa-IPV (Kinrix) (batch number 3KS4F, expiry date 22-MAR-2024) for prophylaxis.   On 12-APR-2023, the patient received Kinrix (intramuscular, right thigh). On 12-APR-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: patient younger than 4yo got Kinrix), inappropriate schedule of vaccine administered (Verbatim: 3rd dose of dtap and polio) and vaccine administered at inappropriate site (Verbatim: the patient received kinrix on thigh). The outcome of the inappropriate age at vaccine administration, inappropriate schedule of vaccine administered and vaccine administered at inappropriate site were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-APR-2023 The vaccine administration facility was the same as primary reporter. The reporter was consented to follow up. The reporter reported that patient received third dose of dtap and polio at 7 months old, which led to Inappropriate age at vaccine administration, Inappropriate schedule of vaccine administered. The patient received Kinrix on thigh, which led to vaccine administered at inappropriate site.; Sender's Comments:  US-GSK-US2023059931:Same reporter
8 days after vaccine patient had a inflammed arm near injection site that lasted a couple of says. The arm was warm and a little itchy.
Experienced some pretty weird stuff; had pain as the second dose really hurt while being administered; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Experienced some pretty weird stuff) and VACCINATION SITE PAIN (had pain as the second dose really hurt while being administered) in a 23-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Experienced some pretty weird stuff) and VACCINATION SITE PAIN (had pain as the second dose really hurt while being administered). At the time of the report, FEELING ABNORMAL (Experienced some pretty weird stuff) and VACCINATION SITE PAIN (had pain as the second dose really hurt while being administered) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test normal: normal normal. On an unknown date, Electrocardiogram: normal normal. On an unknown date, Thyroid function test: normal normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Upon internal review on 04-Aug-2021, the age was corrected to 23 years.    This case was linked to MOD-2021-211825 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Symptoms: pruritic chest Intervention: VS stable. Monitored. Stayed an additional 15 minutes due to appointment at the hospital, total 30 min. Instructed patient to go to the nearest ED if s/sx worsens. No SOB noted. Denies pain. States may take Benadryl at home.
breakthrough scare--flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (breakthrough scare--flu like symptoms) 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 INFLUENZA LIKE ILLNESS (breakthrough scare--flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (breakthrough scare--flu like symptoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Polymerase chain reaction: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment information was provided.
Right upper extremity weakness and atrophy. Difficulty with hand (R) fine and gross motor skills. Loss of grip in right hand. Intravenous immunoglobulin (IVIg) treatment starting 7/21/2016.
- Symptoms:  - nausea, headache, unable to eat due to nausea - liver HBV elevated reported from blood tests - yellow urine - yellow skin all over body - chill Treatment:   - livery biopsy  on 6/14 at hospital - No clear treatment, patient 's condition is not improving at this time when reporting this form.
Reported to clinic very fussy and crying. Welps on face, abd, arms and back. Eye swollen. BENADRYL 12.5ml 3.75 ml given. Welps bone but continued redness after 45 min. No resp. difficulty noted. Instructed to given BENADRYL every 6 hours as need. Report to ER for any resp. difficulty.
This spontaneous report as received from a nurse, She states that doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patients. The patients were vaccinated with M-M-R II. Other suspect therapies included ROTATEQ, oral. No concomitant medications were reported. On an unknown date the patient experienced doses of MMR II and ROTATEQ that were exposed to 50f for 48 hours were administered to patients. No treatment information was reported. Doses of MMR II and ROTATEQ that were exposed to 50f for 48 hours were administered to patients is not related to M-M-R II and ROTATEQ, Oral. At the time of the call, she does not know who received the doses of improperly stored vaccine, but she would like to know if they should be revaccinated. She will call to provide the details where she is able to retrieve the information. SR # provided. It is not know at this time if there have been any adverse effects. Rotavirus vaccine Date given 11/02/2012. Lot # 0210AE. Additional has been requested.
Patient had no problems at the time of either first or second vaccine. He started having chest pain and hemoptysis on 7/2/2021 and was seen an a local emergency hospital on 7/6/2021. He was diagnosed with a pulmonary embolism, by CTA. No history of VTE and no provoking factors - had short flight prior to onset of symptoms.
Patient developed Red swollen upper L arm/deltoid swelling redness - small oozing yellow blister like fluid. Area warm to touch, itching and painful. after receiving Menveo vaccine to left upper deltoid.
Spiked fever to 103F on Mon (8-Jan) 0300. Febrile seizure 1745 lasting about 2 minutes. Patient admitted to the ER.
Patient received Pentacel, Prevnar, & Rotateq on 7/13/09.  Within minutes, patient developed 2 small hives on feet & legs.  No breathing dificulties or any other hives.  At 7PM, patient screamed inconsably for 1 hour the leg where the pentacel was given was firm and swollen.  Tylenol was given. Within 1-2 hours symptoms resolved.  Recheck next AM was completely normal.
Patient got her second dose of SHINGRIX on 7/27/18 and on 8/10/18 was diagnosed with and sought treatment for Shingles. She said she had a rash.
Received my initial vaccination on 12/22/2020 with the typical site reaction of redness, swelling, and tender to touch.  These symptoms lasted until 12/26/2020.  On 12/30/2020 noted that injection site is reddened, warm to touch, and has pruritus.   Diameter of the redness is 2-3 inches.   No other signs or symptoms are noted at this time.
injection site became itchy, hard and hot.  Upon look at in the mirror it appears red as well.; injection site became itchy, hard and hot.  Upon look at in the mirror it appears red as well.; injection site became itchy, hard and hot.  Upon look at in the mirror it appears red as well.; injection site became itchy, hard and hot.  Upon look at in the mirror it appears red as well.; off label use; booster; Red/swelling arm; This is a spontaneous report from a contactable pharmacist (patient). A 59-year-old (non-pregnant) female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0175) via intramuscular route, administered in arm left on 17Sep2021 09:15 (at the age of 59-year-old) at dose 3 (booster), single for covid-19 immunisation. Medical history included MCTD (on immunotherapy), hyperlipidemia and patient had allergies to Bactrim, Antihistamine. Concomitant medications were not reported. No covid prior vaccination, no covid tested post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications were not reported. The patient historical drugs included Prednisone 5mg QD, Mycophenolate 1000mg, BID, Nifedipine XL 30mg, QD, Cetrizine 10mg QD, Atorvastatin 40mg QD, Cyclobenzaprine 10mg, HS, Calcium, QD, Budesonide/Form 160/4.5mcg inhaler QD. Patient previously received first dose of bnt162b2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EH9899) via intramuscular route, administered in arm right on 29Dec2020 16:00 (at the age of 59-year-old) at dose 1, single for covid-19 immunisation and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EL3247) via intramuscular route, administered in arm right on 19Jan2021 16:00 (at the age of 59-year-old) at dose 2, single for covid-19 immunisation. On 19Sep2021 20:00 the patient experienced injection site became itchy, hard and hot. Upon look at in the mirror it appears red as well and on an unspecified date in on 2021 red/swelling arm. Reported Event: About 2.5 days after receiving the vaccine, injection site became itchy, hard and hot. Upon look at in the mirror it appears red as well. The patient did not require the initiation of new medication or other treatment or procedure. Patient did not receive treatment for the adverse events. Information on organ involvement: Generalized prickle sensation: Yes, Localized injection site urticaria: Yes. Just around injection site red hard hot 2 diameter. Do you consider the Pfizer product had a causal effect to the adverse event. Yes. Outcome of the events injection site became itchy, hard and hot. Upon look at in the mirror it appears red as well and red/swelling arm was resolved on an unspecified date in 2021.  Follow-Up (13Oct2021): Follow-up attempts are completed. No further information is expected.
Less than 36 hours post receiving vaccine left eye started feeling swollen.; Later realized had a stye. Ive never in life had one before. Maybe just a coincidence but unsure.; 72 hours post receiving vaccinefeeling so lethargic; 72 hours post receiving vaccinefeeling so lethargic and exhausted; could hardly function, yet at the sametike had great difficulty falling asleep.; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Apr2021 at 14:45 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia and penicillin allergy. The patient did not receive any medication within two weeks of vaccination. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 21Mar2021 at 13:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 at 21:00, the patient experienced less than 36 hours post receiving vaccine left eye started feeling swollen, later realized had a stye. Never in her life she had one before. Maybe just it was a coincidence but unsure. On an unknown date in Apr2021, the patient experienced 72 hours post receiving vaccine felt so lethargic and exhausted, could hardly function, yet at the same time had great difficulty falling asleep. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. On 05Apr2021, the patient underwent COVID-19 virus test (Nasal Swab) and the result was negative. The clinical outcome of the events left eye started feeling swollen, later realized had a stye, felt so lethargic and exhausted, could hardly function, yet at the same time had great difficulty falling asleep was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
vaccines administered without temperatures being monitored; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT MONITORING ERROR (vaccines administered without temperatures being monitored) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT MONITORING ERROR (vaccines administered without temperatures being monitored) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT MONITORING ERROR (vaccines administered without temperatures being monitored) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT MONITORING ERROR (vaccines administered without temperatures being monitored).    The Moderna COVID-19 vaccines stored in the freezer but did not have device to monitor and recorded the temperatures, so could not verify the highest or lowest temperatures. The vaccines were administered with no monitored temperature.  The storage condition at the time of the excursion was frozen. The vial in the box were of unknown size. The maximum temperature reached as 31 degree celcius and minimum temperature was zero degree celcius. The excursion duration was unknown. The vial were returned to the freezer. The vials were always frozen, thawed to administer the vaccines and then discarded. The concomitant and treatment medication was not reported.