chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CMA mistakenly administered a MMRV instead of MMR to patient. Patient also received varicella on this visit. No adverse reacion noted during post vaccination period.
Site initially sore  then bicep becomes hard   On the first of January bicep area becomes extremely red and very warm to touch
VACCINE WAS ADMINISTERED TO A MINOR-BOOSTER DOSE 0.25ML GIVEN
Tinnitus developed in both ears about 5 days after vaccination and has not gone away.
Searing, crushing chest pain starting in the upper left pectoral, solar plexus, extending to and down left arm and neck. Admission to ER for suspected cardiac event.  Intense pain continues for 4.5 hours despite multiple administrations of fentanyl. ER tests negative for heart attack. CT interpretation does not rule out suspected aortic dissection due to fluid around aneurysm (later ruled out with second CT). Transfer to another Hospital for possible cardiac repair. Surgeon disagrees with CT reading. Three days in ICU and Step Down, CT, Cardiac Echo, Carotid Echo, Chest X Ray, Blood Tests all negative for cardiac event.
3 Doses administered >12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 Doses administered >12 hours post puncture) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016J21-2A, 040A21A and 042L20A) for COVID-19 vaccination.     Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), CYANOCOBALAMIN, FOLIC ACID (VITAMIN B12 & FOLIC ACID), DICLOFENAC, GABAPENTIN, LIDOCAINE (LIDODERM), DOCUSATE SODIUM, SENNOSIDE A+B (SENNA S), THYROID, TRAMADOL and ASCORBIC ACID (VITAMIN C ASC ACID) for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 20-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 Doses administered >12 hours post puncture). On 20-Jan-2022, EXPIRED PRODUCT ADMINISTERED (3 Doses administered >12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.
Hardness; Big red spot about 1 inch below the deltoid muscle; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Big red spot about 1 inch below the deltoid muscle) and INDURATION (Hardness) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced ERYTHEMA (Big red spot about 1 inch below the deltoid muscle). On 17-Feb-2021, the patient experienced INDURATION (Hardness). At the time of the report, ERYTHEMA (Big red spot about 1 inch below the deltoid muscle) and INDURATION (Hardness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Per mom patient has a localize reaction on her left arm. Red, swollen and hot to the touch. Will monitor for now if it gets worse or does not go away in 2 days she will make an appointment and bring her in to see a provider.
itchy rash on his legs, knees, wrists, stomach, arms, head and "butt"; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash on his legs, knees, wrists, stomach, arms, head and "butt") in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001f21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included No adverse reaction.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced RASH PRURITIC (itchy rash on his legs, knees, wrists, stomach, arms, head and "butt"). At the time of the report, RASH PRURITIC (itchy rash on his legs, knees, wrists, stomach, arms, head and "butt") outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Upon internal review on 04-Aug-2021, age units was updated to years.
About 5 minutes after vaccine, rash started to form  near site.  Then I felt like my body was burning from the inside out, sweating, hives, face turned red, itching all over the body, tongue tingling .  I was sent by ambulance to the ER.
Mother brought child in 06/03/04 complaining of left vastus lateralis pain from injection site of DTAP given 06/02/04. Formed a large red welt (3 inches in circumference) very warm and itchy. Per MD apply ice and take Benadryl 25mg every 4-6 hours. Return to office if redness gets larger.
ON 4/5/2021 RECEIVED THE UNEVENTFUL  VACCINATION SHOT. ON 4/10/2021 ABOUT MIDNIGHT STARTED TO COUGH VERY STRONGLY WITH A VIRTUALLY CONTINUOUS COUGHING SPELL FOR THE NEXT TWO HOURS.  STOPPED THE COUGHING  WITH ROBITUSSIN.  SIMULTANEOUSLY , HAD SHORTNESS OF BREATH, EXTREME FATIGUE AND HEADACHES.
I did not have an adverse reaction to the vaccine. I tested positive for COVID-19 on 03/23/2022. I had a telehealth visit with doctor and I got prescription for Paxlovid. The medication upset my stomach a little bit and left a funny taste in my mouth. As of today, I still have shortness of breath.
felt pretty sick; pharmacist made a med error and give me a double dose/full dose of Moderna (100 mcg); Inappropriate schedule of vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (felt pretty sick), ACCIDENTAL OVERDOSE (pharmacist made a med error and give me a double dose/full dose of Moderna (100 mcg)) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F214) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer (first dose) on 30-Dec-2020 and Pfizer (second dose) on 20-Jan-2021. Past adverse reactions to the above products included No adverse reaction with Pfizer and Pfizer.    On 07-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (pharmacist made a med error and give me a double dose/full dose of Moderna (100 mcg)) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 08-Nov-2021, the patient experienced ILLNESS (felt pretty sick). On 07-Nov-2021, ACCIDENTAL OVERDOSE (pharmacist made a med error and give me a double dose/full dose of Moderna (100 mcg)) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, ILLNESS (felt pretty sick) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided No treatment medications were provided   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Significant follow up - event added, patient demographics added, reporter detail updated.
Rec'd 3rd in series TWINRIX shot. No problems with first 2. 6/15/11 Pt c/o (L) arm muscle pain - tightening - cannot straighten arm - tingling (L) hand - poor grasp (L) hand. To MD 6-15 - MD gave pt muscle relaxant, pain med (TYLENOL) - ice to (L) arm.
Left arm itching , swollen, red at injection sight.  Pounding headache above left eye, diarrhea, rash on left and right leg.
This case was reported by a physician via other manufacturer and described the occurrence of elevated liver enzymes in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced elevated liver enzymes. On an unknown date, the outcome of the elevated liver enzymes was unknown. It was unknown if the reporter considered the elevated liver enzymes to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced raised liver enzymes. The other manufacturer asked to communicate with reporter or patient's physician for further information.
Patient complained of headaches after receiving vaccine. Mild headache was still present the following morning when she was seen by me. Normal physical examination.
Articulation pains; lower back pain, left arm pain, disorder mental, unknown things.  11/16/06 Received medical records from VAMC which reveal patient experienced chronic low back pain, left knee & shoulder pain.  MRI showed discogenic & degenerative changes of facet DJD & right neural foramina narrowing. No radiculopathy.  Left shoulder subacromial bursitis.  Patient received multiple rounds of PT/OT & continues in chronic pain clinic. Other medical history includes neurosis, histrionic, acute stress reaction, organic affective syndrome, gen anxiety, HTN, osteoarthorsis of knee, LS spondylosis, Major depression with psychosis (with at least 2 hospitalizations, last d/c 1/06)), RVT of right leg, dyslipidemia.
was administered to a patient 7 days past the expiration date with no reported adverse event; Initial information received on 18-Oct-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves an unknown age and unknown gender patient to whom DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] vaccine was administered to a patient 7 days past the expiration date with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 14-Oct-2022, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (strength, formulation, dose, route: unknown) (lot number: C5779AA and expiry date: 07-Oct-2022) in unknown administration site for Immunization, on the same day, the patient was administered 7 days past the expiration date with no reported adverse event (expired product administered).  It was reported, the reporter wanted to reach out and see if anyone could advise whether there is any wiggle room with the expiration date. If not, is there any recommendation on whether the patient be re-vaccinated immediately or wait a certain amount of time?". Healthcare professional reported expired Tenivac vaccine administered 1 week after it expired. No additional information reported.  Action taken with DIPHTHERIA AND TETANUS TOXOIDS (TENIVAC) was not applicable.  At time of reporting, the outcome was Unknown.  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.
Swelling redness, warmth and pain at left leg/thigh after IM injection of Dtap and IPV. Treated with Tylenol, Tylenol with Cold and Benadryl.
Inconsolable for 2 hours straight, fevers of about 101 for 3-4 days.
Burning sensation about an hour after shot.  Redness past the shot area about 3 inches in diameter.  Continued burning for one day.  Hoarse throat, and difficulty breathing.  Low grade fever, thought maybe I just had a cold, but art is very sore and very red 30 hours later.  Throat not as sore, have taken allergy pills and advil.
Initial report received on 18 July 2012 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a two-year-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) database. The subject had received 3 doses of PENTACEL; lot number C3324AA received on 01 March 2010, lot number C3404AA received on 04 May 2010 and lot number C3451AA received on 12 July 2010 and one dose of DAPTACEL; lot number C3473AA received on 12 April 2011 (routes and sites of administration not reported). On 07 June 2012, the subject developed a paroxysmal cough with a whoop, approximately one year and two months after the last dose. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 18 June 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 20 June 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 03 July 2012, the subject's cough had resolved. The duration of the cough was reported at that time as 18 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Right arm swelling red & rash noted Mom gave Benadryl & rash gone.
Information has been received on 19-DEC-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, a family nurse practitioner, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 16-JUL-2007, the patient's healthcare provider at a physician's office administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. On or about 03-NOV-2016, the patient was treated by a family nurse practitioner at a physician's office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; and a diminished quality of life. The outcome of the events is not recovered. The causality of the events is related. Additional information has been requested.
the patient's mumps titer was low; This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. The patient was a nurse. Her pertinent medical history and drug reactions or allergies were not provided. Concomitant therapies included tildrakizumab (ILUMYA). The reporter did not know if the patient received measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) in the past.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis.  On an unknown date, the patient's mumps titer was low (mumps antibody test negative). The outcome of the event was unknown.  The relatedness between the event and the suspect therapy was not reported.
when pt recv vax 2JAN96-probably pertussis rxn cried non-stop x 4hrs;
The day I got my shot, by 5:30pm I was to tired and week to even move.   I didn?t know I was pregnant at the time because it was so early. 7 days later I found out I was pregnant, 4 weeks along. And three days later on 3/25 I miscarried.
pt recv flu vax & devel asthma-type condition dx extrinisic asthma caused by dust;
heart palpitations, dizziness, fatigue, shortness of breath (diagnosed as premature ventricular contractions by a doctor based on ECG results)
This spontaneous prospective pregnancy report was received from a 35 year old female pregnancy patient regarding herself. The patients medical history included thyroidectomy in 1987. The patient had no drug allergies or reactions. On 15-JUL-2013, the pregnant patient was by mistake vaccinated wtih a dose of GARDASIL, (lot number, expiry date was not reported) instead of pertussis by the nurse. Concomitant therapies included SYNTHROID. On an unknown date, the patient was found to be pregnant with LMP of 04-JAN-2013 and EDD of 11-OCT-2013 and was due on 05-OCT-2013. There were no symptoms from having received the GARDASIL injection. Blood work for pregnancy was performed. There was no treatment rendered for the events. The patient sought medical attention(doctors visit). Additional information has been requested.
Lower grade fever 99.5 for several days, chills, fatiged, joint and muscle pains, headaches, wheezing for a few days (all these started 4 days after vaccination and lasted for 4-5 days) . The skin rash started a litle later than 5, 6 days but it is still lingering.  Oral thrush/mouth ulcers with a white like sods now yellow tongue.  Very bad taste of mouth and some skin pimples that thought where mosquito bites... These last symptoms snuck up on me and I dont seem to be able to shake them off.  At present I dont feel very well and I my level of energy is very, very low.
a 16 year old patient received Flublok Quadrivalent / no AE; Initial information regarding an unsolicited valid non-serious case received from a Pharmacist and a Nurse on 24-Oct-2019.  This case is linked to cases 2019SA304586, 2019SA304580, 2019SA304588, 2019SA304589, 2019SA304590, 2019SA304591 and 2019SA304592.  This case involves a 16-year-old patient (unknown gender) for who received QUADRIVALENT RECOMBINANT INFLUENZA VACCINE [Flublok QIV]) (Batch No: QFAA1938, Expiry date: 30-Jun-2020) (Product administered to patient of inappropriate age).  The patient s past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to the inappropriate age at vaccine administration.  It was not reported whether the patient 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.
Headache; Fatigue; This is a spontaneous report from a contactable Nurse.   A 30 Years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 07Jan2021 at 03:15 PM at single dose on right arm for COVID-19 immunization. Relevant medical history were not reported.  Concomitant medication included unspecified multivitamins. The patient experienced fatigue on 09Jan2021 and headache on 10Jan2021. No treatment was received for the events. At the time of the reporting the patient had not yet recovered from the events.   The information on the lot/batch number has been requested.
Dizziness, weakness,headaches, aches & chills fever of 102.2
Information has been received from a licensed practical nurse concerning a female (age not reported) who in December 2006, was vaccinated with Gardasil (yeast) which may have been given by the SQ route or a partial SQ route. Subsequently, the patient developed slight injection site soreness (date unknown). The nurse reported that the nurse who administered this vaccination was left handed and his technique appeared "odd" and it may have looked like a SQ injection when it was really intramuscular. The patient sought unspecified medical attention. At the time of this report, the patient had recovered from the event (date unknown). Additional information has been requested.
High fever to 103.5 (oral) despite ibuprofen 600 mg and acetaminophen 1000 mg, alternating every 2 1/2-3 hours. Fever began on July 5 and resolved on July 7. There were no symptoms of local infection, only side effects of the high fever: headache, malaise and fatigue, thirst, myalgias.
blood in the urine; Aches; chills; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD URINE PRESENT (blood in the urine), PAIN (Aches) and CHILLS (chills) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced CHILLS (chills). On 09-Feb-2021, the patient experienced BLOOD URINE PRESENT (blood in the urine) and PAIN (Aches). At the time of the report, BLOOD URINE PRESENT (blood in the urine), PAIN (Aches) and CHILLS (chills) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment medication included paracetamol.
Concern for Bell's palsy.  Started with pain behind and in R ear 2/8/2021.  2/12/2021, noticed drooping of R upper eyelid and R side of mouth Treated with valtrex 1 g tid x 7 days and prednisone 60 mg qd x 7 days
Patient did not have an adverse event, no reaction at all. Patient was given Menactra before the nurse  checked the system. Patient had already had this dose at another facility and it was repeated here due to records not being updated.
Patient reporting pain at the injection site, radiating down her left elbow and up the shoulder. Patient described the shoulder pain as soreness.
Within short time of receiving vaccine, client  became apprehensive, complained of feeling like she could not breathe, like throat swelling.  RN administered epi autoinjector 0.3 mg IM into patient's left thigh at 12:35 pm.  RN alerted staff to call 911.  Patient BP taken at 12:30 was 153/115.   O2  applied via nasal cannula at 3L/min.  Patient stated she had taken a benadryl tablet before coming to the vaccine site.  Within approx 3 min, patient stated she was feeling better, but then leaned forward and gagged a few times, no actual vomiting, spit out some saliva but otherwise tolerated the oxygen, was leaned back in her seat  and appeared more relaxed.  Diphenhydramine 50 mg IM administered in client's left deltoid.  Patient's bp at 12:47 149/92.  EMS arrived at approx 12:48 and took over care of patient.  Patient was stable at time of transfer (walked to stretcher) and was taken to Drs Hospital for further evaluation.  Patient's husband was notified of her condition and transfer to the hospital. Nurse manager spoke with patient at approx 4:15 pm and patient stated she had just been discharged from the ER and was feeling much better.  Patient stated her husband was there with her and driving her to the vaccine site where she had left her car.