chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I was walking at my local grocery store the day after my vaccination. I felt decent in the morning but started to feel sore, cold and had a hard time concentrating. I then woke up passed out on the ground. A local doctor or nurse was present and said I had low blood pressure (which I?ve never had before). I followed his advice. I told him that it was my third dose. I figured I should report this as I?ve never had issues with my prior vaccine doses.
Information has been received from a healthcare professional via a pregnancy questionnaire for GARDASIL a pregnancy registry product, concerning a 25 year old female patient with a polycystic ovarian syndrome and no previous pregnancies reported who on 27-JUL-2011 was vaccinated with a first dose of GARDASIL (Lot # 668554/0306AA), on 28-SEP-2011 with a second dose of GARDASIL (Lot # 668554/0306AA) and on 07-FEB-2012 with a third dose of GARDASIL (Lot # 668554/0306AA). Concomitant therapy included PROMETRIUM, ondansetron hydrochloride and citranatal as a prenatal vitamin. It was reported that the patient had her LMP on 05-JAN-2012 and on 01-MAR-2012 an ultrasound was performed which showed normal results and a fetus of 8 weeks and 3 days was visualized. In February 2012 the patient experienced low progesterone. The estimated delivery date would be on 08-OCT-2012. At the time of the report the outcome of the patient was unknown. Additional information has been requested. Follow-up information received on 16-NOV-2012 from a health professional via a pregnancy questionnaire. On 15-OCT-2012 a normal male infant was born (birth weight 8 lbs and 13 oz) 42 weeks after the last menstrual period. It was reported that the patient did not have any complication during her pregnancy. The infant had no congenital anomalies and there were no other complications or abnormalities for the infant. The mother had hypertension post-partum on approximately 15-OCT-2012 which improved on an unknown date in 2012. The relatedness for the event post-partum hypertension was not provided. Additional information is not expected.
RED, ITCH, BURN, SWOLLEN AROUND INJECTION SITE FOR SEVERAL DAYS AFTER INJECTION.
Immediate discomfort at injection site. Eight hours later ?. Fever (100 degrees), chills, body aches, headache, slight nausea, weakness and dizziness. Lasted about 16 hours.
fever; body ache; headache; little nausea; loss of appetite; malaise and did not feel well; This is a spontaneous report from a contactable consumer. This Consumer reported for her son (Patient). A 28-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was not reported) via an unspecified route of administration on 29Mar2021 as single dose for COVID-19 immunization. Medical history included covid-19 and nephrocalcinosis. The patient concomitant medications were not reported. Caller reported that her son developed symptoms early Monday morning, 7-8 days later, the patient experienced fever, body ache, headache, little nausea, loss of appetite, feeling unwell and malaise. Caller stated that her son wanted to get tested for covid and asked if the test would not come back negative because of the shot. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected
Chills, nausea, fever, body aches,  hard, warm lump around injection site, and extreme fatigue.  Started about 21 hours after second vaccination.
About eight hours after I got my vaccine, I had an acute event and a chronic event. Acute, I developed a very high fever and chills for 48 hours. A week or so after that, I had a severe reaction of my arthritis. My arthritis gotten times worse after receiving the vaccine and is still the same level of pain. It has crippled my hands and I have had to start an immune repressive medication.
From 5:30 AM to 12 Noon on 6/21/2019, I experienced chills and fever and was exhausted. I was weak and tired the rest of the day. I felt better by 6/22, but still had some lingering symptoms. I also experienced redness, heat and soreness in my arm in the location of the injection.
Reported some chicken pox-like spots, swelling at injection site (approximately 1-2"), and periodic headache. Recommended BENADRYL and hydrocortisone. Pt. already taking ibuprofen.
Pt had extreme fussiness, screaming, and crying starting the evening of his vaccinations (10-9-23) and  up to today (10-12-23). He also has a runny nose, congestion and productive cough. Pt was febrile on 10-9-23 thru 10-11-23 - pt felt warm- mom did not actually take his temperature.  She treated him with Tylenol every 4 hours but it did not relieve his symptoms.
Swollen lymph node on armpit of same arm vaccine was injected that lasted 9 days. Rash on arm at site of injection that lasted 3 days.
Left sided weakness in shoulder, foot and leg.  Balance issues.  High blood pressure (may not be related).  Admitted to  via Emergency Room on July 14th.  Cat Scan (July 14th) of brain to rule out stroke in Emergency Room showed something in brain, but not stroke related.  Admitted to hospital and received Brain (7/15), Cervical and Thoracic MRIs (7/16).  Brain showed a small lesion near the front at the top and a larger one in the middle at the top, both near the center.  Cervical and Thoracic MRIs clear.    Subsequent lumbar puncture CSF was normal, but we're still waiting for some outstanding tests.  MRI imaging are with specialist neurologist at . Discharged on 7/17.   specialists reviewed MRIs.  Thinks smaller lesion is older, 5 years + and larger lesion could have occurred within last 3 months.  In the weeks since hospitalization, balance and normal function have returned to left side.  Neurologist thought lesion would reduce in size and symptoms would improve, and they have.   She is recommending another MRI at her facility in a few weeks to determine if lesion is reducing in size.
arm sore; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (arm sore), PYREXIA (fever) and CHILLS (chills) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN (arm sore), PYREXIA (fever) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN (arm sore), PYREXIA (fever) and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient took medicine for his cholesterol and his heart rate. No relevant concomitant medications reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Follow-up received on 21-Apr-2021,patient received second dose and no adverse event reported.
With both the first and second doses I experienced vaginal bleeding, possibly an early menstrual cycle the day following the shot.
A nurse reported the occurrence of an injection site reaction in a 16-month-old male who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. The pt's medical history, concurrent conditions and concurrent medications were unknown. On 07/18/2002 the pt received his 4th injection of Infanrix (lot DTPA536A9). Post-immunization, on 07/18/2002 the pt developed an injection site reaction characterized by "swelling as big as a grapefruit" and a "knot". The reporter stated that the injection site reaction was possibly related to Infanrix administration. As of 07/22/2002 the injection site reaction persisted. The reporter indicated that 4 other subjects developed a knot at the injection site following receipt of Infanrix lot DTPA536A9. However, they were not identifiable.
allergic reaction; Face went numb; Hard to swallow; Voice got hoarse; Inside of her ears got very itchy; Scalp also got itchy; This is a spontaneous report from a contactable consumer, the patient. A 58-years-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in the left arm on 24Feb2021 (Batch/Lot Number: EM9809) (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma since many years ago, but it was under control and fibromyalgia since many years ago. Concomitant medications included pregabalin at 250mg daily (100 mg once a day and 150 mg second part of the day) for fibromyalgia, budesonide, formoterol fumarate (SYMBICORT) inhalation powder, at 2 inhalations twice a day for asthma, escitalopram at 20mg tablet once a day for asthma, rosuvastatin calcium at 5mg tablet once a day for an unspecified indication, venlafaxine hcl at 50mg tablet twice a day for an unspecified indication, montelukast sodium at 10mg once a day for an unspecified indication and ciclosporin (RESTASIS) eye drops at one drop in each eye, twice a day for an unspecified indication. The patient was previously received the first dose of BNT162b2 (Lot number: EL9262), via an unspecified route of administration on the left arm on 03Feb2021 15:59 (at the age of 58-years-old) as a single dose for COVID-19 immunization and experienced tip of her tongue, lips, and part of cheek close to her mouth went numb on 03Feb2021, 45-60 minutes after the shot and the patient was recovered from the events on 03Feb2021 as they went away. Within 5 minutes after getting the vaccine shot on 24Feb2021, the patient had a much bigger allergic reaction and she experienced face went numb, it was hard to swallow, her voice got hoarse, the inside of her ears got very itchy and her scalp also got itchy. The patient was treated with diphenhydramine (BENADRYL) at 25mg tablet that night. The outcome of events, allergic reaction, face went numb, hard to swallow, voice got hoarse, inside of her ears got very itchy and scalp also got itchy was recovered on an unspecified date.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021122392 first dose
Initial unsolicited report received from a consumer (patient's husband) on 05 October 2015. This case is linked to 2015SA154152, 2015SA154153, 2015SA154190 (same reporter, different patients). This case involves a female (age not reported) patient who was vaccinated with a dose of INFLUENZA QUADRIVAL A-B VACCINE (Quadrivalent influenza vaccine) (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date (over the week end). Previously patient received unspecified vaccine for the last couple of years with no ill effect. Medical history was not reported. Concomitant medication was not reported. On an unspecified date, the patient experienced little soreness that usually. Laboratory investigation and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
seven people she has talked to have referred getting headache since they got their shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "seven people she has talked to have referred getting headache since they got their shots".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300266655 same SD/AE, different patient.;
36hrs post 3rd dose of vax experienced severe rxn including myalgia, fever & h/a;
patient stated woke up on 11/5 with left eye swollen, red, itchy and blood shot. States face, hands, arms, and legs itch as well. Face is the worst .
Nausea, headaches, frequent illness including viral spinal menengitis, numbness and tingling in different areas of the body. First shot 10/31/08, second shot 12/31/08.  Symptoms began 1/15/09.  No physician is interrested in determining if this is related to Gardasil.  3/6/09 MR received for DOS 2/9-10/2009 with D/C DX: Hx of Aseptic meningitis and Headache. Pt initially presented to local hospital with c/o H/A, neck stiffness and pain, phono/photophobia, GI distress, nausea and vomiting. Pt was DX with aseptic meningitis and admitted x week. Pt currently presnting with transient neuro deficits including L & R sided paresthesias, dysarhtria, and difficulty speaking the last half of words. Pt c/o visual obstruction (like TV snow) during episodes.  BP 86/58. O2 sat 90% RA. PE (+) for mild facial asymmetry-? chronic. Started on Lexapro for depression and OCD traits and possibly developing migraines.
Patient fainted within 6-10 minutes of receiving Hep A vaccine. He appeared disoriented for several minutes after being lifted from the floor. He was evaluated by PAC and parents were instructed to take him directly to E.R. for further evaluation and observation.
I had a scratchy throat and started feeling more and more fatigued, headache and shortness of breath. I had been exposed to COVID-19, my husband was positive. I took a home COVID-19 test on May 23, 2022 that came back positive. Work required that I get a PCR COVID-19 test. They gave me DECADRON that helped me feel better for thirty-six hours. Once my PCR COVID-19 came back positive I was scheduled for the monoclonal infusion therapy. After the infusion therapy I felt like I was going backward in getting healthy so I rested. I am now started to feel better.
Patient was hyperventilating prior to shots being given. Approximately 30 seconds after all vaccines were administered, she stated that she felt nauseous. Then, her eyes rolled back and she passed out. She woke up with a startle after 10-20 seconds and felt lightheaded for about 1 minute. She felt normal after that. Vitals not recorded during event.
Follow up to FAERS18694343: Patient received casirivimab instead of intended COVID vaccine. At 48-hr follow up, patient reported arm soreness. Patient received COVID vaccine on December 31
DIFFICULTY BREATHING; FAST HEARTBEAT; DIZZINESS; SWELLING OF FACE AND THROAT; FACE TURNED RED AFTER RECEIVING THE JANSSEN COVID 19 VACCINE; RASH; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: It was unknown if the patient had drug abuse or illicit drug usage, consumed alcohol or smoked. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced difficulty breathing, fast heartbeat, dizziness, swelling of face and throat, face turned red after receiving the janssen covid 19 vaccine, and rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the difficulty breathing, fast heartbeat, rash, dizziness, swelling of face and throat and face turned red after receiving the janssen covid 19 vaccine was not reported. This report was non-serious.
pain near my injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "pain near my injection site". Additional information: The patient was wondering if having pain near the injection site after booster was normal. The patient received booster on 20Oct2021 and it still hurt several times during the day. The lot number for bnt162b2 was not provided and will be requested during follow up.
I had a Mammogram in March, and everything was normal. All the sudden I noticed a lump on my breast. I went to have it checked out and it is breast cancer. I started Chemotherapy 11/2/22. I also take Paclitaxel, Trastuzumab, Pepcid, Tylenol, Benadryl, Zofran, and Dexamethasone. Ketoconazole Cream, Fluconazole Tablets, Cortisone, AYR Gel, Afrin, and Allegra. I am still dealing with this at this time.
Immediate significant swelling and exquisite pain around the injection site, fever lasting more than 48 hours (5 days), significant nausea, aggravation of joint swelling, herpes simplex infection on the side of the nose, lesions extending up inside the left nostril.
SKIN ITCH ALL BODY, NETTLE,  FROM JANUARY 24  TO NOW
fainted/passed out; fainted/passed out; This is a spontaneous report from a contactable pharmacist. A contactable physician reported similar events for 3 patients. This is one of 3 reports. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: ER8729; Expiration Date: 20Jul2021), via an unspecified route of administration on 06apr2021 as SINGLE DOSE for covid-19 immunization and saline [sodium chloride] via an unspecified route of administration from on unspecified date (Batch/Lot Number: 6023228) for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient had just received the Covid 19 vaccine and was still being watched within the 15-minute post vaccination time. On 06Apr2021, the patient was fainted and passed out had some issues with vaccines in the past. HCP wants to know if there have been any reports of having these reactions associated with the specific lot number: ER8729. The events considered as medically significant with outcome unknown.; Sender's Comments: Based on the temporal association, a possible contributory role of vaccination with BNT162B2 to the reported events fainted and passed out cannot be excluded.  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.
TERRIBLE MIGRAINE HEADACHE; This spontaneous report received from a consumer concerned an 18 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 06-APR-2021, the subject experienced terrible migraine headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from terrible migraine headache. This report was non-serious.
Angioedema; Itchy rash all over for 3 months since i got the vaccination; Fever; Chills; Muscle aches; Joint pains; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANGIOEDEMA (Angioedema) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was not provided by reporter.  The patient's past medical history included COVID-19 in December 2020. Concomitant products included MONTELUKAST SODIUM (SINGULAIR), DOXEPIN, FAMOTIDINE, OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) and CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE]) 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 RASH PRURITIC (Itchy rash all over for 3 months since i got the vaccination), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle aches) and ARTHRALGIA (Joint pains). On an unknown date, the patient experienced ANGIOEDEMA (Angioedema) (seriousness criterion medically significant). At the time of the report, ANGIOEDEMA (Angioedema) and RASH PRURITIC (Itchy rash all over for 3 months since i got the vaccination) outcome was unknown and PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle aches) and ARTHRALGIA (Joint pains) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Complement factor C3: normal (normal) normal. On an unknown date, Complement factor C4: normal (normal) normal. On an unknown date, Full blood count: normal (normal) normal. On an unknown date, Metabolic function test: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication includes Famotidine, Claritin, Singulair, Doxepin, Benadryl, Kenalog injection.  Fever, Chills, Myalgia and Arthralgia Resoled after few days.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Scleral hemorrhage of the Right eye, covering about 1/3 of visible sclera. Vision was not impaired. No bleeding outside of scleral tissues. No pain associated.
This case was reported by the local police dept. Officer (NAME) reported that a woman with seizure history was found dead in bed at home. Seizures since age 13.The family reported a cardiac vessel disease diagnosis (NOS). The family reported that the decedent was reported to have received a Covid19 booster vaccination on 12/16/21 at approximately 1500 Hours. Her sisters related that the decedent began to suffer from chills, body aches, and head ache around 21-2200h. The decedent was last known to be alive at approximately 0900H on 12/17/2021. The decedent was found unresponsive in bed by her family at approximately 1415H and EMS was called. I observed and photographed prescription medications at the scene. The decedent was clad casually and signs of a resuscitation attempt were observed. No signs of trauma were observed. Rigor mortis was developing. Livor mortis was observed over the dorsal body surfaces. The decedent's extremities were warm to the touch; and her torso was hot to the touch. The local Police Department reported no suspicious circumstances. The decedent was transported from the scene to the local County Medical Examiner's Office.
After about one week from the first shot - have a large red circular rash on the shoulder area surrounding injection site.  No pain - mild swelling and warm to the touch.  The swelling and warmth left by following afternoon but rash remains.  Rash mildly itchy.  No treatment needed.  Immediately following the shot - had swelling, mild fever, and sore arm only.  Gone within four days.