chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of feeling unwell in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovering/resolving. It was unknown if the reporter considered the feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The health care professional also stated during the report that there had been several patients that had commonly reported "not feeling well" after receiving SHINGRIX. This case was linked to the case US2018148548, reported by the same reporter for different patient.
2 hrs later rash neck, hot flash, wheezing; throat tight, difficulty breathing;
Follow-up info received from the physician provided pt info, medical history, vaccination dates, lot numbers and outcome. Information regarding Prevnar was received from a pediatrician regarding a 28 month old female who developed Streptococcus pneumoniae pneumonia and empyema. The pt received her second dose on 5/19/03 at 19 months of age. The child was hospitalized on 2/11/04 for Streptococcus pneumoniae pneumonia. The child subsequently devleoped an empyema that had to be evacuated thoracoscopically. The child was discharged after 13 days.
Information has been received from a physician concerning a 16 year old female, who on 16-APR-2007 was vaccinated with a first dose of Gardasil (Lot# 656050/0245U).  Subsequently, after receiving the vaccination the patient experienced a heavy menstrual cycle.  No laboratory diagnostics were performed.  The patient sought unspecified medical attention.  At the time of the report, the patient's outcome was unknown.  No product quality complaint was involved.  Additional information is not expected.
pt had sz actively lasting about 5 mins; was seen in ER; dx febrile sz;  t38.3C in ER:
Patient received flu shot at 1330 on 11/5/2005 and within one-half hour developed left arm pain radiating to left hand. Pain progressed throughout afternooon and at approx 1700, she developed some shortness of breath and a closing sensation in her throat.  She presented to Emergency dept at 1817 and was given Benadryl 50 mg IM and Vicodin 5/500, 2 tabs, and heating pad to shoulder.  Chest symptoms and pain improved. She states she has no egg allergy and has received flu shots in the past without problems.
This is a spontaneous report from a contactable consumer (patient). A 49-year-old non-pregnant female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in the left arm on 10Apr2021 at 10:14 (Lot Number: EW0150) as dose 2, single for COVID-19 immunization.  Medical history included ongoing anxiety, ongoing ADHD, and ongoing blepharitis all from an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ZOLOFT taken for anxiety, DEXEDRINE taken for ADHD, and ORACEA taken for blepharitism, all from an unspecified start date and ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received BNT162B2 (lot number: EN6206) on 20Mar2021 at 10:19 on the left arm for COVID-19 immunization. The patient previously received bupropion and experienced allergy and hives. Since the vaccination, the patient has not been tested for COVID-19. It was reported that on 11Apr2021, the day after the second dose, at 07:00 AM, the patient woke up with hives all over her legs and stomach. Since then, she has had hives everyday. Some days, not many. Other days, literally her entire legs are covered. Her index (also reported as C4) was measured at >50 (standard is <10) on 14Jul2021. Her doctor said she has chronic urticaria and she believes it is a result of the vaccine. The event resulted in a visit to the doctor's clinic. The patient received antihistamines and prednisone as treatment for the event. The patient has not recovered from the event. The event was reported with a seriousness of persistent/significant disability/incapacity.  Follow-up on 23Aug2021. This case is being submitted to notify that the serious information for this case was first received by the Company on 23Aug2021 and not on 09Aug2021 as previously reported.
He had diarrhea many times throughout the night and all day the next day. I live an hour and a half from him and he traveled home on Tuesday having to stop to go to the bathroom twice.  He got home and had diarrhea all day on Tuesday 12/15/2009.  He also told me all week that he was feeling very weak.  He was even having trouble walking.  I had told him all week to go to the emergency room and he kept telling me he would be ok.  Finally on Friday 12/18/2009 he agreed to call the emergency squad after I told him I would meet him at the Hospital.  The emergency squad arrived and being a big man he decided to walk to the squad.  He went down the first of two steps and died. They tried to bring him back but was unsuccessful.
Developed COVID 2.5 weeks after first vaccination.   Presented to ED due to SOB; imagine test showed pneumonia, tested covid 19 +, treated with remdesivir, dexamethasone, and O2 resulting in improvement over 5 days. Upon discharged home with home oxygen and follow-up with PCP.
Mild, subjective sensation of throat swelling about 25 minutes after the injection. Received solumedrol, benadryl, and pepcid with resolution of symptoms.
Pt had a local reaction to the injection site of a 50 cent piece size redness and warmth. The nurse at the facility of where she received the injection during an on-site clinic event states it is not a reaction that the patient needs to be seen for. She states she had marked the parameters and will watch it through the day. I spoke with our Standing Order physician: and she states this reaction can happen occasionally and just to keep an eye on it.
17 yo female received 1st dose Moderna COVID 19 vaccine. A follow up second dose was administered per CDC recommendation on  4/28/21
shortness of breathe, he said he cannot breathe which lasted for 2 minutes; A spontaneous report was received on 3Feb 2021,  from a Consumer concerning a 50-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events shortness of breathe, he said he cannot breathe which lasted for 2 minutes.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: UNKNOWN) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 13 Jan 2021, the patient experienced the events shortness of breathe. he said he cannot breathe which lasted for 2 minutes.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On 13 Jan 2021 the outcome of events shortness of breathe was resolved.On 13 Jan 2021 the outcome of events he said he cannot breathe which lasted for 2 minutes was recovered/ resolved. .
Muscle vaccine was administered, has been sore for 12 days. Patient has problem lifting her arm up.
double vision; cross-eyed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIPLOPIA (non-serious), outcome "not recovered", described as "double vision"; STRABISMUS (non-serious), outcome "not recovered", described as "cross-eyed".  Additional information: Patient asked if there was any information regarding how many people have reported having vision problems after getting the Comirnaty vaccine and stated he has double vision and is cross-eyed after getting the vaccine. Also reported that patient has been having vision problems for a few weeks after taking the vaccine like double vision and eyes are crossed. Patient states his vision problems would come and go, but now they are permanent. Patient also wanted to know if any of those symptoms and side effects are reversed. Patient asks what can he do to prevent further damage from the vaccine and asks if there is any statistics on how many people have reported vision problems after taking the vaccine.  Follow-up attempts completed. No further information is expected.
Severe headache and neck pain particularly in the anterior neck with redness and burning of anterior neck chest and ears. Also on anterior neck a feeling of terrible tightness and muscle spasm like head wants to pull down. Under chin and sides of tounge  hot red burning sensation. Much worse after I take my thyroid medicine in the morning. I have called my doctor and am awaiting a call back if it gets worse I will go to urgent care.
Pt recvd vax APR92 & approx 1 wk following vax pt devel rash on back & chest;
Initial unsolicited report received from other health professional (office person medical assistant) on 17-May-2018. This case involves a 21-month old patient (gender not reported) who was vaccinated with a dose of ADACEL instead of 4th dose in the series of DTaP (Batch number, expiration date, dose, route and site of administration was not reported for both vaccines) on an unspecified date. It was an actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration. No adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
approximately 11 days after the vaccine injection my arm became noticeably reddened and itchy in the area of the injection site.  It also feels warm to the touch.
Left hand numbness, left lip and left tongue numbness occuring about 1:30 p.m. and lasting about 20 minutes.  I took an aspirin and rested for awhile and then the numbness went away.  This happened on 02/18/2021.
flare of mass cell activiation syndrome; Initial information received on 27-Aug-2019 regarding an unsolicited valid serious case received from a non-health care professional  This case involves a 18 years old female patient who experienced flare of mass cell activation syndrome (Condition aggravated), while she received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and TUBERCULIN TEST (TUBERSOL).  The patient was found to have an egg and corn allergy and mass cell activation syndrome (mast cell activation syndrome.).  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  On 30-Jul-2019, the patient received a 0.5 ml booster dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6208AB and Exp. Date 08-Jul-2020) via intramuscular route in unknown administration site and was treated with TUBERCULIN TEST (TUBERSOL) (lot number, expiry date, dose, route and site of administration were not reported).  On an unknown date, the patient developed flare of mass cell activation syndrome (condition aggravated) (Unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and TUBERCULIN TEST.   Details of lab data not reported.  Final diagnosis was flare of mass cell activiation syndrome and flare of mass cell activiation syndrome.   It was not reported if the patient received any corrective treatment.  At the time of reporting, the patient did not recover from the event.  Batch number of Tubersol was requested.  List of documents held by sender: none.; Sender's Comments: This case concerns a 18 years old female patient with history of egg and corn allergy and mast cell activation syndrome who developed flare of mast cell activation syndrome after vaccination with MENACTRA and Tubersol. The time to onset is unknown. However, Lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
Significant increase in knee joint and muscular pain with different quality from chronic condition which is typically well-controlled with current medication abs injection regimen; Also significant increase in pain of hand/finger  joints ?again, different quality and level from chronic problem which is well-controlled with medication.  Knee joint/muscle pain unrelenting and finally made appt with my orthopedist who I saw today and received steroid injections ?.for the first time between 6 month hyaluronic series
Bleeding in the middle of the cycle; This is a spontaneous report from a contactable consumer(patient). This 40-year-old female patient (not pregnant) received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0167)on 13May2021 16:30 via an unknown route in left arm at 40-year-old for Covid-19 immunization. Medical history and past drug history were not reported.  Patient had no known allergies.  Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, or any other medications the patient received within 2 weeks of vaccination. Patient experienced adverse event of bleeding in the middle of the cycle on 26May2021. The event resulted in doctor or other healthcare professional office/clinic visit. No treatment received for the adverse event. Outcome of the event was unknown.  Since the vaccination, the patient had not been tested for COVID-19. The reported was assessed as non-serious.  No follow-up attempts are needed. No further information is expected.
I woke up on 3/02/21 totally incontinent.  I could not control my urine.  The flow was bright red, filled with blood.  I called my healthcare provider and the doctor at that clinic gave me a urine test.  He found nothing.  There was no pain, only blood for about six bouts of irination.  He sent out to a clinic and they said I had an infection caused by E-coli.  (The vaccine had obvioiusly lowered my resistance to infection because I had none before at all.)  Also, he found that I was in heart failure - about 30% function.  They recommended I be hospitalized.  My daughter and I drove back to my home state and primary care physician, who concurred.  I was hospitalized for heart failure at the hospital in my home state.    This was the first time ever my heart had been compromised.  I have now to see a cardiologist, take meds, and do cardio rehab.  They found my heart was enlarged and I had fluid build-up around my heart also.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown demographics. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On unspecified dates beginning in December 2015, the patients were vaccinated with doses of improperly stored GARDASIL 9 (lot # L043213, expiration date: 28-AUG-2017; dose and route were not provided). The vaccine was exposed to temperature of 32 degrees Fahrenheit for 30 days. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Tiredness; Muscle pain; kind of Joint pain; generally feeling unwell; feeling no energy at all; This is a spontaneous report from a contactable consumer reported for himself/herself. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 3 via an unspecified route of administration on 24Sep2021 as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. Reason for no lot number: of COVID-19 Vaccine: Other: LOT#: Consumer stated, sorry but I got another call coming in and I can't answer. The patient medical and concomitant medication history were reported. On Sep2021, patient had the booster shot on Friday and patient did not have serious side effect, but patient had like tiredness, muscle pain, kind of joint pain and generally feeling unwell. Patient was just feeling no energy at all. How long is this last?" Patient, just wanted to know how long it lasted. Its been 24, you know its been more than 1 day. Consumer was unwilling to complete the report. Further probing could not be done. Hence, limited information available over the call. The outcome of the events were unknown.  The lot number was not provided. Information on lot number has been requested during follow up.
pt recvd vax 17JUL95 & 22JUL95 pt exp generalized rash & blisters all over body;there was no fever;pt recovered;
Pt received flu-zone vaccine on 12/10/2019. Pt came in on 3/20/20 to complain about pain, swelling, numbness to her three fingers and a lump on her left shoulder. I have advised pt to contact her family doctor. Patient was contacted by rph, from store on 3/27/20. Per rph, pt told him that her pain is getting better. I contacted pt on 3/30/20 pt stated that she was hospitalized a week ago and her symptoms are getting better. I contacted patient's doctor, Dr on 3/30/20 and again on 3/31/20. Md's office manager contacted me on 3/31/20 at 5:27 PM told me that he has touched the patient's injection site and he told patient that the side effect will go away eventually. Md's office manager, contacted me on 3/31/20 at 5:27 and informed me that Md has discussed the side effects with the patient. He told patient that the side effects will eventually go away.
Bloody nose; Rapid heart rate; High blood pressure; Nausea; Vomiting; Severe chills; Body aches; Blinding headache; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er2613) via an unspecified route of administration in the right arm on 26Mar2021 at 13:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriatic arthritis. The patient was allergic to unspecified medications, food, or other product. The patient received unspecified concomitant medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Mar2021 at 14:00, the patient experienced bloody nose, rapid heart rate, high blood pressure, nausea, vomiting, severe chills, body aches and blinding headache. The events resulted in emergency room/department visit or urgent care. Therapeutic measures were taken as a result of the events which included treatment with TOURADOL, BENADRYL, ZOFRAN, ATIVAN and unspecified pain medications. The clinical outcome of the events bloody nose, rapid heart rate, high blood pressure, nausea, vomiting, severe chills, body aches and blinding headache was resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
The day after the 2nd shot, patient developed blisters on his lips and mouth. The care facility said that he had a nut allergy -- but he had never been allergic to nuts. He stopped eating and drinking and his BP had dropped to 60/40. By Jan 16th they called to say he was dying and he passed away on 1/18/21.  Patient had COVID19 from Oct 29th - early November. By Nov 21st he had lost 40 lbs. He was 6'3" and had gone from 189lbs to 149 lbs with COVID. By Nov 21st when we could visit, he had recovered from COVID, but was very thin and weak. He could not bathroom alone and kept falling.  He didn't seem to have a bad reaction to the 1st COVID shot, But he immediately reacted to the 2nd shot and passed away within 6 days.
Average increase in blood sugar levels by 50 to 80 points, that haven't returned to prior levels yet. Also achiness, and tiredness.; Average increase in blood sugar levels by 50 to 80 points, that haven't returned to prior levels yet. Also achiness, and tiredness.; Average increase in blood sugar levels by 50 to 80 points, that haven't returned to prior levels yet. Also achiness, and tiredness.; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) solution for injection via an unspecified route of administration on left arm on 22Dec2020 02:30 at a single dose for Covid-19 immunization. Medical history included CREST Syndrome, type 2 diabetes, osteoarthritis, allergies to Sulfa and Dermabond tape. The patient previously took acetylsalicylic acid (ASPIRIN) and experienced allergy. The patient took other medications in the last two weeks. On 26Dec2020, the patient experienced average increase in blood sugar levels by 50 to 80 points, that haven't returned to prior levels yet. Also, she experienced achiness, and tiredness on 26Dec2020. No treatment received for the events. The patient was not diagnosed with Covid-19 and has not been tested prior to vaccination. Outcome of the events was unknown.  No follow-up activities are needed. No further information is expected.
I experienced a sharp pain in the left shoulder that was like an episode I had 20 years before called Parsonage Turner syndrome. I experienced 2 episodes so I spoke to my provider and advised them of my previous diagnosis. The doctor was unable to confirm that it was related but did advise it could be a link between the 2 as the vaccinations can trigger. I took OTC medication for this. The issue resolved after a week or so. I did have a second episode that happened in December spontaneously. I went back to my doctor who again prescribed tramadol. This episode lasted for about 2 weeks. I have a follow up with a neurologist. I did get my booster which was Pfizer and I did not experience an episode following that vaccine.
This case was reported by a consumer via call center representative and described the occurrence of low back pain in a 68-year-old female patient who received SHINGRIX for prophylaxis. On 11th February 2019, the patient received the 1st dose of SHINGRIX. In February 2019, 5 days after receiving SHINGRIX, the patient experienced low back pain. On an unknown date, the outcome of the low back pain was not recovered/not resolved. It was unknown if the reporter considered the low back pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had no history of having back pain. The patient reported that she had the 1st dose of SHINGRIX on the 11th of February. About 5 days after the injection she started having severe lower back pain. This was the 1st time that she was experiencing it. The reporter did not consent to follow up.
Pt presents to ED via EMS for mental status changes and hypoxia 2/10. COVID positive 2/10, on 6 liters nasal oxygen with a saturation of 100%. On 2/11 pt firing up sepsis; wbc 28.3; lactic 6.1, 4.8, and 7.5; patient received 1L bolus in ER; on IV Zosyn, Vanco, and NS at 125cc. 2/12 RRT called for hypotension and hypoxia. Pt placed on 15L HF with non rebreather, but he remains hypotensive and hypoxic. Pt asystole on the telemetry monitor. Writer checked on patient. Pt bradycardic, not breathing. Pt became deceased 2/12.
Patient had a high fever accompanied with shaking.  Attributed it to the flu shot.  She received a pneumonia shot as well.