chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chief Complaint: "COVID-positive". Additional Medical History:  This 84-year-old male with a history of atrial fibrillation, COPD, diabetes mellitus, hypertension, myelodysplasia and acute myelocytic leukemia comes to the ED after he tested positive for the COVID-19 infection at the home today.  The patient states that his wife tested positive for the COVID-19 infection during last week.  He has been experiencing a mild nonproductive cough, fever, chills and a generalized body ache since yesterday.  He also noticed an intermittent bleeding from his nostrils for the last 3 to 4 days. Associated Symptoms: chills, cough, fever
This spontaneous report as received from a consumer refers to himself, a 64 year old male.  On 14-NOV-2016, the patient was vaccinated with PNEUMOVAX23 for prophylaxis (lot number and expiration not reported). On 15-NOV-2016, the patient experienced fever, body aches and his arm was red and swollen at the injection site. The outcome of  fever, body aches and his arm was red and swollen at the injection site was reported as recovered on 16-NOV-2016. No further information was provided. Additional information is not expected.
I woke up this morning with the injection site being itchy.  It is also swollen.  There is a rash about 3 inches in diameter around the spot of the injection.  I can touch the spot with no issues.
The first day of the injection I could feel immediate pain/tightness in my left armpit. The next morning I felt sick and achey all over. This morning I woke up to a cluster of Petechiae on my left breast.  Armpit lymph nodes are tender and swollen on left arm pit.  There is a red rash on my left arm near the site of injection.  There is also a red rash on my left breast from armpit to 1/2 down my breast. It hurts for fabric to touch my armpit.
Patient fainted and loss consciousness for approximately 1 minute about 5 minutes after being vaccinated.  Patient was pale, and had shallow breathing.
No additional AE; received her first dose of GARDASIL 9 at the age of 7 in 2013; inadvertently gave 7 years old a dose of Gardasil 9; This spontaneous report was received from a consumer via a company representative referring to a 7 years old female patient. The patient's concomitant medication, medical history and drug reactions or allergies were not reported.  On an unknown date in 2013, the patients was inadvertently vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (1 dosage form; strength, frequency, route, lot# and expiration date unknown) for prophylaxis (Product administered to patient of inappropriate age and inappropriate schedule of product administration). No additional adverse event or product quality concern.
Patient presents with (L) arm swelling, redness & some itching on 7/25/12 - that developed after getting Tdap on 7-20-12. Patient tried ice & BENADRYL with no relief. Patient was advised to ice twice a day, TYLENOL as needed and given a prescription of prednisone 20 mg x 5 days.
Patient informed us 11/13/20 via phone that the day after she got her vaccine she developed an injection site rash. She iced the area and the rash went away. However ever since the rash went away she has been experiencing pain consistently. She is going to follow up with her PCP.
Headache, Myalgia, Fever, NauseaVomiting, swelling at injection site
Case number PHEH2014US025015, is an initial spontaneous report received from a nurse on 09 Dec 2014. This report refers to an 88 year old female patient. Historical condition and concomitant medication were not reported. The patient was vaccinated with FLURIVIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 16 Oct 2014. The nurse reported that before administration, the FLUVIRIN had 12 separate temperature excursion lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperatures were in between 46 to 49 degree F. No adverse event was reported following this mal administration.
Fever, sweating, fungal infection under both great toes, vomiting, headaches, pain in both legs, numbness. Treated at Medical Center for nausea & vomiting no acknowledgement or idea of symptomology or so reported by said treating staff.
the injection site is red and swollen/swelling with red silver dollar spots; arm is sore; she had a very red and tender arm; the injection site is red and swollen; This is a spontaneous report from a contactable consumer (patient herself).   An 80-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6206), via an unspecified route of administration, administered in right arm on 29Mar2021 14:20 (reported as Monday) (age at vaccination: 80 years) as DOSE 2, SINGLE for covid-19 immunization at Physician Office. The patient medical history was not reported. Concomitant medication included levothyrxoine sodium (SYNTHROID). The patient said that she was basically healthy. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6202), via an unspecified route of administration, administered in his right arm on 08Mar2021 as DOSE 1, SINGLE for covid-19 immunization. Patient was was okay with the 1st Covid shot. The night after the second shot, she had a very red and tender arm. The next morning, it was red and swollen and redder. It has been the same for the last 2 days. The arm was sore with red patches the size of 2 silver dollars. Patient took a Benadryl thinking that would help and used an ice patch. The arm was a little redder this morning. Caller added that pain wise and everything, it was about the same.  The discomfort was about the same. The area was redder and the redness has worsened as in bigger than it was  last night.The patient had no prior vaccinations within 4 weeks. The outcome of the event was not recovered.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 65-year-old female patient who received SHINGRIX. Co-suspect products included ENBREL for an unknown indication. The patient's past medical history included rheumatoid arthritis. Concomitant products included methotrexate, cyclobenzaprine and tramadol. On 25th March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient started ENBREL at an unknown dose and frequency. On 2nd May 2018, 38 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. The reporter considered the shingles to be unrelated to SHINGRIX. Additional information was received as follows: The patient reported that she diagnosed herself with shingles. It had not been confirmed by a health care professional. The patient was not taking ENBREL for a few months and that ENBREL was not being taken during the vaccination due to affordability. The patient began taking ENBREL again just prior the shingles, with no specific restart date. The patient felt that she was already immunosuppressed and that the ENBREL caused her shingles. The patient had denied permission to contact their physician.
Breakthrough case admission after 3 vaccines Moderna 3/5/21 Lot# 040A21A;  Moderna 4/1/21 Lot# 026B21A;  Pfizer 10/7/22 Lot# GJ3277
no stamina at all; Brain fog lasted 3 months; daily headaches; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), administered in arm left, administration date 15Aug2021 17:30 (Lot number: ew0179) at the age of 64 years as dose 3 (booster), single for COVID-19 immunization. The vaccination facility type was the pharmacy/drug store. Relevant medical history included: "Immune issues" (unspecified if ongoing). Concomitant medications included: fluticasone propionate (FLOVENT); montelukast sodium (SINGULAIR). Vaccination history included: BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (dose 1, single; Lot number: el3246, vaccine location: right arm), administration date/time: 14Jan2022 at 09:00 AM, when the patient was 63 years old, for COVID-19 immunization; BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (dose 2, single; Lot number: el9265, vaccine location: right arm), administration date/time: 05Feb2021 at 08:00 AM, when the patient was 64 years old, for COVID-19 immunization. The patient had no other vaccine in four weeks. The patient had no COVID-19 prior vaccination. The following information was reported: FATIGUE (disability) with onset 16Aug2021 10:30, outcome "not recovered," described as "no stamina at all"; FEELING ABNORMAL (disability) with onset 16Aug2021 10:30, outcome "recovered" (Nov2021), described as "Brain fog lasted 3 months"; HEADACHE (disability) with onset 16Aug2021 10:30, outcome "not recovered," described as "daily headaches." After 6 months, the patient had all types of tests by cardiologists and neurologist. The patient did not have headaches before and was a marathon runner. She no longer run. The adverse events (AE) resulted in disability or permanent damage. The events "no stamina at all," "brain fog lasted 3 months," and "daily headaches" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: tests: (unspecified date) unknown result, notes: all types of tests by cardiologists and neurologist; Binax (SARS-CoV-2 test): (25Jan2022) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of fatigue, feeling abnormal, headache.  Follow-up attempts are completed. No further information is expected.
suffocated his chest, his chest would feel like really pressured, discomfort and annoying; a lot of pain; shortness of breath; This spontaneous case was reported by an other and describes the occurrence of CHEST DISCOMFORT (suffocated his chest, his chest would feel like really pressured, discomfort and annoying), CHEST PAIN (a lot of pain) and DYSPNOEA (shortness of breath) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced CHEST DISCOMFORT (suffocated his chest, his chest would feel like really pressured, discomfort and annoying), CHEST PAIN (a lot of pain) and DYSPNOEA (shortness of breath). At the time of the report, CHEST DISCOMFORT (suffocated his chest, his chest would feel like really pressured, discomfort and annoying), CHEST PAIN (a lot of pain) and DYSPNOEA (shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information was not provided.    Reporter did not allow further contact
he is feeling nauseous. everything wants to come out; thirsty; she cannot eat; she has a headache from hell; she didn't get a wink of sleep; does not feel good; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiry date unknown), via an unspecified route of administration on 20Apr2021 as a SINGLE DOSE for COVID-19 immunisation. Medical history and concomitant medications were not reported. About 1 hour after the vaccine, the patient developed side effects. Caller stated she has a headache from hell, she can not eat and everything wants to come out. Caller stated this does not feel good stating she feels bad. Caller wanted to know what she can do. Caller stated got the 1st dose of the vaccine yesterday, April 20 and she is calling to report that she is feeling nauseous, thirsty and cannot eat. Caller wants to know if when she can feel like a normal person again. Patient reported that she will be 63 in about a week. The caller stated that she got the first shot yesterday and all was fine on the way home but when she was home her head was pounding. She has a headache the size of the Mississippi river and she didn't get a wink of sleep. She said the headache is so horrible. She asked when this will go away. Outcome of the events were not reported.  No follow-up attempts are Possible; information about lot/batch number cannot be obtained.
his finger on his right hand were numb and tingly; his finger on his right hand were numb and tingly; tiredness, fever and headache; tiredness, fever and headache; tiredness, fever and headache; This is a spontaneous report from a contactable consumer (patient's daughter). An 87 year-old male patient received BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that her father received the Pfizer COVID-19 vaccine and experienced the normal side effects of tiredness, fever and headache (onset date unknown). She also reported that on the morning of the report the patient's finger on his right hand were numb and tingly but had gone away at the time of this call. Caller reported the vaccine was given on his left side. At the time of the report the events finger on his right hand were numb and tingly had resolved on an unknown date, whereas the outcome of the events tiredness, fever and headache was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt recvd 1st dose of Hep B vax shortly thereafter, pt devel a rash & exp SOB; presented to ER over a 4hr period-sx resolved; following day pt presented to MD; sx had resolved but pt stated that just didn't fel well;
Arm was getting sore and stiffing and as days went on till after second shot was seen by ED, and PT have  not Frozen shoulder Shot was close to Shoulder capulituits . I have received yesterday 2/3/2021 a cortisone shot to the shoulder and will receive PT
strong rash (aching red area at the injection site, sometimes very warm) Arm pain throughout the area, numbness in the hand
No symptoms noted or reported.  Patient was not at the approved age for the Moderna vaccine.  It was discovered at check out.
numbness to forearm then to lower leg that then took on a dermatomal pattern, brain fog w word finding issues that progressively worsened, LLE weakness.  ct brain neg. MRI/MRA head and neck neg. labs neg. MRI of c spine t spine l spine s spine neg.  emg and eeg neg. discharged from hospital. symptoms fluctuating.  slowly improving.
Developed a herpes zoster rash/infection- rash, hot to the touch, visible blistering
Information has been received from a nurse via a company representative concerning a 26 year old female with a history of warts from childhood who on 02-FEB-2007 was vaccinated with a first 0.5 mL dose of GARDASIL (lot #655619/1427F), injection in left deltoid. Concomitant therapy included hormonal contraceptives (unspecified). It was reported by the nurse that the patient informed the clinic that she had a breakout of warts in her forearm 4 days after vaccination, on 06-FEB-2007. At the time of the report, it was unknown if the patient had recovered. The patient sought unspecified medical attention. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 3/14/2007. Additional information is not expected.
Patient fainted about 5 minutes or so after recieving his flu shot while shopping.  Patient was thirsty, with a red chin and bloody lip after the fall.  Was speaking well and declared he was fine.  Patient showed no signs of allergic reaction.  Mother planned on taking him to his pediatrician's office nearby.  It is unknown if they ended up going or not.
Significant myalgias, fever, and increased dypnea requiring resumption of oxygen (had been tapered off the day before).
pain, swelling, and redness at the injection site; swelling, and redness at the injection site; redness at the injection site; This case was reported by a consumer and described the occurrence of injection site pain in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included stiff joint, drug allergy (prior history of allergic reaction to clopidogrel) and generalized rash.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site swelling and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had arthrosclerosis, prior history of allergic reaction to clopidogrel.  The patient stated she was on Clopidogrel for a blood clot about 2 to 3 years ago and after about 6 months using it she developed a body rash. The patient experienced pain, swelling, and redness at the injection site. For tolerance after 2nd dose of Shingrix, refer case US2020158029.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020158029:2nd dose
This spontaneous report as received from a registered nurse, via a company representative, refers to a 15 year old male patient. Information about the patient's medical included Attention deficit/hyperactivity disorder (ADHD) and Acne. Information about the patient's concurrent conditions was not provided. According to the reporter, the patient was vaccinated on 03-DEC-2015, with a dose of GARASIL 9 lot number L014415, expiration date: 25-JUL-2017 (administration route was not reported). The reporting nurse stated that this dose corresponded to the 3rd one in the series, but that the previous two doses were GARDASIL doses. Concomitant therapies included VYVANSE 50 mg and amphetamine 5mg daily. On -4-DEC-3025, "about midnight", the patient developed a severe headache, for which he took 2 tablets of MOTRIN at about 7:00 AM, and his headache "decreased a bit." According to the nurse, the patient went later to the clinic at 8:00 am, and when she saw him he was "sitting on the clinic floor writhing in pain". The reporter stated that the pain being felt by the patient, was in his frontal lobe. The patient's body temperature was elevated to 100.3 F. The patient was then administered a TORADOL injection for treatment and was sent home. The outcome of headache and body temperature increased was unknown at the time of this report. The reporter did not provide a causality relationship assessment between the events and therapy with GARDASIL 9 and GARDASIL. Additional information has been requested.
chest pain; sudden very high blood pressure; 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 CHEST PAIN (chest pain) and HYPERTENSION (sudden very high blood pressure) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 CHEST PAIN (chest pain) and HYPERTENSION (sudden very high blood pressure). At the time of the report, CHEST PAIN (chest pain) and HYPERTENSION (sudden very high blood pressure) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided.  Treatment medications was not provided.   Reporter did not allow further contact
Pt. received Menactra on 5/15/07 at 2:45 PM and then that night developed hives all over his body. No resp. distress. Hives resolving on their own by 5/16/07. In the AM of 5/16/07 pt woke up with headache, nausea and pain in hands. Feet normal.
26AUG fever 103, 27AUg began wheezing; seen @ Hosp ER; CXR done "slight case pneumonia prescribed Augmentin; 30AUG no fever, no wheezing;
rash, burning, itching  started on 12/29/21 and is continuing now all over the body.  12/31/21  called md Live for treatment.
Fever 101.6 on ibuprofen, severe headache, arm pain, cellulitis skin changes, mild asthma exacerbation.
MOM REPORTS: LEFT ARM BECAME RED, WARM, & SWOLLEN.  HAD DECREASED ROM, C/O DISCOMFORT IN ARM. BY 4 AM, TEMP= 104.  WENT TO PMD, DX WITH CELLULITIS.  PMD ORDERED: KEFLEX, STEROID TOPICAL CREAM, BENADRYL, IBUPROFEN, AND ICE TO SITE.  MOM REPORTS MUCH IMPROVED 11-18-10.
pt recv vax 6JAN96 & 20MAY96 pt exp maculopapular rash & hives, & was examined by a dermatologist;an anti-HBs titer on 29MAY96 was negative;
This spontaneous report was received from a certified medical assistant referring to an unspecified number of patients of unknown age and gender. Medical history, concomitant medications and concurrent conditions were not reported. On an unspecified dates, the patients were vaccinated with an improperly stored doses of PNEUMOVAX 23 (dosage and route administration were not provided; lot number L018503 expiration date 16-MAR-2017. No adverse effects were reported. The administered vaccines experienced a temperature excursion of 15 degrees C for 9 hours on an unspecified date. Data logger was not involved. Previous temperature excursion was 0 degrees C for 24 hours on an unspecified date. A product quality complain was not involved. This is one of three reports from the same source. Additional information has been requested.
Aches & pains, especially in my left arm. Numerous Dr. visits / tested for Guillain Barre / lost numerous days off work. Had to go to the E.R.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot # M028551, expiration date: 07-JUN-2018) (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion more then (>) 5 degrees Fahrenheit but less then (<)14 degrees Fahrenheit for 1 hour. Data logger was involved. There were no previous excursions reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA002294:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Depression." (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT. Vaccination history included: Covid-19 vaccine (Dose Number: 1, Unknown Manufacturer), for COVID-19 Immunization. Patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19. Clinical course: No real change in symptoms except when I would eat a meal right afterwards I would feel sick (sometimes I did throw up) and really dizzy. Patient received paxlovid as treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.