chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Per patient report below:  "? achy wrist and elbow in my left arm  ? chills and fever, profuse perspiration  ? ringing in the ears  ? lightheadedness to the point that I shouldn't drive to work today  ? random charlie horse-like spasms in my right thigh (weird)  ? my wife told me that I was making shallow rapid breaths while sleeping last night "
Chills; Headache; 100.6F fever; body aches; This is a spontaneous report from a contactable consumer (patient herself).   A 22-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247) via an unspecified route of administration in Arm Left on 09Feb2021 13:45, as DOSE 2, SINGLE (age at vaccination was 22-years-old) for covid-19 immunisation. Medical history included eczema. Concomitant medication(s) included ibuprofen, calcium carbonate (TUMS [CALCIUM CARBONATE]), triamcinolone and ascorbic acid, colecalciferol, cyanocobalamin, pyridoxine hydrochloride, retinol palmitate, tocopherols mixed (MULTIVITAMIN GUMMY BEARS), dosing details and therapy dates unknown for all. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247) via an unspecified route of administration in Arm Left on 19Jan2021 13:30, as DOSE 1, SINGLE for covid-19 immunisation. On 10Feb2021, 01:00 the patient experienced chills throughout the first night after receiving the second dosage. Woke up with a headache, body aches, 100.6F fever. No treatment was received by the patient. It was reported that the patient did not have Covid prior to vaccination and Covid was not tested post vaccination. At the time of this report, the outcome of all the events was not recovered.  Follow-up attempts completed. No further information expected.
This patient's mother requested the vaccine, following the publicized guidance that people from 16 to 64 with complicated medical conditions were eligible to receive COVID-19 vaccine in PA's group 1A.  The vaccine was given as part of our COVID immunization clinic (2 patients scheduled every 5 minutes) before we noted that she was 5 months shy of her 18th birthday, which is the minimum age for the Moderna vaccine.  The patient actually appeared to be in her mid 20's, and had absolutely no adverse reactions during her 15+ minute observation period.
Became lightheaded after administration. No loss of consciousness. Developed a headache. Has history of headaches. Lightheadedness resolved in 1-2 minutes after started. Given food, fan and drink. Head between legs. Lightheadedness resolved.
vertigo and vomiting - others I know have had the same symptoms without any prior history of such issues   Happened in June, September and October - 3 separate events
After 2 days patient had soreness in right arm and redness around injection site with bump.
Still experiencing Extreme migraine headaches, fatigue, cough, muscle aches, floaters in right eye
She felt her body warm and visibly red chest and extremities. Were treated with BENADRYL, Solumedrol, oxygen was supplied. Laboratories were made and she was under observation.
Patient went in for First Monovalent Pfizer Vaccine. Pharmacy ensured that they were administering Monovalent First Dose, Pharmacist administering dose knowingly gave patient Bivalent Pfizer Booster instead on the Monovalent First Dose.   Patient did NOT have adverse reaction to Bivalent dose that was given.
broke out in rash 2 days post vax legs,stomachache,arms,neck;very itchy
5/25/12 - VARIVAX. 5/31/12 - Itching red vesicles c/w chicken pox rash. 6/16/12 - Target lesions on face/arms/back c/w e. multiforme. 6/18/12 - Target lesions noted to be where the previous pox lesions were (still with tiny scabs in center of e. multiforme).
Around 2:00 pm  I had pain in my left shoulder blade going up to my neck it lasted for about 10 minutes, since then it has come and gone but neck pain stayed. I got chills and ran a slight fever so I  took Ibuprofen. The fever left and the chills are still going on, since yesterday, I can't seem to get warm .I have no energy I'm  very lethargic. Arm is sore but that's like any shot.
A non-serious report of administration of expired FLUMIST was received from an Air Force non-commissioned officer and a health care professional concerning a 21-year-old male. The patient's medical history and concomitant medications were not reported. On 06-Oct-2008, the patient was given FLUMIST via nasal administration by an immunization health technician. The vaccine was found to be expired when a nurse in the same clinic noted that the lot# of the administered FLUMIST (expiration date 24-Mar-2008) was different from the lot# of the other supply of FLUMIST with expiration date of 25-Dec-2008. The expired lot of FLUMIST was given to 17 adult individuals including this patient. The reporter stated that prior to being informed by the immunization clinic, the expired lot of FLUMIST was already suspended for use by their office and that suspended lot is collected by a contracted company for disposal. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Compliant Investigation results.
Patient inadvertently given double dose (1ml instead of 0.5ml) of vaccine. Patient notified,  reported no adverse events. Denied skin reaction at the site.
Case number PHEH2011US00552 is an initial spontaneous report received from a nurse on 01 Aug 2011. This report refers to an adult female patient. She was given only the MenA powder conjugate component of MENVEO (batch number: A10053) reconstituted with a sterile diluent instead of MenCWY liquid conjugate component, intramuscularly on an unknown date. No other adverse reaction was reported.
Case number PHEH2016US024151, is an initial spontaneous report received from a pharmacist on 16 Sep 2016. This report refers to a 24 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUAD 2016/2017 (batch number: 165803) at a dose of 0.5 ml intramuscularly on 16 Sep 2016, when she was at the age of 24 years old. No adverse event was reported following this administration error (inappropriate age at vaccine administration).
Given 5/14/18. Mom called on 5/15 at 3:46pm stated child was lethargic and temp rectally was 97.1 (F) MD was contacted and were referred to ER. PT admitted for apnea, altered mental status, hypothermia, for acute resp. failure.
21APR97 mom called stated pt arm red & hot & swollen day p/vax;took pt to MD was given ATB & antihistamine per mom was told pt had cellulitis;
left deltoid swollen and reddness noted approx. 3 inches over deltoid area. pt told to applt cold comperss and to give tylenol or motrin according to weight  handout given about imm. aftercare told to return to clinic as needed pt with out fever able to move arm without distress
Pt received primary series pfizer instead of bivalent vaccine. Pt is not reporting any side effects
Arrives to the Emergency Department at this time complaining of SOB that onset two days ago.  fever and fatigue.  diagnosed with COVID 2 weeks ago. Secondary to COVID-19 pneumonia/PE: Started on Decadron.  Started vitamin-C and zinc supplements.
sore arm; headache; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm and headache. On an unknown date, the outcome of the pain in arm and headache were recovered/resolved.   It was unknown if the reporter considered the pain in arm and headache to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left deltoid and experienced sore left arm and headaches. The reporter consented to follow up. For tolerance of 2nd dose of Shingrix, refer case US2019178962.
29 y.o. female who was seen at SVH COVID Vaccine Clinic today for her first  dose of the COVID 19 vaccination.    She was given the Pfizer vaccination in the right deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience throat and chest tightness.  She denied rash, difficulty breathing, difficulty swallowing, wheezing, hoarseness, stridor, itching, lightheadedness, dizziness, lip swelling and tongue swelling.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , hypotension, rapid progression of symptoms, respiratory distress and tongue swelling.   PMH includes anxiety. Takes lexapro 10 mg for this.  She is currently 21 weeks pregnant. Feels baby moving.    ALLERGY REVIEW OF SYSTEMS:  Patient denies chills, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, cough, chest tightness, shortness of breath, wheezing, rash, dizziness and headaches       Previous Reactions: none    Objective    Vitals Vitals:   02/24/21 0857 BP: 126/68 Pulse: 93 SpO2: 100%      Physical Exam Vitals and nursing note reviewed.  Constitutional:      General: She is not in acute distress.    Appearance: Normal appearance. She is well-developed. She is not diaphoretic.  HENT:     Mouth/Throat:     Mouth: Mucous membranes are moist.     Pharynx: Oropharynx is clear.     Comments: Clear oral airway Eyes:     Conjunctiva/sclera: Conjunctivae normal.  Neck:     Thyroid: No thyromegaly.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.     Heart sounds: Normal heart sounds.  Pulmonary:     Effort: Pulmonary effort is normal. No respiratory distress.     Breath sounds: Normal breath sounds. No wheezing.  Musculoskeletal:     Cervical back: Neck supple.  Skin:    General: Skin is warm and dry.  Neurological:     General: No focal deficit present.     Mental Status: She is alert and oriented to person, place, and time.  Psychiatric:        Mood and Affect: Mood is anxious (slightly).        Thought Content: Thought content normal.        Judgment: Judgment normal.         Assessment/Plan  Treatment included: water and snacks Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP.  Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health)
Employed as a nurse at this hospital. Around 8 PM she received her COVID-19 vaccine.  She waited the 15 minutes she was required to wait and then walked to her car.  She reports that as she walked to her car she had a pain in her left shoulder which was short-lived but followed by numbness and tingling of her left arm and the left side of her face going up the back of her head.  Symptoms started around 8:20pm.  She reported back to the clinic to report the symptoms--she lives along and wanted to be assessed before going home.   In the clinic, she was assessed by myself.  Employee noted that she had not eaten.  She ate in the clinic and had something to drink.  While in the clinic over the next 10-15 minutes, she noted that she had some numbness and tingling in her feet and calves bilaterally.   No leg pain or swelling.   Around 9pm, the clinic was closing and she could no longer be monitored under observation.  She opted to go to the ER for observation.    Per ER note-- She denies any headache.  She denies any left-sided weakness.  Patient is right-handed.  She also reports some mild chest heaviness that lasted for about 20 minutes and then resolved.  No shortness of breath.  No dizziness, syncope or presyncope.  No nausea or vomiting.  No rash.  No visual or speech changes.  No ataxia.  Patient continues to have the left-sided numbness and tingling but states that it is less intense than it was.  She denies any other complaints.  Follow up this AM-- Pt is only fatigued and has some muscle soreness where she had the vaccination.  All of her symptoms have resolved and she is not having any further sxs of chest tightness or numbness
Felt hot, but temp not measured; chills; pain swelling, warmth at site;
Menstrual changes. Spotting started evening of vaccination date and has continued through 9/12/21.
Swollen hot spot 3 inch diameter on arm at injection site. Could not move arm. Fever, joint aches, major lethargy/fatigue, nausea, diarreha, headache
Child received Tdap Boostrix Lot #C2770AA instead of Dtap Infanrix Lot #AC14B060AB.  Mother was notified 09/04/2008.
4-5 hrs after receiving Dtap/hib broke out with whelps; spoke with MD via phone, MD suggested giving Benadryl. Today 2 days later still has fine rash noted on back, bottom, face area.
Admitted with presumed shock secondary to urinary tract infection started on meropenem and IV fluids.  CT of the abdomen showed a 15 cm length of ascending colon with generalized wall thickening and enhancement concerning for colitis. Cardiology was consulted and titrated medications including changing to oral clonidine to a patch, adjusting metoprolol, and discontinuing valsartan and hydrochlorothiazide.  This resulted in stabilization of her blood pressures on the discharge. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Dizziness and confusion.  Four days later the skin around the injection site started sloughing.  There was no discoloration of the skin anywhere, nor any drainage.  The circumference was the size of a pen cap. The top to layers of skin came right off when I rubbed it.  The area around the site was unaffected.  The nurse didn't contaminate the needle and properly cleansed the injection site with alcohol.
Pt received Hep A and B vaccines. Was going to walk around store a few minutes before leaving. Pt felt nauseous approximately 3 min after receiving vaccines and sat down in a chair. Passed out, hit head, and started shaking. Witnesses described it as seizure-like. 911 was called and responded. Pt did not leave with them.
This is a spontaneous report from a contactable pharmacist who reported for his son,via Pfizer-sponsored program. A 19-year-old male patient received the second dose of TRUMENBA at single dose for immunization in Aug2017 at the age of 18 years. The patient medical history and concomitant medications were not reported. Patient previously received the first dose of meningococcal group b rlp2086 in Jun2017 as immunization. Patient was diagnosed with "mono" in Nov2017. Outcome of the event was unknown.Patient was scheduled to have his 3rd injection in Dec2017 and pharmacist wanted to know if it was ok for his son to get it or if it should be delayed.Pharmacist did not see any relation taking the vaccine and developing mono.Information on the batch number has been requested.; Sender's Comments: The company  and reasonably does not attribute the event to meningococcal group b rlp2086 based on the information currently available and the pathophysiology of the event.
I HAVE BEEN SUFFERING SINCE THE FIRST PFIZER INJECTION ......  MARCH 3RD 2021FIRST INJECTION ... MADE ME VERY SICK FEVER, CHILLS, VOMITING, HEADACHE, FELT LIKE BUGS CRAWLING IN THE TOP OF MY HEAD. THIS WENT ON FOR THREE DAYS ? THEN FOLLOWED ON/OFF FOR TWO WEEKS OF HEADACHES AND FEELING FOGGY.  MARCH 7 -10TH 2021 SEVERE PAIN IN MY LEFT HIP AND LOWER BACK ? EXTREME BLADDER PRESSURE MARCH 24TH 2021 INJECTION SWOLLEN GLAND?S, LYMPH NODES, FEVER, VOMITING, CHILLS,  SEVERE PAIN IN MY HIPS AND LOWER BACK ? THIS LASTED 5 DAYS ? HEADACHES HAVE FOLLOWED EVER SINCE THE PAIN IN MY HIPS AND LOWER BACK IS SO SEVERE THAT AT TIMES IT IS HARD TO WALK ... SEVERE  CRAMPING IN MY SHINS AND FEET TO THE POINT I CANNOT CONTROL MY TOE AND FOOT POSITION - LIKE THEY ARE POSSESSED ...  TO DATE I HAVE SEEN (3) NEUROLOGISTS, HAD X-RAYS (2) MRI?S, CAT, AND SPEC SCAN ...  FINDINGS INFLAMMATION TO MY FACET JOINTS AND SACROILIAC ? SEVEN (7) SPINAL INJECTIONS LATER AND LOTS OF DRUGS AND I AM NO BETTER ...  APRIL 2020 I WAS DIAGNOSED WITH COVID AND RECOVERED WITHIN A WEEK FIRST INJECTION BATCH # EN185  EXP DATE 08/21    SECOND INJECTION  BATCH #ER1741 EXP DATE 06/21
Patient up to date on COVID vaccines who admitted with COVID detected PCR and possible complications from COVID.  No hypoxia during stay.  Provider d/c note:  "73 YO male with CKD, CAD, cardiomyopathy and COPD.  Came in with weakness and was found to be in shock.  Likely a combination of septic shock and hypovolemic shock.  He required a very short course of pressors in the ER but recovered quickly.  The patient was noted to have COVID and Norovirus infection.  No bacterial infection was found.  The patient was treated with supportive care.  Patient didn't require any oxygen or have any respiratory symptoms.  His diarrhea resolved and he was discharged home in a stable condition."
Onset of Shingles type rash on left abdomen in dermatomal distribution starting on second day after vaccination. On day one after vaccine, experienced myalgias, chills and fatigue. Next day rash developed. Treated with steroid cream with some improvement. Have previous hx of Varicella zoster as child.
HPV 16, Cancer Cells that had to be removed via cold knife cone  Now have HPV 16 again
on 5/23/09 developed headaches that progressed to lethargy, slurred speech and imbalanced gait. He was hospitalized 6/2/09 (and remains hospitalized) with waxing and waning symptoms. He has abnormalities on MRI that were initially presumed to be from acute demylinating encephalomyelitis however the pattern was not really ideal for this diagnosis. He was treated with standard steroids without much improvement. His EEG showed diffuse slowing and a pattern that might be suggestive of a metabolic abnormality but his metabolic studies have been negative.  7/9/09 DC summary received DOS 6/2/09 to 6/24/09 FINAL DX: Postinfectious or infectious involment of basal ganglia, Acute disseminated encephalomyelitis 'ADEM'. Patient presented with headache and altered mental status, sleepiness, ataxia. URI symptoms. Progressed to slurred speech and and discoordinated movements. Drooling, tongue tremor. Decreasing PO intake. IVIG. Parkinsonial like symptoms: tremors, rigidity, shuffling gait.  6/26/09 Received hospital medical records for6/2 -6/24/2009. FINAL DX: likely viral encephalitis; thrombocytopenia secondary to viral illness. Records reveal patient experienced HA, nasal congestion, sore throat, dry cough x approx 2 wks.  Seen by PCP where strep test neg.  Briefly improved then worsened w/severe HA, gen malaise, fatigue,  & altered mental status.  Dx w/sinusitis & tx w/antibiotics.  Continued to worsen until unable to verbally respond or recognize family members.  Taken to PCP due to decreased oral intake, difficult to walk, falling asleep while walking, speech slurred.  Seen in ER where CT scan, CXR & labs were WNL.  Tx w/steroids & d/c to home.  Continued to have difficulties.  Returned to PCP who dx w/sinusitis & changed antibiotics.  Continued to worsen & seen in different ER.  Neuro consult done.
Swelling around tooth #19. X-rays were taken and it was recommended that I get a root canal. I had an infection and started on an antibiotic. After about 1-2 weeks my swelling was gone. The endodontist gave a second opinion and confirmed that I need a root canal. I received root canal.
Patient was very anxious to receive vaccines, Hep A, MENACTRA, HPV, given. Several minutes after injection patient was sitting up on bed became unresponsive. Placed in supine position. O2 given. Became rigid & stiff. After becoming responsive he con't to breath rapidly. EMS was activated. Patient was transported to hospital.
Fever for 3 days. Extreme joint pain in shoulders, back, neck, left hand and left wrist for 6 days after vaccine. I am still experiencing these symptoms and they are severe.
Pt recvd a dose of Engerix-B on 7JUL92; approx 1 wk p/vax pt ached; also arm felt fatigued or weak; also a circular area where inject given would tingle & occasionally feel cold;
blacked out; vertigo; she states if was like her knees buckled; fell asleep; rubbing below her ear on her neck, slightly behind the ear and just under her skull bone, equilibrium was off; double vision; This case was reported by a consumer via call center representative and described the occurrence of blackout in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included vertigo (experienced earlier before receiving Shingrix, in yoga class when she tilted her head back.). Concurrent medical conditions included multiple myeloma (received infusion treatments for the same).   On 27th August 2019, the patient received the 1st dose of Shingrix. On 28th August 2019, 1 days after receiving Shingrix, the patient experienced double vision, sleepiness and balance disorder. On 12th September 2019, the patient experienced blackout (serious criteria GSK medically significant), vertigo and joint disorder. On an unknown date, the outcome of the blackout, vertigo, joint disorder, sleepiness and balance disorder were unknown and the outcome of the double vision was recovered/resolved.   It was unknown if the reporter considered the blackout, vertigo, double vision, joint disorder, sleepiness and balance disorder to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix at the infusion center where she receives her infusion treatments for multiple myeloma.  On the 2nd day after receiving Shingrix, the patient was lying on the floor with her dog. She felt asleep and when she went to get up her equilibrium was off and she had double vision for about 2 hours.  The day before reporting, she was at her counter, and reached up to put something away and then she felt like her knees buckled and she was not sure but believed she might have been blacked out.  The patient remembered thinking like what had happened.  The patient also experienced vertigo the night before the date of reporting. The patient rubbed below her ear on her neck, slightly behind the ear and just under her skull bone when she experienced vertigo. The patient was encouraged to continue to express the events to her physician. On the day of receiving Shingrix, the patient was in the infusion center having her port flushed, which was because she received infusion treatments for Multiple Myeloma. The reporter consented to follow up. The reporter was willing to get authorization form. She notified her PCP via email about the events, but she was under the care of her hematologist/ oncologist who was the doctor that recommended her to receive Shingrix.
Slight headache and fatigue; Slight headache and fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 31Mar2021 (Batch/Lot number: unknown) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "obesity" (unspecified if ongoing); "depression" (unspecified if ongoing); "Penicillin Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), HEADACHE (non-serious) all with onset 31Mar2021, outcome "recovered" (2021) and all described as "Slight headache and fatigue". It was unknown if therapeutic measures were taken as a result of fatigue, headache.  Additional information: It was unknown whether the patient received any other vaccines within 4 weeks prior and other medications 2 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Unknown if patient had COVID-19, Since the vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.