chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FEVER (105 F); BODY ACHES; CHILLS; This spontaneous report received from a parent concerned an 18 year old male. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-APR-2021, Laboratory data included: Body temperature (NR: not provided) 105 F. The patient experienced fever 105 F, body aches and chills, 12 hours after receiving the covid-19 vaccine ad26.cov2.s. The reporter did not have any additional details about the patient's vaccination experience and did not had access to the vaccine card. The patient was with patient's mother at another location at the time of the reporting. The reporter had seen patient at the emergency room and requested would call back with the additional information needed to document the experience. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, body aches, and fever. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210417614-covid-19 vaccine ad26.cov2.s -Fever. This event is labeled and is therefore considered potentially related.
Left arm went entirely numb for 2 hours after the injection. The following evening there was a headache. The following morning there was nausea, muscle pain, and headache. Also extreme fatigue
Arm swelling, soreness, flu-like symptoms (nausea, headache, light-headedness), pain at injection site.
spoke w/MD on call 23JUL98 PM regarding inc swelling from shoulder to fingers p/Td given;was advised to go to ER for eval;did not go as swelling began to dec;24JUL98 f/u reports dec swelling now but still sore @ arm;
Presents with red erythematous, swollen, circumferential, warm to touch 20cm in length area on (R) arm beginning at deltoid and ending above elbow.
patient received an expired dose of DAPTACEL with no reported adverse event; Initial information received on 16-May-2023 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves an unknown age and gender patient who had received an expired dose of diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 16-May-2023, the patient received an unknown expired dose of suspect diphtheria-15/tetanus/5 AC pertussis vaccine, suspension for injection (batch number, expiry date unknown) via unknown route in unknown administration site for immunization with no reported adverse event (expired product administered) (same day latency). Information on the batch number was requested.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event patient received an expired dose of daptacel with no reported 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 the 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.
With Moderna my upper arm was sore for days.; I also had flu like symptoms for 3 - 4 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (With Moderna my upper arm was sore for days.) and INFLUENZA LIKE ILLNESS (I also had flu like symptoms for 3 - 4 days) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 vaccination: Pfizer (All Pfizer shots). Past adverse reactions to the above products included Injection site pain with Pfizer.    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 PAIN IN EXTREMITY (With Moderna my upper arm was sore for days.) and INFLUENZA LIKE ILLNESS (I also had flu like symptoms for 3 - 4 days). At the time of the report, PAIN IN EXTREMITY (With Moderna my upper arm was sore for days.) and INFLUENZA LIKE ILLNESS (I also had flu like symptoms for 3 - 4 days) outcome was unknown.            Concomitant medication was not provided. Patient went to get Vax '23 where patient got all other Covid shots (all Pfizer). The pharmacist said there wasn't a difference between the 2 vaccines and got Moderna.  Treatment information was not reported.   Reporter did not allow further contact
Approximately 25 -30 min after receiving vaccine I felt pressure in my left ear, the side of the shot, and listening to my car stereo sounded like I was underwater.  That lasted about 60-90.  After the pressure subsided, I was left with a semi severe ringing in my ear for about 2 days before diminishing to a slight ringing that continues to persist.
One week after shot I developed mild itch near injection site and noticed large patch of raised bumps. The following day it red but not itchy or painful. Today (day 3) it is red but improving, some itchiness at one time during the day but otherwise not bothersome. I?ve been taking Benadryl at night and Allegra during the day plus applying OTC hydrocortisone
7 days after injection, bulls eye rash and whelps appeared on trunk and spread to legs. Ct went to ER but left without being examined. CT c/o itching and redness with malaise. Ct took zantac , Zyrtec and benedryl X 4 Days. then it resolved completely.
numbness in her extremities; tingling in her extremities; break out like herpes near her buttocks/break out on top of her eye; has a dry throat no matter how much she drinks; stated that she has a choking feeling like something is stuck in her throat; stated that she has a choking feeling like something is stuck in her throat; stated that she has aches/pains in her body; has a crawling itch in her body and legs; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 03Apr2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient stated that she got vaccinated on 03Apr2021 and had a mild side effect. Stated that after 5-7 days that she had numbness and tingling in her extremities and a break out like herpes near her buttocks. Stated that 15Apr2021 morning she had a breakout on top of her eye. Was scheduled to go to urgent care 16Apr2021 at 8am. Stated that the nurse told her to take Benadryl. Stated that she had a dry throat no matter how much she drank. Stated that she had a choking feeling like something was stuck in her throat. Stated that she did not have a fever. Stated that she had aches/pain in her body. Stated there was crawling itch in her body and legs. Stated that she got worried about it. Is for the Pfizer Covid vaccine. Stated that she called the CDC earlier and left a message. Stated that she would ask her doctor when it all went away if she should get the second dose. Stated that her second dose was on 24Apr2021. Outcome of the events was unknown.   Information on the Lot/Batch number has been requested.
patient reported lips feeling number ~15 minutes following injection of vaccine. patient was given benadryl which helped the symptom. patient was monitored for 45 minutes following dosage, no other symptoms
t101.8, lt arm swollen, rash on arms & chest, some urticaria lt arm;
This patient complains of pain in his left deltoid for 2 weeks after Tetanus injection. Also after 2 weeks pain in left shoulder going cross to the right shoulder. The patient was seen in the clinic on 12/27/00 with those complaints. No redness or swelling at the injection site on 12/27/00. The patient states pain comes and goes now.
Smell gunpowder even though there is no gunpowder around me; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185) via an unspecified route of administration on 25Jun2021 at 10:30 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies (reported as N/A). Concomitant medications were not reported. 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 COVID vaccine. On 25Jun2021 at 22:00, the patient experienced smell gunpowder even though there was no gunpowder around patient. The event did not result in doctor or other healthcare professional office/clinic visit/emergency visit. No therapeutic measures were taken as a result of reported event. The clinical outcome of the event smell gunpowder even though there was no gunpowder around patient was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient presented to office with febrile illness and noted to have vesicular rash on abdomen, back, face, and legs.
TDAP and MCV4 was given on 08/03/2021 with mom TDAP and MCV4 was given on 08/16/2021 with dad
CP _ on leg, back, buttocks ____ was seen 12/14/05 On zoverene, benadryl
Pt presented to office with T 104.9 crying irritable vomited x 1.
This spontaneous report as received from a health professional refers to a 2 year old patient. On 25-JUL-2014 the patient was vaccinated with MMR II (HSA, lot # J011332, EXP date: 13-SEP-2015, dose and route not reported) and a dose of (oka/merck) VARIVAX (lot # J013907, expiration date: 30-OCT-2015, dose and route not reported), both vaccines were stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
Information has been received from a physician concerning a 43 year old female pt who on 11/1/01 was vaccinated with a dose of MMRII (lot 640234/1091L). On 11/12/01, the pt developed a fever, subsequently visited another physician and azithromycin (Zithromax) was prescribed. On approx. 11/13/01, the pt developed a non-pruritic rash. Follow-up information from a physician indicated that the pt developed a rash 10 days after the vaccination. The physician stated that "I told her to follow-up with me if it did not resolve. It did." No further information was available.
On the 7th I started feeling cold symptoms in the morning but by the afternoon my fever spiked to 105.5. I developed a cough and sever congestion as well from about 1pm on and went the following morning to the urgent care to be tested for Covid and was positive. I've experienced fatigue, cough, runny nose, headache, body aches, fever, chills, diarrhea and digestive issues. I've taken Tylenol and ibuprofen alternating to mitigate the fever. I'm still congested but the severe symptoms lasted from the 7th to the 13th. The 15th was the first day I was able to stay awake all day without being severely fatigued. I received the MAB infusion on May 10th.
sore arm; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EL3247) on left arm on 21Jan2021 10:00 AM at a single dose for COVID-19 immunization. Medical history included Penicillin allergy. Patient was not pregnant. Concomitant medications were not reported. No other vaccine administered in four weeks. No other medications administered in two weeks. Patient experienced sore arm on 21Jan2021 10:30 AM with outcome not recovered. No treatment was received. No COVID prior vaccination. No COVID tested post vaccination.
Rash started chest, then spread front torso, neck, chin, ears, cheek. It appeared very similar to a scarlet fever rash, small red bumps, extremely itchy. It moves around her body in different places, flares up in water. I started with hydrocortisone cream, zyrtec and benadryl, that did not help, then she was given a topical steroid cream I don't know which one, and now she is starting an oral steroid for 5 days. It is finally starting to dissipate, but she has itched herself so badly in places that it is now scabbing.
In addition to severe flu-like symptoms (which seem to be covered in the listed side effects, which resolved in about 10 days), I had the following: My whole shoulder muscle swelled up and became hard, itchy, and red; this lasted for about 10 days Severe fatigue and inflammation of both of my achilles tendons; this is ongoing I reported the Achilles' tendonitis to the pharmacist by phone and to my doctor by email when it did not resolve after 2 weeks. My doctor has prescribed rest , ice, and diclofenac gel, but my insurance is refusing to cover the gel.
Severe fatigue; This is a spontaneous report based on information received by Pfizer from  Abbvie (manufacturer Control Number#: 21K-163-3856245-00). A contactable consumer (patient) reported a patient of unspecified age and gender received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) intramuscularly on 09Mar2021 as a single dose for COVID-19 immunization and tofacitinib citrate (XELJANZ; strength 5 mg) orally at an unspecified dosage from 2018 and orally at an unspecified dosage from 25Feb2021 for rheumatoid arthritis. Medical history and concomitant medications were not reported. In 2021, the patient experienced severe fatigue. Tofacitinib citrate and BNT162B2 were also considered suspect. The action taken with tofacitinib citrate in response to severe fatigue was dose not changed. The outcome of severe fatigue was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Headache, joint ache/pain. On 8/11/00, headaches continue.
Patient was scheduled for COVID vaccine dose number 2 and vaccine was given too early.  Given on day 14 vs day 21.
Cannot hear out of it at all; have tinnitus in my left ear; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 12Mar2021 16:45 (Batch/Lot Number: EN6208) as SINGLE DOSE for covid-19 immunisation, at 42 years old. Medical history included blood clot from an unknown date. Patient is not pregnant. Patient did not have COVID prior vaccination. Patient was not tested for COVID post vaccination. No other vaccine in four weeks. Concomitant medication included apixaban (ELIQUIS) taken for an unspecified indication, start and stop date were not reported. The patient experienced cannot hear out of it at all and have tinnitus in her left ear on Mar2021 (reported as 02:30), 24 hours after the first dose. Took 2 weeks to return after the first dose. Outcome of cannot hear out of it all was recovered on an unspecified date while unknown for tinnitus.
Left arm 3 cm x 5 cm erythematous, warm to touch, mild pain with palpitation, mild swelling and lymph enlargement. Prescribed Keflex 250/5 6.8ml TID for 10 days, recheck 3 days in clinic.
NO ADVERSE SYMPTOMS; another dose of M-M-R was inadvertently administered; unspecified patient was administered a dose of MMR II; This spontaneous report was received from a physician refers to an adult patient (age reported in 20s or 30s) of unknown age and gender. The patient's pertinent medical history, drug reactions/ allergies, concurrent conditions were not reported. The patient's concomitant therapy included sterile diluent. On 03-DEC-2019, the patient was vaccinated with first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)  (strength, dosage, route, lot number and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age). On 09-DEC-2019, the patient was inadvertently vaccinated with another dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (inappropriate schedule of product administration). No adverse events were reported.  No product quality complaint was reported. The outcome of inappropriate schedule of product administration, product administered to patient of inappropriate age and no adverse event were  unknown.
After the initial screaming from the vaccines, patient continued to cry all night and was very cranky the next day. Opposite from her usual very happy self, I could barely get her to smile for 2 days. Even breastfeeding would not console her. She also had a fever. She was given infant Tylenol the next day which seemed to help.
I started to feel like itching on my skin but it is on different parts of my skin; I don't know if it is something in vaccine or it is something in my food or something else, like that kind of allergy; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date in Jan2021 at a single dose for COVID-19 immunization. The vaccine was administered at a hospital. Medical history was not reported. Concomitant medication included unspecified medications; patient reported that he takes a lot of medications. On 19Jan2021, five days prior to the report, the patient experienced itching on his skin but it is on different parts of his skin. He stated, "I don't know if it is something with vaccine or it is something else but I, like a 5 days ago, I started to feel like itching on my skin but it is on different parts of my skin and I felt this is not nice and now I am looking for information like if you have like allergy or something. I don't know if it is something in vaccine or it is something in my food or something else, like that kind of allergy. I don't know what we can do with it." The patient received corrective treatment. On 23Jan2021, he took some Benadryl and on the morning o 24Jan2021, he took his Zyrtec (name not clarified) from his regular allergist. He stated that he has been prescribed for that. Outcome of the events was unknown.   Information on the Lot/Batch number has been requested.
Information has been received from a physician's office concerning an 8 year old male who on 07/02/1996 was vaccinated with first dose of varicella vaccine SC in the arm. On 04/06/2001, the pt's "doctor diagnosed chicken pox." Subsequently, the pt recovered from the chicken pox. No further info is expected.
My right big toe started curling upward and stuck there for 5 long scary minutes. All my leg muscles are fine, I could feel except my bended right big toe. Never ever I eas able to flex backward only; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 59267100001) via an unspecified route of administration in the left arm on 03May2021 at 15:15 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to penicillin. The patient was healthy. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. Concomitant medication was not reported. On 07May2021 at 20:30, the patient experienced her right big toe started curling upward and stuck there for 5 long scary minutes, all her leg muscles were fine, could feel except her bended right big toe, never ever was able to flex backward only one big toe, other toes were fine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events reported. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events her right big toe started curling upward and stuck there for 5 long scary minutes. All her leg muscles were fine, she could feel except her bended right big toe. Never ever she was able to flex backward only one big toe, other toes were fine was resolved on an unknown date in May2021.  No follow-up attempts needed. No further information is expected.
Patient is a 15 year old female who presents following administration of the second dose of Pfizer COVID19 vaccine in the left deltoid. Patient states that she developed a tender, pruritic, red rash at the site of the injection about 10 minutes following the administration.  She relates that she also developed smaller red rashes on the left distal portion of the arm.  She states that this did not happen with her first dose of Pfizer vaccine. She states she also feels slightly dizzy, but relates that she only at a grilled cheese for lunch and minimal water intake.  She denies a history of anaphylaxis and denies allergies to medications, foods, other vaccines.  She affirms a past medical history of low vitamin D (currently treated with supplemental vitamin D gummies) and low iron (untreated).  She further relates that she had her tonsils removed about 1 year ago.  She denies chest pain, difficulty breathing, swelling of the face/lips/tongue/throat, skin rash/itching, cramping abdominal pain, nausea, and vomiting.     Exam (update as needed): GEN: Alert and oriented x 4, NAD. HEAD: NCAT EYES: PERRL, EOMI ENT: Ears normal, Nose normal, OP normal with exception of no tonsils noted, no evidence of angioedema NECK: Supple, without LAD.  CV: RRR, no m/r/g PULM: Clear to auscultation bilaterally, no accessory muscle use ABD: Soft, no tenderness. SKIN: Skin warm and dry.  0.5mm ecchymosis noted 2 cm below the AC joint and in the correct anatomical position for IM injection.  Roughly 5cm of erythema and edema of the left deltoid injection site. The area is mildly tender to palpation, but nonfluctuant.  Two 0.5cm erythematous macules located on the left forearm that are nonfluctuant and nontender to palpation. MSK: FROM, MS 5/5 NEURO: Alert and oriented x 4, CN 2-12 grossly intact, no ataxia, gait steady   Clinical Impression/Field Tx: Vaccine site reaction.  Vital signs within normal limits.  Physical exam otherwise normal. Gave patient 10mg OTC Zyrtec from her personal supply.  About 30 minutes following administration, the vaccine site was significantly less erythematous and edematous.  Patient did not develop any other symptoms.  Patient felt comfortable leaving the site. Advised patient and parent that patient should take 25mg diphenhydramine PO once, once they arrive at home.   Instructed patient to consult the patient?s PCP regarding the post-vaccination reaction.  Patient instructed to go to emergency department should she develop chest pain, difficulty breathing, swelling of the face/lips/mouth/tongue/throat, worsening skin rash, or cramping abdominal pain with nausea/vomiting.  Patient and parent demonstrated understanding of post-vaccination instructions.     Medications administered: Patient self administered 10mg of Zyrtec.   Disposition:  Home