chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Around 9/18 I started having a restless leg feeling in my right leg.  My leg would alternate between feeling heavy/numb to tingling.  About 6 or so days later the restless feeling turned to leg pain.  On 9/25 the pain was primarily in my right calf.  The pain is an aching throbbing pain.  The skin on my calf hurt to just touch it.  On 10/01/21 I went to Urgent Care for the calf pain.  They did lab work to rule out a clot.  Those lab results came back normal except there was an indication that I may be anemic.  About 6 hours after I left Urgent Care on 10/1 my right foot started tingling.  The pain in my foot alternated between an achy, throbbing pain to tingling and numbness in the heel and toe area.  I also noticed a small rash developing on my heel area.  On 1004/2021 I received my second does of the Pfizer vaccine.  On 10/06/21 I returned to Urgent Care because the pain in my right foot was getting worse.  When I walk it feels like I am being poked with pins and needles.  I have been unable to follow up with my PCP due to her being out of her office due to illness.
This spontaneous report was received from a pharmacist concerning to a patient of unknown age and gender. The patient's current conditions and medical history were not provided. Obn 15-OCT-2015, the patient was vaccinated with an expired dose of with PNEUMOVAX 23 (lot # K010016, expiration date 05-AUG-2015) (strength, dose, anatomical location and route of administration were not provided). No adverse effect was reported. There was no product quality complaint involved. Additional information has been requested.
shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number X7Z52, expiry date 5th November 2022) for prophylaxis.   On 25th February 2021, the patient received the 1st dose of Shingrix. On 8th March 2021, 11 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details provided as follow: The patient developed shingles after the 1st dose of Shingrix. No further information was provided. The reporter consented to follow-up. The reported batch number X7Z58 was not available in sales data sheet, hence updated to X7Z52.
Patient got fainted for 2 seconds after receiving last shot (Gardasil 9) She was quickly recovering right after it.
Fever, chills, headache lasted approximately 12 hours.   Soreness @ injection location lasted 2 days.
SORE ARM; LOW GRADE FEVER; MINOR HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced sore arm, low grade fever, and minor headache. The action taken with covid-19 vaccine s was not applicable. The outcome of the low grade fever, sore arm and minor headache was not reported. This report was non-serious.
2 inch by 2 1/2 inch indurated, mildly erythematous area around site of sc PPV23 given on 10/23/07 in posterior right upper arm.  No systemic S/S of reaction.
Gave extra dose of Moderna Bivalent - patient originally received their first bivalent booster at our facility 09/2022.
period was late; bad headache for a week; fatigue; overall not feeling well for a week; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Apr2021 12:00 (Lot number: EW0167) at the age of 46 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Irritable bowel syndrome" (unspecified if ongoing), notes: IBS; "Hypothyroidism" (unspecified if ongoing); "Hashimoto's disease" (unspecified if ongoing), notes: Hashimotos. The patient took concomitant medications.  The following information was reported: MENSTRUATION DELAYED (non-serious) with onset 2021, outcome "unknown", described as "period was late"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "bad headache for a week"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "fatigue"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "overall not feeling well for a week". Therapeutic measures were not taken as a result of menstruation delayed, headache, fatigue, malaise.  Additional Information: The patient had no known allergies to medications, food or other products. The patient received unspecified medication within two 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. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
1/11- noticed itching on hips, 1/12: went swimming  at 09:30 and noticed hives along hips and outer thighs, took 50 mg of Benadryl PO, checked O2- 95% on room air, no signs of shortness of breath; applied cortizone 10 to sites, 1/12 afternoon: hives lessening on hips and thighs but spread to armpits and elbows. Benadryl 50 mg PO taken at bedtime. 1/13: hives still present on hips, gone on armpits, spread to belly button and inner thighs. Will take another 50 mg of Benadryl PO and continue to monitor. New to area, no PCP at this time. However husband is ER nurse and I am also a nurse.
April 9, on waking I felt tired, at noon I became nauseous, had a huge headache and the beginning of body aches April 10, felt achy still and fatigued. I stayed in bed until late afternoon for a shower April 11, on waking I felt weak, shaky. At 9:00, I got a headache and went back to bed. I worked for 3 hours but I felt so unsteady, with my heart beating harder/faster that I returned home to bed. April 12 - I felt normal again on waking and all day.
Initial report received on 23 February 2012 from the Investigator participating in a study under the reference number M5A16. A case of pertussis disease in a 22-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3614AA received on 01 June 2010, lot number C3683AA received on 18 August 2010 and lot number C3669AA received on 11 October 2010 (routes and sites of administration not reported). The subject developed cold-like symptoms and a cough on 19 January 2012, approximately 1 year and 3 months after the last dose. The subject also experienced paroxysmal cough, posttussive vomiting and apnea (onset dates not reported). Laboratory testing included positive PCR on 02 February 2012 and positive culture on 03 February 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 03 February 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 14 February 2012, the subject's cough had resolved. The duration of the cough was reported at that time as 20 days. Investigator causality assessment is not required as per protocol. Company Medical Assessment: No vaccine protects 100% of individuals against infection and it is not unexpected to find cases of pertussis after only 3 doses of PENTACEL. This patient had not received the booster dose that is recommended at 15-18 months of age. Because this case was solicited from an electronic database, medical records are not available so it is unknown if the child had an underlying medical condition or was taking concomitant medications that could have increased vulnerability to infection or inhibited immune response to vaccination. This is one case out of a cumulative total of 51 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 23 February 2012. These 51 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Documents held by sender: None.
Pt died within 24 hours of immunizations 3/28/08-autopsy report received cause of death:sudden unexpected infant death. 3/28/08-autopsy report received-COD: Sudden unexpected infant death.
I believe that these vaccinations made my son mildly Autistic and I noticed it after he got the immunizations.
Woke up with arm so swollen it was twice the size of his left one. Red with bruising in middle, hard bump, and skin was warm to the touch. On 9/5/10 arm still swollen, red, warm, and bruised, not skin is peeling a little.
Adacel was accidentally administered to a 2 year old patient/ no AE; Initial information was received on 24-Jun-2021 regarding an unsolicited valid non-serious case received from a Other health care professional via Agency (Reference number- 00655775) and transmitted to Sanofi on 24-Jun-2021.  This case involves a two-year-old male patient who was vaccinated with 0.5 mL (once) dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (total) (lot number C5687AA, expiry date 09-Dec-2021) via intramuscular route in left thigh on 24-Jun-2021 for prophylactic vaccination (inappropriate age at vaccine administration).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was a case of actual medication error due to product administered to patient of inappropriate age (latency was on same day).  At the time of reporting, patient had no adverse event.  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.
The patient received a dose of vaccine 6/25/21 at 9:40 am that was reconstituted 6/24/21 at 3:30 pm.  No adverse events reported.
On 1/15/13 patient returned to pharmacy to report soreness/redness at injection site and "chicken pox" like eruptions (3) on left cheek/forehead. Reported some resolution on 1/16/13 and was seen by Dr on 1/17/13, determined to be injection reaction.
received the vaccine on 12/16/20 - On 12/18/20, he developed a low-grade fever, chills, body aches, and felt fatigued
This case was reported by a consumer via patient support programs and described the occurrence of injection site pain in a 84-year-old female patient who received SHINGRIX for prophylaxis. On 8th November 2018, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient indicated soreness of arm at the injection site. No other side effects besides the soreness at the injection site.
This case was reported by a nurse via sales rep and described the occurrence of generalized rash in a 82-year-old female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received SHINGRIX. In September 2018, immediately after receiving SHINGRIX, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was unknown. The reporter considered the generalized rash to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced rash from head to toe immediate onset in September 2018 with ongoing symptoms. The reporter thought this was from the vaccine. The reporter agreed to follow up with GlaxoSmithKline.
Employee reports that she was unable to talk properly.  Reported tongue pain, although unsure of swelling.  Reports lasted past her bedtime and was resolved by the time she woke up.
Each day, from 3/7/21 through 3/13/21 felt lightheaded for a few seconds, less than a minute.   The last on on the 13th lasted the longest and may have been over a minute.  This did not cause any problems.  It was very noticeable, caught my attention each time, like there was nothing I could do but pay attention to how I was feeling and then it was gone.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Sep2021 at 12:00 as dose 3 (booster), single (Lot number: FC3184) at the age of 46 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Natural Killer Cell Deficiency" (unspecified if ongoing), notes: Natural Killer Cell Deficiency; "numerous environmental and food allergies" (unspecified if ongoing), notes: numerous environmental and food allergies; "numerous environmental and food allergies" (unspecified if ongoing), notes: numerous environmental and food allergies; "PCOS" (unspecified if ongoing), notes: PCOS; "chronic fatigue syndrome" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa; "known allergies: gluten" (unspecified if ongoing), notes: known allergies: gluten; "known allergies: soy" (unspecified if ongoing), notes: known allergies: soy; "known allergies: egg" (unspecified if ongoing), notes: known allergies: egg; "immunocompromised" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient started anti viral treatment of Paxlovid for covid 19 treatment on 13Jun2022 and stopped on 17Jun2022. Patient's physician would not prescribe another round of Paxlovid due to FDA not recommending it. Although in an article that Withheld and other people were able to be prescribed a second round. Patient was extremely ill and developed secondary infections. Patient was completely stuck. Because doctor gave Paxlovid, they said patient was not eligible for any of the other treatments because was made to quarantine for 10 days even though symptoms came back and tried to get help. It's a terrible system and high risk people like need to be allowed to have a second round of Paxlovid when they rebound because was almost hospitalized when  rebounded. Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and the suspect drug BNT162B2.
Patient called the pharmacy at 07/21/2019 around 11:15 am to talk about symptoms that occurred after his vaccine administration that was given by the intern. Patient reported feeling extreme fatigue, cold, and chills from about 6:00 am to 1:00 pm the following day. He took aspirin and reported feeling better. He also reported redness and a warm feeling approximately 1 inch below the injection site.
12/22/21: The patient is a pleasant 49-year-old male with a past medical history of hypertension, hypokalemia and obstructive sleep apnea who presents to the emergency room complaining of diarrhea. The patient states he has had watery diarrhea for the past 3-4 days.  He felt he was becoming dehydrated and therefore presented to the emergency room for further evaluation.  He denied complaints of shortness of breath, fever, nausea, vomiting or altered taste sensation.  He had a nonproductive cough with chills and muscle aches in his legs.  He tested positive for COVID-19 in the ER.  Upon arrival in the emergency room his temperature was noted to be 102.9° F.  His O2 saturation was 89% on room air.
Vaccination failure; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Jan2021 as dose 1, single (Lot number: EL3249), in left arm, on 06Feb2021 as dose 2, single (Lot number: EL9261), in left arm and on 05Aug2021 as dose 3 (booster), single (Lot number: Ew0186) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 18Jan2022 as dose 4 (booster), single (Lot number: 028kz1a), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN, stop date: 10Apr2022; VITAMIN D3; ASPIRIN [ACETYLSALICYLIC ACID]. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received anti-viral (Paxlovid) as COVID 19 treatment from 11Apr2022 to 16Apr2022. Clinical course: The patient received other medication within 2 weeks of vaccination. Return of symptoms and pos test 8 days after treatment. No known allergies were reported.
Began getting chest pains and shortness of breath  within a month of receiving the vaccine injections.  The symptoms continued to get worse.  Had difficulty walking and with any exertion.   Had an echocardiogram on 8-25-21. Had a heart catheterization on 9-10-21 in which a stent was placed in a coronary artery.   The symptoms improved somewhat with the stent but still very short of breath and have difficulty with walking and exertion.
Symptoms beginning one day after vaccine? Fever of 104 degrees for 3 days, joint pain in hips, feet, hands, knees, ribs, neck, and low back recurring daily and continuously to this date, severe daily headaches continuing to this day, extreme fatigue daily to this date, insomnia to this date, and thinning hair to this date. The Rheumatologist tried Hydrochloriquin, Celebrex, and Gabipentin without success. Also, moved to an autoimmune protocol diet, helping some with inflammation.  Took steroids for 8 days in Jan. 2022 for major flare up.
Patient became rigid and fell down and could not get up, she can no longer stand unassisted. She has become incontinent and now has to where a diaper, and leans to her right side while sitting and standing. She cannot focus for very long. And she becomes rigid and stiff for periods of time. She is no longer able to bath herself or care fir her basic needs. Even with intense therapy hasn?t reached her baseline.
Initial unsolicited report received from a medical assistant on 13 January 2017. This case is linked with 2017SA007206 and 2017SA007211 (same reporter, same vaccine). This case involves a 18-months-old female patient who was vaccinated with doses of DAPTACEL (batch number: C5117AA, expiry date: 19-JAN-2019, dose and dose in series were not reported) and HEPATITIS A VACCINE (HEP A) (batch number: M032492, expiry date, dose and dose in series were not reported) both via intramuscular route in thigh on 10 January 2017. Both vaccine given on same thigh. Patient had no illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions. Concomitant medications were not reported. On 11 January 2017, one day following the vaccination, the patient developed a knot at the injection site. The patient was seen by physician. Laboratory investigations and corrective treatment were not reported. The outcome of event was reported as unknown. List of documents held by sender: none.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 10-SEP-2015 the patient was vaccinated with an improperly stored dose of GARDASIL 9 (0.5 ml; lot # K026247, expiration date: 29-JAN-2017; dose, frequency and route unspecified). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion 3 times. The storage criteria was refrigerator (R) . The total cumulative excursion time (hour), the lowest recorded(Fahrenheit degree/Celsius), Celsius conversion of the lowest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 200, 32, 0 and R; 24, 33, 0.555555556 and R; 124, 34, 1.111111111 and R. This is one of several reports received from the same source. Additional information has been requested.
Pericarditis, heart problems that I?m still being treated for. Fatigue, ill, can?t function to drive or work
I tested positive for COVID-19 on January 10, 2023. I had a cough and sore throat and I was prescribed PAXLOVID the same day I tested positive. I had sent an email to my primary care team about next steps and I was prescribed the medication.
Severe abdominal pain on lower left side began 3am 4/11/21 and continued throughout the day. I sought medical treatment at 10:30am 4/12 at the ER. Through CT scan with contrast, the doctor determined it was diverticulitis and treated with antibiotics. I am still recovering, no history of diverticulitis, and unknown if this is an adverse effect.
Dizziness, Fever, Tachycardia, lightheaded Narrative:
This spontaneous report as received from a healthcare worker refers to an unspecified patients of unknown age and unknown gender. On an unknown date, the unspecified patients were vaccinated with improperly stored GARDASIL. No adverse effects were reported. No product quality complaint was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
Chills and a fever at the same time- tried wearing layers when cold but then I get hot 5 minutes later- I?m constantly sweating or having chills  Headache that hasn?t gone away in 3 days- Tylenol- doesn?t help   Dizziness- sitting down a lot- helps a lot  Nausea- tried eating saltine crackers- doesn?t help at all
Pain and significant swelling at injection site lasting 9 days. Stiffness, redness and itchiness.
Information has been received from a healthcare worker concerning an 8 year old male who on 8/23/96 was vaccinated with a dose of varicella virus vaccine live (lot # 617074/0561D). On 5/13/04, the patient experienced an outbreak of chicken pox. The patient presented with over 50 sores in the physician's office on 5/14/04. No specific treatment was prescribed. No product quality complaint was involved. No further information was provided. Additional information has been requested.