chrisvoncsefalvay/vaers-outcomes huggingface dataset:
14 cm x 14 cm area on upper left thigh, tender to touch, warm and erythema. Treated with ibuprofen and BENADRYL and ice.
This patient has numbness in both feet for 2 months. Originally hot and cold sensations to the feet for 15 minutes only, generalized body aches for 24 hours. The patient is improving.
While monitoring post-vaccination a woman yelled from her car window that ?he? fainted. Upon arrival, it was noted that a young man in the passenger seat was slumped with his head on his chest and unresponsive. It was witnessed that the passenger stiffened and started shaking as if he was having a seizure. The nurse was called. It was noted that the shaking lasted just a few seconds and he then relaxed and opened his eyes. Once the RN, received call that there was a person having a seizure, 3  nurses went to the scene.  Once RN arrived at the car the patient was awake and alert. The patient was assessed, and he was able to answer questions. History of the patient from the mother revealed that he has responded to other vaccines in the past by having a vagal response. RN noted that there were no signs of patient being postictal. Patient was alert, oriented and stated that he was feeling better. EMS arrived and assessed patient and noted that he was in no distress. Patient denied transport to ED. RN educated patient on importance of reporting this to nurse prior to next vaccination.
Thanksgiving 2021 developed URI, neg covid, cough, HA, fatigue, no fever.  Approx 3-4 days. Christmas time 2021 developed GI virus with diarrhea, fever (101.6), fatigue, laryngitis, N/V, Dizziness/feeling off kilter- went to ER-got IVF, neg covid test, lab work, anti-emetic given.  Went home- lasted approx 6-7 days.   Dizziness continued to present time.  Saw an ENT -told me not an inner ear issue; Neurologist- not a migraine issue; Ortho/Neuro Sx- not coming from neck; Saw Neuro Ophthalmologist- dx of Convergence Insufficiency.  Did Vestibular therapy-no improvement & did Convergence therapy- no improvement.  Tried Nortriptyline and Meclizine- no improvement.   Changed Neurologists- got additional dx imaging-all normal.  got more labs- low B12- told to take B12.  Doing home vestibular exercises and taking increased dose of Meclizine- helps some, still getting dizzy spells.
Three and a half hours post vax, the pt developed tonic clonic seizures. First seizure was brief; the second lasted approximately 2 minutes in the ER. No fever. No more problems since 06/29/2000
it itches; arm is swollen; a very delayed injection site reaction; arm was getting hard on the deltoid; it was red, redness like in a crescent moon shape, settled down in the lower deltoid; it was hot; Am getting sore in deltoid at injection site; A spontaneous report was received from reporters ( HCP and Consumer) concerning a 47 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events such as Injection site pain,Injection site swelling,Musculoskeletal stiffness ,Injection site reaction ,Injection site erythema , injection site warmth and pruritus.  The patient's medical history was not provided. The relevant concomitant medications were amitriptyline 25 mg ,Xiidra,Aimovig 70 mg,Duloxetine 30 mg , Armour Thyroid ,Cyclobenzaprine,spironolactone 50 mg ,esomeprazole, Ubrelvy,celecoxib 250 mg, clonazepam 0.5 mg, biot-E testosterone and progesterone, Vitamin D3 and  Omega 3 200 mg .  On 6-Jan-2021, prior to the onset of the events, the patient received their first dose of two planned doses of mRNA-1273 (batch number:  027L20A ) intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection.  On 6-Jan-2021, the patient experienced a non- serious ,sore injection site. On 15-Jan-2021, the patient experienced non serious,a very delayed injection site reaction, arm was getting hard on the deltoid,started getting sore , it was swollen , it was hard , it was red , it was hot ,redness like in a crescent moon shape, settled down in the lower deltoid . On 16-Jan-2021 the patient experienced non serious event such as arm is hot, swollen and it hurts. On 20-Jan-2021 the patient experienced non serious events it itches.  No laboratory details was provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   On 8-Jan -2021 the outcome of the event (sore injection site) was resolved.
Headache, Myalgia, fatigue, arm soreness Narrative:  Headache, myalgia, fatigue, arm soreness;  resolving.
Pain at the injection site for booster shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 37-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 at 18:15 as dose 3 (booster), single (Lot number: GH9694) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, Unknown manufacturer), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 21Sep2022 at 21:30, outcome "recovering", described as "Pain at the injection site for booster shot". Therapeutic measures were not taken as a result of vaccination site pain.  No follow-up attempts are possible. No further information is expected.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Aug2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 10Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad (chadox1 ncov-19) (COVID-19 VACCINE ASTRAZENECA), on 12May2021 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Apr2022, outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: Other medication in 2 weeks reported as yes.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Large swollen area on shoulder surrounding injection site (about 5cm wide, 8 cm high) with redness in an arc near the bottom (closer to the elbow). No pain or itching. Seems to be fading now, 2 days later.
Got (DAPT- Hib) in left arm 4/6/04 approximately 11:30 am. By that evening was markedly irritable, unable to sleep, complaining at arm pain. 4/7/04 awake with progressive swelling of left upper arm eventually extending from shoulder- elbow, painful to touch. Temp -99 went to patient first 4/7/04 pm- started on Zithromax for possible cellulitis.
Within 5 min. or less, post vax, pt drawed up right fist and became stiff. Eyes rolled back, pt very pale and became unconscious for 3-4 seconds. B/P 104/60, mom to report back. Pt left alert after 10-15 min.
This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with a first dose of GARDASIL (Lot number, expiry date, dose and route were not specified) in the unspecified arm. On an unknown date, the patient experienced a paresthesia reaction such as pins and needles in arm and fingers after receiving the first dose of GARDASIL. The outcome of paresthesia reaction such as pins and needles in arm and fingers was reported as not recovered/not resolved. Additional information has been requested.
she tested positive for Covid-19 Virus; she tested positive for Covid-19 Virus; This is a spontaneous report from contactable consumer (patient) received from a Pfizer-sponsored program. A female patient of an unspecified age received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration dates were unknown), via unspecified route of administration on an unspecified date, as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that, after getting the first dose of vaccine she tested positive for Covid-19 Virus. She wanted to know if she can still get the 2nd dose of vaccine. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on unspecified date. The outcome of the event was unknown.  Information on the Lot/Batch number has been requested.
Patient received Pfizer Vaccine at 3:40pm, then sat for 15 minutes and left the clinic. Patient returned at 4:45pm to clinic and stated while she was driving she felt very anxious and felt tingling/numbness left arm to her hand opposite of her injection site. She stated chest tightness and pressure and felt very warm. Offered water and snacks since patient's last meal was at 10am this morning. Took first set of vitals: HR 87, Temp 97.8F, SpO2 100% at room air. Offered instant ice pack. Patient sat down for 10 minutes and proceeded to lay down on the cot because she felt weak. patient was very anxious and distressed. Stated her symptoms were not improving. Denies any previous medical history or allergies to medications. Stated she did not taken any medicaitons within 12 hours. Stated she had chest tightness similar to previous covid infection. Patient started closing her eyes and had visible eye tremors. Hands were cold and clamy. Face was flushed and red. she stated she had chest tightness and denies chest pain. Patient stated she had previous chest tightness due to previous covid19 infection. Clinic called 911 and fire department arrived on scene. Fire department provided vital signs; 12 lead : sinus rhythm no stemi, HR 80, RR 20, BP 148/100, SpO2 90%. Patient decided to go to ER with friend instead of going with paramedics .
Rash, red spots, raised, itchy; chest area. Headache, stomach age and sore throat for 2 days. Treatment with Benadryl, Aveeno bath and calomine lotion.
Information has been received from a physician concerning a 12 or 13 year old female who approximately 2 months ago (approximately May 2008), was vaccinated with GARDASIL (lot # not reported) and developed alopecia.  There were no other concomitant medications or no other vaccines.  The patient's alopecia resolved two weeks after the onset.  The patient sought unspecified medical attention.  No other information was available.  Additional information has been requested.
This is a spontaneous report from a contactable prescribing physician communicated to a Pfizer sales representative. A currently 68-year-old female patient of an unspecified ethnicity received PREVNAR 13 at single dose in left arm on an unspecified date, maybe some time in Oct2016 (not sure) for immunization, recommended for 65 and older. No other vaccines were given at the same time. The patient medical history was not reported. There were no concomitant medications. The patient previously took influenza vaccine and experienced adverse reaction. The patient had stated she will never get a flu shot again but had agreed to the Prevnar 13 because the physician told her she was over 65 years of age and really needed it. On an unspecified date the patient experienced redness/erythema at the site, upper left arm swelling, tender to touch, inflammation. There was no systemic reaction, only local including redness, swelling, erythema which caller clarified again as redness, and swelling. The left arm was larger than normal with whole upper left arm swelling, and it was tender to touch. This was the first time the physician had seen this much inflammation and redness. The outcome of the events was unknown. The reported assesse the events Redness/Erythema at the site and Tender to touch as related to Prevenar 13.
Pt reported chest tightness and throat tightness following vaccination. Time course following vaccination unknown.
Pt recvd DTP/OPV/PEDVAX on 23SEP91 & on 29SEP pt exp a hard lump ( 1 1/2" to 2" round) @ the DTP inject site;
My knee joint pain started on 4/23/18 during the night. Thinking this might be related to the Exemestane I had been taking for 6 months, I stopped taking exemestane on 5/1/18. Knee and joint pain did not disappear. I had a single gout attack on 5/11/18 during night, first time ever. Fatigue started at 5/11/18, and continued to be a problem till today's date. I'm an active women, never had join paints or a gout attack before.
seizure; uncontrollable jerking of my arms and torso; felt a little feverish; This case was reported by a consumer via media and described the occurrence of seizure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced seizure (serious criteria GSK medically significant), jerkiness and fever. On an unknown date, the outcome of the seizure, jerkiness and fever were recovered/resolved.   It was unknown if the reporter considered the seizure, jerkiness and fever to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and felt a little feverish and then had a seizure like system of uncontrollable jerking of arms and torso and lasted about 15 seconds. The reporter asked could that be a reaction to shot. The follow-up would not possible as no contact details were available.
FEELING TIRED; ARM HURT; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 20-JUL-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included leflunomide.  On JUL-2021, the patient experienced arm hurt. On an unspecified date, the patient experienced feeling tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm hurt, and was recovering from feeling tired. This report was non-serious.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021 at 3:51 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 3:56 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 40.47   Concomitant products were not provided.  On 02-Mar-2021, Excursion time was 09,10,11 AM, 12,2,3 PM temperature was 27,29,32,3335,36  total doses given for the day was 177, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 02-Mar-2021. 16 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021.  On 30-Mar-2021, Excursion time was 09Am temperature was 33  total doses given for the day was 173, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 30-Mar-2021. 3 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021.  On  02-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 00, 9 AM: 51, 10 AM: 34, 11 AM: 44, 12 46: 41, 1PM: 35, 2 PM: 36, 3 PM: 36, 4 PM: 36 and 5 PM: 00.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported
PENTACEL INADVERTENTLY GIVEN OUTSIDE OF AGE RANGE TO CHILD 5 YEARS AND 3 MONTHS AT TIME OF VACCINATION.
Expired vaccine given to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 500E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and medication information provided.  No treatment information provided.
patient hospitalized for COVID disease. diagnosis date 8/24/21. Presented to the ED with generalized weakness, low heart rate, low blood pressure over last few days. Chest Xray shows LLL Infiltrate.
Sudden dizziness while laying down. Obviously nausea followed. My mouth and throat felt incredibly dried. I had a panic attack on top of it. I drank Benadryl and used my TENS machine (for the panic attack). Fell asleep feeling that way, woke up next morning with metallic taste.
Information has been received from a 78 years old male patient referring to himself. On an unknown date in October 2014, the patient was vaccinated with ZOSTAVAX in the right arm (lot #, strength, dose and route were not reported) at a pharmacy to prevent shingles. On 10-MAY-2015 the patient developed red rash on the side of chest cavity around to his back. He went to his dermatologist who confirmed for this that he had an outbreak of shingles. The patient was treated with valacyclovir, 1 gram, 3 times a day for 10 days. The outcome of herpes zoster was unknown. Causality assessment was not provided by the reporter. Additional information has been requested.
pt recv vax & exp immed rxn of redness @ inj site;c/o stinging in lt arm, face became flushed;T101.4;c/o heart racing;radial pulse was unable to obtain d/t # of skipped beats;BP on arrival in hosp ER 193/92 w/tachycardia heart;
One week after receiving the vaccine in my left arm, I developed a red, warm, slightly itchy and sore spot where I received the vaccine.  It?s also hard and sore.  I?m applying ice to the area for comfort.
received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired vaccine) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Dec-2021 at 3:49 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 17-Dec-2021 at 3:49 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired vaccine). On 17-Dec-2021 at 3:49 PM, EXPIRED PRODUCT ADMINISTERED (received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. Vaccine was expired on 24 October 2021.   Most recent FOLLOW-UP information incorporated above includes: On 17-Dec-2021: Non significant Follow up, contains no new information.
This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175), via an unspecified route of administration in the left arm on 27Apr2021 at 15:00(at the age of 62-years-old), as a single dose for COVID-19 immunisation. Medical history included scoliosis. The patient did not take any concomitant medications.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Apr2021 at 07:00, the patient experienced tightness in heart area which began the day after the vaccine. The tight sensation would come and go. During the day when the patient was moving around it would go away. The tight, heavy sensation returned during sleeping hours and the patient would feel it in the morning when woke up. It would dissipate when the patient moved around during the day and return again. On 30Apr2021, three days after the injection, the patient woke up with the heavy, tight feeling and it became worse around 10:00 and the patient became light headed and the arms and hands tingled. The patient called the doctor and they told to go to the ER. The patient went to the hospital where they did a chest X-ray, EKG, and a stress test. The results from all of the tests showed a healthy heart. The events resulted in emergency room/department visit or urgent care. On 30Apr2021, the patient underwent chest X-ray, EKG and stress test and the results were unknown. The clinical outcome of the events tightness in heart was recovering and the clinical outcome of the events light headed and arms and hand tingled were unknown. No follow-up attempts are needed. No further information is expected.
The night of vacc. admin. patient's arm (Left) started to become red, swollen and warm at site of vacc. Measured 4 inches x 3 inches and was red and indurated. Told to apply cold compress and take Motrin.
The next morning after the first dose I started with nose bleeds and sensitive nasal passages, especially the left nostril. Muscular pain and tenderness, easily fatigued? following months have been more of the same, muscular pain and weakness have increased while nose bleeds and sinus tenderness have decreased