chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Ringing in ears; Left arm, lower down the injection site, was warm; Left arm swollen, lower down the injection site, was swollen,; Left arm, lower down the injection site, was red; lower down the injection site Like a spot on her left arm,; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in ears), VACCINATION SITE WARMTH (Left arm, lower down the injection site, was warm), VACCINATION SITE SWELLING (Left arm swollen, lower down the injection site, was swollen,), VACCINATION SITE ERYTHEMA (Left arm, lower down the injection site, was red) and VACCINATION SITE RASH (lower down the injection site Like a spot on her left arm,) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039AZIA) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history provided).    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced TINNITUS (Ringing in ears), VACCINATION SITE WARMTH (Left arm, lower down the injection site, was warm), VACCINATION SITE SWELLING (Left arm swollen, lower down the injection site, was swollen,), VACCINATION SITE ERYTHEMA (Left arm, lower down the injection site, was red) and VACCINATION SITE RASH (lower down the injection site Like a spot on her left arm,). At the time of the report, TINNITUS (Ringing in ears), VACCINATION SITE WARMTH (Left arm, lower down the injection site, was warm), VACCINATION SITE SWELLING (Left arm swollen, lower down the injection site, was swollen,), VACCINATION SITE ERYTHEMA (Left arm, lower down the injection site, was red) and VACCINATION SITE RASH (lower down the injection site Like a spot on her left arm,) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No medical history and concomitant medications were provided.  No treatment information provided
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 62-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose 5 (booster), single (Lot number: GH9703) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "PMLS" (unspecified if ongoing); "Hashimoto's Thyroiditis" (unspecified if ongoing); "Periodic Limb Movement in Sleep" (unspecified if ongoing). Concomitant medication(s) included: ROPINIROLE taken for periodic limb movement disorder. Past drug history included: Amoxycillin, reaction(s): "Known allergies: Amoxycillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 12Jan2023 to 16Jan2023.
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored M-M-R II (lot number L012479 expiration date 10-APR-2017 and lot number L009545 expiration date 19-MAR-2017). The vaccines were exposed to 9.7 degrees centigrade for a cumulative time frame of 4 hours and 41 minutes. There was no previous excursion. This report was for data logger. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
PER PATIENT, SHE AWOKE THE NEXT MORNING WITH RED BUMPS FROM HER LEFT HAND UP HER LEFT ARM THAT LASTED FOR 2 DAYS.  DID NOT GO TO ER/UC, DID NOT REPORT TO CLINIC.
On 7/12/00, 1 day post vax, this child was up with a fever of 107F with no seizure, projectile vomiting. During or late that day, fever was 100-102F, heaving. Went to see PHD, no fever, no vomiting, abdomen tenderness, was hungry and normal on 7/13/00. Dx'd with vaccine reaction or viral infection.
stroke; This is a spontaneous report from a non-contactable pharmacist.  A 71-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly at the age of 71-years, at single dose in right arm on 02Apr2021 09:00 (Lot number: EP7533) for COVID-19 immunisation. The patient medical history was not reported and there were no known allergies. Concomitant medications included rivaroxaban (XARELTO); empagliflozin (JARDIANCE); lisinopril all taken for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly at the age of 71-years, at single dose in right arm on 05Mar2021 09:00 (Lot number: EN6199) for COVID-19 immunisation. The patient experienced stroke on 11Apr2021 (Stroke 7 days after injection (as reported)), it resulted in "Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event) and Disability or permanent damage". The patient was hospitalized for stroke for 2 days. The patient was not diagnosed with COVID prior to vaccination and he had not been tested for COVID since the vaccination. Event outcome was not recovered.  No follow up attempts are possible. No further information is expected.; Sender's Comments: The reported stroke is likely due to an underlying medical condition and unrelated to BNT162B2. Although temporally related, there is no sufficient evidence that the reported stroke is related to BNT162B2. Note that the patient's medical history was not reported, however, patient is taking rivaroxaban and lisinopril for unspecified indication. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Patient's daughter reported on 10/1/21 that after receiving the vaccine earlier in the week, the patient's are had a lot of swelling and bruises inexplicably covered the arm from injection site to elbow. Reported no fever/nausea, but some general feelings of unwellness. Also stated the patient is on warfarin and was not sure as to the relation between this reaction and her warfarin or her flu shot. Patient lives in an assisted living facility and has not sought additional treatment for her condition at this time. The patient's daughter said she would assess patient's condition this afternoon and would then help the patient determine the next steps of action.
Patient was given Covid-19 Bivalent (grey top) Vaccine which was beyond the usage date of 01/11/2023, lot #GJ6738 on 01/17/2023. Attempted to reach patient by phone today, 03/28/2023, and had to leave a voicemail for patient to call back. Reports filed with local registrar and Pfizer. Awaiting response from Pfizer on efficacy of vaccination. Staff has been reeducated on 7 rights and Covid Vaccine Safety Workflow. The remaining doses of BUD vaccines have been discarded.
Slight malaise, diff. sleeping, itchy. 2 250 mg ibuprofen x BID 3 days prn.
All over pain. every muscle and joint started hurting after 2nd day. sharp pains in chest and left side . hands numbs. feet tingle and hot. brain fog .
About 30 minutes after injection, started getting sick to my stomach. By the evening, I felt real chilled and running low grade fever. My arm had a huge knot where the injection had been given. My arm swelled all around and real real hot. Temp in arm. Used cold compress arm was very painful. See my MD on 11/07/2002. Still had and still have a knot in arm. MD said a reaction to the vaccine. Arm still hurts.
Vaccine was administered beyond use date. Patient was monitored with proper follow up. No abnormal side effects or adverse reactions were present.
Light headed, dizziness, general weakness, headaches, stomach cramping, stomach tightness and feeling nauseous began occurring within days after receiving GARDASIL. Cases of general unwell feeling were mild and chalked up to coming down with a cold or the flu. Symptoms become more common and consistent in the first 60 days of receiving the vaccines. As time has gone by, these symptoms have become more frequent and severe. Stomach tightness and cramping lasting 1-2 days now is constant as well as general weakness and feeling dizzy and light headed.
Erythema, swelling and tenderness (6 x 7 cm in diameter) over right deltoid; red streak into axilla - treated with pain relief, ice packs and antibiotics.
Case previously recorded as MA2009-5997. Initial case report received via agency, from a health care professional on 24 NOV 2009: A 14-month-old boy, was vaccinated with S-OIV FLUVIRIN (batch no. 102127P1) on 23 NOV 2009. No adverse event was reported. Agency ref. no.: NA09-008811.
Left arm red, hard, hot to touch area the size of a baseball. Pain with palpation. Received VARIVAX in left arm diagnosis of cellulitis. Given Rx. KEFLEX 500mg 1 po tid x 7 days. To use TYLENOL or MOTRIN warm packs.
pt recvd vax & felt anxious; diaphoretic; nubness & tingling of extremities; chest tightness; disoriented; given meds; epi; to ER;
Shoulder was sore after shot. Hands were cold (freezing) within a day, Joints at hands are swollen and can barely use; joints at shoulders ache; Hips and knee joints ache;  oxycotin prescribed for pain but patient did not like side effects
Information has been received from a pharmacist concerning a 52 year old female who on 22-APR-2011 was vaccinated with a dose of ZOSTAVAX 0.65ml in the left deltoid (Merck) (lot#: 669590/1507Z) (Expiration: 02-FEB-2012) and immediately a large lump appeared at the injection site. The patient did not know if it was administered subcutaneously or intradermally. On an unspecified date, the patient sought medical attention via office visit. There was no lab diagnostic performed. At the time or the report, the patient had not recovered. Additional information has been requested.
Pt developed fever on 3/17/19 that persisted, Tmax 104. Seen in UC on 3/18/19 and Dx with viral illness. Then seen again in my office on 3/21/19 given continued fever and found to have pneumonia on exam. Started on amoxicillin which resolved fever by 3/23/19.
pt c/o pain lt deltoid area;area red, hot & swollen;cellulitis noted p/5cm c 5cm induration noted;
After a couple of days developed "lump" on arm. Five days later felt "aching, throbbing sensation in L dorsal hand between thumb and index finger. No swelling, weakness, tingling or pain between each site."
Initial and follow-up information has been received from a Certified Medical Assistant concerning a 67 year old female with no known drug allergies or pertinent medical history, who on 20-FEB-2008 was vaccinated IM (also reported as SQ) in the left deltoid with a 0.65mL dose of zoster vaccine live (Oka/Merck) (lot # 659324/1835U). Subsequently, a few days after vaccination on 23-FEB-2008 or the 26-FEB-2008 the patient developed a vesicular rash and pain following dermatome distribution at the right scapular area. Unspecified medical attention was sought in the office. There were no lab studies performed. The patient was diagnosed with shingles, with lesions on her right shoulder, chest, and back. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested.
No adverse event; She received her second vaccination of GARDASIL 9, 2 weeks after the scheuled date; This spontaneous report was received from a female patient of unknown age, reporting on herself. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported.   On 18-JAN-2020, the patient was supposed to have her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported), however, the patient received the second dose of her vaccination with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 2 weeks later, on 01-FEB-2020. No adverse reactions were reported.
poor Pneumovax response; Literature Report. This literature marketed report was received from a health care professional concerning to a 41-year-old male patient. The patient's medical history included pyrexia, lymphadenopathy, cytomegalovirus infection, pneumonia, appendicitis, cholecystitis, epididymitis, sinusitis, meningitis aseptic, transaminases increased, inflammatory marker increased, hypogammaglobulinaemia and antinuclear antibody increased.   On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength, formulation, dose, frequency, route of administration, lot number and expiration date were not reported).  On an unknown date, the patient had a poor pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) response (vaccination failure).    The outcome of vaccination failure was unknown.   The causality assessment between vaccination failure and Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23) was considered to be related.
Cellulitis of left groin and Inner thigh requiring hosp for 23 hours received IV Clindamycin.
bruised/red area on anterior rt thigh 1 1/2cm x 1cm, MD rx w/Motrin
Dizzy, myalgias, H/A, stuffy nose resolved after 24 hrs. No flu shot.
Breakthrough menstrual bleeding/clotting for approx 12 days while on long term continual oral contraceptive.
Patient had sweating, chills, and hot flashes for approximately 5 minutes. Self-resolved with sips of water. Monitored patient for over 15 additional minutes and patient felt well enough to leave on his own.
Pt first noticed ache in right shoulder which moved down to the elbow, then wrist. Later on, tingling in hand and fingers.
Mom stated evening shots were given. Patient began with some redness to thigh. Continued with Tylenol sent to daycare in AM. Daycare reported area larger. Saw MD at 3:00pm. Red and swollen 13x9.5; warm to touch.
The patient reported redness, inflammation, soreness at the injection site. She also experienced body aches and vomiting the day after the vaccine.
Started with a rash on both sides of my hips and then each day the rash appeared on my thighs, buttocks and now randomly on my elbows and knees
Large red induration about 4 inches across and 6 inches down the arm. Red, painful and hot to the touch. Resolved after 4 to 5 days.
Arm swelling, pain, redness, malaise. Began within 24 hours. Resolving at day 6. No treatment needed.
This spontaneous report was received from a registered nurse refers to a 4 year old patient. The medical history, concurrent conditions and concomitant medications were not reported. On 28-OCT-2016, the patient was vaccinated with a dose of improperly stored PROQUAD lot # M032497, 02-JAN-2018. No adverse effects were reported. Additional information has been requested.
This spontaneous report was received from a Licensed Practical Nurse and refers to a 52-year-old patient. No information regarding the patient's medical history and concurrent conditions was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VAQTA injection (dose and route of administration were not reported) lot # N002921 with expiration date on 08-APR-2018. The vaccine underwent a temperature excursion of 0.1 degrees Celsius for 6 hours. Digital data logger was involved in the recording of the excursion. Unspecified previous excursions were reported. No adverse events were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1712USA001308.
Red and purple Large spot taking up entire upper thigh. Vaccinated thigh swelled up to twice size of other thigh. Burning. Itching. Pain. fever on and off.  Treatment was an oral antibiotic, a topical antibiotic, a topical steroid and Benadryl and Motrin every six hours. No significant improvement. Went back to doctor 2 days later. Now on new oral antibiotic.
Still after 7days after the 2nd shot in my left arm  I am still in a considerable amount of pain.  very hard to move my arm.  Also, on the 3rd day after the shot my face, neck, chest and back broke out into a red rash.
pt recv vax; severe swelling of rt thigh w/ limping; T 102;
Upper body chills, joint pain in elbow, shoulder and back, cough, no fever. Current symptons have lasted 10 days including current date, 7/12/21
I tested positive for covid 3 days after receiving the Moderna bivalent booster. My husband tested positive 2 days after receiving the vaccine. We have friends and colleagues who are reporting the same thing has happened to them.
My right arm where injection was given still hurts badly, the pain has also gone into my ribs. I can't raise my arm up over my head, I can't sleep on right side as it hurts. I know there is some soreness for a few days. This is 3 weeks of pain not lessening at all.
Facial drooping within 12 hours of vaccines. Pt was taken to the ER when first started, but the facial drooping had gone away upon arrival. Drooping happened 3-4 times after ER visit. Pt was seen by neurology and infectious disease. MRI was completed.
severe upper abdominal pain/very bad stomach ache; flush through her body; rash/flush through her body; she felt a little weird; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Feb2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. About 30-35 minutes after receiving the injection, in Feb2021, the patient developed severe upper abdominal pain/very bad stomachache. She also experienced a rash/flush through her body in Feb2021 and she felt like she was going to die. After experiencing that, she felt a little weird for a minute or so. Then the flush/rash happened again but not as bad as the initial flush. The stomachache lasted for 2 hours then it stopped. The patient had recovered from severe upper abdominal pain/very bad stomachache and she felt a little weird in Feb2021, the outcome of the other events was unknown.   Information on about lot/batch number has been requested.
Information has been received from a mother concerning her 15 month old female daughter who on 23Jun2003 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) SC administration. Concomitant medications were not provided. On 28Jun2003, the pt developed fever of 103 for 3 days (June 28th through the 29th). It was unknown if the pt recovered from fever. The pt was seen by her physician but the cause of her fever was unknown. No product quality complaint involved. Additional information has been requested.
Patient was given a Pfizer dose that was diluted with 0.9 mL of 0.9% NaCl instead of 1.8 mL of 0.9% NaCl. Patient experienced fatigue starting 07/11/2021.
positive test for COVID-19, Paxlovid, moderate flu-like symptoms for about a week
Received a TIV one month previous to 11-10-07.  Presented at Health Center 11-10-07 and saw CFNP. Pt c/o of severe pain in left arm, from left side of neck to left elbow, which awakens her at night. Pt is taking Tylenol for pain control, but took Vicoden 11-9-07. On exam, left bicep tenderness, subacromium bursa tenderness, and deltoid muscle tenderness, full range of motion, normal stabitlity, strength and tone.  No skin discoloration or edema.  Naprosyn 500mg, 1 BID.
Itchy at  injection site; Tender at vaccination site; Large circular blotch in the skin; Little swollen at vaccination site; Arm hurt; Redness at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Tender at vaccination site), PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE MACULE (Large circular blotch in the skin), VACCINATION SITE SWELLING (Little swollen at vaccination site) and VACCINATION SITE PRURITUS (Itchy at  injection site) in a 41-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.     Concomitant products included MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE] for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site). On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt). On 22-Jan-2021, the patient experienced VACCINATION SITE PAIN (Tender at vaccination site), VACCINATION SITE MACULE (Large circular blotch in the skin) and VACCINATION SITE SWELLING (Little swollen at vaccination site). On 23-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy at  injection site). On 22-Jan-2021, PAIN IN EXTREMITY (Arm hurt) had resolved. At the time of the report, VACCINATION SITE PAIN (Tender at vaccination site) had resolved, VACCINATION SITE MACULE (Large circular blotch in the skin), VACCINATION SITE SWELLING (Little swollen at vaccination site) and VACCINATION SITE ERYTHEMA (Redness at injection site) outcome was unknown and VACCINATION SITE PRURITUS (Itchy at  injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included lotion application on the affected area.
felt like she had Covid; felt like she had Covid; stomach cramps; chills; aches; not feeling good; temp was around 101- 101.6/fever 102; Icy hot sensation; lethargy; arm was red and swollen; arm was red and swollen; This is a spontaneous report from a non-contactable nurse (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. Medical history included covid-19 from Jul2020. The patient's concomitant medications were not reported. The patient got her injection on Tuesday (specified date unknown) at 3pm. Felt good but then woke up with stomach cramps. She went to work and at around 1pm she started having chills, aches and not feeling good at 4:30 pm her temp was around 101- 101.6 so she took Tylenol went to bed. She woke up with fever 102 and felt like she had Covid all over again reporting that she had covid in Jul. Having what she has heard described as "Icy hot sensation" and lethargy and not feeling good with chills aches. Then on Thursday her arm was red and swollen with the redness expanding swelling and her fever was going back up. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available, the local reactions and flu like symptoms following vaccination with BNT162B2 are more likely attributed to the vaccine use.  Further information like diagnostic detection of virus genetic material or virus protein antigen needed for meaningful medical assessment on protective effects with the vaccine.