chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Periorbital swelling; Generalized facial edema; Oropharyngeal edema; Felt faint; Tingling lip; Facial redness; Appears pale; A spontaneous report was received from a healthcare professional concerning a 56-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced lower lip tingling, pale in color, periorbital and generalized facial edema and facial redness.   The patient's medical history was not provided. No concomitant product use was reported.  On 13 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) in the left arm intramuscularly for prophylaxis of COVID-19 infection.   On 13 Jan 2021, at 0845, 7 minutes after receiving the Moderna COVID-19 vaccine, the patient arrived for observation at urgent care. The patient stated she felt faint and her lip was starting to "feel swollen" and tingling. Initial vital signs were: blood pressure  147/79, heart rate  69, respirations  20 and oxygen saturation  99 percent. A nurse practitioner and doctor evaluated the patient and noted patient had oropharyngeal edema and lungs were clear to auscultation (CTA).   At 0851, diphenhydramine 25 milligrams orally was given with no effect. Facial redness and edema worsened.  At 0855, epinephrine 3 milligrams was given with improvement, but after 5 minutes, facial redness and lower lip worsened.   At 0902, a second dose of epinephrine was given.  At 0903, vital signs were: blood pressure  162/87, heart rate  104, respirations  20 and oxygen saturation  100 percent on 4 liters of oxygen. Facial redness and edema improved but still had swelling and tingling of lower lip.  At 0909, emergency medical services (EMS) were called and patient was transported to emergency room/department.   Treatment for the event included diphenhydramine, epinephrine and oxygen.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, lower lip tingling, pale in color, periorbital and generalized facial edema and facial redness, were considered unknown.; Reporter's Comments: This case concerns a 56-year-old, female patient. The patient's medical history was not provided. The patient experienced serious, unexpected event of periorbital swelling, facial swelling, oropharyngeal edema and unexpected events of Paraesthesia oral, erythema, pallor and dizziness. The events occurred 8 minutes after the first dose of mRNA-1273 (Lot number: 041L20A) administration. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
In January 2000, the pt experienced rapid heart beat, shaking, and ringing in his ears. He has experienced these symptoms periodically.
LOSS OF VISION IN ONE EYE AND WENT TO ER BECAUSE HE THOUGHT HE WAS HAVING A STROKE.  DX BY MD WAS MIGRAINES.  PATIENT STATES THAT HE HASN'T HAD MIGRAINES IN 20 YEARS.
I am not certain of the brand of vaccine given.  I do believe it was injected too high on the arm and possibly into my joint.  I have had shoulder pain for 6 weeks now.  It has improved, but is still not resolved.  It only hurts with certain movements now and ibuprofen does seem to help the pain.  Ortho doc says it's probably bursitis from inappropriate administration and that the pain could last for a couple of months.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with VAQTA lot # N008823, M018767, N014945, M033611 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VAQTA.; Sender's Comments: US-009507513-1708USA002081: US-009507513-1708USA007446:
Low Grade Fever, treated with Ibuprofen for 24 hours Hoarseness and Dizziness for 24 hours
Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection site) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (Soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. Treatment information mentioned Tylenol.
Rigors, itching at vaccine site, extreme swelling at vaccine site, heart pounding, breathlessness, severe pain everywhere in my body
pt recvd 4th dose of vax 31AUG93 & 3SEP93 exp flu-like sx, felt weak, achy, had a diminished appetite & devel a fever of 103; 9SEP93 presented to MD & was dx w/acute arthritis, unspecified site & serum react to the vax;
pt w/ attention deficit disorder recv vax 20jan97; concomitant therapy included clonidine. the pt exp soreness @ inject site, followed by a red, purple, tender, warm "crater" @ inject site; the area was about 1/4 of an inch deep;
Large red/hard/warm area at site of flu vaccine injection - redness nearly to elbow.
Brief head jerking movements to left. Began to occur, 3 hours post vax. Also, head appears to drop briefly white crawling, no other symptoms occurred. Normal development continuing. Stable, not progressing.
Lump on left and right anterior leg. The lump on right leg already nearly gone. On the left leg lump no redness or sign of infection.
This spontaneous report was received from a currently 72-year-old, female patient who was reporting on herself. The patient's concurrent conditions included breast cancer and myeloproliferative neoplasm disease. The patient did not have any known drug reactions or allergies. In approximately 2013, reported as 4 to 5 years ago, the patient was vaccinated with ZOSTAVAX for shingles (dose, route of administration, anatomical location, lot# and expiration date were not reported). However, the patient stated, that she was uncertain if the vaccine was ZOSTAVAX. Concomitant therapies included hydroxyurea, aspirin (manufacturer unknown), lansoprazole and unspecified thyroid medicine. On an unknown date, reported as now, the patient blowed up with shingles, had spots in the middle of her back, that itch as well as stiffness of the neck and swelling in the abdomen that came and went. The patient believed, that shingles hit her nervous system. Since an unknown date, the patient was taking acetaminophen for pain (onset date not reported; acetaminophen was also reported as concomitant medication). The patient did not seek medical attention and did not receive any treatment for remaining events. No laboratory test was performed. The outcome of the reported events was reported as not recovering. Causality assessment was not provided. Upon internal review, the event of shingles hitting nervous system was determined to be medically significant.
blood pressure 81 systolic; Dizziness/Lightheadedness; Injection site bruise; Very hungry; Felt abonormally cold; Pain with injection; Burning during injection; Not feeling 100% normal; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizziness/Lightheadedness), CONTUSION (Injection site bruise), BURNING SENSATION (Burning during injection), HUNGER (Very hungry) and FEELING COLD (Felt abonormally cold) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2020, the patient experienced FEELING ABNORMAL (Not feeling 100% normal). On 12-Jan-2021, the patient experienced BURNING SENSATION (Burning during injection) and VACCINATION SITE PAIN (Pain with injection). On 13-Jan-2021, the patient experienced DIZZINESS (Dizziness/Lightheadedness), CONTUSION (Injection site bruise), HUNGER (Very hungry), FEELING COLD (Felt abonormally cold) and HYPOTENSION (blood pressure 81 systolic). On 12-Jan-2021, BURNING SENSATION (Burning during injection) and VACCINATION SITE PAIN (Pain with injection) had resolved. On 13-Jan-2021, HYPOTENSION (blood pressure 81 systolic) outcome was unknown. At the time of the report, DIZZINESS (Dizziness/Lightheadedness), CONTUSION (Injection site bruise), HUNGER (Very hungry), FEELING COLD (Felt abonormally cold) and FEELING ABNORMAL (Not feeling 100% normal) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, Blood pressure measurement: 1)81 systolic 2) Increased to 100 which is less than normal for her at 120/70, but better.. On 13-Jan-2021, Electrocardiogram: (normal) 1)Normal with exception of some "slight thing that went down and was basically insignificant. 2)Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included IV fluids, food and water. No concomitant medications were provided by reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Pt had immediate feeling of racing heart, tickly throat, and lightheadedness. Felt fine after several minutes with no treatment. Did not lose consciousness at all.
Bedbound for the next 10 days with tremendous somnolence and headache. Followed by symptoms indistinguishable from Long Covid up till now (almost 19 months later)?although now about 60% better: disabling fatigue, headache, brain fog, orthostatic dizziness and mild tinnitus.
4/9/21 Patient presented to ED by squad for 2 days of weakness and progressive worsening of SOB. He also reported a cough and sats at home were 70-89% on chronic 3L O2 per NC. He reportedly had a symptomatic COVID infection in October 2020. He did swab + for SARS-Co-V-2 in ED. ID was consulted and pt was treated for an acute COPD exacerbation and and acute COVID-19 infection. Patient was placed on NIPPV, given IV decadron, zithromax and rocephin. He had gradual improvement and was discharged to rehabilitation 4/15/21
PT WAS 11Y 8MO AND RECIVED 12 ANMD OVER COVID PFIZER DOSE. PER MOP PT, PT HAS NTO EXPERINCED AND ADVERS REACTIONS.
Information has been received from a healthcare worker concerning a 57 year old female secretary with a history of right lower lobe pneumonia (15-FEB-2007), rhinitis and fatigue and no known allergies who on 09-APR-2007 at 12:30 was vaccinated into the left arm with a first dose of Pneumovax 23 (Lot #655588/0883F) during follow up for her resolved pneumonia. There was no concomitant medication. On 10-APR-2007, the patient developed cellulitis from injection site to left elbow. The left elbow to upper arm was hot, red swollen and painful. There was no fever and distal pulse were 2+ to 3+. The patient was given LEVAQUIN 750 mg orally once a day for 10 days. The patient was to follow-up in 48 hours. On 25-APR-2007, the patient recovered. No product quality complaint was involved. Cellulitis from injection site to left elbow and left elbow to upper arm hot, red, swollen and painful were considered to be other important medical events. This is one of two reports received from the same source. Additional information is not expected.
Received second vaccine on 2/3/21 and started having chest pain on 2/5/21. Went to ER on 2/6/21.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20-year-old male patient received BNT162b2 (BNT162B2), on 15Aug2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 20 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Bone marrow transplant recipient" (unspecified if ongoing), notes: Bone marrow transplant recipient. No Known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Positive, notes: Very faint positive test line on at-home rapid tests about 4 days after completing Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid as COVID 19 Treatment from 29Oct2022 to 03Nov2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Rotator cuff tendinitis; Vaccination site erythema; Tiredness; This spontaneous case was reported by a physician and describes the occurrence of ROTATOR CUFF SYNDROME (Rotator cuff tendinitis), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and FATIGUE (Tiredness) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ROTATOR CUFF SYNDROME (Rotator cuff tendinitis), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and FATIGUE (Tiredness). At the time of the report, ROTATOR CUFF SYNDROME (Rotator cuff tendinitis) was resolving and VACCINATION SITE ERYTHEMA (Vaccination site erythema) and FATIGUE (Tiredness) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered VACCINATION SITE ERYTHEMA (Vaccination site erythema) and FATIGUE (Tiredness) to be probably related. No further causality assessment was provided for ROTATOR CUFF SYNDROME (Rotator cuff tendinitis).    Treatment information was not provided Action taken with mRNA-1273 in response to the events is not applicable
Intense migraine; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 04Mar2021 at 08:30 (at the age of 30-year-old) as a single dose for COVID-19 immunisation.  Medical history included prolactinoma, PCOS (Polycystic ovary syndrome). Concomitant medications included metformin (MANUFACTURER UNKNOWN), cabergoline (MANUFACTURER UNKNOWN), fish oil (MANUFACTURER UNKNOWN), vitamin d3 (MANUFACTURER UNKNOWN), all for unknown indication from unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration in the left arm on 04Feb2021 at 15:00 as a single dose for COVID-19 immunisation and took sulfonamide(sulfa) for unknown indication and experienced an allergy. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient had not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. The patient had intense migraine on 16Mar2021 at 13:00 PM, migraine came on suddenly and lasted 3 hours. No history of headaches. The patient did not receive treatment for the reported event. The clinical outcome of the migraine was recovered with sequelae.   Information about lot number cannot be obtained. No further information is expected.
Patient was the last patient of the day to receive a COVID vaccine.  Medical Assistant administered the vaccine from a punctured vial.  Six doses had already been drawn up from the vial.  When questioned, MA stated she was able to withdraw the full 0.3 mL dose from the vial.  Contacted Pfizer.  Pfizer sent documentation stating:   Additional Doses from Vial  If low dead volume syringes and needles used in your preparation allow for a full seventh dose to be removed from one vial, Pfizer Medical Information is not aware of any information suggesting that the dose should not be used.
Received 2nd immunization on 2/19/03. On 2/23/03 experienced nodule at site with redness, itching and swelling. On 2/27/03 reports swelling, redness and itching over entire back of upper arm. Also complained of mild nausea.
Pt recvd 3 doses of Engerix-B 30OCT90, 18FEB91, 15MAY91 & 4OCT91 it was determined that pts titer was neg p/3 doses of Engerix-B;
Pt assessed after receiving COVID-19 vaccination drive thru site. She reported onset of mild lightheadedness and a non-specific "funny feeling" in her head. No vertigo or presyncope. No other new neurologic changes such as vision changes or extremity weakness. No chest pain, palpitations, dyspnea. No other signs of allergie/anaphylaxis (ie rash, throat swelling, GI side-effects). She reports hx of high blood pressure and is on one BP medication but cannot recall the name. States she took it today. Reports eating breakfast this morning. Exam notable for BP 140/85, HR 60. Pt well-appearing, no acute distress, no obvious CNS or peripheral deficits. RRR, normal s1/s2, no m/r/g. Lungs CTAB. No obvious rash or facial swelling.    During course of evaluation pt reported symptoms improved but did not quite resolve. Advised pt to continue monitoring at vaccination site for additional 15 minutes. Offered juice, crackers, fluids which she declined though did drink some of her own water.    Upon reassessment pt reported continued improvement though symptoms had not completely resolved. Offered to have EMS come assess pt though she declined. Warning signs/symptoms discussed with pt for when to seek out care at ED. She is in agreement.
Patient came to clinic 11-30-2022 to receive 2nd Moderna Covid vaccine. At this appointment she stated that she had severe chest pain, shivering, left arm pain and left shoulder numbness one day following her first Moderna vaccine on 11-02-2022.  She stated that chest pain was worsened upon movement such as sitting up in bed. Chest pain was described as occurring off and on throughout the day and covering upper mid chest area. She states that chest pain had resolved by the next day.  States that arm pain and numbness improved by the next day.  Patient states she was very ill for 2 days.
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 10-SEP-2014, the patient was vaccinated with a dose of VARIVAX (Merck) (dose number and route were not reported), 0.5 ml, lot # K005182, expiration date 10-APR-2014. Co-suspect and concomitant therapies were not reported. The registered nurse reported the 26 patients received doses of VARIVAX (Merck) (from lot # K005182, expiration date 10-APR-2014 only) that were improperly stored. No adverse effect reported for any of the patients. This is one (1) of twenty seven (27) reports from the same reporter.
Approximately 8 hours after the administration of the vaccine, patient began to experience aching muscles. Overnight, patient experienced fever, chills, aches, and persistent vomiting. The following day, patient continued to experience aches, tiredness, and chills. Symptoms resolved approximately 48 hours post-vaccine. Patient states they have never felt so terrible in their life and will not be getting additional covid-19 booster shots, etc.
Information has been received from a health professional concerning a 7 year old white male with no medical history or allergies who on 23 Mar 2000 was vaccinated subcutaneously in the right arm with Varivax (lot # 632275/1453J). There were no reported prior adverse events to vaccination for the patient or siblings. On 17 Apr 2006, the patient was seen by a physician for a sore throat and was treated for strep. It was noted that he had a throat culture done and it was positive (previously reported as negative). He was treated with amoxicillin. On 27 Apr 2006 the patient was seen by a physician and it was documented that he dad the chicken pox. It was noted that greater than 100 lesions comparable to varicella were observed. Benadryl was prescribed. Medical attention was sought. The outcome was reported as recovered (date not specified). No product quality complaint was involved. The patient's sister (WAES0605USA04173) was also diagnosed with breakthrough chicken pox. No additional information is expected.
Mild rash- anterior neck and left forearm associated with skin tingling; resolved within 15 minutes with Benadryl 25 mg po x 1 dose
Patient had delayed reaction to the vaccine, after approximately 5 minutes after receiving vaccine she began reporting feeling light-headed, woozy, tingling in her tongue, hands, and finger tips. 50 mg of Benadryl adminstered after 30 minutes. Called 911. Patient then transported to Hospital.
patient states his right arm is ache. pt states he was dizzy after the vaccine but that resolved the next day. patient states he has difficulty walking but upon further questionning to get more details patient stated that he always has difficulty walking due to age. I advised patient to seek care form his provider
body aches after the booster dose; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches after the booster dose) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 39F21A, RA182 and 20G20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal. Concomitant products included PARACETAMOL (TYLENOL [PARACETAMOL]), URSODEOXYCHOLIC ACID (URSODIOL) and MESALAZINE (MESALAMINE) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, the patient experienced MYALGIA (body aches after the booster dose). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) ongoing since an unknown date for Myalgia, at an unspecified dose and frequency. At the time of the report, MYALGIA (body aches after the booster dose) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had an antibody test done before she received the booster dose and her antibody test came back low.   This case was linked to MOD-2021-396808 (Patient Link).