chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BLOOD PRESSURE ELEVATED/FELT BLOOD PRESSURE IN THE LEFT SIDE OF THE HEAD; DIZZINESS; HOT FLASHES; NAUSEA; LOW GRADE HEADACHE; TINGLING SENSATION; SHOOTING WEIRD PAINS IN BODY; SENSATION FELT ACHY; SENSATION FELT HOT; FELT LIKE ARM SWOLLEN; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypertension, drug allergy, hypothyroidism, and venous malformation in left temporal lobe. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191, expiry: UNKNOWN) dose was not reported, administered on 05-DEC-2021 for prophylactic vaccination. Concomitant medications included lisinopril for hypertension, and levothyroxine for hypothyroidism. On DEC-2021, the patient experienced felt like arm swollen. On 05-DEC-2021, the patient experienced sensation felt hot, shooting weird pains in body, sensation felt achy, and tingling sensation. On 06-DEC-2021, the patient experienced low grade headache. On 14-FEB-2022, Laboratory data included: Blood pressure (NR: not provided) 160/100. On an unspecified date, the patient experienced blood pressure elevated/felt blood pressure in the left side of the head, dizziness, hot flashes, and nausea. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 140/90 elevated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shooting weird pains in body, and tingling sensation on DEC-2021, had not recovered from low grade headache, and the outcome of sensation felt hot, felt like arm swollen, blood pressure elevated/felt blood pressure in the left side of the head, nausea, dizziness, hot flashes and sensation felt achy was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
My arm was sore for a long time, then got a sudden pain up left arm and shoulder, Difficult to move shoulder arm and neck, Shot on left arm
Pt. described some additional bleeding and what seems to be a hematoma. Bleeding stopped by the time he contacted me. Advised patient to use cold compress for 15 minutes. Will check back with pt. later tonight to assess situation.
Day after injection site hot to touch, red, raised and painful to sleep on that arm.  Rash and itching (neck, arms, eyes, face, scalp and face-Cough.
Since the beginning of June, I've had a series of health problems that are unusual for me -- 1) UTI symptoms followed by 2) symptoms like a Yeast infection paired with 3) chills and 4) nausea.  About the same time, I started experiencing 5) lower back pain and 6) numbness and sluggishness in my right leg accompanied by 7) knee pain in my right leg and 8) acute pain in my lower left abdominal area.  Most of these symptoms have resolved after antibiotics and other meds ,but the knee pain and nausea remain.
RA where vacc was administered reaction swollen, red, hot. Redness extended to forearm. DTaP Aventis Lot # C4335AA.
Patient has experienced pain and discomfort in right arm since vaccine was administered.  She feels this has spread from the injection site to her shoulder and down her upper arm.  Also states she no whas limited range of motion with arm. Patient is planning to see her doctor for treatment.
Patient with localized pain and swelling of right upper arm following Moderna COVID-19 vaccine. -  NAPROXEN 500 MG TABLET -  Advised rest, ice, naproxen, and antihistamines for localized reaction. -  ED if pain worsens or numbness, loss of strength of arm occur. -  Provided patient with opportunity to enroll in V-safe CDC COVID-19 vaccine side effect monitoring program.
fever, cold sweats, muscle pain, arm pain and swelling and hotness, insomnia
Patient reports being in her usual state of good health when she presented for COVID19 Vaccination. She reports onset of diplopia  without other symptom approximately 45 minutes after vaccination.  Later that night she notes  onset of full L eye ptosis which resulted in resolution of the diplopia. She was evaluated by ophthalmology the next day, 2/11, and was referred to the ER where she had a brain CT with no acute changes and unremarkable labs.  Treatment with Plavix 75mg was initiated. She was evaluated in my office on 2/16 for persistent ptosis of her L eye and her exam  is consistent with isolated third nerve palsy.   Diabetes and lipid levels are at target.
11am Resident vaccinated. 2pm Chest congestion, STAT dose of Solumedrol and non rebreather applied. Resident had small amount of emesis and was suctioned. Was being monitored and expired at 2:30 pm
Complex seizures (2) lasting >15 minutes.  Resulted in Emergency Room visit and 2-day inpatient stay.
Lumps under my arm pits; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (Lumps under my arm pits) 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 SKIN MASS (Lumps under my arm pits). At the time of the report, SKIN MASS (Lumps under my arm pits) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  No concomitant medication was provided. No treatment information was reported.
Patient has a possible local reaction on thigh area from vaccine. Redness, swelling, watery blisters.
Pt was administered vaccine on 11/5/13 and just today, 11/12/13. She noticed a red area about the size of half dollar around the injection area. It was not bumpy, warm, or irritated. Pt told to monitor area and to call back if any worsening of symptoms.
Information has been received from a RN concerning a 69 yr old white female who in Nov 1995 was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine (lot 647038/0926N), IM in the left deltoid. There was no illness at the time of vaccination. Subsequently on 05Aug04 the pt developed erythema, slight swelling, soreness from about 2 inches above injection site to just below elbow. Also reported as warmth, redness, swelling and pain down arm. Subsequently, the pt recovered. Unspecified medical attention was sought. No product quality complaint involved. No further information is expected.
Dizziness; dizzy like vertigo; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication included: ELIQUIS. Vaccination history included: BNT162b2 (Dose 1, ), administration date: 13Mar2021, when the patient was 61-year-old, for Covid-19 Immunization; BNT162b2 (Dose 2, ), administration date: 31Jul2021, when the patient was 61-year-old, for Covid-19 Immunization; Bnt162b2 (Dose 3), for Covid-19 Immunization. The following information was reported: DIZZINESS (non-serious) with onset 13Oct2022, outcome "unknown"; VERTIGO (non-serious) with onset Oct2022, outcome "unknown", described as "dizzy like vertigo".  Course of the event: After she got the booster yesterday she sat down for 15 minutes and then she went home and was dizzy and she laid down and got up and still dizzy and eventually went away and woke up to got the bathroom and was really dizzy like vertigo and when she woke up at 8 and had subsided a little and she went downstairs and she had to take her time and was a little dizzy.  Caller said dizzy was not listed in the side effects and said nothing about dizziness.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201236069 same patient, different drug, different event;
Broke out in rash, had to take Benadryl; This spontaneous case was reported by an other health care professional and describes the occurrence of RASH (Broke out in rash, had to take Benadryl) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 RASH (Broke out in rash, had to take Benadryl). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at a dose of 1 dosage form. At the time of the report, RASH (Broke out in rash, had to take Benadryl) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.
Written informed consent obtained prior to vaccination. The patient received 0.5 mL IM (L) deltoid of PPV 23 at approximately 12 PM on 2/25/11. She was feeling well at time of vaccination. No immediate reaction per patient. Later in day she says she had muscle soreness on injection site. The next morning, woke up with a "blotchy rash" at the site which spread down her arm and to her neck and chest. Had bad episode of dyspnea. Went to emergency room ? on-call service and symptoms improved with epinephrine and BENADRYL. As of 2/28/11, only has mild muscle soreness. Rash has resolved. Patient was afebrile.
redness below sight of inj;4cm & welt or hive like appearance w/in the reddened area of 2cm in size of the lt anterior thigh below inj site;
bad chills; Sleepy; Headache; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 07Feb2021 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, the patient had bad chills, was sleepy and out of it and he had a headache, it was not terrible or severe. The patient's wife wanted to know if the second dose was going to be worse. She heard that the second dose was worse than the first dose. All the people that they know that had the vaccine did not have any reactions. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Very large rash on left upper arm, it is hot to the touch, very itchy, a little sore.
First day really tired after shot, slept for 12 hours , next day sever headache, chills, nausea , sore throat , felt like my body was fighting off the flu , next day the chills were gone , headache and sore throat was mainly the problem . Looked at my throat to see my tonsils swollen with pus pockets went to the doctor the next day and got a strep test which came back negative and was told it was probably me having a reaction to the vaccine
Near immediate knot pain at neck/shoulder. ~4hr, arm soreness, headache, trouble sleeping. ~20hr, pain in armpit similar to knot pain (swollen lymph node?) And persistent low-grade headache. ~24hr, chills, poss fever, continued armpit pain and headache.
Information has been received from a medical assistant referring to a 6 month old female patient. No relevant medical history or concurrent conditions were reported. On 01-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Received my second dose of Pfizer vaccine on 4/5/21. Six days after injection I developed a small patch of hives on my neck. They lasted for approximately two weeks then cleared up. Received my Pfizer booster on 12/19/21. On 12/25/21 I woke up with hives behind my knees, in my groin area, and a large patch on the left side of my stomach. Hives also appeared on my wrists and in front of my elbows. Antihistamines did not help. Finally went to the doctor on 1/7/22 and was given a cortisone shot and took a 7 day course of prednisone. As of today hives have cleared up and itching has stopped.
uncontrollable shivers, chills, tiredness, muscle ache, headache, stomach ache, nauseous
2:22 pm- vaccine given, 2:37 pm- 15 minutes observation completed, no complained of issue after 15 minutes observation.  She went back to work. 4:15 pm- companion called that patient is not feeling well.  I directed patient to go to the medical clinic for evaluation.   4:17 pm- staff and I assessed patient  VS: BP 109/77, P-102bpm, O2 98%RA, R-18, Temp 99.3F.  Patient complained of hot flashes, dizziness.  She wanted to drive home.  Staff advised her not to drive in this condition.  Patient tried to reach her supervisors by phone to report her condition.  I notified staff that patient is not feeling well.   4:29 pm- patient said she is feeling better. Pulse-88bpm, O2 98% RA.  She denied feeling dizzy, still feels hot, arm sore, and requested water.  I notified Dr that patient requested to go back to her break area to eat and drink some water.  She wants to take her break from now until 545pm.  Patient wants to resume her duty after her break.  Dr. agreed.  Dr. provided her phone number to patient over the phone.  Patient may contact Dr. anytime until 8 am tomorrow if she starts to feel bad again.  Patient acknowledged and understood.  I notified staff that patient wants to go back to work after 545pm.
Initial unsolicited report received from a consumer via social media on 10 Oct 2016. This case is linked with 2016SA188144, 2016SA188556, 2016SA188803, 2016SA188804, 2016SA188805, 2016SA188806, 2016SA188807, 2016SA188808, 2016SA188809, 2016SA188810, 2016SA188811, 2016SA188812, 2016SA188813, 2016SA188814, 2016SA188815, 2016SA188816, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188820, 2016SA188821, 2016SA188833, 2016SA188834, 2016SA188835, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188839, 2016SA188840, 2016SA188841, 2016SA188842, 2016SA188843, 2016SA188844, 2016SA188845, 2016SA188846, 2016SA188847, 2016SA188848, 2016SA188849, 2016SA188850, 2016SA188851 (Same reporter source, same vaccine). This case involves a patient (age and gender not reported) who was vaccinated with a dose of Flu shot (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient got sick. The patient's laboratory data and corrective treatment was not reported. The outcome of event was unknown. List of documents held by sender: none.
holes in her lungs; This initial spontaneous report was received from a lawyer regarding a case in litigation and referring to a female patient (pt) of unknown age. The pt's concurrent conditions, medical history or concomitant medications were not reported. On an unspecified date, the pt was administered zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dosage, route of administration and anatomical location were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date after receiving zoster vaccine live (ZOSTAVAX), the patient suffered holes her in lungs, all caused by the suspect vaccine. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the Company product and caused by zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live ZOSTAVAX), she sustained severe and disfiguring personal injuries. Further, as a tragic consequence of Company's wrongful conduct, the pt suffered serious, progressive, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The pt suffered and incurred damages, including medical expenses; the loss of accumulations, and other economic and non-economic damages. The outcome of the event was considered not recovered/not resolved. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered the event of holes her in lungs to be disabling (reported as disfiguring).
Experienced HSV-2 outbreak after virus having been dormant for 2.5 years, majority of which time was not under treatment with Valcyclovir. Outbreak occurred 6 days after 2nd vaccination.
Vaccine leaked out during administration and patient did not get full 0.5 ml; Vaccine leaked out from syringe during administration; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Vaccine leaked out during administration and patient did not get full 0.5 ml) and DEVICE CONNECTION ISSUE (Vaccine leaked out from syringe during administration) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced UNDERDOSE (Vaccine leaked out during administration and patient did not get full 0.5 ml) and DEVICE CONNECTION ISSUE (Vaccine leaked out from syringe during administration). On 29-Mar-2021, UNDERDOSE (Vaccine leaked out during administration and patient did not get full 0.5 ml) had resolved. At the time of the report, DEVICE CONNECTION ISSUE (Vaccine leaked out from syringe during administration) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Rebound of Covid symptoms after a negative test; This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 (Rebound of Covid symptoms after a negative test) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Rebound of Covid symptoms after a negative test). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Rebound of Covid symptoms after a negative test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         No concomitant medications were reported.  It was reported that patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  Device date reported as 06-Jun-2022.  Company Comment: This Spontaneous case concerns a patient of unknown age and gender, with no medical history reported, who experienced the unexpected, non-serious AESI of COVID-19, which occurred on an unknown date after the third dose of mRNA-1273 vaccine. Patient reported rebound of COVID-19 symptoms after a negative SARS-CoV-2 test. The patient received treatment for COVID-19 with Nirmatrelvir, Ritonavir (Paxlovid). Additional information was solicited for accurate and complete medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This Spontaneous case concerns a patient of unknown age and gender, with no medical history reported, who experienced the unexpected, non-serious AESI of COVID-19, which occurred on an unknown date after the third dose of mRNA-1273 vaccine. Patient reported rebound of COVID-19 symptoms after a negative SARS-CoV-2 test. The patient received treatment for COVID-19 with Nirmatrelvir, Ritonavir (Paxlovid). Additional information was solicited for accurate and complete medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Could not lift arm, been to doctor 3 times since, now they say it is bursitis of shoulder, never lifted or injured or had any problem with shoulder till this shot, on prednisone now.
Weakness, nausea, vomiting, abdominal pain, decreased level of consciousness ataxia 1 hour post flu immunization.
tested positive for covid-19; tested positive for covid-19 with symptom; developed a low grade fever; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 20Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the 1st dose of the Covid-19 vaccine on 20Mar2021. On 23Mar2021 patient developed a low grade fever. On 03Apr2021 patient had high fever and went to hospital, a swab test was done and patient was positive for covid-19. The reporting consumer questioned if the patient should receive the second dose tomorrow. The outcome of the events was unknown.  Information related to batch/Lot number was requested.
she received her second dose of GARDASIL-9 10 months after her first dose and then received her third dose of GARDASIL-9 6 months after her second dose; No additional adverse effects reported.; This spontaneous report as received from a female patient of unknown age who reported on herself. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On an unknown date, 10 months after the first dose, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. It was reported that she was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis six months after the second dose (inappropriate schedule of drug administration). No adverse effects were reported.
lt arm w/red rash on inject site; sl swollen & tender to touch; t100.6;