chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen glands below the jaw; Extreme sensitivity of the teeth in the back or the mouth on top and bottom of both sides; Severe acne on lower half of the face; High blood sugar/insulin resistance; High blood sugar/insulin resistance; painful soreness in the throat on the upper right side; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Apr2021 at 12:45 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included type 1 diabetes and celiac disease. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included insulin lispro (HUMALOG), pramlintide acetate (SYMLIN), bupropion (MANUFACTURER UNKNOWN) and escitalopram (MANUFACTURER UNKNOWN); all for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 12:00, the patient experienced swollen glands below the jaw, extreme sensitivity of the teeth in the back or the mouth on top and bottom of both sides, severe acne on lower half of the face, high blood sugar and insulin resistance, painful soreness in the throat on the upper right side. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 25Apr2021, the patient underwent test for COVID-19 via nasal swab and the result was negative. The clinical outcome of the events swollen glands below the jaw, extreme sensitivity of the teeth in the back or the mouth on top and bottom of both sides, severe acne on lower half of the face, high blood sugar and insulin resistance, painful soreness in the throat on the upper right side was resolving at the time of this report. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Swollen lymph nodes in arm pit, left breast (which doubled in size), and back of neck both sides just below the base of the head. Also excruciating pain all over body.  Much more pain than is normal. Migraine and pain did not respond to acetaminophen. I held an ice pack on my armpit and my breast which did nothing for the swelling, but after a while it helped with the pain.  Today is day 4 and the swelling has started to go down and the body aches have lessened but I am still in a large amount of pain in my armpit and left breast. I cannot put my arm all the way down to my side and I cannot reach my hand up to my throat.
Headache, Fever, Chills Narrative: Had fever and chills night of injection Took Tylenol. Mild headache the next day.
This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 54-year-old female patient who received Influenza vaccine Quadrivalent. Concurrent medical conditions included lung cancer (stage 4). Concomitant products included CLARITIN, SUDAFED and TAGRISSO. In April 2017, the patient received Influenza vaccine Quadrivalent (intramuscular). On 24th April 2018, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza B virus infection. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza B virus infection was recovered/resolved. It was unknown if the reporter considered the vaccination failure and influenza B virus infection to be related to Influenza vaccine Quadrivalent. Additional information was reported as follows: The patient had stage 4 lung cancer and is susceptible to illnesses like influenza. On 24th April 2018, the patient was diagnosed with influenza B. She had gone to her doctor's office because she had been sick for the past 5 days from the date of reporting. The case was considered as suspected vaccination failure as the time to onset for the event was not provided.
Heart fluttering, chest pain, and shortness of breath started 3 days after shot. Heart fluttering stopped after a few days. Chest pain/tightness and shortness of breath continues
Pain in left shoulder blade radiating to left chest under breast. Pain increases when lying down and taking deep breaths. Pain decreases when leaning forward. Pain started on 11/11/21 and became worse. ER visit made on 11/17/21 and diagnosed with Pericarditis. No fluid buildup or blood clots. Prescribed Naproxen and encouraged to rest.
Firmness, redness, and itchiness in a space around the injection site about 1 inch in diameter. Appeared one week after injection
Patient arrived for vaccine and passed screening, received vaccine. When nurse went to enter into Immtrac2 it was recorded the patient received vaccine on 1/28/21 and 2/24/21 of Pfizer then came to us and received dose 1 of Moderna. This was verified with the patient whom seemed confused and stated she only did what her son told her to. Contacted Poison  Control and spoke with toxicologist whom stated no intervention required.
10/09/09 received immunization; that evening nauseated, coughing, some swelling tongue and throat; Saturday hives face and neck-took BENADRYL; Sunday hives all over took prednisone; 10/12/09 office visit prednisone; 10/13/09 ER and 10/23/09 ER->IM SOLU-MEDROL and KENALOG, PO pred. 10/27/09 clinic.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 09-JUN-2017, the patient was vaccinated with improperly stored VARIVAX injection, lot # M046004, expiry date: 18-NOV-2018 (dosing details not reported) which was reconstituted with properly stored sterile diluent (MERCK) (lot#, expiry date unknown) for prophylaxis. It was reported that the vaccine was exposed to a temperature range of 6 F to 14 F for a duration of 180 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA007776.
Patient experienced nausea and dizziness post vaccination. BP 90/50, HR 71, RR 29. 10 minutes later, patient had no nausea or dizziness; AOx3; walked home with friend.
No additional adverse effects reported; administered via intramuscular routes; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not reported. On 14-DEC-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) recombinant human albumin (rHA), lot # S007811, expiration date 14-MAR-2021 (strength and dose were not provided) and with varicella virus vaccine live (oka/merck) (VARIVAX) lot # S011952, expiration date 16-APR-2021 (strength and dose were not provided); both vaccines were administered via intramuscular route (incorrect route of product administration) for prophylaxis. The vaccines were reconstituted with sterile diluent (lot #S005076, expiration date 05-NOV-2021). No additional adverse effects were reported.
Developed ulcerative lesions in her mouth Aug 06. Treated for peritonsilar abscess with abx. No improvement. Had CT to R10 peritonsilar abscess-negative.  ENT gave dx at Lichen Planus-erosive.  Had tissue bx. Ct and pain report included
This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unspecified dates the patients were administered improperly stored GARDASIL (unknown route and strength). Concomitant medications were not reported there was no known adverse effect. The outcome of th event was unknown. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
no signs of allergy since receiving Pfizer Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "wheat allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "no signs of allergy since receiving Pfizer Covid".  Additional information: Consumer stated that your vaccine may be remediate that wheat allergy for me; I got your vaccine, this has happened. Is there a correlation between the vaccine and maybe mean that feeling my wheat allergy no more. He got the two doses of your vaccine (Further clarification was unknown hence captured as unspecified vaccine), last dose 3 weeks ago. He had a wheat allergy. Since he got your vaccine, he pushed himself to wheat and he had not got a reaction. So no more, he eat wheat. Its only when he got your vaccine that this has happened. Consumer also stated, It was not a concern. It was a good thing. The only difference was he was not feeling allergy himself.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Extreme pain and itching. Swollen area from shoulder to elbow - "orange skin" swollen area very firm. Headache, cough/congestion.
Chills, fatigue, headache, nausea, and muscle aches that lasted about 36-48 hours.  Mild rash on face, neck and upper body started at 48 hours after vaccine and lasted about 12 hours.  Arm soreness for about 3 days.
Large red area around injection site about 2 in by 4 in. started blotchy then very red and now a more defined red outline of area, with the inside lighter in color. Skin is harder in that area and warm to touch. Sometimes is itchy,
33 y.o. male with a past medical history relevant for anxiety presents to the ED following a syncopal episode after receiving his first COVID-19 vaccine. The patient denies any precipitating symptoms and fell to the ground, noting that a similar situation occurred when he last had blood drawn. He notes that he has only consumed coffee today, without any other food or water intake, and has not taken any anxiolytics in some time.
Erythema, swelling about 7 cm diameter. Vertigo about 4 hours after injections - lasted < 5 min.
My arm 2 days after the second dose started to itch terribly and  became red and swollen
Hospitalization for COVID19 PNA, hypoxia. 1/1-1/10/22 Treated with baricitinib daily, Remdesivir, dexamethasone, zinc daily and  vitamin D3 daily
This is a spontaneous report from a contactable consumer (pfizer colleague), the patient. A 40-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via intramuscular route of administration in the left arm on 15Nov2021 at 10:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included salbutamol (ALBUTEROL) and budesonide, formoterol fumarate (SYMBICORT); both for unknown indication from unknown date and unknown if ongoing. The patient did not receive other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: E23247) via an intramuscular route of administration on 10Mar2021 (at the age of 39-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an intramuscular route of administration on 31Mar2021 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. On 15Nov2021 at 18:00, the patient experienced soreness at the injection site. The event did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of event. The clinical outcome of the event soreness at the injection site was resolving at the time of this report.
Difficulty swallowing, coughing and throat tightness - Epi pen given x1 - Solu-Cortef 100mg IVP
This spontaneous report was submitted in relation to an emergency department visit whereby a menigitis rule-out work up was associated with a recent administration of HPV Vaccine.
feel weak; tired; had slept 3 times due to weakness; slight cough; feel like he is getting a cold; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (feel weak), FATIGUE (tired), HYPERSOMNIA (had slept 3 times due to weakness), COUGH (slight cough) and NASOPHARYNGITIS (feel like he is getting a cold) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced ASTHENIA (feel weak), FATIGUE (tired), HYPERSOMNIA (had slept 3 times due to weakness), COUGH (slight cough) and NASOPHARYNGITIS (feel like he is getting a cold). At the time of the report, ASTHENIA (feel weak), FATIGUE (tired), HYPERSOMNIA (had slept 3 times due to weakness), COUGH (slight cough) and NASOPHARYNGITIS (feel like he is getting a cold) outcome was unknown.      No relevant concomitant medications were reported.  Treatment information not provided.
Information has been received from a registered nurse concerning a 7 year old female with no pertinent medical history, drug reactions or allergies, who had an upper respiratory tract infection and viral pharyngitis at the time of vaccination, on 25-JAN-2001, with her first dose of varicella virus vaccine live (Oka/Merck) (Lot # 635461/1246K). Concomitant therapy, that same day, included Prevnar (lot # 472546). On 30-MAR-2007, the patient developed a rash over her entire body. On 31 MAR 2007, the patient was seen in the doctor's office and diagnosed with post Varivax varicella. Supportive care was recommended. At the time of reporting the outcome was unknown. Additional information is not expected.
This spontaneous report was received from a medical assistant and refers to multiple unknown patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (dosing details and route of administration unknown) (lot # M033209 with expiry date 09-JAN-2018; lot # M038228 with expiry date 06-MAR-2018; lot# M049123 (RHA) with expiry date 13-OCT-2018) for prophylaxis, which reconstituted with sterile water diluent that was not involved in the temperature excursion. Medical assistant did not know which of vaccine lot numbers were administered. The administered doses experienced a temperature excursion of 6 degree Fahrenheit(F) to 14 degree Fahrenheit(F) for a time frame of 20 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no Product Quality Complaint (PQC) involved. No additional information was provided. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments:  US-009507513-1706USA001442: Original Case: 1706USA001442.
Pfizer-BioNTech COVID-19 Vaccine  Swollen & inflamed (right) eye, right (axilla) tenderness, & fatigue.
After about 4 days with a temperature of 37.7 centigrade: high blood pressure -- > systolic 190 diastolic 115 (despite Ramipril 5mg morning and evening) Vertigo Acufene General discomfort duration of symptoms: 5 days
Patient intended to receive her second dose of her Shingrix shot but instead it was misunderstood that she needed her second dose of her Covid shot. She has no adverse effects from the vaccine itself, but this was her 4th dose of the pfizer covid 19 shot, as she got 2 other doses elsewhere
Developed severe rash around Cpap mask, ears, neck and various outbreaks on legs and chest.    Went to Dr. for wellness visit on May 13 and he prescribed  a mild steroid salve.  That helped some.  Face and neck reddened and swelled and began to subside after several weeks.   I was doing some woodworking with cedar which also caused a serious allergic reaction which I believe worsened the rash that was going on in my body.   I went to allergist on July 2; earliest appointment I could get.   Condition was already clearing up.  She took biopsy.  And urged me to continue treatment with steroid ointment.
Pfizer COVID 19 vaccine: got COVID; Pfizer COVID 19 vaccine: got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 17Apr2021 as dose 1, single (Lot number: EW0162) and on 08May2021 as dose 2, single (Lot number: EW0169) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history included: "several TIA's (Transient ischaemic attack) years ago when birth control pills" (unspecified if ongoing), notes: several TIA's (Transient ischaemic attack) years ago when birth control pills; "high blood pressure diagnosed probably 20 years ago" (unspecified if ongoing), notes: high blood pressure diagnosed probably 20 years ago. Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID]. The patient takes blood pressure pill and a daily aspirin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Pfizer COVID 19 vaccine: got COVID". Therapeutic measures, Paxlovid from 25Feb2023, were taken as a result of vaccination failure, covid-19.
injection site pain; Fatigue; nausea; Dizziness; fever; chills; shaky hands; general feeling of being unwell; This is a spontaneous report from a contactable other health care professional (reported for herself). A 33-years-old female non-pregnant patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6201/Batch number was not reported), dose 2 via an unspecified route of administration, administered in arm left on 08Feb2021 at 13:30 (at the age of 33-years-old) as dose 2, single for covid-19 immunisation at Public Health Clinic/ Administration facility. Medical history included attention deficit hyperactivity disorder from an unknown date and unknown if ongoing and pneumonia from an unknown date and unknown if ongoing. Concomitant medication(s) included vyvanse (LISDEXAMFETAMINE MESILATE) taken for an unspecified indication, start and stop date were not reported, trazodone (TRAZODONE) taken for an unspecified indication, start and stop date were not reported and Daily multivitamin. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient has no reported allergies. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL2348/Batch number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 18Jan2021 at 15:00 (at the age of 33-years-old) as dose 1, single for covid-19 immunisation and experienced vaccination site pain at Public Health Clinic/Veterans Administration facility. The patient experienced injection site pain on 08Feb2021, fatigue, nausea, dizziness, fever, chills, shaky hands and general feeling of being unwell on an unspecified date in Feb2021. Therapeutic measures were taken as a result of events fatigue, fever and chills included treatment with OTC acetaminophen. No treatment was given for the other events. The outcome of the events was not resolved.  Follow-up attempts completed. No further information expected.
no adverse event; VARIVAX had t/e on 16-AUG-2023 and was administered to patient; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 13-SEP-2023, the patient was vaccinated with a 0.5 mL dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # reported as W039699) (route not reported) that had a temperature excursion on 16-AUG-2023. The temperature of excursion was 25.8 °C for a time frame of 9 hours 24 minutes. There were no previous excursions. The reported also stated that the freezer units have ice packs in them that never melted during the excursion.  Lot # W039699 is an invalid lot number for varicella virus vaccine live (oka/merck) (VARIVAX).  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2309USA006884: US-009507513-2309USA009905: US-009507513-2309USA009906: US-009507513-2309USA009907: US-009507513-2309USA009908: US-009507513-2309USA009909: US-009507513-2309USA009910: US-009507513-2309USA009911: US-009507513-2309USA009912: US-009507513-2309USA009913: US-009507513-2309USA009914: US-009507513-2309USA009915: US-009507513-2309USA009927: US-009507513-2309USA009928: US-009507513-2309USA009930:
The mother of the child wrote down on the consent and screening form that the child's date of birth was 11/3/2008. This would make the child 12 years of age and eligible to receive the vaccine.  The immunization record system has that the child's date of birth is 11/3/2021, making the child 10 years old and not eligible to receive the vaccine.
On 7/11/01, pt developed generalized bone pain and left deltoid swelling and pain. She c/o redness in area. On 7/12/01, she developed a feeling of heat in right upper deltoid and also c/o itching. On 7/13/01, symptoms inc in severity. On 7/14/01, she developed temp of 102. On 7/16/01, she returned to work. She was treated with Augmentin 500mg x 10 days.
1/12/22 pt had a positive COVID test; at home in hospice care; palliative care; pt passed away at home 2/19/22
Standard reactions  except I have been spotting vaginally and cramping since the day after getting the shot. I have the Mirena birth control implant and do not have a monthly period and have not had one for many years nor do I get the cramps and other symptoms of having a period.   For the past 9 days since getting the vaccine,  I have had spotting and cramping off and on daily.   This is NOT normal for me!
Got super ill the next day, cold sweats, nausa, direhea, fever was also suoer sensitive to sound and felt very lathargic slept for almost 36 hours straight
Experiencing severe body aches (8/8.5 out of 10), at times cannot get out of the bed abs extreme fatigue (worst in the nighttime and early morning). Resting heart rate has increased from 65 to 99, and experiencing heart pounding most times. No respiratory symptoms at all. COVID and flu tests all are negative
Cheat pain. Started quickly and got moderate within an hour.  Lasted for over 7 days. Right in center of chest under sternum. Felt like a tightness in my heart area.