chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The evening of vaccination I had side effects of extreme fatigue, headache, chills, sweats, nausea, insomnia, and arm pain/tenderness. Some time late at night I was crawling to get to the bathroom and collapsed, hitting my head on the tile floor and resulting in a scalp laceration. I went to our health center when they arrived in the morning and they sent me to local Hospital. They sutured the laceration and did lab work, ECG, chest x-ray, and head CT, and kept me for several hours for observation. Following this, I continued to have severe fatigue for about a week.
When vial was drawn up 0.8 ml diluent was used not the full 1.8 ml
This spontaneous report as received from a pharmacist refers to a 60 years old female patient. The patient's relevant medical history, relevant concomitant medications, and relevant past drug history are unknown. On 04-SEP-2014, the patient received a dose of PNEUMOVAX 23 (dose and route not reported lot # J006242) that had expired on 03-AUG-2014. It was unknown if there was relevant lab data. It was unknown if the patient sought medical attention. As of 06-SEP-2014, it was unknown if the patient was still on PNEMOVAX 23 and the outcome of receiving expired PNEUMOVAX 23 was unknown. This is one of the several reports from the same reporter. Additional information has been requested.
pt recv vax;mom states cried off & on for several hr;to er;would not stop crying;pale;MD felt nl;apap given & sent home;no further problems;
Case number PHEH2012US011251 is an initial spontaneous report received from a nurse on 31 May 2012. This case refers to a 27-year-old male patient. He was vaccinated with a complete dose of MENVEO (batch number: 022011) intramuscularly on 30 May 2012. It was reported that the MenA lyophilized conjugate vaccine component of MENVEO had expired in Apr 2012. The MenCYW liquid conjugate component of MENVEO that was administered had an expiration date of Jul 2012. The batch number provided corresponds to MenA lyophilized conjugate component of MENVEO. No adverse reaction was reported following vaccination. No additional information was available.
Fever 102.8 Myalgia  Chili?s Muscle spasm Severe headche
This is a spontaneous report from a contactable consumer (an office manager, who is also a medical assistant) via a Pfizer sales representative. An adolescent male patient of an unspecified ethnicity received TRUMENBA via an unspecified route of administration on 14May2018 at a single dose as meningococcal B vaccine. The patient's medical history and concomitant medications were not reported. The adolescent fainted after administration of the vaccine on 14May2018 around 1200. The reporter stated that they monitored the patient's pulse and let him sit. The patient's blood pressure was also tested but results were not reported. The patient recovered from the event on the same day. The reporter did not have further details to provide. The batch/lot number for the vaccine, meningococcal group b rlp2086, was not provided and will be requested during follow up.
Body really ached; arm was sore; Migraine Headache; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine Headache), PAIN (Body really ached) and VACCINATION SITE PAIN (arm was sore) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included ZOLMITRIPTAN for Migraine.    On 21-Jan-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced MIGRAINE (Migraine Headache) and VACCINATION SITE PAIN (arm was sore). On an unknown date, the patient experienced PAIN (Body really ached). On 24-Feb-2021, MIGRAINE (Migraine Headache) had resolved. At the time of the report, PAIN (Body really ached) and VACCINATION SITE PAIN (arm was sore) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: updated event outcome , reporter address, patient demographics.
Pfizer BioNTech COVIS 19 Vaccine EUA developed body aches, chills, malaise, vomiting the morning after the vaccine
devel back pain, numbness of the fingers; both arms became weak; now has numbness from the breasts to pelvis; hospitalized on 12OCT93 to r/o vax related myilopathy & MS:
patient described symptoms of "covid arm",  awoke 8 days after receiving the vaccine with redness, itching, and a lump at the injection site
16 year old male with history of essential hypertension developed facial weakness left eye tearing and tongue numbness and asymmetric smile.
76 years female received her PNEUMOVAX 23 vaccine at pharmacy in her left deltoid. Patient comes today (09-17-2016) complaining of pain and discomfort at the injection site in the left shoulder. She also reports having a low fever at 100. On physical exam the area of injection is warm, tender, hard, swollen, and red. The swelling extend down to the level of elbow. Patient is able to move her arm. Patient advised to go to emergency and refused to call 911 for her.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients. On 10-JUN-2014, an unspecified number of patients were administered PROQUAD (lot#, expiration date, dose, route and indication not reported that were exposed to improperly stored temperatures outside the product insert. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Patient attended outside Community Event during which the Mobile Vaccine Unit (Mobile unit--operated by hospital in collaboration with the City) and was administered Pfizer Vaccine.  On follow up (to ensure those who attended event were scheduled for second vaccine) it was identified through the IS (Immunization System) that this same patient had received a Moderna Vaccine on Feb 9th, 2021. Patient was contacted and confirmed that his card indicated the same--Moderna Vaccine on 2/9/21 -given by Family Health Center and Pfizer Vaccine on 6/12/21-City Mobile Unit.
high fever 101 for several hours.  chills,  body aches, confusion, not able to sleep, not hungry,  fever broke 24 hours later,  felt fine 2 days later and was able to workout and run.
Rash on entire upper right arm with swelling and warm to the touch at injection site. Also ithcy at deltoid area as well as right palm.
Pt broke out in itchy rash (hives) on right side of chin/mouth.  It is the same side as her dental work and no where else on her body.  She is on antibiotics (amoxicillin) for dental issues but has been on the amoxicillin for a few days and the rash started later the day/the next day after her vaccine so she thinks it was caused by her vaccine.  She was told to take Benadryl, apply cortisone and use ice if needed.  The area appeared swollen but pt states that this was because of dental work.
Got the shot on Fri. at 12:30 pm, next morning I was so sick I didn?t get out of bed the whole day. Achy, upset stomach, extreme headache and itchiness at injection site. Injection site had an egg size lump. First day didn?t bother me but by the 3rd day the itchiness was very intense. This was my 2nd Covid shot.
Client reported malaise, chills, pain at injection sites, numbness in both legs and muscle aches with temp. of 103.6F, 12 hours after receiving vaccines. Mom treated with Advil and Benadryl. Temp. decreased to normal within 8 hours but 4 hours later, increased to 100F. Mom will call physician this morning.
Skin irritations/inflammation/ intense itch Suddenly throughout entire body? back, arm, shin, along long borders of lips, top of big toe, hands extreme and near knuckles, back of legs. etc. Began in February and it?s still continuing into July  Dark spot on toenail- never had prior Indent on same area where darkness resides Baby toe has black under nail
Body aches-esp leg and knee.  Problem now with pain left hand, middle finger and base left thumb, left wrist.
Exercise intolerance; Chest pain; Lymphadenopathy; Fever; Severe neck pain; Fatigue.; Myalgia; Headache; Dizziness; This is a spontaneous report from a contactable physician. A 45-year-old female patient received the second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number:EL9262 ,expiration date not reported), via an unspecified route of administration, administered on the right arm on 23Jan2021 14:00 (at the age of 45-years-old) at single dose for COVID-19 immunization. Medical history included asthma and known allergies: latex. Concomitant medications included melatonin (manufacturer unknown), ubidecarenone (COQ10 [UBIDECARENONE]), ergocalciferol (VIT D); fexofenadine hydrochloride (ALLEGRA), and birth control all taken for an unspecified indication. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number:Ek9321, expiration date not reported), via an unspecified route of administration, administered on the left arm on 02Jan2021 18:00 at the age of 45 years-old at single dose for COVID-19 immunization and experienced headache, myalgia, chills, lymphadenopathy and brain fog on 03Jan2021. On 24Jan2021 08:00, the patient experienced fever, severe neck pain, fatigue, myalgia, headache, and dizziness. On 25Jan2021, the patient experienced fever, lymphadenopathy, fatigue, myalgia and dizziness. On 26Jan2021 and 27Jan2021, the patient continued to experience the events previously stated with headache. On 28Jan2021, the patient continued to experience the events previously stated with chest pain. On 29Jan2021 to 31Jan2021, the patient continued to experience the events previously stated. On 01Feb2021, the patient experienced continued fever, fatigue, lymphadenopathy, chest pain, and exercise intolerance. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 28Jan2021.  Events resulted in physician office visit and was treated by steroid. Outcome for events reported were not recovered.
Vaccine administered had a leakage between the syringe and needle; Pharmacist believed the patient did not receive any dose of Moderna vaccine; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of DEVICE CONNECTION ISSUE (Vaccine administered had a leakage between the syringe and needle) and UNDERDOSE (Pharmacist believed the patient did not receive any dose of Moderna vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (Vaccine administered had a leakage between the syringe and needle) and UNDERDOSE (Pharmacist believed the patient did not receive any dose of Moderna vaccine). At the time of the report, DEVICE CONNECTION ISSUE (Vaccine administered had a leakage between the syringe and needle) and UNDERDOSE (Pharmacist believed the patient did not receive any dose of Moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the pharmacist.  Treatment of these events were not provided.  This report refers to a case of Vaccine underdose AND Syringe Connection Issue for mRNA-1273, lot # unknwon  with no associated AEs.   Reporter did not allow further contact; Sender's Comments: This report refers to a case of Vaccine underdose AND Syringe Connection Issue for mRNA-1273, lot # unknwon  with no associated AEs.
Swelling, redness & tenderness around vaccination site, 15cm x 13cm.
pt. recvd dose M-M-R II & exp. "mumps-like syn".
Chest tightness, nasal congestion, light headedness within 15 minutes of injection. 2 hours later chills, headache, fatigue.
This case was reported by the mother of a consumer and described the occurrence of swelling at the injection site in a 5-year-old male subject who was vaccinated with DTAP, unknown manufacturer. A physician or other health care professional has not verified this report. In April 2006, the subject 5th dose of DTAP at the age of 3 years and 3 months following two bouts of pneumonia and an immunology screen showing depressed tetanus immunity. This was considered to be a decreased therapeutic response. The dates of previous DTAP administrations were not provided. This was considered to be an inappropriate schedule of drug administration as the 5th dose of DTAP was given too soon. No adverse events from that administration were reported. On 25 March 2008, the subject received a 6th dose of DTAP and an unknown amount of time later developed swelling at the injection site, injection site redness, injection site pruritus and low grade fever. On the evening of administration of the 6th dose of DTAP was considered to be an extra dose. At the time of reporting the outcome of the events was unspecified. Follow-up information received via the subjects mother on 28 March 2008 indicated that according to the child's physician, the child had received a different DTAP vaccine and not INFANRIX as was previously reported. Above details have been changed accordingly.
Patient stated that she had severe headaches, body pain, insomnia, and fever for a few days.
I have swollen lymph nodes under my right arm pit. I saw my doctor and was ordered a mammogram, and ultrasound, but I have not had anything further done at this point. The results came back clear, and said most likely the swollen lymph nodes were related to the vaccine. The lymph nodes are still swollen at this time.
Severe swollen arm and four days later neck spasms started from neck down to swollen arm.  Nausea.  Spasms have not stopped and continue in roof of mouth, lower head and neck, both front and back, also in esophagus and chest.
very sick starting the day after vaccination, got steadly worse over 3 days, dizzy, nausea, exhaustion, foggy headedness
A report was received from a healthcare professional on 10/28/2003 concerning a female vaccinee of approximately 16 years of age who experienced overwhelming pain at the injection site immediately after receiving Fluvirin on 10/17/2003. On 10/17/2003 the vaccinee experienced overwhelming pain at the injection site.  An ice pack was applied and the pain decreased to soreness.  The vaccinee had a prior history of influenza vaccination with no adverse events.  The vaccinee recovered on an unspecified date. There was insufficient information to determine the reporter's causality assessment. Update 1 01 March 2004 Follow up information received from a healthcare professional indicated that a 15 year old female vaccinee also experienced swelling and redness at the injection site which lasted 24 hours following receipt of Fluvirin. No follow up pending.
Received vaccine about 2:00 p.m. on 12/10/2004. At approximately 5:30 p.m. noticed a knot about the size of a pea at injection site. It grew larger.
Immunized on 7/15/09, on 7/16/09 at 3 a.m. adolescent began to c/o of numbness and tingling along with weakness in both upper extremities elbows to hands and bilateral lower extremities knees to feet, gait per mom was "stumbling", Temperature 99.6. Adolescent also c/o of back tenderness and pain with touch.  Mom administered Motrin. Mom states child had meningitis fall 08 and had been seen by neurologist.  On 7/16/09 neurologist contacted by mom and adolescent seen on 7/17/09.  Per mom, full neurological exam completed on 7/17/09, at that time numbness and tingling, weakness of arms bilaterally was greatly improved but some numbness, tingling and weakness of the lower extremities remained.  Mom stated that neurologist noted some weakness of lower extremities (knees to feet) but no weakness of upper extremities.  No treatment given by neurolgoist.  All s/s subsided within a few days.  As of today, there is no weakness, numbness, tingling, no c/o of pain and gait is steady.  Son continues to be active in sports.
Devel fever on 7APR92, no appetite, face flushed, eyes droopy;
105 temp, seizure-seen in ER, also diagnosed with stomach flu, 2 weeks later had pneumonia seizure with high fever, seen at hospital
boils on the lower left leg and knee, started out as what looked like large bug bites that were very itchy then turned into pus filled boils on the leg.   treated with doxycycline and triamcinolone acetonide, day 9 still have spots but drastically reduced.
Initially arm was slightly sore at injection site, barely noticeable.  Within 48 hrs had headache, pain and stiffness in joints in arms, legs, back and more so in neck. Also more tired/fatigued than usual and some mental confusion ("brain fog"). These things varied over the following 4 weeks. By the forth week stiffness and pain in neck and shoulder area remained along with headaches.  Most of other problems had resolved.
The  day after the injection  I felt "puny" and by that early afternoon I noticed a red, raised 3 -inch diameter circle surrounding the injection site on my left arm. The red site itched and hurt a bit when touched.  (Note: I took a Benedryl pill and put some Cortozone-10 ointment on the circle the second day after the injection when the circle appeared.) That day and the next the tissue within the red, 3-inch diameter circle got progressively harder - it felt as firm/hard as a golf ball. (I took another Benedryl pill the third day after the injection, but switched to Benedryl ointment, which worked better for the itch than the Cortizon had.)
I received the Flu Vaccine thru work and Twenty minutes after receiving the Flu Shot : I had severe chest pains and I passed out. I regained conciousness and went home for the rest of the day. My arm got red , & swollen. I broke out in hives and had a 103-104 degree fever. The needle hole weeped clear liquid. I got delirious and tried to cut my arm off with a butcher knife. I saw the company doctor. I also saw my Primary Care Physcian. They both told me that it was an allergic reaction to the Flu Vaccine and that I should never get it again or it would kill me.....   8 months later, I'm still having problems and went back to my primary care physican. He sent me for MRI's and Sonograms on my arm and to a Surgeon. They found 7 small (5mM)  areas of Fluid but concluded that they would re-absorb into my body and that they were Sterile Abscesses. They never cultured them though , but they concluded that they were Sterile abscesses like children get when they get a shot. I've been putting up with this pain and constant symptoms for 2 1/2  years now. I recently have been in severe pain and now am on Oxycoten and Tramadols so I can function to go to work. I also was told that they found a Mass in my left breast now, because I went to the Hospital 2 days before Christmas (2003) because I was in so much pain that I thought that I was dying. I went for Mammagrams , sonograms, MRI's on my arm and sonograms for my arm. I have went to a Breast surgeon specialist and have had to have a Stereotactic Core Biopsy done on my left breast . Thank God they have told me that it's not cancer but then I have to ask... what the heck is it? The Flu Shot was given 2 1/2 years ago........ and I still have the needle hole and it still weeps liquid out of it and it still gets red and swollen and I break out in hives and I get fevers and I have severe pain that I've been on heavy pains killers for over 3 months now. I have exhausted my sick leave and my vacation here at work... I am now taking time off as Leave Without Pay. Can you help me? I dont' know where else to go and what else a doctor can do for me; I need help.  ps. I don't know that Lot# of the Flu Vaccine that I got or the Specific Mftg. Name ; but my old Boss is helping me find out the information.  I would appreciate any help that you can give me.  Thank you. 11/10/06 Received medical records from 2nd hospital which reveal patient seen in ER only on 12/22/03.  Hospital states has no record of patient visit in 2001.   HPI: left side pain of arm, chest & abdomen x several weeks.  Patient stated had sterile abscess of left arm from flu vax evaluated by surgeon who advised to just monitor.  Stated she was in hospital with MI after flu shot created allergic reaction. EXAM: tenderness over left chest. 11/10/06 Received medical records from 3rd hospital which consisted only of left breast biopsy report of fibroadenoma.  T/C to MR dept confirmed that is only records they have of patient for 2004. 11/28/06 Received medical records from first hospital which are from 1994 & only records available at hospital for unrelated liquid hydrocarbon splash into eyes.  Was treated & released from ER.
High blood pressure; Felt miserable; Fever; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (high blood pressure), FEELING ABNORMAL (felt miserable), PYREXIA (fever) and FATIGUE (tired, She just wanted to go to bed) 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 HYPERTENSION (high blood pressure), FEELING ABNORMAL (felt miserable), PYREXIA (fever) and FATIGUE (tired, She just wanted to go to bed). At the time of the report, HYPERTENSION (high blood pressure), FEELING ABNORMAL (felt miserable), PYREXIA (fever) and FATIGUE (tired, She just wanted to go to bed) had resolved.            No concomitant medication reported.   Patient experienced side effects from all the three doses of Moderna vaccine.  No treatment medication reported.  It was reported that her symptoms lasted for one and a half days.   This case was linked to MOD-2022-584186, MOD-2022-584194 (Patient Link).   Reporter did not allow further contact
Myalgia, Fever, Red swollen circle around injection site, fatigue Narrative:
Headache, body aches, fever, nausea,thirsty overnight, sore injection site and left deltoid.
Patient received 5y- 11 y dose for the covid vaccine. She was supposed to receive 12 and older dose.  No symptoms. No signs.
This is a spontaneous report from a contactable consumer. A male patient in his late 40s received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced muscle soreness and fatigue, which he has had on and off since then.  The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Very red, very hot, very sore arm. A wide area extending from the injection site. Almost down to my elbow is all red and hot and puffy. My arm is actually very swollen and I have a bruise at the injection site. My arm is hard to move around or lift anything with it.
pt c/o funny feeling in shoulder p/shot; returned to office 9JUN; no edema or redness @ inject site; c/o enlarged lymph node; deep cervical on lt very tender to touch; small marble size noticed p/injection;
sore throat. N/V, body aches. Denies fever, dyspnea.
Fever up to 104. Seen by doctor on 2/23/02 and 2/25/02.
Common vaccine reations: sore limb, lethargic, lack of appetite, low grade fever, runny nose. Head started itching. 12.5mg of Benadryl administered. 8:00 PM itching reappeared but was proceded by full body itching. 12.5mg of Benadryl readministered after contacting Urgent Care. Child was very restless, achy, and only mildly comforted by Benadryl.