chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The subject was a 3-year-old, HIV-infected enrolled in a study on 03/04/2006. The subject reportedly expired and the date of death is unknown. On 12/28/2005, the subject's HIV viral load was greater than 227,000 copies/mL. On 02/01/2006, the subject's CD4 cell count was 2,724 cells/mm^3. On 01/04/2006, 01/18/2006, and 02/28/2006, the subject received the study agent, Pneumococcal 7-valent Conjugate Vaccine. The participant was last seen at the clinic for the week 8 study visit on 02/28/2006. On 05/12/2006, telephonic contact was attempted with the participant's mother on numerous occasions but none of these attempts were successful and eventually the cell phone number was not in use any longer. A formal letter requesting the participant to come to the clinic was sent to the participant's home: however this also did not yield any response. On 03/18/2009, one of the study nurses telephonically contacted the subject's mother. She was very rude and said the her child had died and that the site should never attempted to contact her again. She then hung up the phone without providing any further information regarding the cause or date of death. Please note that the participant's death is considered unconfirmed as the mother did not come to the clinic to provide further details. This death has also not been confirmed at the Death Registry. The agency has been informed of this case and has allowed Independent Committee to review it. Note that discovery of this case was the result of a request of the study team to actively pursue these lost to follow-up. It is not expected that further information on the cause will be found. The site Principal investigator has assessed the event of presumed death, unconfirmed, as probably not related to the study agent, Pneumococcal 7-valent Conjugated Vaccine. The Medical Officer has assessed the event of presumed death, unconfirmed, as not related to the study agent, Pneumococcal 7-valent Conjugated Vaccine.
I received the first dose of the covid-19 on Wednesday., Jan.17th at approximately 3p.m. I did fie and waited until the had a chance to check the sight. I was fine all night and until two days later. I had the chills and a sore arm. When I awakened Saturday morning my arm was red and warm. I did not feel badly. I have had the redness and slight warmth each day. I went to the dr. on Monday. She thinks it is fine but ordered a low does steroid and oral cream. I decided to wait on the steroid for a few days as I am not feeling badly. My arm is still lightly red and slightly warm. I have no heart palpitations or other side affects. It is not blistery.
asked if this was a blood clot; a big black spot next to her knee, and if she touched it, it hurt; a big black spot next to her knee, and if she touched it, it hurt; This is a spontaneous report from a contactable consumer (patient). A (age: 70; unit: unspecified) female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on 12Apr2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 12Apr2021 the patient experienced a big black spot next to her knee, and if she touched it, it hurt. The patient called to report that she received the first dose of the COVID-19 vaccine yesterday 12Apr2021 and she was supposed to receive the second dose on 03May2021. When she got home yesterday afternoon, she ended up with a big black spot next to her knee, and if she touched it, it hurt. It was a little larger than a quarter coin, about the size of a silver dollar. She stated it was next to the inner part of her knee. The patient asked if this was a blood clot. She stated that she was worried with all the information about blood clots and the COVD-19 vaccines. She stated that she did not know if it was a blood clot but asked if it was a blood clot. The clinical outcomes of the events a big black spot next to her knee, and if she touched it, it hurt were both unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Terrible headache, body pain, chills, fever of 102.8 F., weakness and dizziness.
Extreme pain in both hips and right shoulder for approximately 1 month now.  No previous injuries or pain ever experienced in these affected areas.
Soreness at site of inject.  Inflamed lymph nodes neck etc. Elbow swollen and feels like fluid in it. Cannot straighten  arm all the way. Pain, taking NSAID
patient administered MMRV and varicella instead of MMR and varicella. Provider and parent notified. No further intervention required at this time.
severe toothache type pain from inject site to hand w/pain in elbow also pain cont;
7 year old who received MMR and DTaP 2 days ago, now with very large red, hot, swollen, very tender area on left deltoid portion of upper arm. Area was getting much worse today (than yesterday). Diagnosis: Cellulitis + reaction.
Generalized axillary swelling under left arm noticed 2 days after vaccine. Headache, groggy feeling, fatigue since vaccine.
I was extremely fatigued with muscle soreness especially in my left arm pit. As of 4/18/2021 I noticed a large knot/lymph node in my arm pit and the soreness was constant.
Numbness in left arm extending to thumb, index and middle finger at night especially. Very, very severe rash all over body; feel as if skin is on fire. Have not been able to sleep.
(L) deltoid pain immediately after. 11 hours later syncopal event at home X2, c/o tingling in arm. Worsening arm pain 72 hours after dose.
Flu-like symptoms.  Swollen lymph glands, muscle & joint pain, mild headache, burning eyes, low-grade fever, lethargy
Extreme pain in arm,  unable to lift higher than shoulder after 2 hours until about 48 hours after. Woke up at about 3am with high fever, chills, extreme headache, and extreme nausea. Small amount of vomit. Took Tylenol. Laid on bathroom floor for about 3 hours with tremors before I was able to turn onto my side. Another hour before I could sit upright, and approximately another before I could get up and back to bed. Slept a lot the next two days. Mild headache and nausea persist to this day. Very mild pain persists at injection site.
My heart was racing. I was feeling dizzy. It continued and did not stop. I was also having cold sweats. I went to the emergency room and they registered my BPM at 151. They admitted me over night with a monitor. They put me on a blood thinner Eliquis, Lipitor, Diltiazem. They ran a lot of test, took and xrays, and determined there were no issues. The determined it had to be genetic or old age. I had a follow up visit with a heart doctor. I have had 4 episodes since then at home.  It has been 7 days since it happened last.
Patient was 17 years old when first dose was given, at time of vaccination the vaccine was approved for 18 years old and over. Patient stayed and monitored after vaccination and reported no issues.
stomach ache; is now in a wheelchair; has to get all food through a feeding tube; horrifically suffered; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 12-year-old female patient received BNT162b2 (BNT162B2), 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: ABDOMINAL PAIN UPPER (medically significant), outcome "unknown", described as "stomach ache"; WHEELCHAIR USER (non-serious), outcome "unknown", described as "is now in a wheelchair"; FEEDING TUBE USER (non-serious), outcome "unknown", described as "has to get all food through a feeding tube"; EMOTIONAL DISTRESS (non-serious), outcome "unknown", described as "horrifically suffered".  Additional Context: This ex-nurse called the number about 30,000 people that have been killed by the Covid-19 Vaccines including Pfizer's Vaccines; The 1.4 million people who have been disabled, injured and had side effects from the Covid-19 Vaccines including Pfizer; but specifically, about (name-withheld) who was in the Pfizer so called investigation, the criminal trial, the clinical trial better yet, or worse. (Name-withheld), this poor little 12-year-old at that point where she got the vaccine the trial recorded her as having a stomach ache. Patient is now in a wheelchair getting, you know as a nurse, of course you do, has to get all food through a feeding tube. Patient: Name captured phonetically, was not spelled out by reporter, initials not provided, left as unknown. Reporter called specifically about her and wants to know why her actual results in the clinical trial were recorded as a stomach ache when in fact she's now a severely disabled young woman, 13 years old now; horrifically suffered from this trial and this shot; and caller does not know how you as a nurse; how you as a nurse can actually accept a paycheck from Pfizer. She wants to specifically understand how you could record her as a stomach ache result from the trial now just disabled. Caller asked this agent to have you actually looked into that specific case? and if not, why have you not? Patient parents have tried to get the information from Pfizer and folks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Softball size area of erythema and itching around sites of immunizations in right leg on 02/27/2004.
3rd dose administered; Shingrix given instead of another vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 71-year-old male patient who received Herpes zoster (Shingrix) (batch number 7ff7c, expiry date 28-MAY-2024) for prophylaxis.   Previously administered products included Shingrix (had completed the Shingrix series in 2021).   On 10-MAR-2023, the patient received the 3rd dose of Shingrix. On 10-MAR-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: 3rd dose administered) and wrong vaccine administered (Verbatim: Shingrix given instead of another vaccine). The outcome of the extra dose administered and wrong vaccine administered were unknown.   Additional Information: GSK receipt date: 10-Mar-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The patient received 3rd dose of Shingirx instead of another vaccine, which led to extra dose administered and wrong vaccine administered.
vaccinated on  4-21-18 / the second dose is not administered yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 21st April 2018, batch number 54KZ4).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up. This case was linked with case US2021152864 and US2021152861, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021152864:Same reporter US-GLAXOSMITHKLINE-US2021152861:Same reporter
Information has been received from a literature article, title as stated above which was based on data from the Varicella Active Surveillance Project (VASP) concerning two previously healthy two year olds, who each received one dose of VARIVAX (Oka/Merck) and developed a rash.  The time intervals between their vaccination and rash onset for the two patients who had experienced varicella related hospitalization (VRH) and who had received 1 dose of VARIVAX >42 days before rash onset was 271, 280, 291, and 1445 days.  The children each developed one of the following complications: cellulitis, dehydration, and/or bleeding diathesis.  The children were hospitalized for 1 day.  The outcome was not reported.  In the opinion of the author, the data demonstrated the sizeable and continuing reduction in severe varicella-related morbidity with the use of the varicella vaccine since 1995.  It was also noted that the data highlighted the fact that the majority of hospitalizations that occurred during this time period were preventable through implementation of existing vaccination-policy recommendations.  The author noted that varicella incidence and varicella-related hospitalizations (VRHs) and deaths have decreased substantially since the implementation of the varicella vaccination program.  A copy of this published article is attached as further documentation of the patient's experience.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Parkinson's Disease" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED 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: Unknown results. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: It was reported other medication in 2 weeks: Yes. Adverse event reported congestion, fatigue, sore throat. The Covid-19 was treated with paxlovid from 15Jul2022 to 19Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
sick from the shot; Initial information was received on 30-Sep-2020 regarding an unsolicited valid non-serious case received from a consumer or non health care professional.  This case is linked to case 2020SA270398 (same reporter).  This case involves a 65 years old patient who experienced sick (malaise), while he/she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick (malaise) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was considered non-serious.  Details of laboratory data were not reported.   It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available on batch number for this case.
sore throat, cough, nausea, diarrhea, and feeling icky all over.  COVID monoclonal antibodies
Information has been received from a physician concerning a 16 year old female (also reported as 18 year old ) who on 16-APR-2007 was vaccinated with a dose of GARDASIL. Since 1 day post-injection, the patient had progressive bilateral leg numbness and weakness and motor weakness. The physician inquired about the possibility of Guillian Barre Syndrome. At the time of this report, the outcome was unknown. Upon internal review, progressive bilateral leg numbness and weakness and motor weakness were considered to be other important medical events. No further information is available.
Several days after the first dose, I developed shingles and needed medical attention for this. 12 hours after the second dose, I developed fevers, chills, rigors, body aches for 5-6 hours.
pt had swelling of lower eye lids after injection similar to her reaction when exposed to mosquito repellent.  I observed the patient for an extra 20 minutes (in addition to the original 15).  Pt was fine otherwise....no SOB, chest tightness, throad constriction, or light headedness.  Pt's mom felt comfortable taking her home and giving her an antihistamine.
Redness and swelling in arm, bodyaches similar to flu, fever of 101, emesis.
Case number PHEH2014US001694 is an initial spontaneous report received from a consumer on 22 Jan 2014. This report refers to a female patient of an unknown age. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1309001, expiry date: Apr 2014) on an unknown date in 2013. On 29 Oct 2013, post vaccination, she experienced left arm pain which was persistent at the time of this report. Seriousness and causality of the event was not reported.
Unfortunately our records indicate pt was given an expired vaccination. The confounding factor is that our EHR used to autopopulate lot numbers and expiration dates, so if the MA didn't catch it to change it, it could be entered incorrectly. It is more likely this is the case than she actually received an expired vaccine, but we can't say for sure. I explained the situation to the MOP and offered to repeat pt.'s vaccination. MOP is thinking about it. MOP can't remember any adverse events at the time.
Worst headache I?ve ever had, completely debilitating, couldn?t eat or drink, move or talk for 72 hours (after moderate migraine for 72 hours). Moderate migraine started 3 days after shot, severe headache started day 6 lasted thru morning of day -0 and gradually dissipated after that. Itchy rash at site of shot for the entire duration of the headache is what made me think it was vax reaction since it was so long after shot. No other reactions, no achy-ness or fever or anything else.
Fever to 102.9-103 degrees, upper respiratory infection symptoms, and injection site pain and entire anterior thigh erythema for 4-5 days.
side effects; Headache; chills; bodyache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects), HEADACHE (Headache), CHILLS (chills) and MYALGIA (bodyache) 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 COMPLICATION (side effects), HEADACHE (Headache), CHILLS (chills) and MYALGIA (bodyache). At the time of the report, VACCINATION COMPLICATION (side effects), HEADACHE (Headache), CHILLS (chills) and MYALGIA (bodyache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Mild, Systemic: Weakness-Medium, Additional Details: Patient fainted 2 minutes after dose administration followed by full body contraction which lasted 30 seconds. Patient indicated post-incident he had a needle phobia and had previously fainted during blood drawing appointments
unusually heavier menstrual flow; This is a spontaneous report from a non-contactable consumer (patient). A 35-year-old female patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Left Arm on 12May2021 15:00, at the age of 35-years-old, (Lot Number: RHTSFD) as 2ND DOSE, SINGLE for Covid-19 immunization. Medical history included Fibroids. Historical vaccine includes first dose of BNT162B (lot number: ER8731) on 19Apr2021, left arm. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient's concomitant medications were not reported. On 14May2021, patient experienced unusually heavier menstrual flow with outcome of not recovered. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the event.  No follow up attempts are possible. No further information is expected.
Headache; This is a spontaneous report received from a Pfizer Sponsored Program via a contactable Nurse (Patient). A 27-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE via an unspecified route of administration on Dec2020 07:30AM (reported as three weeks ago as of 13Jan2021) in the left arm at single dose for COVID-19 immunisation. There was no medical history. There were no concomitant medications. There was no additional vaccine administered on same date of the Pfizer suspect. There was no prior vaccination (within 4 weeks). The patient works in a hospital and wants to know if she can take Ibuprofen before the vaccine. She got her second dose and did take Ibuprofen. She received the first dose of the Pfizer COVID 19 vaccine three weeks ago. She is unsure of the date and she is driving and can't access information. The first dose was received at 07:30AM in the left arm. She received the second dose 13Jan2021, 45 minutes ago at 07:30AM in the left arm. She took the Ibuprofen for a headache this morning (13Jan2021). It was just a mild headache but she had to then drive an hour to get the location to received her second dose of the vaccine. After she took Ibuprofen, she read online that it might blunt the immune response. She is asking if that is true? The Ibuprofen took care of the headache; the headache is completely resolved and not serious. No any AE(s) required a visit to physician or ER. Event outcome of headache was recovered on 13Jan2021.  Information on the lot/batch number has been requested.
Per LPN on site pt c/o facial swelling and tongue "feeling strange" 7 minutes after vaccine given,  Assessed by LPN, vitals taken, all within normal limits.  LPV suggested calling 911, pt refused.  Patient called her husband who also instructed her to refuse EMS treatment.  Pt monitored for 20 minutes, insisted on going home to her husband who is an EMT.  Offered Benadryl on site by LVN.  Pt refused.  LVN requested to follow pt home to ensure she was safe, pt followed home by LVN, husband was waiting in front yard.
On April 06, this 21 -year-old female received the Moderna Covid vaccine on her right deltoid at 19:26.  That same evening at 20:42, the patient reported feeling tired, no treatment was requested for her "feeling tired," instead the patient went to bed.    On April 07, 2021, I spoke to the patients' provider who stated the patient no longer feels tired today.
chest pain shortness of breath, Sensitivity troponin level greater than 1000 concerning for myocarditis vs myocardial infarction
The first night, in addition to chills and joint pain (my joints were on fire ), I had extreme pain and cramping in my calves from 9pm to 3am. Throughout the next seven days, the lower leg pain and overall fatigue has continued.  Each day, between mid to late day, I have to lay in bed and take my foot and massage the opposing calf due to tightness and uncomfortable pain.  Each night, the calf pain worsened when compared to the day.  I prop my pillow under my knee.