chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 12-11-09, patient reported localized redness and warmth about 1-2 inches in diameter at the injection site. Patient denied fever, feverish symptoms or pain upon questioning. The localized redness was of an irregularly defined border. Her arm was also sore as patient expected. Doctor will see the patient on 12/10/09 to follow up. Treated with Keflex 500mg-one capsule three times daily as per doctor prescribed by phone (6pm 12-9-09) MD consulted for patient to continue antibiotics, monitor improvement and contact her in a few days. Patient was instructed to start applying Hydrocortisone 1% cream for redness and antibiotics for infection treatment. MD will culture if no improvement. Patient contacted pharmacy on 12/10 4:30 to report plan and that she notes improvement in appearance.
swollen lymph nodes under arm; extremely large swelling under arm that spread to front of chest.; large swelling also at site of shot and itchy.; large swelling also at site of shot and itchy.; This is a spontaneous report from a contactable consumer(patient) reported that. A 67-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 09Mar2021 14:15 (Batch/Lot number was not reported) as DOSE 2 SINGLE for covid-19 immunization. The patient past Medical history included chronic lymphocytic leukemia from an unknown date and unknown if ongoing, diabetes mellitus from an unknown date and unknown if ongoing. Concomitant medication(s) included insulin (INSULIN) taken for an unspecified indication, metformin (METFORMIN) taken for an unspecified indication, dapagliflozin propanediol monohydrate (FARXIGA) taken for an unspecified indication, simvastatin (SIMVASTATIN) taken for an unspecified indication, and acetylsalicylic acid (ASP) taken for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On an unspecified date the patient experienced swollen lymph nodes under arm, extremely large swelling under arm that spread to front of chest and large swelling also at site of shot and itchy. No treatment was reported. The event outcome was recovering.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Moderna Booster Vaccine expired 11/9/21 (prior to administration). No adverse reaction noted with pt
Trace pain/reddness 1 day after. Day 3 - office exam, 15 x 15 cm swelling, redness pain. Borders drawn - advised tylenol/ibuprofen; cool compress. if redness exceeds borders, call office
Patient completed two Pfizer COVID vaccines in June 2021. She was recently diagnosed with CVA. She came to the ED complaining of left lower extremity numbness and confusion with one week of headache. She was tested covid positive on 12/26/21. She had 102.0 fever, but she did not have respiratory symptoms during her hospitalization. She was discharged home on 12/27/21.
Two weeks after vaccination patient developed Barking Cough and Pertussis SxS.
Pain and swelling began to occur a few days after vaccine at base of middle finger in knuckles on left hand, and right shoulder pain intensified.  Pain and swelling subsequently also occurred in same area on right hand.  On 11/13/2014 nodules were noticed on both thumbs on joints under fingernails and at base. Since that time pain has intensified and traveled to many other joints -- to feet and some larger joints.  Joint weakness where there was none prior--I was able exercise vigorously---running 15-25 miles per week with no joint pain and engaging in high intensity exercise classes 3 times per week. Within weeks of receiving the shot I grow fatigued easily, have half the energy I used to have, and sense joint weakness and instability in many joints.
Mother brought patient back c/o sore throat, cough, and swollen lower lip. None of these symptoms were present prior to immunizations. I brought patient back and done an O2 check it was O2 97% and HR 102. Patient tells me he is breathing fine. I was instructed to administer BENADRYL 7.5mL pre Dr.
after not having a menstrual cycle for 8 months ,2 weeks after 2nd injection I got a  very heavy period and brutal cramps
Headaches, fever of 100.6, hot sweats, cold, bone ache.  Unable to move beacuse of the pain in my body
Headache, stomach ache, general ill feeling.  Did not feel well enough to remain at school and went home.  Out of school on 12/8/09 and returned to school on 12/9/09.
Left-sided tender supraclavicular lymph node; This is a spontaneous report from a contactable Physician(patient). This 40-year-old female patient (not pregnant) received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number= EK4176), intramuscular at left arm on 09Jan2021 09:15 at single dose for covid-19 immunisation.  Medical history included Eosinophilic Esophagitis, chronic constipation, allergy to tree nuts.  Concomitant medication included macrogol 3350 (MIRALAX). Patient previously received first dose BNT162B2 (Lot number: EH9899) intramuscular at left arm on 19Dec2020 14:30 at single dose for covid-19 immunisation. The patient experienced Left-sided tender supraclavicular lymph node developed the morning after 2nd dose of COVID vaccine on 10Jan2021 06:30 with outcome of recovering. No treatment was received. There was no other vaccine in four weeks, no covid prior vaccination, covid tested post vaccination. Event was non-serious.
Heart palpitations (worse with activity) Fatigue Shortness of breath Chest tightness  * symptoms varied across several weeks
Today the caller fell carrying a package; She hit right where the vaccine was and its red; she hit right on where she got the vaccine and an instant knot came up on her arm; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported for herself. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, in left arm on 21Apr2021 as dose 1, single for covid-19 immunisation. Medical history included stroke. The patient's concomitant medications were not reported. patient previously received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), for covid-19 immunisation. She got her second dose yesterday 21Apr2021 and everything was fine on her left arm. On 22Apr2021 today patient fell carrying a package and she hit right on where she got the vaccine, and an instant knot came up on her arm. She hit right where the vaccine was, and its red. Patient inquired if it could be a blood clot. Patient had a history of a stroke, so she was scared. The outcome of the events was unknown.  Communication: The caller declines to file a safety report, no further information or details were captured at this time. The caller was provided with phone number, and hours of operation prior to cold transfer due to a high call volume.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
gave the vaccine it bleed a little covered with a cotton ball applied pressure until it stopped. covered with a Band-Aid. about a minute later child asked to use restroom 5 seconds later child fainted in the chair. the mother and the intern caught the child in the chair and laid them down on the ground. Once the child regained consciousness, the intern then came to come get me. Once I arrived the child vomited and we then proceeded to monitor the child for the next 20 minutes.
some redness around her eyes; itchy; scaly lids; Tongue feels swollen and her lips; Her mouth feels very dry; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Mar-2021 and was forwarded to Moderna on 17-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of OCULAR HYPERAEMIA (some redness around her eyes), PRURITUS (itchy), EYELID EXFOLIATION (scaly lids), LIP SWELLING (Tongue feels swollen and her lips) and DRY MOUTH (Her mouth feels very dry) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025AZ1A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced OCULAR HYPERAEMIA (some redness around her eyes), PRURITUS (itchy), EYELID EXFOLIATION (scaly lids), LIP SWELLING (Tongue feels swollen and her lips) and DRY MOUTH (Her mouth feels very dry). At the time of the report, OCULAR HYPERAEMIA (some redness around her eyes) and EYELID EXFOLIATION (scaly lids) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Pain in underarm/armpit on the side of the vaccine; Pain, swelling, redness, and fever at injection site/ Injection site pain; Pain, swelling, redness, and fever at injection site/ Injection site swelling; Pain, swelling, redness, and fever at injection site/ Injection site redness; Pain, swelling, redness, and fever at injection site/ Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Sep2023 at 17:30 as dose 1, single (Batch/Lot number: unknown) at the age of 30 years, in right arm for covid-19 immunisation; influenza vaccine inact split 4v (FLUARIX QUADRIVALENT), on 27Sep2023 as dose 1, single (Batch/Lot number: unknown), in left arm for influenza immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: JUNEL; SEROQUEL; WELLBUTRIN; VYVANSE; HYDROXYZINE. Past drug history included: Cefzil, reaction(s): "Known allergies: Cefzil". Vaccination history included: bnt162b2 (Dose 1, Single, Vaccination site: Arm Left, Vaccine Administration Time: 05:00 PM), administration date: 25Jan2021, for COVID-19 immunisation; bnt162b2 (Dose 2, Single, Vaccination site: Arm Left, Vaccine Administration Time: 05:00 PM), administration date: 06Oct2021, for COVID-19 immunisation, reaction(s): "Inappropriate schedule of vaccine administered"; bnt162b2;bnt162b2 omi ba.4-5 (Dose 3 (Booster), Single, Vaccination site: Arm Left, Vaccine Administration Time: 05:00 PM), administration date: 17Oct2022, for COVID-19 immunisation. The following information was reported: AXILLARY PAIN (non-serious) with onset 28Sep2023 at 14:00, outcome "not recovered", described as "Pain in underarm/armpit on the side of the vaccine"; PYREXIA (non-serious) with onset 28Sep2023 at 14:00, outcome "not recovered", described as "Pain, swelling, redness, and fever at injection site/ Fever"; VACCINATION SITE PAIN (non-serious) with onset 28Sep2023 at 14:00, outcome "not recovered", described as "Pain, swelling, redness, and fever at injection site/ Injection site pain"; VACCINATION SITE ERYTHEMA (non-serious) with onset 28Sep2023 at 14:00, outcome "not recovered", described as "Pain, swelling, redness, and fever at injection site/ Injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset 28Sep2023 at 14:00, outcome "not recovered", described as "Pain, swelling, redness, and fever at injection site/ Injection site swelling". Therapeutic measures were not taken as a result of axillary pain, vaccination site pain, vaccination site swelling, vaccination site erythema, pyrexia.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300314962 same patient, different vaccine dose/event;
Information has been received from a consumer, who is the mother of the patient, concerning her 14 year old daughter with sulfonamide allergy and a history of hypersensitivity who on 06-AUG-2008 or 08-AUG-2008 was vaccinated with GARDASIL for her first dose.  Concomitant therapy included montelukast sodium, (MSD), allergy shots once a week and ZYRTEC.  "A few days after receiving GARDASIL" the patient started to throw up once a week, was coughing and was losing her hair all over.  Then the patient started to have knee and back pain and then had gone to the emergency room on 28-SEP-2008.  At the hospital the patient was diagnosed with appendicitis and had emergency surgery to have her appendix removed.  The patient had been in hospital from 28-SEP-2008 to the following Monday.  The patient was still feeling tired, but she was recovering.  No further adverse effect information was provided.  Additional information has been requested.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patient were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX lot # L015048 with exp. 29-APR-2017, (route and dose were not provided). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Day 1 to 2---Left arm tenderness at the site for 2 days, no redness/rash/lump. Day 3---no side effects Day 4 to Day 5---At about 8 pm, I noticed slight swelling underneath my left eye, that looked like a bag.  My face was also red.  The sides of my face, jaw line,  & both sides of my neck were itchy.  I went to bed since I was supposed to work the next morning at 6 AM (OB Nurse).  I work up at 4:15 AM & my face was quite swollen, specifically my left side, my face & neck was warm to the touch &  itchy.  I immediately took 50mg of Benadryl & called my internal medicine doctor. Day 5---I was to be seen in the clinic at 7:00 AM.  The Benadryl helped some.  I was not having any breathing difficulty.  I was prescribed 5 days of Prednisone.  By about 1:00 PM,  the swelling was worsening & my lips were tingling.  I called the doctor again & they told me to go to the ER.  I never had issues with my airway.   The swelling was always worse on my left side of my face.  I received IV fluids & Solumedrol & was discharged with an epi pen, & told to continue the Benadryl, Prednisone, & Pepcid bid.  CoVid test done in ER was negative. Day 6---The facial swelling/redness/itching remained but was improved.  I was very tired. Day 7---Same as Day 6, but less swelling. Day 8---Facial swelling/redness/itching gone, but tiredness remained.  Started to notice a chest heaviness/feeling of constant excitement in the center of my chest, even when at rest. Day 9-10---Tiredness remained.  Intermittent Chest heaviness/feeling of excitement in the center of my chest remained. Day 11---Feeling more normal.
No additional adverse events; administration of expired MMR II; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's  medical history, concurrent conditions and concomitant medications was provided.   On 17-AUG-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)(recombinant human albumin (rHA))(strength, dosing schedule and route of administration were not reported) lot # S025157, expiration date: 13-AUG-2021, 0.5 milliliter for prophylaxis. Administered dose was evaluated as supported. No additional adverse events reported.
sudden high fever (101-104) sudden confusion  sudden extreme exhaustion sudden extreme leg weakness (couldn't walk) pneumonia kidney infection
Patient was given monovalent vaccine instead of bivalent vaccine. Daughter, who is caregiver, states that she was acting more tired and had a runny nose the evening after the vaccination. Daughter states that patient was also shaking before going to bed.
allergic reactions; Caller does not think that she will be able to complete the series/ Caller has also had to cancel her second dose; Consumer reporting AE for GARDASIL 9. Consumer states she is 51 years old and received her first dose of GARDASIL 9 on 05JUL2022. Consumer states GARDASIL 9 was recommended to her from her OBGYN after she had HPV cancer removed when she was 48 years; Caller stated that she experienced a rash for a few weeks after she received the first dose of her vaccine.; Information has been received from a 51-year-old female patient, referring on herself. The patient's medical history included human papillomavirus infection (HPV) and had precancerous polyps in 2021. She had them removed in 2021 and in June 2022, she discovered that they came back, during check ups (she received a puncture and they showed up as "Cervical intraepithelial neoplasia III (CIN 3)". Additional medical history were reported that she has had a hard time with anesthetics in previous years. The patient stated that she had to have them removed a second time. The concurrent conditions and concomitant therapies were not reported.   On 05-JUL-2022, the patient received the first dose of started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection in the left bicep (strength, lot #, expiry date, and route of administration were not provided), administered for prophylaxis. The patient stated that hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was recommended to her from her obstetrics and gynaecology (OBGYN) professional after she had HPV cancer removed when she was 48 years old.   On an unspecified date in 2022 (reported as "few weeks after she received the first dose of the vaccine"), she experienced a rash for a few weeks after she received the first dose of her vaccine. She received the vaccine in her left bicep. The patient stated that the rash did not spread, and it stayed in one area. She used Lanolin cream to keep the rash moist, and the rash was gone on an unspecified date in 2022 (reported "by the 29th"). The patient was scheduled to receive her second vaccine on 12-SEP-2022, but had to cancel the appointment (Inappropriate schedule of product administration). On an unknown date, she stated that she experienced allergic reactions to nylon sutures, metal, gluten, adhesives and nickel.  The outcome of the allergic reactions was not reported.  The causal relationship between the rash and the allergic reactions with the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.
Arm is swollen; Like a bee sting; Large bump; Arm is itchy; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm is swollen), ARTHROPOD STING (Like a bee sting), PAPULE (Large bump) and PRURITUS (Arm is itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced PERIPHERAL SWELLING (Arm is swollen), ARTHROPOD STING (Like a bee sting), PAPULE (Large bump) and PRURITUS (Arm is itchy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 05-Mar-2021, PERIPHERAL SWELLING (Arm is swollen), ARTHROPOD STING (Like a bee sting), PAPULE (Large bump) and PRURITUS (Arm is itchy) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant product use was not provided by the reporter.  Treatment information also included ice packs.   This case was linked to MOD-2021-066040 (Patient Link).
Initial report received on 16 February 2012 from the Investigator participating in a study under the reference number M5A16. A case of pertussis disease in a 2-year-old female subject was identified by the investigator based on review of data from the database. The subject had previously received 3 doses of PENTACEL; dose 1 lot number C3542AA received on 25 January 2010, dose 2 lot number C3589AA received on 25 March 2011 and dose 3 lot number C3607AA received on 24 May 2010 (route and site of administration not reported). The subject developed a cough on 26 December 2011, approximately 1 year and 7 months after the last dose. On 29 December 2011, the subject developed cold-like symptoms and then a paroxysmal cough with whoop on 31 December 2011. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 04 January 2012 and negative culture on 04 January 2012. Chest x-ray findings were negative for pneumonia. The patient was not hospitalized. Corrective treatments consisted of azithromycin starting on 05 January 2012 for 5 days. At the time of final contact on 12 February 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 48 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
The second day (3/4/21) after the injection I woke up feeling rather achy. By noon I was experiencing a feeling of total body aches and nothing would take the aches away. I finally took 3 advil and the aches went from horrible to tolerable. My left arm though felt very hot to the touch and it was swelling and very red. It swelled all the way to my elbow. There was a definite distinction of where the redness and swelling started and stopped. 3/5/21 the fatigue was also a problem. Any activity was debilitating. My upper arm was swollen and red all through Sunday (3/7/21) evening. Monday (3/8/21) morning it was starting to go down.  At 5:00 pm on Monday, it is still slightly red and warm to the touch.
Patient became light headed and slumped per the vaccinating nurse and she rushed over to escort him to the ground. I arrived at that time as patient was being escorted to the ground.Patient was diaphoretic, red, and per patient he felt light headed. He never lost consciousness. Vitals were taken and patient was stable. B/P was 115/76, HR 65, RR 35, 99% on room air, and blood sugar was 97. Patient had no complaints of pain. Paramedics were called and patient was taken to the nearest hospital.