chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dx complex regional pain syndrome type II of left lower extremity on 2/21/23. Notable temperature deficit in the left foot along with discoloration, skin changes, allodynia, reduced ROM, paresthesias, and significant pain. Had foot surgery to remove a benign mass on 12/14/22 and was in a boot until 1/23/23. Rx physical therapy; physical therapy noted the onset of CRPS symptoms.
Vaccine was given in my left arm and immediately developed a hard, red, hot lump and remained in this condition.  Late friday night the lump started to break down and a rash began to form.  Rash was raised, red streaks (lines of varying length) that covered my anterior left arm, lateral left breast and torso, none on abdomen or left hip, some on left lateral thigh.  Still fading, but present today.
No adverse event reported but Pfizer monovalent was given by mistake when it should have been Pfizer bivalent. The patient reports no side effects other than a sore arm.
Was extremely tired and just wanted to sleep for three days!; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8731) via an unspecified route of administration in the left arm on 14Apr2021 at 10:45 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took morphine (MANUFACTURER UNKNOWN) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in the left arm on 24Mar2021 at 10:45 (at the age of 63-year-old), as a single dose for COVID-19 immunisation. On 14Apr2021 at 20:00, the patient was extremely tired and just wanted to sleep for three days. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event extremely tired was resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Chills - throughout day on 22 Feb  Mild fever - 0630-1400 on 22 Feb, peaked around 1200 Fatigue - morning of 22 Feb  All symptoms resolved by morning of 23 Feb
Swollen lymph node and tenderness near left collarbone 5 days after vaccination.
I have continued numbness/ wekness in my legs, especially my left leg from the knee down
This spontaneous report as received from a male patient via a healthcare worker refers to a female patient of unknown age. On an unknown date the female patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, frequency and route unspecified) for unknown indication. The patient developed chickenpox after receiving ZOSTAVAX. The reporter stated that this female patient was not seen by their office. The outcome of the event was unknown. Additional information is not expected.
Within 20mins feeling tired; Muscles are tightening more than usual.; Joint pain, more than usual.; Breathing is shallow and takes effort to draw in.; Breathing is shallow and takes effort to draw in.; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 50-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in the right arm on 31Mar2021 at 11:00 (Batch/Lot Number: Er8732) at 50-years-old as a single dose for COVID-19 immunization. The patient did not receive any other vaccine within four weeks of the suspect vaccine.  The patient did not have COVID prior to the vaccination.  Medical history included rheumatoid arthritis (RA) from an unknown date and unknown if ongoing, lupus from an unknown date and unknown if ongoing, fibromyalgia from an unknown date and unknown if ongoing, sulfonamide allergy from an unknown date and unknown if ongoing.  Concomitant medications included unspecified medications from an unknown date to an unknown date; within 2 weeks of vaccination. On 31Mar2021 at 11:30, the patient experienced: within 20 mins feeling tired, muscles are tightening more than usual, joint pain, more than usual, breathing is shallow and takes effort to draw in; all considered non-serious and no treatment was received.  The clinical outcome of the events was unknown. The patient was not tested for COVID post vaccination.    No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a physician refers to a 11 year old female patient with asthma, peanut allergy, shrimp allergy, dog, cat allergy and dust mites allergy. On 27-AUG-2013, the patient was vaccinated with a first dose of GARDASIL lot # J006850 exp. date 31-MAR-2016, 0.5 ml, intramuscular. Concomitant therapies included EPIPEN. On 30-AUG-2013, after receiving her first dose of GARDASIL, the patient experienced severe swelling that was 8x10 cm and bumpy rash. Physician also reported that the patient was seen in her office on 30-AUG-2013 and she instructed to use cool towel (as a treatment for the events). There was no lab diagnostics studies performed. The outcome of severe swelling that was 8x10cm and bumpy rash was unknown. Causality was not reported. Additional information has been requested.
Shortly after 1st dose Pfizer vaccine given patient complaint of "throat swelling" without difficulty swallowing or breathing. Given 5o mg of diphenhydramine and albuterol inhaler, then transferred to ED.  Per ED note: "Her main complaint to me was feeling of swelling in her throat. I do not see objective evidence of this on exam, she is not in respiratory distress, thus epinephrine was held. She was given IV methylprednisolone and famotidine, already received benadryl. After about 10 minutes she started to feel better and her symptoms resolved in ED. Tryptase and C4 sent per protocol (within normal limits). She was observed for 5 hours with no recurrence of symptoms and was discharged with a prednisone burst x 4 days. I recommended she take benadryl every 4-6 hours for the next 24 hours and then as needed after. She already has an epi pen."
BlurredVision, Headache, Diarrhea, Chills, fatigue Narrative:
pt recvd vax & exp redness, swelling, & tenderness @ the inject site;
3 days after shot, 103 deg F temperature for 3 days.  5 days after shot, hives appeared all over his body.  Hives lasted for 7 days.  Fever reducer and Benadryl given.
Lt thigh with small lump-palpable. No open skin incident: syringe hub broke with injection at needle intact per ma; needle was completely out of skin.  Mom concerned possibly lump D/T needle broke inside skin.
I developed foot drop in my left foot shortly after my second vaccine. It didn't occur to me that it could be related to the vaccine until I heard recently of a couple of other people that developed foot drop after their COVID-19 vaccine. I have fallen twice, once breaking my arm.
This spontaneous case reported by a nurse, describes the occurrence of product temperature excursion issue (there was an excursion from the freezer) and administered expired product (administered to 118 patients) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 939901) for COVID-19  immunization. No medical history reported. On Nov 1, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Nov 1, 2021, patient experienced product temperature excursion issue (there was an excursion from the freezer) and administered expired product (administered to 118 patients). At the time of the report, product temperature excursion issue (there was an excursion from the freezer) and administered expired product (administered to 118 patients) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided ; Sender's Comments:  MOD21-068797: MOD21-068620: MOD21-068645: MOD21-068696: MOD21-068796: MOD21-068703: MOD21-068705: MOD21-068707: MOD21-068709: MOD21-068711: MOD21-068713: MOD21-068716: MOD21-068795: MOD21-068717: MOD21-068718: MOD21-068721: MOD21-068722: MOD21-068723: MOD21-068724: MOD21-068727: MOD21-068729: MOD21-068731: MOD21-068732: MOD21-068733: MOD21-068734: MOD21-068735: MOD21-068736: MOD21-068738: MOD21-068794: MOD21-068739: MOD21-068768: MOD21-068769: MOD21-068770: MOD21-068771: MOD21-068772: MOD21-068774: MOD21-068775: MOD21-068776: MOD21-068778: MOD21-068780: MOD21-068781: MOD21-068782: MOD21-068783: MOD21-068784: MOD21-068785: MOD21-068786: MOD21-068788: MOD21-068791: MOD21-068792: MOD21-068793:
Injection site rash began on day 9.  No pain, just redness surrounding injection site.
slept all day; dizzy like I was cae sick; slight headache; nauseated; vomited; chills; This spontaneous case was reported by a patient and describes the occurrence of HYPERSOMNIA (slept all day), DIZZINESS (dizzy like I was cae sick), HEADACHE (slight headache), NAUSEA (nauseated) and VOMITING (vomited) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Migraine.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced HYPERSOMNIA (slept all day), DIZZINESS (dizzy like I was cae sick), HEADACHE (slight headache), NAUSEA (nauseated), VOMITING (vomited) and CHILLS (chills). At the time of the report, HYPERSOMNIA (slept all day), DIZZINESS (dizzy like I was cae sick), NAUSEA (nauseated) and VOMITING (vomited) outcome was unknown and HEADACHE (slight headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant  information was  provided. No Treatment information was  provided.
pt recvd vax;mom described as being cranky 2dec & 3dec;on 4dec in eve,fever of 103.8;no fever in early am 5dec,by 11am had fever of 101.8 w/ rash on forehead & bridge of nose,poor appetite;to MD 5dec,MD said rxn to vax;6dec fever 102;
VERY PAINFULL ABDOMONAL CRAMPING, STARTING 11:00 PM AND LASTING FOR ABOUT 1 MIN. THIS REPEATED 4 TIMES, FOLLOWED BY DIARRHEA FOR A COUPLE HOURS (AFTER THE 2ND DOSE)
chronic hepatitis. not a, b, c, just an inflamed liver.  High fever for one month (104-105) Mono.  Extreme stomach pain, high fever. 2 ER visits, ER July 15, 2021 ER July 19, 2021. Numerous Doctor visits this past year.  Bloodwork levels of AST and ALT go up and down but have not ever return to normal. Now have an autoimmune. Stomach pain from elevated liver comes and goes. Dx with hepatitis.
After 5 days, her father had a fever, not feeling great and loss of energy but feeling fine now; After 5 days, her father had a fever, not feeling great and loss of energy but feeling fine now; After 5 days, her father had a fever, not feeling great and loss of energy but feeling fine now; This is a spontaneous report from a contactable consumer (reported for father) from Regulatory Authority. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), first dose via an unspecified route of administration on 16Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced after 5 days, patient had a fever, not feeling great and loss of energy but feeling fine now on 21Mar2021. Reporter asked if patient (her father) could take the 2nd dose. Customer and/or medical inquiry forwarded or referred. Clinical outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I was recently diagnosed with Shingles. I don't know if this is related to the Pfizer vaccine I received, but I started having symptoms about a week and half after taking the vaccine.  I had chicken pox as a kid, and the case has been really mild, but I thought this was important to report, because I have read where other people reported similar things happening.
Patient complained of chest pain at 11:14 am N.P. and R.N. began assessing the patient at 11:15am. EMS was radioed at this time by POD director.  EMS in to assess patient vitals were obtained, patient described pain as piercing and EKG was initiated  at 11:20 am and completed at 11:22am. 11:35 am Patient noted  rubbing chest N.P. encouraged patient multiple times to be transported to ER for further evaluation  Client denied immediate transport each time she was encouraged to do so.  Patient  verbally expressed that she was fine and left with accompanied by her boyfriend at 11:41am.
9-20-2019 FIRST TIME MENINGOCOCCAL SHOT - SEVERE PAIN AS IF PENETRATING THROUGH THE BONE OR BONE PAIN. CONSTANT ACHE IN THE BONE, AS PER PATIENT SHE WAS ABLE TO MOVE AFTER 3 DAYS. PATIENT NOT SEEN IN OFFICE - 2ND TIME 10-21-2019 - SEVERE PAIN ARM 6-7/10 RIGHT ARM (+) PAIN ON THE NECK. MISSED SCHOOL FOR TWO DAYS AFTER THE SHOTS.
1. Very sore arm began about 9pm on day of immunization, radiating to the shoulder, mid-back and sternum. I do not notice any swelling or redness to the site.  2. 3am day after immunization- woke with chills, shakes, body aches, nausea and headache. Temp. was 99.8. I'm taking ibuprofen.
Chills, fever, muscle aches and joint aches, nausea and severe headache
This case was reported by a consumer via call center representative and described the occurrence of immunocompromised in a patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced immunocompromised (serious criteria GSK medically significant), shingles and product supply issue. On an unkown date, the outcome of the immunocompromised, shingles and product supply issue were unknown. It was unknown if the reporter considered the immunocompromised and shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had shingles within the past year having had the previous vaccine. The patient took medications that caused to be immuno-compromised. At the time of reporting, the patient 2 months behind in dosing. The reporter asked, how the GlaxoSmithKline came along with production of the 2nd dose of SHINGRIX and if delayed of the 2nd dose cause any compromise in outcome.
Anthrax, yellow fever and Typhoid immunization on 1/17/03. PT presents today with rash on trunk.
Burning in chest left and right side mainly right.Burning in right side of stomach.  Burning begining on right side of stomach, up through chest down both arms and legs.  Tingling in elbows and knees.  Diarrhea with excessive weight loss.  Pail, restless nights, symptoms so severe would wake me up.  No treatment is getting better monthly, but not fully recovered to date.
(R) anterior thigh with 4-5 cm area of redness, warmth and mild edema within 24 hours of vaccination. Surface of area is irregular with many small flat vesicles filled with clear yellowish fluid. No drainage, no tenderness.
Patient felt heart racing, palpitations and went to ER where she was discovered to be in Supraventricular Tachycardia.
Patient's reaction(s) noted during COVID vaccine observation period:  dizziness  Actions Taken: VS taken and WNL, taken by Nurse         Disposition: Patient declined ED visit
I felt rapid heartbeat, I could feel them, and I could not sleep. This lasted a few days and I traveled out of state. At 1 am I thought something is wrong, I went to the emergency room. They kept me for 2 days, thinking I had Afib, but I did not. I came home my doctor put me on a Holter monitor and then a week later I could feel my heart double beating again. I had a home ECG, my doctor had me monitor. My doctor switched my meds. My sinus rhythm with supraventricular tachycardia.
Had an unexpected and unusual localized reaction to the PPD test. Symptoms included increased erythema, tenderness, and a nodule (5 mm). It is suspected that a 0.1 ml of anthrax vaccine was erroneously administered to the sm instead of the standard PPD solution.
gave a 2mo male a DTaP/IPV diluent of Pentacel only today. She thought she was giving the HIB. She also gave a DTAP and IIPOL, no adverse event; gave a 2mo male a DTaP/IPV diluent of Pentacel only today. She thought she was giving the HIB. She also gave a DTAP and POL, no adverse event; Initial information received on 29-Apr-2019 regarding an unsolicited valid non-serious case received from a other health care professional.  This case involves a two months old male patient who received a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5) /HIB(PRP/T) VACCINE [PENTACEL] lot UJ073AAA, expiry date: 13-Jun-2020 via unknown route in unknown administration site on an unknown date, IPV (VERO) [IPOL] lot P1A17 and expiry date: P1A17 via unknown route in the left thigh and DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5366AA, expiry date : 07-Feb-2020 via unknown route in the left thigh on 29-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included was PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) and HEPATITIS B VACCINE (HEPATITIS B VACCINE).  It was an actual medication error due to inappropriate reconstitution technique and extra dose administered. A 2 month old patient received DTaP/IPV diluent of Pentacel only today instead of Hib diluent and also received DTaP and Ipol on 29-Apr-2019 separately.  No adverse event not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  Information on the batch number was requested.  List of documents held by sender: none.
pneumonia; had an infection; getting really sick; Night sweats to chills; Night sweats to chills; Very fatigued; I was running 102-103 fever/very high fever; This is a spontaneous report from a contactable consumer. A 43-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 19Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient took the first dose of the Pfizer vaccine and ended up getting really sick and going into the hospital. They determined he had an infection and pneumonia. Things spiraled in the wrong direction. In the afternoon then by the next morning the patient was quite ill. He was sick for like 15 days. Temps for 102-103F. Night sweats to chills. Very fatigued. He would get better, then sick again, then better again and then ended up in the hospital. The events started on 20Feb2021. The patient was hospitalized for the events pneumonia, infection, and getting really sick from 07Mar2021 to 10Mar2021. The patient underwent lab tests and procedures which included body temperature: 102-103 fahrenheit on an unspecified date, investigation: unknown result on an unspecified date. Therapeutic measures were taken as a result of pneumonia, had an infection, getting really sick, i was quite ill, temps for 102-103f, night sweats to chills, night sweats to chills, very fatigued, i was running 102-103 fever/very high fever. Treatment for severe infection and Pneumonia : the patient had "a lot of injection going in his arm, they gave him fluids they gave medications, they tried to bring the Fever Down, they tried to bring the infection down to help clear out the Pneumonia." The outcome of the events was recovering.   Information on the lot/batch number has been requested.
No local injection site reaction. Patient states she had itchy watery eyes 6 hours after injection on 3/11. Was treated 3/13 for conjunctivitis and upper respiratory infection. Patient returned to clinic on 3/20 stated she was better but still had post nasal drip - she wanted reaction reported.
CLOTS; CARDIOVASCULAR SIDE EFFECTS; This solicited report received from a physician via JS2021-31955: COVID 19 Booster Exploration concerned an adult female of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no illness and was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 01 total, administered on unspecified date (therapy start date and therapy end date were not provided) for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. On an unspecified date, the physician stated that the patient had clots and transient cardiovascular side effects. Physician refused to provide diagnostic data. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the clots and cardiovascular side effects was not reported. The reporter provided no causality assessment.  The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and clots, and cardiovascular side effects as related. Company causality between covid-19 vaccine ad26.cov2.s, and clots, and cardiovascular side effects was not related.   This report was serious (Other Medically Important Condition, and Life Threatening).; Sender's Comments: V0 20220201193-COVID-19 VACCINE AD26.COV2.S- clots, cardiovascular side effects. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).