chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills; Black diarrhea; Black diarrhea; Bullseye rash on abdomen; Aches and pains; Severe pain in armpit; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Nov2021 at 19:00(at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history includes hypertension and hypothyroid. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN), melatonin (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN) and liothyronine sodium (CYTOMEL) all for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the vaccination. On 10Nov2021 at 19:00, the patient experienced chills, black diarrhea, bullseye rash on abdomen, aches and pains and severe pain in armpit. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, black diarrhea, bullseye rash on abdomen, aches and pains and severe pain in armpit were not resolved at the time of this report.   The lot number for, BNT162b2, was not provided and will be requested during follow up.
I had lymph node swelling under my left armpit & joint pain that began May 12 & resolved within a couple days. I am a competitive marathoner (currently training ) & run everyday & noticed shortness of breath/chest tightness & elevated heart rate when I was running, worse during hard workouts.  I think that began around May 14. I am still having elevated heart rate and some shortness of breath during hard workouts.  It has taken a day and a half, sometimes up to 2 days, for chest tightness to go away, but it comes back every time I do a hard workout.
Information has been received from a nurse concerning a female patient who on unknown dates, was vaccinated with the first and second dose of GARDASIL vaccine (yeast). The nurse reported that the patient experienced fever and dizziness after each dose of GARDASIL vaccine. The nurse would follow-up with medical services to see if she would give the patient her third dose. The patient sought unspecified medical attention. Additional information has been requested.
thinks her symptoms were mild because of the first dose of the vaccine; only a little congested; tested positive for COVID; mild symptoms, sneezing and runny nose; mild symptoms, sneezing and runny nose; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (mild symptoms, sneezing and runny nose), RHINORRHOEA (mild symptoms, sneezing and runny nose), COVID-19 (tested positive for COVID), NASAL CONGESTION (only a little congested) and ASYMPTOMATIC COVID-19 (thinks her symptoms were mild because of the first dose of the vaccine) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXINE), MULTIVITAMIN & MINERAL, FISH OIL and CALCIUM, COLECALCIFEROL (CALCIUM WITH D3) for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced SNEEZING (mild symptoms, sneezing and runny nose) and RHINORRHOEA (mild symptoms, sneezing and runny nose). On 17-Feb-2021, the patient experienced COVID-19 (tested positive for COVID). On 19-Feb-2021, the patient experienced NASAL CONGESTION (only a little congested). On an unknown date, the patient experienced ASYMPTOMATIC COVID-19 (thinks her symptoms were mild because of the first dose of the vaccine). The patient was treated with GUAIFENESIN (MUCINEX) at a dose of Unknown and PARACETAMOL (TYLENOL) at a dose of unknown. At the time of the report, SNEEZING (mild symptoms, sneezing and runny nose), RHINORRHOEA (mild symptoms, sneezing and runny nose), COVID-19 (tested positive for COVID), NASAL CONGESTION (only a little congested) and ASYMPTOMATIC COVID-19 (thinks her symptoms were mild because of the first dose of the vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, COVID-19: positive and 11-feb-2021 negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow-up received significant information. Event outcome updated to resolved and patient declined further follow-up.
Worst part so far is inability to sleep, feels like heart racing since at least 07/06/2021  around noon or 1:00; many many feelings like heart flip flops during same period - these things are continuing.  injection site still hot, red and swollen and painful. Had fever  100.4 to 101.6 for twelve hours, head and body aches, joint pain - the fever and aches and pain started subsiding today. - the fever, aches and pains I understand are fairly common.  Really had not expected the feeling that my heart is racing and flip flopping or the inability to sleep - may have got two hours last night - so that is why I am reporting.  Not planning to seek medical care unless it continues another night or two.
itchy and scaly ears; itchy and scaly ears; Plaque psoriasis flare-up; Fatigue and fever after first dose of covid vaccine; Fatigue and fever after first dose of covid vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4484013-00.  A 51-year-old female patient received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 51 years intramuscular for covid-19 immunisation; risankizumab RISANKIZUMAB, since 01Oct2019 (ongoing) (Batch/Lot number: unknown), subcutaneous for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), PYREXIA (non-serious) all with onset Mar2021, outcome "recovered" (2021) and all described as "Fatigue and fever after first dose of covid vaccine"; EAR PRURITUS (non-serious), SKIN EXFOLIATION (non-serious), outcome "unknown" and all described as "itchy and scaly ears"; PSORIASIS (non-serious), outcome "not recovered", described as "Plaque psoriasis flare-up". The action taken for risankizumab was dosage not changed.  Additional information: Solicited report from the privacy by a consumer of a 51-years-old female with events of non-serious fatigue and fever after first dose of covid vaccine and plaque psoriasis flare up with Skyrizi (Risankizumab). There was no reported medical history. On an unknown date, the patient experienced plaque psoriasis and flare up. On an unspecified date in Mar2021, the patient experienced fatigue and fever after first dose of covid vaccine. On an unspecified date in 2021, the fatigue and fever after first dose of covid vaccine was resolved. Pfizer BioNTech Covid-19 Vaccine (Tozinameran) was also considered as suspect. On an unspecified date in Mar2021, the patient had fatigue and mild fever after first dose of Pfizer vaccine. She had occasional itchy and scaly ears, especially after travel. It was unknown whether the patient was enrolled in a COVID-19 Vaccine trial. Primary reporter contact for lot number information was unsuccessful.  Causality for Risankizumab: The reporter's causality for the event(s) of fatigue and fever after first dose of covid vaccine onset in Mar2021 with Risankizumab was not related and no reasonable possibility. The reporter's causality for the event(s) of plaque psoriasis flare up with Risankizumab was probable and a reasonable possibility. The reporter's causality for the event(s) with Pfizer BioNTech Covid-19 Vaccine (Tozinameran) was not reported.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
5/17 mom called same day, very red hurt, swollen. 5/18 mom called left arm from shoulder to elbow is huge, swelling under arm, very hard.
Pt reported rash devel chest & neck, numbness & tingling of neck, throat, face, difficulty swallowing; called ER & advised to take APAP & sx subsided w/in 2 hrs & pt states all sx gone by morning;
Prsented to office 12/13/2001 for 2 month checkup where he received Prevnar, DTaP, Comvax and IPV. Went to ER where he was admitted with febrile illness prob secondary to immunizations and sepsis. Note: Medical record does not substantiate a diagnosis of sepsis.
very sleepy; This case was reported by a consumer via interactive digital media and described the occurrence of sleepiness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th September 2020, the patient received Shingrix. In September 2020, less than a week after receiving Shingrix, the patient experienced sleepiness. On an unknown date, the outcome of the sleepiness was unknown.   It was unknown if the reporter considered the sleepiness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and feel sleepiness.
This case was reported by a nurse via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 4-year-old female patient who received KINRIX (batch number 3425B, expiry date 17th April 2018). Concomitant products included MMRV. On 26th October 2016, the patient received KINRIX (intramuscular) 0.5 ml. In October 2016, less than a week after receiving KINRIX, the patient experienced extensive swelling of vaccinated limb, injection site erythema, injection site itching, injection site warmth and injection site induration. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema, injection site itching, injection site warmth and injection site induration were unknown. The reporter considered the extensive swelling of vaccinated limb, injection site erythema, injection site itching, injection site warmth and injection site induration to be probably related to KINRIX. Additional details were provided as follows: This case was previously reported to health department. At 11.33 hours, the patient received a dose of KINRIX on her left arm. On the same day, the patient concomitantly received MMRV (non-GSK) vaccine on her right arm. The batch number reported for MMRV was M015700 with expiry date as 26th September 2017. On 28th October 2016, two days after receiving the vaccination, the patient was brought back to the physician's office because her left upper arm was red, swollen and itchy. The swelling extended two inches from the elbow up to the shoulder and the area was hard, red and warm. The physician was also notified about this situation. Further details were unable to obtain. The reporter's call was transferred to Medical Information (MI). The reporter also reported similar adverse events for 4 other children (see cases US2016180181, US2016180270, US2016180271 and US2016180187) that received the same lot of KINRIX vaccine.
Increased heart rate at 11:40, dizziness & tingling feeling from 12pm - 2pm. Went to urgent care at 230, BP was 160/100 and heart rate was 140
Sjogren syndrome; diabetes; prediabetes; small fiber neuropathy / small diameter neuropathy; This spontaneous case was reported by a consumer and describes the occurrence of SJOGREN'S SYNDROME (Sjogren syndrome) and DIABETES MELLITUS (diabetes) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced SJOGREN'S SYNDROME (Sjogren syndrome) (seriousness criterion medically significant), DIABETES MELLITUS (diabetes) (seriousness criterion medically significant), GLUCOSE TOLERANCE IMPAIRED (prediabetes) and SMALL FIBRE NEUROPATHY (small fiber neuropathy / small diameter neuropathy). At the time of the report, SJOGREN'S SYNDROME (Sjogren syndrome), DIABETES MELLITUS (diabetes), GLUCOSE TOLERANCE IMPAIRED (prediabetes) and SMALL FIBRE NEUROPATHY (small fiber neuropathy / small diameter neuropathy) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Reporter told that she wanted to talk with a scientist and or the research people about the adverse events that she had after the vaccine. She reported these conditions but did not specifically state if these were the side effects she wanted to talked about with the scientist include small fiber neuropathy, small diameter neuropathy, diabetes, prediabetes and Sjogren syndrome. Concomitant medications were not reported.  No treatment information was provided by the reporter. Company comment: This is a spontaneous case concerning a female patient of unknown age, with no medical history reported, who experienced the serious (medically significant) unexpected events of Sjogren's syndrome and diabetes mellitus which occurred in context of SPIKEVAX 2023-2024 dose administration which was described as unknown dose of COVID-19 vaccination schedule. Latency cannot be calculated due to vaccination and events onset dates unknown. It was provided that the patient called to talk with a scientist and/or the research people about the adverse events that the patient had after the vaccine. Mentioned conditions included small fiber neuropathy, small diameter neuropathy, diabetes, prediabetes, Sjogren syndrome; however, it was not specifically stated if these were the side effects the patient wanted to talk about with the scientist. There is no information disclosed on events clinical course, etiologic and diagnostic work up, any accompanying circumstances and/or risk factors, treatment received. Events outcome as unknown at the time of the report. The benefit-risk relationship of SPIKEVAX 2023-2024 is not affected by this report.
Starting on Sept 17 around 3:30 PM, pt's symptoms: bluish/purple color changes/ diarrhea/irritable/fussy/red throat (inside)/very tired/fast heart beat at times/difficulty breathing/paleness/jerking-twitching/weakness/loss of appetite/wheezing/congestion. 11/6/08-office records received for DOS 9/17/0-returned to office 2 1/2 hours after immunizations with C/O not sleeping well, fussy, wheezing turning blue around mouth.  1/8/09-records received for DOS 9/17-9/25/08 DC DX:Questionable seizures. Episodic behavior, episodes of cyanosis, eyes rolling body beoming limp, twitching during one episode. Tired drowsy.
Case PHEH2016US024895 is an initial spontaneous report received from a pharmacist on 23 Sep 2016. This report refers to unknown demographics patient. Medical history and concomitant medication was not reported. The patient was vaccinated with expired FLUVIRIN (batch number: not reported, expiry date: not reported) at a dose of 0.5 ml single dose intramuscular on 22 Sep 2016. No adverse event was reported following this medication error.
It was reported that an 18 months old male pt received a Daptacel vaccination (C1354BA) and IPOL (W0290-2), sometime between the hours of 11:30-12:00pm on the morning of 7/7/03. The next morning at 8am, the pt developed a fever of 100.2 degrees F and experienced a seizure. The pt was taken to the hospital, given Tylenol and was sent home. It was reported that the pt has fully recovered from these events. The reporter of this case is the same reporter of case 2003-01488. Seriousness criteria-other medically significant (OMIC). Follow up on 12/29/03: "From additional information received on 12/12/03 through telephone contact with the responsible physician it was reported that the physician's telephone number provided in the previous version was incorrect.  The correct telephone number was provided, as well as the fax number and address.  No other information was reported." A 15-day follow up report received 01/09/2004 adds: From additional info received on 12/29/2003 from a physician, it was reported that the pt received his 4th dose of Daptacel, administered intra-muscularly in the left thigh and his 3rd dose of IPOL, administered subcutaneously in the right thigh on 07/07/2003 at 11:30 AM. It was reported that the pt's birth weight was 8 pounds and 4 ounces and that the pt has one brother. The pt experienced a fever and seizures on 07/08/2003 at 8:00 AM. He was diagnosed with his 1st episode of febrile seizures rule out vaccine induced seizures. No relevant diagnostic tests were performed. Concomitant medications at the time of vaccination included Children's Tylenol for pain. The pt's pre-existing medical conditions included speech delay and fine motor delay. The mother's niece had a history of febrile seizures as well. No other info was provided at this time.
Patient was vaccinated for COVID-19 on 1/16/21 and 2/6/21, so was fully vaccinated when testing positive for COVID-19 on 10/11/21.
Fever for 4 days; Chills; Sore & achy joints; Headache; Dizziness; Extreme fatigue; Itchy armpits; Lymph nodes down to the center of chest were itchy; Chest, back, and abdomen areas have been very sensitive. I was prescribed Toradol. I am still experiencing extreme nerve pain.
Thursday evening (April 15) I noticed the injection site felt hard again and a little warm.  Overnight and into the morning, the hardness, redness, and tingling/itching feeling spread larger to encompass an area the size of my palm.  It feels very warm and the skin seems somewhat bumpy.
Severe headaches, eye pain, ear pain, jaw pain on the left side, extreme stiffness in neck.  Sent to hospital. Outpatient surgery on both temples. Biopsy. Diagnosed with Greater Cell Arteritis. Inflamation of the temporal arteries. On medication- pregnezone 50 mg daily, fosamax 70 mg weekly. Also dealing with a side effect of the prenezone- elevated blood pressure and on medication 5ml amlodipine daily.
Noticed significant decrease in insulin sensitivity resulting in high blood sugars. Had to manipulate boluses to try and find the right correction bolus. Lasted for approx. 1.5-2 weeks post injection.
Fever 105 (AX) from 11/14/01 around 11:50 PM to 11/15/01 6:00 PM
Tiredness; Chills; Fever; Doesn't feel good, weak; Lymph node swollen, hurts, can't touch it; Nauseous; Headache; This is a spontaneous report from a contactable consumer (Patient). A 61-year-old female patient received the second dose of BNT162B2 (COMIRNATY Formulation: Solution for injection) via unspecified route of administration as a SINGLE DOSE on 07Apr2021 02:35PM for COVID-19 immunization. The patient had no relevant medical history and family history. Patient received historical vaccine of first dose BNT162B2 (COMIRNATY) via unspecified route of administration in left arm on 17Mar2021 02:35 PM for COVID-19 immunization. Medical history and concomitant medication was not reported. No family history. Patient reported as does not think her medications had anything to do with the events. she takes all the same medications and didn't have any events with the first vaccine. On 07Apr2021 at 14:35 after second vaccine she got headache right after that and still ongoing. On 08Apr2021 lymph node under arm swollen hurts and she can't touch it and still ongoing, she was nauseous around 5 or 6 in evening. On 08Apr2021 2:00 AM she had chills, tiredness, doesn't feel good weak and fever was 100.5 then it went higher and lower. Second shot on Wednesday and she really sick was 25 percent better today. No Prior Vaccinations (within 4 weeks). The outcome of event recovered for Chills, Fever on 09Apr2021, Nauseous on 08Apr0221 and not recovered for Tiredness, Headache, Doesn't feel good, weak, Lymph node swollen, hurts, can't touch it.  No follow-up attempts are needed. No further information is expected.
This is a spontaneous report from a contactable consumer. This 91-year-old female consumer (patient) reported for herself that she received bnt162b2 (COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 06May2021 (at the age of 91-year-old) at 1st dose single for COVID-19 immunization. The patient was scheduled for her second dose tomorrow. The patient medical history and concomitant medications were not reported. On May2021, after the first dose the patient experienced metallic taste that tasted iodine, patient mentioned that it went away immediately. It was reported that patient did not provide her prescribing physicians information. Patient wanted to know if this has been a reported side effect of the vaccine and if so, should she proceed in getting her second dose. Her physician advised her to proceed in taking the second dose. Response: Spoke as per attached (Off-Label or No Info) (v15.0). No info found as per the CONS-what are the risks of the vaccine (v7.0) and the updated FACT SHEET FOR RECIPIENTS AND CAREGIVER, under WHAT ARE THE RISKS OF THE COVID-19 VACCINE. Also spoke from the FAQ-COVID-19 Vaccine-receiving second dose after side effect from first dose (v1.0) stating that "The decision to receive the second dose for any other reason cannot be made by . We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knew your health situation and has access to information that can better help inform this decision. Referred to HCP for best clinical recommendation. The outcome of event was recovered on May2021. Information on the lot/batch number has been requested.
About three days after I had my shot, I noticed I was trembling, mildly shaking and didn't think anything of it until about a week after. I Went to my DR and they told me to see a neurologist but I haven't seen one because I do not have the funds for the co-pay. This happens often, like a tremor all over my body. It hasn't gone away and I have not had this problem before. I have videos of it and everything, it started in my limbs but not it is my whole body. It is kind of like being cold and trembling but all day it happens.
Fever, movement described as "convulsions" by daycare provider. No other physical signs of illness on exam. No other seizure like activity. Fever abated within 24-48hr.
Case number PHEH2016US021873, is an initial spontaneous case received from a physician on 25 Aug 2016. The report refers to a 69 years old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with expired FLUVIRIN (batch number: 1517501, expiry date: Jun 2016) at a dose of 0.5 ml intramuscularly on 25 Aug 2016. No adverse event was reported following this administration error.
Pt reports: "feeling of itchiness across her entire body and 'burning on the inside.'" "Itchiness and a tightness in her throat"
EXTRACTION OF THE MODERNA VACCINE FROM THE VIAL WAS NOT CONSISTENT WITH A MODERNA TECHNIQUE (I.E. MORE THAN 20 BOOSTER DOSES WERE DRAWN UP FROM THE VIAL).
A few days after I had a swollen Lymph node. Saw Dr. and had an ultrasound. US was normal. Lymph node went down about 3 weeks later.
Redness and swelling at the injection site - patient was counseled to use acetaminophen or ibuprofen and to ice the area several times a day - she was also instructed to seek medication attention if the reaction got worse or did not get better.