chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; slight flu like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 06Apr2021 at 10:00 as dose 2, single (Lot number: EW0151) at the age of 69 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Hysterectomy", start date: 1978 (unspecified if ongoing); "illness" (unspecified if ongoing); "B/P" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Hormone" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL TARTRATE ACCORD oral taken for blood pressure measurement, start date: 2012 (ongoing); CITALOPRAM oral taken for depression, start date: 2019 (ongoing); ESTRADIOL [ESTRADIOL BENZOATE] oral taken for hormone therapy, start date: 1999 (ongoing); WELLBUTRIN oral taken for depression, start date: 2012 (ongoing); ATORVASTATIN oral taken for blood cholesterol, start date: 2020 (ongoing). Vaccination history included: BNT162b2 (Dose: 1st, Time: 9:30, Anatomical Site of injection: Upper arm, Route of administration: Intramuscular, Batch/Lot number: Pfizer EN6208), administration date: 16Mar2021, when the patient was 69-year-old, for Covid-19 immunization, reaction(s): "Sore arm", "Slight flu like symptoms". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "slight flu like symptoms". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: I had just sore arm and slight flu like symptoms with first immunizations. Lasted 2 days- 4rth (2nd booster) on my 14May2022 reaction was horrible but nothing needing hospital, (husband through I should) Injection site was hot and red for about 2 weeks whole arm ached and today that muscle is still sore.  Had temp around 100 degree for about a week. Extremely tired and achy and brain fog. Every joint ached and had headache off and on. I looked pale and felt like warm than cold-This basically went for 2 weeks. The muscle in my arm still aches when I use left arm. I still do not have my energy back all the way. So the worst is over but not truly recovered 100 (percent).
Severe cold and flu like symptoms including high fevers for the first 10 days. Continued severe and flu like symptoms with low grade fevers for additional 6 wks. Chronic stuffy nose and postnasal drip every day from 21 April 2016 to present with various cold and flu like symptoms and low grade fevers. While seeking medical assistance with two Clinics, patient was informed that she now has asthma.
oral intake reduced; bloody stool; difficulty sleeping; fear; activities of daily living impaired; feeling sad; wound secretion; Cyst; Crohn's; dizziness; This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) from a non-contactable consumer (the patient) based on the information received by Pfizer from AbbVie Inc. (MFR Control No.21K-163-3943648-00). A 15-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in 2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization; adalimumab (HUMIRA), subcutaneous from 26May2021 (Batch/Lot number was not reported) to 26May2021, at 80 mg (day 1, loading dose), subcutaneous from 09Jun2021 (Batch/Lot number was not reported) to 09Jun2021, at 80 mg (day 1, loading dose), subcutaneous from 23Jun2021 (Batch/Lot number was not reported) and ongoing, at 40 mg (40 mg,1 in 14 D) for Crohn's disease. Medical history included eczema. The patient's concomitant medications were not reported. In May2021, the patient experienced Crohn's and dizziness. In Jun2021, the patient experienced difficulty sleeping, fear, activities of daily living impaired, feeling sad, wound secretion, and cyst. In Jul2021, the patient experienced bloody stool, dizziness, and oral intake reduced. The clinical course was reported as follows: In May2021, the patient experienced dizziness and no change in Crohn's symptoms after start of HUMIRA. In Jun2021, the patient experienced trouble sleeping, feeling afraid/scared, not able to do things other children could do, feeling sad/blue, and cyst inside butt and it was leaking. In Jul2021, the patient experienced dizziness, did not want to eat, and 1 to 2 formed stools a day without bleeding. The action taken in response to the events for BNT162B2 was not applicable, for adalimumab was dose not changed. The outcome of Crohn's was not recovered. The outcome of dizziness, wound secretion, cyst, was recovered in 2021. The outcome of other events was recovering.  The reporter's assessment of the causal relationship of the events with the suspect vaccine, BNT162B2, was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the  limited available information, the causal relationship between BNT162B2 and the events Haematochezia, Crohn's disease, Dizziness , Hypophagia, Insomnia , Fear, Loss of personal independence in daily activities, Depressed mood, Wound secretion and Cyst are considered related.   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 Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Swelling left upper arm, left upper back, over shoulder. Soft tissue swelling. No redness. Non tender. No heat. Onset 1/24/06
Vaccine given at 2:30 PM - 3:30 he noticed facial swelling and difficulty breathing and hives were noticed later on.  He went to ER around 5:30 where they gave him IV's steroids and BENADRYL.  He was monitored for 4 hours and released.
Developed large, reddened, itchy whelps on backs of legs.  Has never experienced this before.
pt developed mental status changes and weakness x 3 days, currently on chemo,  presented to ED, tested positive for COVID presented  with chills, nausea, vomiting, sore throat, rhinorrhea, diarrhea, cough, and shortness of breath.
patient reported sore arm , fever of 101f, pain in shot arm and back and breast, extreme weakness, unable to walk, dizzyness swelling in the lymph nodes, nausea and vomiting for 36 hours. patient stated that she felt better on 12/10/2021 when she called to report this event to me. The patient did not seek  further treatment.
Patient called Monday and stated the morning 2 days after his vaccine he woke up with a rash all over his body. I tried to call the patient to see how he was doing on Wednesday but did not get a call back.
swelling in her armpit and swelling beneath the armpit on the side of her chest and above her left breast; swelling in her armpit and swelling beneath the armpit on the side of her chest and above her left breast; swollen lymph nodes; purple dots along her left side, similar to a bruise; This is a spontaneous report from a contactable consumer (patient) received via medical information team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration in left arm on 23Mar2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient experienced swelling in her armpit and swelling beneath the armpit on the side of her chest and above her left breast and swollen lymph nodes on 26Mar2021, purple dots along her left side, similar to a bruise on an unspecified date in Mar2021. Patient would like to know whether swollen lymph nodes, could last up to 2-4 weeks. It was reported that three days after vaccination, patient noticed swelling under her armpit on the arm where she got the vaccination; it is still swollen; and has purple dots and looks like it was bruised. She was asking is this normal. Outcome of events was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt was crying before, during, & after shots;several min later, pt stopped crying, face less red (not cynosis) in 30min pt gradully back to nl;
FEVER, SHAKES, CHILLS, BODY ACHES, LETHARGY, TEETH/FACIAL PAIN ALSO CONTINUAL ITCHING AT 2ND INJECTION SITE FOR MONTHS.
Dizziness-Vertigo, 5 days so far, not occurring in the morning, dizzy spells begin as the day goes on, by night a constant dizzy spell
chills, sweats, headache, eye pain, nausea,dizziness, fatigue, loss of appetite.
I developed  a 3?x4? bruise 5-6 inches away from my injection site 10 days after my 2nd dose. It?s painful and has a dime size lump inside, looks like it?s getting bigger every day. I have a hex of low platelets, last December is 145 , took it again 3/1/21 and it?s 116 , I don?t know what?s going on , Saw my PC , he sent me for ultrasound. Please advise what to do.
Dizziness to the point of being unable to walk or stand for any reasonable length of time, no treatment aside from rest applied as of yet.
Painful Lymphadenopathy in the vaccinated arm and same side of the neck; This is a spontaneous report from a contactable physician (patient). A 37-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3246) intramuscular in the left arm on 12Jan2021 07:15 AM at a single dose as Covid vaccine. The patient had no medical history. She has no known allergies. Concomitant medications were not reported. The patient had her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EJ1685) intramuscular in the left arm on 22Dec2020 12:45 AM as Covid vaccine. She had no other vaccine in four weeks. She experienced painful lymphadenopathy in the vaccinated arm and same side of the neck that started 24hrs post vaccine on 13Jan2021 07:15 AM. Treatment was not received for the event. She has no Covid prior to vaccination. She did not have Covid tested post vaccination. The outcome of the event was recovering.
Her son was diagnosed positive; Son is completely vaccinated; Her son was diagnosed positive; Son is completely vaccinated; This is a spontaneous report from a Pfizer-sponsored program Support. This is the 2nd case out of 2 cases. A contactable consumer reported for a patient (Son) that the male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced her son was diagnosed positive; son is completely vaccinated on an unspecified date with outcome of unknown. She mentioned that, she got the booster shot today, without even knowing that, her son was diagnosed positive and she was exposed to his like there is no face mask and his son is completely vaccinated(Not further confirmed which vaccine he received) as well and right now, he has the symptoms of COVID-19 virus right now. She want to know how does it matters and she added that, If any, in case they will not be infected, they will be visiting a person, who is immunocompromised, who is vaccinated as well. She wants to know and she wants to ask if there are possibility, They can carry the virus even though the immunocompromised person is already vaccinated. The patient underwent lab tests and procedures which included sars-cov-2 test: positive.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Leg Tingling; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Leg Tingling) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Leg Tingling). At the time of the report, PARAESTHESIA (Leg Tingling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
I became very exhausted in August. There was a delay in the event. After a few days, I went to the ER and they determined I had anemia and gave me 6 pints of blood. I was hospitalized for 2 days. They also did a colonoscopy and found a bleeding hernia. I went to doctor as I remained extremely exhausted. The doctor did a lot of blood work and determined the Epstein Barr virus. The general number is about 32 and mine was at 542 on November 26, 2021. They told me to sleep as much as my body needed and did not prescribe any medication. I was advised to not take the flu vaccine or the booster. I still have not gotten better. I was sent to an infectious disease doctor in December and he also was unable to determine what it was. He did advise me to have the booster and the flu vaccine. My count one month ago was 342.
Patient developed a warm red rash, tender to touch over the area/site of administration says it is "itchy" not painful. Had fever of over 100.5 degree F for 2 days.
(L) arm lesion, redness, swelling for 3 days. No fever, no abdominal pain, no diarrhea, vomiting. Prescription given for ibuprofen 4mL every 6 hrs. KEFLEX 5mL every 8 hrs.
Fever of 103 deg occurred within 6 hours of dosage administered lasted for several hours and broke within 2-3 hours after administrating an additional dosage of children's Tylenol.
received vaccine at 6:40 in am.  started feeling flu like about 8 pm. went to bed. Got up at 3:30 am to take tylenol and felt dizzy and obviously passed out and woke up on floor not knowing where i was.   hit back of Left side of head which has a big bump and strained anterior R neck muscles.
COVID-19 VACCINE.  BLOOD PRESSURE INCREASE. 4 DAYS AFTER INJECTION,
felt tired; hurting; This is a spontaneous report based on the information received by a contactable consumer via Pfizer (Manufacturer Report Number: 2021SA24821).  A 55-year-old female patient received a dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE (reported as TOZINAMERAN, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as DOSE NUMBER UNKNOWN, for COVID-19 immunization and Kevzara (SARILUMAB, Solution for injection, dosage, frequency and route unknown, with an unknown batch number and expiry date) on an unspecified date for unspecified indication. In the context of COVID19 crisis, the batch number and expiration date were not requested. The patient past medical history, medical treatment, family history and concomitant medications were not reported. On an unspecified date, the patient felt tired and hurting (unknown latency) while being treated with sarilumab (Kevzara) and tozinameran (BNT162B2). It was not reported if the patient received a corrective treatment for the events. Action taken with sarilumab (Kevzara) was unknown. At time of reporting, the outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt had vasovagal syncope, dizzy, passed out, sweating, hot and cold. 911 was called. Put ice on pt's neck, spoke to pt to keep awake, blood pressure taken, EMS took all vitals and blood sugar and EKG all normal. pt allowed to leave pharmacy with ride home from girlfriend. followed up with pt 1 hour later by phone, pt is feeling ok but tired.
Patient was brought here by her daughter for altered mental status.  She could only answer questions yes, no or okay.  The patient was in the Hospital 8/17/2021 for dehydration and had similar presentation.  2 weeks prior she was in the  Hospital once again for urinary tract infection.
Patient in office for complete physical exam including pelvic exam and following had blood draw and influenza vaccination. After leaving office husband who is a physician and who was driving reports her face was red and she became chilled. Later she felt weak and had neck pain. He called office 10/1 reporting she was feeling better today but he felt she had allergic or adverse reaction. I theorized possible vasovagal response to all events.
experiencing chills; fever of 100.7; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (experiencing chills) and PYREXIA (fever of 100.7) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no adverse event reported).    On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced CHILLS (experiencing chills) and PYREXIA (fever of 100.7). At the time of the report, CHILLS (experiencing chills) and PYREXIA (fever of 100.7) outcome was unknown. Not Provided          no treatment is provided.   Reporter did not allow further contact
This case was reported by a other health professional and described the occurrence of accidental overdose in a 2-year-old male patient who received FLUARIX QUADRIVALENT (batch number F45C5, expiry date 30th June 2015). On 8th December 2014, the patient received the 1st dose of FLUARIX QUADRIVALENT .5 ml. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced accidental overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the accidental overdose and inappropriate age at vaccine administration were unknown. Additional information received: Inadvertently gave 2 years old male 0.5 mL dose of FLUARIX QUADRIVALENT today 12/8/14. Adult vaccine given to child.
Sore arm; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number: EL9264), via an unspecified route of administration, administered in left arm on 05Feb2021 10:15 (at the age of 75-years-old) as dose 2, single for COVID-19 immunization. Medical history included back fusion in Jul2020 and Aug2020. Concomitant medications included estradiol, triamterene, vitamin D, and melatonin, all taken for an unspecified indication from an unspecified start date and ongoing. Historical vaccine included first dose of BNT162B2 (lot number: EL 8982), administered in left arm on 15Jan2021 10:15 and experienced muscle and joint very sore, fever, and arm shoulder swollen. The patient experienced only a sore arm with the second shot on an unspecified date. Outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.
My first dose I received the Pfizer vaccine when I went in for my 2nd dose the hospital made a mix up with the paperwork and the vaccine, the paperwork says Pfizer but the vaccine I received was Moderna. After my 2nd dose I developed swollen lymph nodes under my left arm. I had two urgent care home visits before I ended up in the emergency room. I had an episode where my heartbeat increased to 164 beats I couldn't breathe not able to take a deep breathe. I had an asthma attack.
Mild local reaction with generalized malaise, myalgias and possible low-grade fever.  24-hours afer vaccination.  Treated with Naproxen.  Patient reports improvement with self therapy.  Physician diagnosis:  Mild systemic reaction to anthrax vaccine, resolving.
experienced tingling and numbness mostly on left but some on right side. also tingling on lips.when i put my head down i feel almost like electricity shooting down both legs.  I also experienced upper abdominal pain. I am also having cramping in feet and calves  mostly at night.
This spontaneous report was received from a nurse, who referred to an unknown number of patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was provided. The patients were administered improperly stored doses of GARDASIL 9 (dose, route of administration and anatomical location were not reported) as prophylaxis on the following dates: with lot# L024993 and expiration date of 17-OCT-2017 on 14-JUL-2016 as well as in the period from 18-JUL-2016 to 22-JUL-2016 and with lot# L036301 and expiration date of 20-DEC-2017 on 16-SEP-2016. The doses of vaccine with lot# L024993 and expiration date of 17-OCT-2017 were stored at the following temperatures: on 14-JUL-2016 at 9.1 degrees Celsius (C) for 8 hours, on 18-JUL-2016 at 15C for 8 hours, on 19-JUL-2016 at 10C for 8 hours, on 20-JUL-2016 at 34.9 degrees Fahrenheit (F) for 8 hours, on 21-JUL-2016 at 34.5F for 8 hours and on 22-JUL-2016 at 34.5F for 8 hours; with lot# L036301 and expiration date of 20-DEC-2017 on 16-SEP-2016 at 47.7F for 8 hours. All temperature excursions were detected by a data logger. No adverse effects were reported. It was also reported that several doses of the improperly stored GARDASIL 9 with the above mentioned lot numbers and expiration dates, which underwent temperature excursions on the same dates, were not administered to the patients. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA006146: US-009507513-1706USA006147: US-009507513-1706USA006149: US-009507513-1706USA006151: US-009507513-1706USA004143: US-009507513-1706USA006150.
I have been in menopause for 3 years and started my menstrual cycle the day after the vaccine.  It lasted 5 days with severe cramps.
This spontaneous report as received from a medical assistant refers to a 3 month old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 25-SEP-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # N022015, expiry date: 10-MAR-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37°F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868: Original Case: 1809USA002868; US-009507513-1902USA009324: Original Case: 1902USA009323; US-009507513-1902USA009323: Original Case: 1902USA009323; US-009507513-1902USA009326: Original Case: 1902USA009323.
Narrative: A 45 yo female with PMH of Asthma, Allergic Rhinitis, Psoriasis, Psoriatic Arthritis and Food Allergy. Per October 5, 2022, Allergy and Immunology consult note: The patient had a historical ADR of Flu vaccine induced fever hives and local swelling including nasal Flu vaccine induced nasal bleeding and swelling. Also on October 5, 2022 the attending reported the patient had a historical ADR of Influenza vaccine induced urticaria and Fever classified as moderate. No other detailed information regarding the vaccines were provided including where it was administered or by who.