chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a nurse inadvertently administered Adacel to a 5 year old instead of Daptacel, No AE; a nurse inadvertently administered Adacel to a 5 year old instead of Daptacel, No AE; Initial information received on 10-Mar-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a five years old patient (gender unknown) who was inadvertently administered DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] by a nurse (lot number and expiration date  not reported) via an unknown route at an unknown administration site for prophylactic vaccination on an unknown date.  Medical history, medical treatment, vaccination  and family history were not provided.   It was an actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the lot number was requested.
Rash, fever, decreased appetite, increased fussiness, not sleeping well for 2 days.
Thought had Shingles; Back pain; This spontaneous case was reported by a physician and describes the occurrence of HERPES ZOSTER (Thought had Shingles) and BACK PAIN (Back pain) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection, solution for Ankylosing spondylitis.    No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In April 2021, the patient experienced BACK PAIN (Back pain). On an unknown date, the patient experienced HERPES ZOSTER (Thought had Shingles). The patient was treated with SULFASALAZINE for Adverse event, at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Thought had Shingles) and BACK PAIN (Back pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered BACK PAIN (Back pain) to be possibly related. No further causality assessment was provided for HERPES ZOSTER (Thought had Shingles).    No relevant concomitant medications were reported.
Pt developed a swollen red area on left thigh at injection site. Pt cried for 55 hours.
FAMILY MEMBER CALLED CLINIC, REPORTED CHILD HAD SHOTS ON 12/5/08.  HEPATITIS A AND FLU.  CHILD HAD A RASH AND HAD COMPLAINED OF ITCHING ON BACK AND HEASE SINCE 3 DAYS AFTER SHOT.  ENCOURAGED TO BRING CHILD TO CLINIC.  OBSERVED RAISED BUMPS UNDER BOTH ARMS, A FEW ON UPPER BACK, STOMANCH AND ON LEFT THIGH AND ONE KNEE. MOTHER STATED SHE HAD BEEN GIVING HER BENADRYL AND JUST YESTERDAY HAD GIVEN HER CALAMINE LOTION ON RASH.  CHILD WAS CALM AND IN NO DISTRESS WHEN HERE.  MOTHER ALSO SAID CHILD LEFT SIDE OF HEAD ITCHED.  ENCOURAGED TO FOLLOW UP WITH A DOCTOR IF CHILD CONTINUED TO ITCH.  NAMES OF CLINICS GIVEN TO MOTHER.
yesterday he felt terrible/felt he was hit with a rubber hose; today he broke out in hives on stomach, back and arms; had pain in his head, eyes, and all over his body; had pain in his head, eyes, and all over his body; had pain in his head, eyes, and all over his body; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DYSAESTHESIA (yesterday he felt terrible/felt he was hit with a rubber hose), URTICARIA (today he broke out in hives on stomach, back and arms), HEADACHE (had pain in his head, eyes, and all over his body), EYE PAIN (had pain in his head, eyes, and all over his body) and MYALGIA (had pain in his head, eyes, and all over his body) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE DYSAESTHESIA (yesterday he felt terrible/felt he was hit with a rubber hose), URTICARIA (today he broke out in hives on stomach, back and arms), HEADACHE (had pain in his head, eyes, and all over his body), EYE PAIN (had pain in his head, eyes, and all over his body) and MYALGIA (had pain in his head, eyes, and all over his body). At the time of the report, VACCINATION SITE DYSAESTHESIA (yesterday he felt terrible/felt he was hit with a rubber hose), URTICARIA (today he broke out in hives on stomach, back and arms), HEADACHE (had pain in his head, eyes, and all over his body), EYE PAIN (had pain in his head, eyes, and all over his body) and MYALGIA (had pain in his head, eyes, and all over his body) outcome was unknown.            No Concomitant medications were provided No Treatment medications were provided.
Scared to get the 2nd dose; "Looked like someone took iron and burnt her"; tingling in the injection site; arm pit was tender; Feels like its burning; she "started feeling like she was revaccinated"; very itchy; rash went around her arm horizontally; rash size of a quarter; started to hurt; That night it got worse; Tired; sore arm; felt a little lump; hot to the touch; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in the injection site), FEELING ABNORMAL (she "started feeling like she was revaccinated"), FEAR OF INJECTION (Scared to get the 2nd dose), BURNING SENSATION ("Looked like someone took iron and burnt her") and PAIN (That night it got worse) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H(or4)21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN (That night it got worse), VACCINATION SITE MASS (felt a little lump), VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE PAIN (started to hurt), FATIGUE (Tired) and MYALGIA (sore arm). On 24-Mar-2021, the patient experienced FEELING ABNORMAL (she "started feeling like she was revaccinated"), VACCINATION SITE PRURITUS (very itchy), RASH (rash went around her arm horizontally) and VACCINATION SITE RASH (rash size of a quarter). On 25-Mar-2021, the patient experienced PARAESTHESIA (tingling in the injection site), BURNING SENSATION ("Looked like someone took iron and burnt her"), TENDERNESS (arm pit was tender) and VACCINATION SITE PAIN (Feels like its burning). On 05-Apr-2021, the patient experienced FEAR OF INJECTION (Scared to get the 2nd dose). At the time of the report, PARAESTHESIA (tingling in the injection site), FEELING ABNORMAL (she "started feeling like she was revaccinated"), FEAR OF INJECTION (Scared to get the 2nd dose), BURNING SENSATION ("Looked like someone took iron and burnt her"), PAIN (That night it got worse), TENDERNESS (arm pit was tender), VACCINATION SITE MASS (felt a little lump), VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE PRURITUS (very itchy), RASH (rash went around her arm horizontally), VACCINATION SITE RASH (rash size of a quarter), VACCINATION SITE PAIN (started to hurt), VACCINATION SITE PAIN (Feels like its burning), FATIGUE (Tired) and MYALGIA (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  No treatment medications provided by the reporter.
Infant had first clonic tonic seizure grand mal type, lasting approx 5 minutes with perioral cyanosis. EMS responded and evaluated in emergency room, no documented fever but parental report of feeling warm.  Subsequently has had at least 4 more seizures over the next 5 days, and recently dx with Parinfluenza upper resp infection. Documented fever with 3rd seizure on 11/11/2011.
Patient's symptoms were very painful chest pains. He felt like his chest was on fire, especially around his heart.
Patient had her Flu-shot on 09/29/20 FLUAD HD lot #279804 she woke up with extreme head ache, nausea and vomiting. She was taken to  Hospital Emergency
High fever every 3 hours; I got a rash; Vomiting; Very Bad Headache; Joint pain; Fatigue; Pain in Injection site; Lymph nodes swelling and pain; Lymph nodes swilling and pain; received the first dose on 18Dec2020 and the second dose on 06Jan2021; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 32-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3746), via an unspecified route of administration on the left arm on 06Jan2021 at a single dose for COVID-19 immunization. There were no medical history and no concomitant medications. The patient has no known allergies. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) on the left arm on 18Dec2020 at 07:30 at a single dose as COVID-19 immunization. The patient had no other vaccine in four weeks, no COVID prior vaccination, and did not test post-vaccination. The patient had a rash, high fever every 3 hours, vomiting, very bad headache, joint pain, fatigue, pain in injection side, lymph nodes swelling and pain on 08Jan2021 at 12:00. No treatment was administered for the events. The events were resolving.
Itching at site of injection; Rash; Redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE PRURITUS (Itching at site of injection) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013120A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE PRURITUS (Itching at site of injection). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE RASH (Rash), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE PRURITUS (Itching at site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
99.6 fever; Body aches; Slight headache; This is a spontaneous report from a contactable consumer or other non-HCP. A 66-years-old non-pregnanat female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9261), via an unspecified route of administration, administered in Arm Left on 28Jan2021 01:30 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. The patient did not had COVID prior vaccination and did not tested for COVID 19. No known allergies has been reported. On 18Feb2021 22:00 the patient experienced 99.6 fever, body aches, slight headache. The patient underwent lab tests and procedures which included body temperature: 99.6. No treatment was received for the event on 18Feb2021. The outcome of event was recovering.
Patient describes extreme exhaustion and tiredness. He also got dizzy and fell down starting about 5 days after the flu vaccination. He has not been seen by a physicain yet. But if symptoms do not subside he will be seeing his PCP.
CHILLS; HEADACHES; MUSCLE ACHES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: Unk) dose was not reported, administered on 09-MAR-2021 at around 5:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced headaches. On 09-MAR-2021, the subject experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headaches, muscle aches, and chills. This report was non-serious.
vaccinated July 24th am parent noted left thigh where DTAP and IPV vaccine were given was swollen, red and indurated. Grandmother measured leg difference - left thigh and calf swollen 2 inches greater than right, child started on Benadryl, called clinic Monday am, child seen Left thigh swollen, area of injection indurated. Medial aspect of left thigh, by 26 redness gone, decrease of swelling, still had induration at site of injection. No systemic symptoms, no pain by 26th.
6 hours after shot, headache, nausea, chills; 18 hours after shot pulse 106; 30 hours after shot Hives on abdomen, thighs, arms, legs; following morning spread to chest to back, down to feet more of a mass of red and puffiness. I have photos.
Pt experienced discomfort within 24 hours followed by induration. Blanching erythema.
He received his first dose of Pfizer COVID vaccine today at 12:30 PM.  Has h/o Ancef allergy with hives.  No h/o anaphylactic type allergies.  Waiting in observation area for 15 min.  After ~15 min, c/o feeling "shaky".  Pt brought back to cot room.  BP elevated.  Denies unusal SOB, scratchy or swelling in throat.  Denies tongue swelling, mouth numbness or tingling.  No c/o rash or itching. No visible rash noted.  Reports that he has chronic respiratory issues.  Brief history reviewed with patient.  He reports that he takes glipizide, but can't remember if he took it this AM or not.  States he only had one cup of coffee all day.  Symptoms progressed to feeling light-headed.  Visible shaking of hands with lifting arms.  Reports that symptoms were somewhat worsening.    After ~15 min more of observation, First Responder was called.  ED personnel arrived within minutes.  Blood sugar per finger stick was 212.  Patient able to ambulate to wheelchair.  C/o tingling in scalp and feeling light-headed.   Agreed to be transported to ED for further monitoring and possible treatment.
Vaccine given at 9:30 AM by 5 PM left arm hard, sore and swollen but no redness. This AM arm much more swollen. Left arm 36cm in circumference and right arm 33cm in circumference. 9'x6' reddened hard area shoulder to elbow.
was administered three vaccines in one visit: tetanus, pneumonia, and flu.  was administered at my  primary health care provider facility and i am not sure of the exact date except that it was either towards the end of january 2007 or beginning of february 2007 (15-jan-2007 through 15-feb-2007).  there was no rash at injection sites, one vaccine administered in left arm, and two other vaccines injected in right arm.  all three were injected at same visit which was approximately 09:00 in the morning.  approximately seven days following the doctor visit I became ill with flu like symptons and the primary sympton was a cough.  i went back for a follow-up visit with a doctor and notified the doctor of my symptons.  doctor said no prescription necessary and that over the counter cough medicine would be recommended.  also, doctor said a lingering dry cough may take several weeks to disappear.
2 days post immun, fever 104-106; hospitalization; IV Antibiotics close observation;
Pt states shortly after leaving Dr and receiving Hep B, she felt really tired and went to sleep. Noted itching "all over" last night. Reports to Dr today c/o itching. Fine reddened papular rash noted on face. She also c/o sweating and chills this AM and some shortness of breath.
Information has been received from a 66 year old female with no pertinent medical history and no drug reactions or allergies won on 17-APR-2009 was vaccinated with a single dose of ZOSTAVAX (Merck). Concomitant therapy included LOTREL. The patient reported that "after getting the vaccine", she started experiencing really bad headaches that lasted about 8 days. She also mentioned that she experienced bruising and soreness at the injection site. The soreness and headaches went away, however, the bruising was still there. The patient sought unspecified medical attention. There were no lab diagnostics studies performed. Additional information has been requested.
Rash on entire body mainly torso. Extra sensitive gums that bled when teeth were brushed. Rash on inside of both lips and in the back of my throat. Diarrhea, body aches, vomiting, mild fever, splotchy skin,
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 12-NOV-2015 the patient was vaccinated with MMRII (lot # L012479, expiration date 10-APR-2017, dose and route not reported), which was exposed to temperatures outside of the recommended temperature. No adverse experience had been reported. This is one of several reports received from the same source. Additional information has been requested.
headache; flu; diarrhea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. Other Case identifier(s): MOD22-000778 (Moderna).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache"; INFLUENZA (non-serious), outcome "unknown", described as "flu"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
She got the vaccine, had no side effects, a little headache in the back of her head.  She woke up with soreness at injection site with feeling going down her arm.  General aches and pains all over.  She does feel nauseous, feels like she has puffy lips, feels her throat is kind of tight, feels cotton mouthed.   She has not called her doctor yet or any other symptoms at this time.   Has an autoimmune anxiety issue that causes hives and allergic reactions.
Pt reported 9 pruritic rash across most of his body and swollen lymph nodes in the axillary inguinal, and pupliteal regions.
4th shot  Booster half dose; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (4th shot  Booster half dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jun-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Dec-2021, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On 20-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (4th shot  Booster half dose). On 20-Dec-2021, EXTRA DOSE ADMINISTERED (4th shot  Booster half dose) had resolved.            Concomitant medication information was not provided by the reporter.                            Treatment information was not provided by the reporter.   Reporter did not allow further contact
6 year old received Flublok instead of Fluzone with no adverse event; received Flublok instead of Fluzone with no adverse event; Both vaccines do look very similar with no adverse event; Initial information regarding this unsolicited non-serious valid case from a pharmacist on 12-Oct-2020 .  This case is linked to case 2020SA284812.  This case involved a 6-years-old patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Lot number and expiration date was unknown for both) via an unknown route in unknown administration site instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Product administered to patient of inappropriate age) and (Wrong product administered) on an unknown date.  Medical history and concomitant medications were not reported.  It was a case of an actual medication due to inappropriate age at vaccine administration and wrong vaccine administered (Latency: Same day).  The reporter also reported that both the vaccines looks very similar (Product confusion).  At the time of reporting, patient had not experienced any 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.  There will be no information available on batch number for this case.
shortness of breath, fluttering of the heart, high blood pressure, very weak, chest tightness
pt adm to Pediatric dept p/seen in ER fever, localized area w/inc redness lt thigh w/redness, warmth; small scab lt anterior thigh w/several small scabs around it;
ADMINSTRATION ERROR- PATIENT CAME IN FOR HER 10 MONTH WELL EXAM.  AFTER GIVING VACCINES TO THE PATIENTS, FOUND OUT THAT ALL DOSES HAD ADMINISTERED PRIOR RO TODAY'S VISIT.
States she felt her heart was racing. Denies CP, SOB. She was talking without difficulty. No rash or hives. Walking without difficulty. No dizziness. Evaluated by EMS. VS-156/70, 90, 22. O2 Sat 100%. Recheck-148/76, 86, 18, 100%. States she felt it could be due to anxiety. No history of anxiety. She declined transfer to hospital. Left to go to work. No complaints. Left at 6:45PM.
Case number PHEH2014US011731 is an initial spontaneous report received from a nurse on 09 Jun 2014 with a follow-up received on 10 Jul 2014. This report refers to a 17 year old female patient. Her past medical history and concomitant medications were not reported. The patient received only Men CWY liquid conjugate component of MENVEO (batch number: M12121) without reconstitution with Men A lyophilized component intramuscularly into left deltoid on 09 Jun 2014 at 13:54. The patient was notified and informed about the CDC recommendation. No adverse events were reported following this medication error (inappropriate preparation of medication). Follow-up received from a nurse on 10 Jul 2014: Site and time of vaccination was updated. Batch number was amended.