chrisvoncsefalvay/vaers-outcomes huggingface dataset:
7 month old patient presented with mother to receive second dose of HIB vaccine. Medical Assistant that was administering the vaccine only administered the conjugate to the patient without reconstituting with the ACTHIB. Medical Assistant did not have another clinical staff member verify the vaccine that was being administered prior to administration. Error was recognized 1 business day later when auditing the vaccines that were administered the week prior.
Small red area on right arm near site of DTAP, progressed throughout day to involve arm from shoulder to elbow.  Temperature to 102 (Given Motrin).  Mother took child to ER last evening (04/20/04) where he was started on Keflex.  Rechecked at PCP on 04/21/04.
Patient had pulmonary embolism right around the time of her second vaccine patient also had a rash on her left arm after her second vaccine.
Severe pain in right arm the evening of vaccine.  Next day I couldn't get out of bed, hold my head up, ached everywhere, neck pain, headache, very tired.
Based upon follow up report received from a nurse on 27-Jun-2018, this case becomes medically confirmed. Initial information received on 26-Jun-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a 22 years old male patient who experienced increased anxiety and received Tdap (caller states that it was manufactured by Sanofi) intravenously on Saturday, Tdap is not to be given IV, while he received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 23-Jun-2018, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6092BA, expiry date - 21-Aug-2020 via IV NOS route in deltoid site. The patient developed a non-serious increased anxiety following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. It was also a case of actual medication error due to Inappropriate route of vaccination. (Other relevant tests included No lab data). Final diagnosis was received Tdap (caller states that it was manufactured by Sanofi) intravenously on Saturday, Tdap is not to be given IV and increased anxiety. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for increased anxiety and as Not Applicable for received Tdap (caller states that it was manufactured by Sanofi) intravenously on Saturday, Tdap is not to be given IV. 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. Follow up report received from a nurse on 27-Jun-2018. On 23-Jun-2018, the patient was also vaccinated with a dose of ADACEL (Lot number, expiry date, dose, dose in series was not reported) via intramuscular route in the deltoid. On an unknown date, the patient had anxiety (for 10-15 minutes after receiving the Tdap) and has had a hard time sleeping. It was reported that the patient didn't exhibit any skin changes at the IV site and IM site where the injection was administered. List of documents held by sender: none.
Skin shows several vesicular lesions just above her waist on the anterior abdominal wall. The lesions cross the midline. She has 2-3 fairly new that are vesicular and multiple that appear to be drying. Recommended Benadryl elixir and Calamine lotion.
Information has been received from a wife concerning her 65 year old husband with no known allergies and a history of hip replacement (3 years ago) who on 10/29/02 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot # 643783/0709M). Concomitant therapy included naproxen. On 10/29/02 the patient experienced pain and lost the ability to move his arm above his waist. As of 11/4/02, the patient gained minimal movement in his arm since vaccination. The patient was treated with ibuprofen. The patient sought medical attention from his primary care doctor. Additional information has been requested.
Approximately 2 weeks after receiving the vaccine patient notice an orange or red circle at the injection site; Approximately 2 weeks after receiving the vaccine patient notice an orange or red circle at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Approximately 2 weeks after receiving the vaccine patient notice an orange or red circle at the injection site) and VACCINATION SITE ERYTHEMA (Approximately 2 weeks after receiving the vaccine patient notice an orange or red circle at the injection site) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 prophylaxis.   Patient did not have any allergy and diseases.     On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE DISCOLOURATION (Approximately 2 weeks after receiving the vaccine patient notice an orange or red circle at the injection site) and VACCINATION SITE ERYTHEMA (Approximately 2 weeks after receiving the vaccine patient notice an orange or red circle at the injection site). At the time of the report, VACCINATION SITE DISCOLOURATION (Approximately 2 weeks after receiving the vaccine patient notice an orange or red circle at the injection site) and VACCINATION SITE ERYTHEMA (Approximately 2 weeks after receiving the vaccine patient notice an orange or red circle at the injection site) outcome was unknown.     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 medications were reported.  Orange or red circle at the injection site was not painful, inflame or sore. Patient originally thought it would disappear.  No treatment information was provided.
Patient presented to the ED on 4/2/21 and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Patient presented to the ED on 4/9/21 and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. He also presented to the ED on 4/21/21. He died on 4/24/21.
86-year-old gentleman with significant known past medical history for COPD/arthritis/hypertension, presented to the ER due to complaints of SOB, requires 2 L of oxygen, has been having a productive cough for the past coupld of days.  + COVID test 10/15/2021.  Completed azithromycin, cetriaxone, steroids.  Discharged home.
Redness / induration / pain x 3 days - left deltoid possible cellulitis also -> Treated with antibiotic & pain relievers.
This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a 60-year-old male patient who received SHINGRIX (batch number 97H72, expiry date 8th February 2021) for prophylaxis. On 10th August 2018, the patient received the 2nd dose of SHINGRIX. On 11th August 2018, 1 days after receiving SHINGRIX, the patient experienced muscle pain, tiredness and shivering. On an unknown date, the outcome of the muscle pain, tiredness and shivering were recovering/resolving. It was unknown if the reporter considered the muscle pain, tiredness and shivering to be related to SHINGRIX. Additional details were provided as follows: The patient experienced muscle aches, shivering, fatigue and tiredness which began 1 day after receiving the SHINGRIX vaccine. The events are improved. This case has been linked with US2018151122, reported by the same reporter.
This case was reported by a physician and described a 52 year old female pt who did not respond to immunization with hepatitis B vaccine (manufacturer unknown).  On unspecified dates, the pt received a series of six doses of hepatitis B vaccine (manufacturer unknown). Subsequently, on an unspecified date in 2003, a hepatitis B surface antibody titer was "negative".   As per follow up report: on 11/14/2003 and 12/18/2003, the patient received booster doses of Engerix B (lot ENG5394A2).
Patient received his 3rd dose (booster) of the COVID Pfizer vaccine 165 days after his 2nd dose of the COVID Pfizer vaccine rather than 180 days after receiving his 2nd dose.
Fever and nausea several hours after the shot for 1 week. Injection site soreness and bruising. Left arm continuing to tingle and go numb, even 1.5 months after injection.
Covid; Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 13-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 13 years intramuscular for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Jan2023, outcome "recovering" and all described as "Covid". The event "covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jan2023) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.
Almost fell in the bathroom; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and FALL (Almost fell in the bathroom) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced DIZZINESS (Dizziness). On 30-Mar-2021, the patient experienced FALL (Almost fell in the bathroom). On 29-Mar-2021, DIZZINESS (Dizziness) had resolved. On 30-Mar-2021, FALL (Almost fell in the bathroom) had resolved. Not Provided          No concomitant medication was provided.  Treatment medication was not provided. Action taken with mRNA-1273 in response to the events were not applicable.  Action taken with mRNA-1273 Moderna vaccine was Not applicable
Bell?s palsy  Steroids and antiviral, eye drops gel eye patch eye mask Missing work to recover. Eyes are functioning properly or mouth. Ears and cheek bones hurts . Massive headaches
A nurse reported the occurrence of an injection site reaction in an 18-month-old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). There was no relevant medical history. On 05/19/2002 the vaccinee received his 4th injection of Infanrix into his right leg. On that date he also received an injection of measles, mumps and rubella virus vaccine (M-M-R II, Merck) into his left leg. Post-immunization, the vaccinee developed an injection site reaction at the site of Infanrix administration characterized by pain, swelling, redness and a large "knot" measuring 3" by 4". On 06/20/2002 the vaccinee was seen by a physician, who prescribed cold compresses and paracetamol (Tylenol). The reporter considered the injection site reaction to be probably related to Infanrix administration.
Client reported that she developed pain in her entire arm, diarrhea, vomiting, and dizziness 24 hours after receiving the first COVID vaccine Moderna. The client stated the symptoms lasted about 2 months. The client did not follow up with her primary care doctor or an allergist. The client did not take any medications for her symptoms. The client has a history of diabetes, hypertension, and cancer. These conditions are currently controlled with Metformin, Insulin, cancer treatment, and a BP medication. The client has a history of allergies to Tetracycline. The client's previous reaction to Tetracycline included hives, itching, swelling, and vomiting.
Chronic rash; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a male patient who received Men B NVS (Meningococcal B vaccine) for an unknown indication.   On an unknown date, the patient received Meningococcal B vaccine at an unknown dose. On an unknown date, less than a year after receiving Meningococcal B vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Meningococcal B vaccine.  Additional details were provided as follows: The case was reported by patient's parent. The age at vaccination was not reported. It was reported that the patient had a chronic rash after getting this vaccine 1 year ago.
Sore arm developed on day of injection in afternoon 9/29/21 9/30/21 developed fatigue, chills, sweats, felt feverish but no fever, photophobia
Stiff neck, elbow/neck pain, red splotches around vaccination site, some diarrhea, aches, nausea, low grade fever.
At first, starting at around 5PM, he became very fussy and upset. I gave him the proper dose of infant Tylenol.  I noticed that the injection site and a large surrounding area on his thigh were very red and swollen.  Then within an hour he was crying inconsolably and wouldn't go to sleep, though he was obviously exhausted.  Didn't want to nurse, wouldn't drink water from a bottle.  When he finally dropped off to sleep, close to 10 PM, it was fitful - he would fuss and start crying in his sleep but I couldn't get him to wake up all the way, or get him to breastfeed for more than a minute, or take any fluids from a dropper or bottle.  I had tried to give him another dose of infant Tylenol at 9:30 PM but he was crying at the time so he mostly spat it back out.  This extreme crying/sleepiness lasted for another 5 or 6 hours. I was about to call 911 close to 3 AM when I finally was able to wake him enough to get him to nurse for about 15 minutes. I was able to give him another dose of infant Tylenol at this point, he then stopped crying and screaming, and fell into what seemed like a more normal sleep.  However, for the remainder of the night he was still very irritable and fussy, and kept waking up crying, though his appetite was poor.  This irritability and fussiness actually lasted for the next few days before he returned to acting normal with a normal appetite again.
Swelling at injection site along with itching, pain and red rash covering 40% of upper arm.
Dark red rash started on upper arm on wrist and bicep on left arm and along left side day one faded away somewhat during the day. Day two rash still present light red with slight itch both arms, legs and most of body concentrated mid section of stomach, back and along arms.  No other symptoms.
pain in arm of injection; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received the 1st dose of Shingrix. On 31st August 2020, less than a week after receiving Shingrix, the patient experienced pain in arm. On 1st September 2020, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient got his first Shingrix shot near the end of August 2020. The patient had pain in arm of injection which was resolved. The reporter did not consent to follow up. For tolerance of 2nd dose, refer case US2020AMR221947.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR221947:2nd dose, same patient
My arm was hurting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Apr2021 (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: PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "My arm was hurting".  Additional information: Patient got first shot but due for second shot. Patient's arm was hurting but patient feels lot better.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Slight dizziness; headache; This is a spontaneous report from a contactable consumer other healthcare professional. A 30-years-old non-pregnant female patient received first dose of bnt162b2 (COMIRNATY, solution for injection, Lot number E29269; Expiration date: not reported) via unspecified route of administration in left arm on 05Feb2021 at 02:45 PM (at the age of 30-years-old) as single for COVID-19 immunization. The patient medical history included anxiety, obesity and arthritis. The concomitant medications included Buspirone, hydroxyzine and vitamin D. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received Buspirone, hydroxyzine and vitamin D within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19, since the vaccination. The patient did not have any allergies to medications, food, or other products. On 05Feb2021 at 02:55 PM (10 min after injection), the patient experienced slight dizziness and headache. Patient adverse event resulted in doctor or other healthcare professional office/clinic visit. Patient did not receive any treatment for the adverse event. It was reported that adverse event was not serious. The seriousness criteria was not resulted in death, life threatening, caused/prolonged hospitalization, disabling/Incapacitating, congenital anomaly/birth defect. The outcome of the event was unknown.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. The patient experienced no adverse events.   This case was linked to MOD-2021-395985 (Patient Link).
Nausea, fever, headache started 4AM morning after received Tdap. Symptoms lasted several days.
dozens of cases ofpeople that broke out in shingles from the vaccine /suspected vaccination failure; dozens of cases of people that broke out in shingles from the vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, doctor saiid that, he had got dozens and dozens of cases of people that broke out in shingles from the vaccine This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation for shingles were not provided.
After getting vaccine, that same evening I started having severe heartburn, chest pain, nausea, headache, fatigue. Then I got Strep throat and the severe heartburn and burning in throat and chest has continued ever since. I have lost 10-15 pounds since vaccination related to burning in throat/neck/chest.
Patient presented with fever of 104.4 x 4 days, rash appeared first on one shoulder then the other. Vaccine administered on 5/30/06. Fever started day 4 after vaccine.
This case was reported by a sales representative via another sales representative and described the occurrence of influenza A virus test positive in a child (age 6 - 10 years) female subject who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLUARIX (release date 20 July 2011). Less than one year after vaccination with FLUARIX, the subject contracted influenza A virus. The subject tested influenza A virus test positive and experienced vaccination failure. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified. No additional information was reported. This case was linked to two additional reports received by the same reporter involving vaccination failure following FLUARIX vaccination. Linked cases include: A0980137A and A0980249A.
mom states pt had high pitched cry that was non consolable for approx 18 hrs off & on; pt felt warm but not hot-actual temp no measured;
Generalized seizure with apnea occurred twice on 7/10/01, post vax, on 6/13/01. Pt was hospitalized and found to have an abnormal EEG. Pt was started on phenobarbital. Per doc 204195, 60 day follow up,patient now has seizure disorder being maintained on phenobarbit, unknown whether seizures are truly a consequence of vaccines or just a coincidental development. The annual follow-up states "pt has been on phenobarbital for a seizure disorder since the event with no seizures since 7/30/01. he is snot slowly being weaned off phenobarbital."
Varicella zoster, rash reb 10-11 dermatome right.6/27 started with discomfort. 6/28 rash first noted. 6/29 seen in office - increased red rash w/o vesicles. + nausea, mild URI sx before rash.
1) Muscle spasm in extremities (not arm where injection given) 2) Also feeling of lower extremity "heaviness/weakness".
I am experiencing lower abdomen stomach cramps. I have a flashing white and sharp blue light occuring over my left eye.  It was so bright that it lights up my car.  I can see it when I walk up my home stairs in the dark. all occurring on 10.4.21 8 hrs after the vaccine.  It continues on day 2, Oct. 5th.  It seems to be slower in frequency.  It is dueler when I put my glasses on.  I have a low grade headache on my right eye.  Finally I have an fatigue body
It was reported that a patient (1 of 2) received a TD Adult vaccination on 08/28/2000. Reportedly that same day, the pt complained of tightness in their throat. No specific provided. Further info requested.