chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doesn't feel good; feels bad; Found some black spots on her leg and her arm after taking this dose, this morning; This is spontaneous report received from a contactable consumer (patient husband).  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 02May2021 (Batch/Lot Number: EW0176) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0153) on unspecified date as single dose. The patient experienced doesn't feel good; feels bad (feeling abnormal) (non-serious) and found some black spots on her leg and her arm after taking this dose, this morning (skin disorder) (non-serious) on 02May2021 with outcome of unknown. The patient had the second dose on 02May2021 in the morning and then she did not feel good, and she found something, and she found some black spots on her leg and her arm after taking this dose, this morning.  No follow-up attempts are needed. No further information is expected.
Immediate metallic taste within seconds of the injection and the taste stayed for a month. Notified the nurse and they did not aware of this and asked her questions and observed her and she was allowed to leave. By the time she was at the lobby she you felt tingling in lips, difficulty swallowing, tongue swelled and turned black and throat  was closing.  She drove to the ER and they gave her an EpiPen and fluids and kept her for observation. An hour later she had severe chills and was offered  5 warm blankets and erratic heart rate and blood pressure fluctuation. In hospital for 6 hrs.
Mother states child had fever & cough from 12-21-12 to 12-27-12. Mother never took child's temp or sought medical evaluation. States child lost wt & cough has returned. Child eating now & is afebrile since 12-27-12.
At about 7 hours post vaccination, the patient experienced extreme fatigue, confusion and weakness. The patient's wife called their doctor who advised them to call 911 due to concern of stroke. Paramedics came to their home, but did not need to take the patient to the hospital. By the next morning, the patient was feeling better. At 4 days post vaccination, the patient's wife states that he is back to baseline.
After getting dust mites into my nasal passage on 05/27/2021, I began having an allergic reaction since I'm very allergic to dust mites.  the next day, I began having an nasal infection, then an uncontrollable rash broke out on my back, and then my lips and the left side of my face began swelling.  I contacted a doctor 06/07/2021 who prescribe Predizone (steriod) since she felt my immune system was overracting.  I was also prescribe Cortisone cream for the rash, Flonase of the nasal passage, and allergy pills.
This is a spontaneous report from a contactable physician received via Pfizer sales representative. A female patient of unspecified age and race/ethnicity received PREVNAR 13 on an unknown date, at single dose, for immunization. Medical history and concomitant medications were not reported. On an unspecified date (about one year before the report), a little while after the vaccination, the patient experienced a horrible rash. The event required visit to handful of specialists and hospitalizations. The event lasted a year and resolved on an unknown date. No follow-up attempts are possible, information about batch number cannot be obtained. Sender's Comments: A causal association between administration of PREVNAR 13 and the onset of rash cannot be excluded, considering the temporal association and the known adverse event profile of the suspect product.
Increased redness, swelling, heat and tenderness. No fever or drainage noted to injection site.
Starting immediately after first dose and continuing on till today continuous migraine headaches,  May 5th a severe case of what was diagnosed as vertigo which included ER admission, core body temperature of 94, vomiting, disorientation. Loss of consciousness. None of these symptoms have ever presented prior to vaccine.  June 24th admsision to ER with numbness in left hand, foot, face and mouth. All tests returned normal given Gabapentin and told to follow up with Neurologist who we were already seeing for headaches. Prior to neurology visit, victim presenting with increased numbness, disorientation and lack of balance.
Information has been received from a physician concerning a 15 year old female patient who on 22-AUG-2007, was vaccinated with a first dose of Gardasil (Lot To be determined). A couple of hours after receiving the vaccine the patient experienced dizziness was lightheaded and had "muffled hearing". Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. It was reported that the patient was scheduled to see her allergist to be tested for an allergy to yeast. No product quality complaint was involved. Additional information has been requested.
pt recv vax & was irritable throughout the noc following vax & cried for at least 3hr;no tx was given;sx resolved the next day;
had numbness/tingling on feet and legs; had numbness/tingling on feet and legs; nerve pain by neck; headache; This is a spontaneous report from a contactable physician.    A 19-years-old patient of an unspecified gender received meningococcal group b rlp2086 (TRUMENBA) , via an unspecified route of administration on an unspecified date at single dose for immunisation.  The patient medical history and concomitant medications were not reported.  The patient on an unknown date  had numbness/tingling on feet and legs  with outcome of unknown , had nerve pain by neck  on an unspecified date with outcome of unknown , headache on an unspecified date with outcome of unknown. The reported events were considered non serious.   The information on the batch number has been requested.
The daughter has lost all smell and taste for her the taste is back. Her smell is slowly coming back but it is not back to normal yet.
stomach ache; constipation; LBM; patient feels very tired; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach ache), CONSTIPATION (constipation), BOWEL MOVEMENT IRREGULARITY (LBM) and FATIGUE (patient feels very tired) 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 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach ache), CONSTIPATION (constipation), BOWEL MOVEMENT IRREGULARITY (LBM) and FATIGUE (patient feels very tired). At the time of the report, ABDOMINAL PAIN UPPER (stomach ache), CONSTIPATION (constipation), BOWEL MOVEMENT IRREGULARITY (LBM) and FATIGUE (patient feels very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Per mom, pt fainted and hit his head on the floor about 2 minutes, post vax. I picked him up and looked at his head and face, at that point I saw that his eyes were rolling back in his head and his lips were turning blue. We layed him on the bed and there was no response from him to my voice. The nurse then asked me what to do? What I wanted to do about patient? The nurse then left the room to get an ammonia stick, to wave under patient's nose. We got no response from him. While she was gone, I continued to talk to him and try to get him to respond. I listened to his chest and his heartbeat was slowing and his lips were still blue. The nurse then left again and went to get another nurse. The both came back. The ammonia was still not working. Patient finally said "mommy" in a very hoarse voice. I then ask for some water for patient to drink. I felt patient and he was burning up. I removed his shirt. When the nurse returned, I had patient take a drink. At that time, I saw that patient's tongue was enlarged and discolored. We put some cold wet paper towels on his head and had him drink some more water. After getting the water down him and the wet paper towels on him, he started to cool down. Patient then started to come around. Patient weighs 27 lbs and his blood pressure was 90/60, when the nurses took it at about 9:20. This all started at about 9:02 and it took about 25 minutes, to revive him to where we could leave. He still acted weak for about 2-3 hours. On another note, I feel as if the nurses at the facility, did not really know what they were doing. My doctor said that this was a severe allergic reaction to the shots and the nurses have said that it was only normal behavior to the shots and that all children do this.
Within 24 hr of vaccine admin, patient reported arm pain with red streak about 2 inches down from injection site with pain radiating down arm within 2-3 days. Two weeks later, pain continued and began in non vaccinated arm with joint swelling in wrist & fingers.
Patient initially presented to ED on 1/3/22 following  a 1 day history of decreased activity, 3 bloody stools while at home, and reduction in lower extremity movement. At the ED she was found to have a BP of 48/32 mmHg, was treated with a 20 mL/kg NS bolus + ceftriaxone 100 mg/kg ceftriaxone, and was transferred to the Clinic PICU. Patient was found to have hemorrhagic shock with GI bleed, with coagulopathy (see item 19). She received phytonadione 5 mg on 1/4 and 1/5, then phytonadione 2.5 mg on 1/6, with normalization of the INR to 1.5 on 1/4, followed by 1.2 on 1/5 and 1.1 on 1/6. The patient also required pressure support with epinephrine and vasopressin, in addition to administration of FFP and 2 units packed red blood cells. Additionally found to have spinal cord infarct extending from T2-T3 to the conus medullaris on MRI on 1/5/22. Patient is still undergoing workup for the GI bleed and spinal cord findings. She is currently admitted.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date, the patient was inoculated with ZOSTAVAX at a pharmacy for routine adult health maintenance and the intended purpose for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, the very virus that ZOSTAVAX is intended to prevent. In 2016, the patient was treated by a physician for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles.  As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.  The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
On 4/1/17 patient sustained two Complex febrile seizures within 24 hours of each other with an URI and fever of 100.7F.
pt recvd vax 9FEB93 & was found to be pregnant; 2NOV93 pt exp a prolonged second stage of labor which required Cesarean section delivery of a female who weighed 7 lbs 11 oz;
Pt. returned to clinic 1/16/14 with redness, pain at injection site and temp of 100. Given KEFLEX. 1/17/14 Returned to clinic w/ increasing redness, pain and report of fever last night. Given Rx for BACTRIM. ROCEPHIN 500mg IM.
Information has been received from a physician concerning a non-sexually active female who on 06-APR-2007 was vaccinated with a third dose of Gardasil. On 13-APR-2007 the patient had her first sexual experience. On approximately 26-SEP-2007 the patient underwent a routine Papanicolaou test. On 03-OCT-2007 the results revealed positive for a high-grade squamous intraepithelial lesion. The patient received unspecified follow-up monitoring. At the time of the report the patient's outcome was unknown. Additional information has been requested.
As described by patient: 3 hours after vaccination started feeling tired and "not right". Left arm had swelling and bruises (Left arm became 2x its size). Temp 104" Took alt. Tylenol and Advil. 10/09/10 Continued with fever and swelling. Used cool compress. Went to work as photographer. She stated she didn't go to the doctor since it was Saturday. 10/10/10 Temp down to 102" Iced arm 3x's stayed in bed all day. 10/11/10 Temp 99.5" continued to take Advil. Arm swelling gone. 10/14/10 Knot in LUA. Never went to Doctors.
Information has been received from a health professional concerning a female who on 9/17/01 was vaccinated with an adult 1.0ml 2nd dose of Hep-A virus vaccine inactivated. On 9/20/01, the pt developed an itchy scalp. On 9/21/01, the pt was awakened at 03:00 with a rash and itching on her trunk, extremities and hands. On 9/21/01, sometime in the morning, the pt took diphenhydramine hydrochloride (Benadryl) and her physician directed her to go to urgent care. The pt was placed on 30mg of prednisone and continued on Benadryl. On 9/21/01, the pt noticed that she had nervousness, agitation and difficulty swallowing. On 9/22/01, the pt returned to urgent care and her prednisone was increased to 40mg. Zyrtec was administered orally and camphor + menthol + phenol (SARNA) administered topically was added to her therapy. On 9/23/01, the pt was instructed to take 40mg of prednisone and a "tapering dose" was started. No further information was provided. Upon internal review, the pt's difficulty swallowing was determined to be an "Other Important Medical Event". Additional information has been requested. F/U info states the DOB as 9/22/55 and the pt is 45 years old. F/U info has been received from an NP which indicated that the pt did not report any adverse events with other vaccinations; however, the pt had told her that she had seen an allergist in the past. No information was available regarding the specifics of the pt's visits to the allergist. The reporter stated that she had spoken to the pt since the event and noted that the pt was doing "well". No further information was provided.
Patient here for nurse visit for Tdap and Menveo  Apple juice provided before administration, patient ate breakfast before visit   Shortly after administration- patient became pale, lightheaded, nauseous  11:45 am Provider came into room and assessed patient  Vomited x1 Blood pressure taken and was 94/60 Patient was laid flat and feet elevated Cool compresses applied to forehead, ice pack applied to nape of neck  11:53 am Second blood pressure 94/56 Patient feeling much better after supportive care measures Alert, laughing, and responding to questions appropriately.  12:15 pm patient left walking  out with dad - no symptoms
vaccination sight pain; nausea; This is a spontaneous report received from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: CN6207) via an unspecified route of administration in the left arm on 30Mar2021 at 13:15 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. The patient medical history included asthma. The patient was allergic to fruit allergy(kiwi). The patient had drug allergy while taking erythromycin (MANIFACTURER UNKNOWN). Concomitant medications included rosuvastatin (MANUFACTURER UNKNOWN) for unknown indication, levothyroxine (MANUFACTURER UNKNOWN) for unknown indication, ibuprofen sodium (IBUPROFEN) for unknown indication and ascorbic acid (VITAMIN C) for unknown indication. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021 at 07:00, the patient experienced injection sight pain and nausea. The adverse events did not result in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported events. The clinical outcome of the events vaccination sight pain and nausea was recovering at the time of report.   No follow-up attempts are needed. No further information is expected.
Pt recv vax on on 4/10/99; on 4/16/99 pt exp stiff neck, painful/ swollen glands, headache, irritable
post menopausal menstrual bleeding; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (Lot Number: ER8735), dose 2 via an unspecified route of administration, administered in arm right on 15Apr2021 12:00 as single dose for covid-19 immunisation. The patient's medical history was not reported. No known allergies. Concomitant medications included thyroid (ARMOUR THYROID); calcium; fish oil; vitamin b complex (VITAMIN B); vitamin C; colecalciferol (VITAMIN D). The patient previously received first dose of bnt162b2 (Lot Number: EN6204) on 25Mar2021 at 12:00 in left arm for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced post menopausal menstrual bleeding on 29Apr2021 15:00. The event did not result in emergency room/physician office visit. No treatment received. This case was reported as non-serious by reporter. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of event was not recovered.
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Looked like hives; patch about 4x4\", pt given rx for epinephrine, and she took benadryl. Pt did not respond to call back next morning.
I have experienced body aches, a fever of 103 degrees, fatigue, dizziness, and soreness at the injection site.
Pt is almost 10Y had 2nd chicken pox on 1/26/10 on LL and first Hep A vacc on RL. Pt came on 1/28/10 that noted redness at injection site LL about 2.5 cm no tenderness, no vesicle, no induration, no rash rest of body. She had first VZV 8/19/02.
Severe soreness and stiffness within one hour of shot. Fatigue after two hours, still prevalent 8 hours later
This is a spontaneous report from a consumer (a Pfizer Employee) who reported for his son. This 11-year-old male patient received on 23Dec2014 at 16:00 a single dose of TRUMENBA in left arm. The patient did not take any other concomitant medications or vaccine and did not have any relevant medical conditions. Approximately one half hour after receiving the vaccine, the patient noticed soreness in his arm and shortly after he had difficulty moving arm. On 24Dec2014 in the morning, the patient threw up a couple times and swelling arm was noticed. Two of his other children received the vaccine at the same time, and they have not experienced any adverse events. Outocme was not recovered.
Breakthrough Covid infection with symptoms; Breakthrough Covid infection with symptoms; This is a spontaneous report from a contactable nurse and a physician. The nurse reported similar events for 11 patients. This is 6th of the 11 reports. A 35-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in deltoid left on 23Dec2020 (Lot Number: EH9899) as single dose, second dose of BNT162B2 intramuscular in deltoid left on 12Jan2021 (Lot Number: EK9231) as single dose for covid-19 immunisation. The patient medical history was none. There were no concomitant medications. The patient was not current smoker and unknown if former smoker. There were no Prior vaccinations. The patient experienced breakthrough COVID infection on 27Mar2021. The patient underwent lab tests and procedures which included Covid PCR nasopharyngeal swab on 30Mar2021 was positive and Covid PCR nasopharyngeal swab 31Mar2021 was positive. The patient was not hospitalized and not admitted to an Intensive Care Unit. The patient did not display clinical signs at rest indicative of severe systemic illness. The patient did not require supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation. The patient did not experience multiorgan failure, cardiovascular, gastrointestinal/hepatic, vascular, renal, neurological, altered consciousness, dermatological and other symptoms. The patient experienced respiratory and dyspnea. The patient experienced Slight SOB (short of breath) and sinus congestion on 27Mar2021. SOB was resolved on 30Mar2021. Sinus congestion was resolved on 01Apr2021. No treatment received. The outcome of the events was resolved in 2021.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information currently the lack of efficacy (Vaccination failure) of the vaccine BNT162B2 cannot be excluded.,Linked Report(s) : US-PFIZER INC-2021389615 Same reporter/ drug, different patient
covid; covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Feb2021 at 16:30 as dose 1, single (Batch/Lot number: unknown), in left arm and on 25Feb2021 at 16:30 as dose 2, single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: If vaccine received: Yes, Other medications in two weeks: No. Anti-viral details: product=COVID 19 Treatment, Brand: Paxlovid, treatment start date=17May2022, treatment stop date=15May2022, Indication: Treatment of Covid-19, Known allergies: No, Other medical history: No  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
Pt given PNEUMOCOCCAL POLYSACCHARIDE PPV23 into right arm in clinic on 8/21/19. Pt returned to clinic on 8/22/19 with site of injection/arm being red, swollen and hot from shoulder to elbow. Pt reports arm in very painful and is tearful. MD examined pt and prescribed doxycycline 100mg PO BID x 15 days to treat possible infection. Pt instructed patient to take acetaminophen for pain and to apply ice to site.
6 days after 2nd vaccine:  1. Tinnitus - left ear.  No treatment.  Disappeared after 12 hours. 2. Sore tongue, lymph nodes, throat. Gradually subsided after 4 days.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old male patient who received SHINGRIX for prophylaxis. On 28th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 28th July 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovering/resolving. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details reported as follows: This case was previously not reported to anyone. The reporter's husband developed a sore left arm within five hours after receiving 1st dose of SHINGRIX vaccine on left arm. The soreness was resolving. This case has been linked with US2018136244, reported by same reporter.
30 minutes post vaccination, pt developed 0.8 red, raised area to right arm at injection site. MD administered Benadryl 25 mg PO and monitored for 15 additional minutes. No worsening of symptoms and pt. was dismissed.
Patient is a minor (16yrs old) whom received the monkey pox vaccine via intradermal (0.1ml)  when it should of been administered subcutaneous (0.5ml).