chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 03May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose:1), administration date: 12Apr2021, for Covid-19 immunisation, reaction(s): "Dizziness". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
few migraines; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Nov2021 18:00 (Lot number: FK5127) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MIGRAINE (non-serious) with onset 09Nov2021, outcome "unknown", described as "few migraines". Therapeutic measures were not taken as a result of migraine.  Additional Information: Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19 and the patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101609879 same reporter/drug/AE with different patient
She states dizzy, in shower and through out the day- "cold sweats" just felt "off" did go to work yet had occ episodes of "faint feeling of cold sweet"  next day she felt fine.. Did not receive second dose of Hepatitis B.
Information has been received from a physician for the pregnancy registry for GARDASIL concerning a 26 year old female who on an unspecified date was inadvertently vaccinated with GARDASIL while pregnant. After the patient received GARDASIL, she had a spontaneous termination at 6 weeks and 5 days from the last menstrual period. The patient had FYA antibodies (noted to be abnormal antibodies indicative of an autoimmune disorder). She was antinuclear antibodies test (ANA) negative with this second termination. the patient was not hospitalized. Subsequently the patient recovered. She had dilation and curettage (D & C) following the spontaneous termination. The reporter didn't necessarily think it was linked but she could not understand the connection to GARDASIL, and she could not find any other reason for the termination. Upon internal review the patient's spontaneous termination was determined to be an other important medical event. The patient also had a first spontaneous termination after the vaccination at 13 weeks from the last menstrual period. (WAES# 0810USA01794) Additional information has been requested.
Just lots of symptoms for 48 hours after: injection site pain, tiredness, headache, muscle aches, chills, nausea, feeling unwell, feeling hot (but no actual temperature).  I did NOT have a severe allergic reaction, just
pain and swelling at injection site; pain and swelling at injection site; This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd September 2020, the patient received the 1st dose of Shingrix. On 2nd September 2020, immediately after receiving Shingrix, the patient experienced injection site swelling and injection site pain. On an unknown date, the outcome of the injection site swelling and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had pain and swelling at injection site.  The adverse reactions appeared right away, and still not recovered.  No other information was provided. The reporter consented to follow up. Address and Email were confirmed.
red rash on neck; This case was reported by a pharmacist via call center representative and described the occurrence of red rash in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number L7SY9, expiry date 4th July 2021) for prophylaxis.   The patient's past medical history included sickness, flu and rash (when got sick or flu).   On 2nd April 2019, the patient received the 1st dose of Shingrix. On 3rd April 2019, 1 days after receiving Shingrix, the patient experienced red rash. On an unknown date, the outcome of the red rash was recovered/resolved.   It was unknown if the reporter considered the red rash to be related to Shingrix.  Additional details were provided as follows: The patient 24 hours later developed a red rash on her neck and no hives.  The rash resolved after 24 hours. The batch number was reported L7SYN, however it was updated to L7SY9 as per sales data sheet.
Shingles outbreak started 3 days after receiving Flu Vaccine. This is the first time I have had Shingles. I researched and found studies that the Flu Vaccine can in fact cause a shingles outbreak in some people, usually within 3-15 days post Flu Vaccine administration.
This case was reported by a consumer via interactive digital media and described the occurrence of death in a male patient who received DTP (A or W not known) for prophylaxis. On an unknown date, the patient received DTP (A or W not known) at an unknown dose. On an unknown date, unknown after receiving DTP (A or W not known), the patient experienced death (serious criteria death and GSK medically significant) and seizure (serious criteria disability and GSK medically significant). On an unknown date, the outcome of the death was fatal and the outcome of the seizure was unknown. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death and seizure to be related to DTP (A or W not known). Additional details were received as follows: The age at vaccination was not reported. The patient's mother reported that, the patient received DPT shot. The patient presented with horrible seizures and he was profoundly handicapped at 2 years of age. The patient died at age of 25 years old (mentally at 16 month). The reporter also stated that the patient's older sister who also received the vaccine was fine. Reported Cause(s) of Death: unknown cause of death.
Initial case was received on 11 August 2010 from a healthcare professional. The reporter was aware of an 8 year old patient, who had received "all DTaP vaccines" (manufacturer and lot number not reported) "on schedule" (dates not reported). On an unspecified date the patient "had come down" with pertussis. The reporter had no specific information and was unable to obtain additional information. List of Documents held by sender: None.
Rash upper chest & neck < 24 hours after receiving PNEUMOVAX & flu vaccines - pruritis same area - no swelling of face or lips, no SOB.
Information has been received from a female who in October 2006, was vaccinated with the first dose of Gardasil (Lot # not reported). Concomitant therapy included Yasmin. In February 2007, the patient experienced facial paralysis. It was reported that the patient could not move the left side of her face, but she was able to talk. Subsequently, the patient recovered from facial paralysis about 4 weeks later. Patient did not receive the second dose of Gardasil. Patient sought unspecified medical attention. It was determined that facial paralysis was an other important medical event. Additional information has been requested.
Pt reported health palpitations post vaccine around 3:45PM (vax administered at 3:12PM). Pt states HP was present until next morning and resolved on its own.
Recieved vaccines on 7-20-07 with immediate redness, warmth, swelling, that progressed slowly until seen 7-23-07. Left are with 9cmX10cm wrapping around upper arm. Right arm with redness no swelling 2cmX2cm area. Parent was doing cool compress, no medication. Keflex 250/5 1 tsp po tid for 7 days.
Upper left arm began itching yesterday.  today it is still itching and I have swelling around the injection site and my arm is red from shoulder to elbow.  Also have a slight fever (99.4 degrees).
presentation of hives; This case was reported by a other health professional via sales rep and described the occurrence of hives in a 56-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Concurrent medical conditions included seasonal allergy.   On 2nd July 2019, the patient received Boostrix .5 ml. On 5th July 2019, 3 days after receiving Boostrix, the patient experienced hives. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to Boostrix.  Additional details were provided as follows: The case was reported by the practice manager. The NDC number was reported as 58160084243. The patient did not see any prior history of reactions to vaccine but patient had seasonal allergies. The patient received Boostrix in left deltoid and had presentation of hives. No other vaccines given at same time. The patient seen for follow up at another healthcare and urgent care site due to presentation of hives.  The reporter gave patient steroid and did not know if steroid injection or oral. The reporter did not consent to follow up.
fainted, fell off chair hitting right forehead. Hx of fainting. Responsive, oriented x3, PERRLA
On 4/18/2021, I started having heart palpitations. It would beat very strongly but it was not racing. I also had feelings of almost fainting. This lasted all of April and May. I had an episode where my heart rate went up to 170. I had a few of these episodes and gradually, as the weeks went by, I got better. I contacted my doctor and wore a monitor. I saw a cardiologist who did a stress test and a whole battery of tests. Eventually, I recovered from this, but nothing was found that could explain what I had experienced. I also went to the ER. I felt funny. I was disoriented and felt lightheaded and just overall not right. I saw a cardiologist, otolaryngologist and I am waiting to see a neurologist.
My arm was sore but it wasn?t terrible and I was a bit fatigue and about 5 days after the vaccination, my right hip and right shoulder were bothering me. My right shoulder was bothering me more than right hip, so I went to chiropractor  and that didn?t help right away but it did help and it?s still bothering me. That was all I really notice after the first vaccine. I did have a slight headache, muscle aches, and fatigue. Later I stumbled into a rocking horse and I thought maybe that had messed me up.
Patient is a 26 y.o. female, with PMH asthma,  pregnant at 32 weeks, seen today for COVID 19.  She has received one Pfizer vaccine approximately 8 weeks ago.  She began having symptoms with cough, and sore throat, tested positive for COVID.   She was monitoring her oxygen saturations at home but  she dropped into low 90's,  contacted her OB/GYM and was told to come to the ED
Pt states her arm was red and swollen the day after SHINGRIX was given. She watched her arm for a couple days and it continued to get more inflamed. She developed a fever and went to walk in clinic to see a CRNP. CRNP stated Patienthad cellulitis and was given an antibiotic and work excuse.
Started to feel dizzy, pale, clammy. Layed down, Blood Pressure taken was 78/56 laying down. HR 67 BP 80/56 sitting up. Had him continue to lay down for 30 minutes or so, color came back started feeling better back to normal within 45 minutes of receiving the vaccine.
This spontaneous report as received from a health professional refers to a 78 year old male patient. The patient's pertinent medical history included hypertension. In 2008 (reported as six years ago), the patient was administered PNEUMOVAX 23 (lot#, expiration date, dose, route and site of administration were not reported). In September 2014 (reported as 3 months ago), the patient was vaccinated with another dose of PNEUMOVAX 23 (lot#, expiration date, dose, route and site of administration were not reported). In 2014 (reported as shortly after), the patient experienced fever and body ache. The outcome of body ache and fever was reported as recovered/resolved on an unspecified date in 2014. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Covid 19 vaccine was given in my right arm subcutaneously. Was not looking when vaccine was given, felt administer rub my arm with alcohol swab, and pinch skin. Did not feel vaccine...however when bandaid was placed knew it was injected subcutaneously instead of IM. Took pictures immediately after.
My left arm where vaccine was administered was sore for the first three to four days as expected.  However, it has now been 8 days and my arm continues to have a dull ache and throbbing.  I did not expierence this with the first shot of the series.
Pt had an appointment for pfizer covid -19 vaccine second dose schedule at 11.20 . Administered  the vaccine at  11.27 am and instructed her to wait for 15 min .She is accompanied by her husband and  son .Few minutes later her husband came up and said  her lips are itching  immediately spoke to the patient asked her if her  throat is closing up or  difficulty in breathing  etc she said all she was feeling  is itching  of the lips and she started to feel something in the throat i offered to call 911 her husband and she refused they said they will wait a little bit .I gave her 20 ml  of  diphenhydramine to  her and  some water . kept on checking on her after  15 minutes she said she is completely fine itching  is gone and the throat feels fine .She left around 12.20 pm .She was completely fine when she left
No Adverse event; total of 47 patients that received the vaccines after the use-by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (total of 47 patients that received the vaccines after the use-by date) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (total of 47 patients that received the vaccines after the use-by date). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (total of 47 patients that received the vaccines after the use-by date) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (total of 47 patients that received the vaccines after the use-by date).    Patient was over 18 years of age.  No relevant concomitant medications were reported. Staff gave patients vaccines past the use date of 18 Jun 2023. On 27 Jun 2023, 3 doses were administered at administration site 2.  No treatment medication reported.   The case corresponds to 34th out of 47 patients as reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-732752 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Follow up received, updated vaccination date and I narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732752:Master case (Patient 1)
This spontaneous report has been received from a nurse regarding an unknown gender patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with an improperly stored GARDASIL 9 (lot# N017697 and expiration date 21-JAN-2020 for prophylaxis) (dose, strength, frequency, route of administration were not reported). The temperature excursion and time frame was between 9 degrees C to 25 degrees C for 17 hours. The data logger was reported. No adverse effects was reported. Product quality complain was not present.
2nd Vaccine I had, severe uncontrollable shaking, similar to a seizure, severe chills, nausea, throbbing headache,  entire body aches/pain and loss of grip in my hands, couldn?t move either of my arms-shot was in left arm-104 temperature, I couldn?t get out of bed and I missed an entire day of work. I?m still dizzy, lightheaded and nauseous and it?s 9 pm!
Shot was on 8/18/2021 at 10:15 a.m. This was my 3rd Covid Shot as this was the Booster Shot. Shot went fine but on 8/20 around 5:30 pm notice I had a red rash from my neck to my waist both front and back.   This was a Friday afternoon and my Doctor's Office was closed so I e-mailed her over the weekend that I had a reaction to the shot that caused me to break out in this rash.  I told her I was taking Benadryl and was instructed to keep doing that.  This rash finally subsided on Wednesday, August s25, 2021.  I have gotten rashes from medications in the past that caused the same type of reaction with wide spread rash on torso for a number of days and while quite uncomfortable did not cause any other health proble.  I am reporting this because I know I may have to have another shot in the future and don't want to not be able to take it because of a rash.  As far as I know this did nothing to hurt me what so ever.
From correspondence received on 11/13/01, it was reported that a 64 year old female patient received a Fluzone SV '01 - '02 lot # UO602BA and a Pneumovax lot 470-393 vaccination administered on 10/30/01 in the right deltoid. On 10/31/01, the patient called and reported she developed an orange size area of redness and swelling 2 inches below injections. On 11/01/01, patient was seen in physician's office the reaction was irregular and the red area was the size of a softball (4' X 5.25").
p/ pt recv vax pt subsequently devel chickenpox consisting of approx 20 blisters
pt had a positive COVID test on 12/17/21 in Senior Living facility; transferred to hospital on 12/20/21 with COVID pneumonia and ARF; O2 supplementation; given Remdesivir, but family requested it to be stopped early; ABX; O2 demands increased; ICU; made some improvement; became unresponsive; intubated; vasopressors started; pt experienced cardiac arrest; CPR with ACLS protocol performed without success; pt died in the hospital
No symptoms reported by the caller; Inappropriate schedule of vaccine administration; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender.  The patient's concurrent conditions, historical conditions and concomitant medications were not reported.  On 06-JUN-2021 the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, frequency, route, lot # and expiration date not reported) for prophylaxis.    On 19-JUN-2021, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1637641, expiration date 16-FEB-2022) 0.5 mL intramuscularly (IM) (frequency not reported) (inappropriate schedule of product administration). No symptoms or additional adverse events (AEs) were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637641; expirationdate: 16-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Nausea; felt very hot; sweats; very bad headache; sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  A 16 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 19Apr2021 (Lot number: EW0169) at the age of 16 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Anxiety" (ongoing). Concomitant medication(s) included: ESCITALOPRAM taken for anxiety (ongoing).  The following information was reported: NAUSEA (non-serious) with onset 20Apr2021, outcome "recovered", described as "Nausea"; FEELING HOT (non-serious) with onset 19Apr2021, outcome "recovering", described as "felt very hot"; HYPERHIDROSIS (non-serious) with onset 19Apr2021, outcome "recovering", described as "sweats"; HEADACHE (non-serious) with onset 19Apr2021, outcome "not recovered", described as "very bad headache"; PAIN IN EXTREMITY (non-serious) with onset 19Apr2021, outcome "not recovered", described as "sore arm".  No follow-up attempts are possible. No further information is expected.
Pt. Mom states she is an RN. Mom states bumpy, rash et swollen. Started in right deltoid, next day was down to elbow. Mom states giving BENADRYL et warm compresses. Enc. Mom to see pediatrician.
Has a red raised quarter sized injection site reaction following injection, today three days later it has started traveling down her arm and a second reaction has occurred.
Chills, headache, nausea, fatigue - 3 days. Aspirin 1x  per day.
Extreme flu-like symptos:  Chest pain/swelling, difficult breathing, face and eyes swelling, muscle pain, weakness, injection site swelling, feeling unwell.  Was bed-ridden for over 24hrs.  Currently monitoring at home.
Received flu shot on Oct 22nd,2005 "inj hurt," red, swollen and began itching 12 hrs post inj. Used Benadryl po and ice packs to site. "Was much better 1 day later.
Pt developed CP, SOA about 60 hours after vaccine administration went to campus health center and eventually ER where he was diagnosed with bilateral PEs.
I went to the hospital on 5/4/2021 because my right face was paralyzed and I was tested and taken in and diagnosed with Bells Palsy, they gave me a CT scan and then diagnosed me with right side Bells Palsy and gave me a steroid prednisone, antibiotic and sent me home. They advised me to follow up with my doctor. I went to Hospital ER
injection site swell; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (injection site swell) in a female 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) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (injection site swell). At the time of the report, VACCINATION SITE SWELLING (injection site swell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter. No treatment details were provided by the reporter.