chrisvoncsefalvay/vaers-outcomes huggingface dataset:
19 month old female received adult Tenivac/no AE; Initial information received on 31-Jan-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 19 months old female patient who received vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] for prophylactic vaccination.  The patient medical history, medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot number not reported via unknown route in unknown administration site.  It was of actual medication error due to Inappropriate age at vaccine administration (Product administered to patient of inappropriate). As per approved recommendation, person from 7 years of age and older must receive this vaccine.  It was reported that no adverse event was noted.  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 batch number was requested.
Tonsillitis; Otitis media; Rhinitis; Temperature (102.6 F); General muscle weakness; Achy joints (knees, hips); Headache; Productive cough with phlegm.
Left arm numbness. Gradual onset with 2nd COVID shot 8/13/2021. States feels like pins and needles. This is a 55 Years old Female with history of eczema is presenting with pain to the left upper extremity that occurred on the 13th.  Patient reports that she had received the Pfizer COVID-19 vaccine, following, her left arm went numb and began to tingle and has been an ongoing symptom.  Reports not being able to move arm well but is able to close her left hand. Symptoms occurred gradually and are still present. Symptoms are described as moderate in nature. Negative vomiting. Negative nauseousness. Negative diarrhea.
Patient received Hepatitis A vaccine instead of Hepatitis B vaccine. She did not have any side effects.
Patient called pharmacy early Monday (7/22) AM reported injection site was sore/red Friday (7/19) but spiked a fever with chills Sat (7/20) which did relieve Sunday (7/21). Monday reported redness was growing came in pharmacy. Injection site was yellow (1" diam) and redness approx. 3" diam. reporting spread over 4 days & now itching. Going to PCP Tuesday.
This spontaneous report as received from a registered nurse refers to a 7 year old patient. The nurse reported that the patient received a dose of 0.5 ml expired VARIVAX (lot # 668253/0926Z; Expire date 15-JUL-2012) subcutaneous on 19-JUL-2012. No adverse effect was reported. This is one of several reports received from the same source. No further information is available.
Itchiness, redness, swelling around the area of the injection in the right arm. It started 26 hours after the 2nd dose of moderna injection was given. I also had fever and body pain / aches within 12 hours of the 2nd dose of Moderna vaccine.   Incidentally, I also had fever, chills, body pain / aches after the 1st dose of the moderna vaccine in late February. At that time, I did not have such a rash/redness/swelling etc.
no adverse event; Nurse reports possible administration of improperly stored vaccines; This spontaneous report was received from Other Health Professional, referring to unspecified patients.  Nurse reported possible administration of improperly stored vaccines. No additional adverse events were reported.   The names of vaccines involved (including lot/exp): hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9): Lot: 1775808  Expiration: 20-AUG-2023; Lot: T030749  expiration date: 16-MAR-2023; Lot: 1687293  expiration date: 30-APR-2023; hepatitis a vaccine, inactivated (VAQTA): Lot: T031202, expiration date; 14-JUN-2022, Lot: U026792 expiration date: 28-OCT-2022; hepatitis b vaccine (recombinant) (RECOMBIVAX HB): Lot: T021327, expiration date: 14-NOV-2022; Lot: U008328, expiration date: 16-DEC-2022.  All lot number were verified to be valid, (route and anatomical location were not reported) administered for prophylaxis.   It was reported that the vaccines had been incorrectly stored at -0.3C for 5 minutes and then at 0.3C for 45 minutes. There was no previous temperature excursion  Follow up information was received from the nurse on 09-JUN-2022.  The patient's demographics were provided for all the patients involved in previous event of temperature excursion.  This spontaneous report was referring to a 11-month-old male patient.  The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 02-MAY-2022, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, lot #U001837, expiration date: 21-NOV-2022, administered for prophylaxis (strength, and route of administration were not provided).  This is one of multiple reports received from the same source.
Pt c/o of left arm pain at site of injection radiating to armpit and left breast. Prescribed Keflex 500mg 1 TID x 7d with cellulitis left upper arm.
Info regarding Prevnar injection was received from a healthcare professional regarding a 12 month male pt who experienced injection site swelling measuring 2" by 2" injection site irritation and injection site hives. At 12 months of age, the pt received the fourth dose on 2/21/06. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 2/21/06. Dose regimen was not provided. Concomitant medications were not reported. Event Details: The pt experienced injection site swelling, an area measuring 2" by 2", injection site irritation and injection site hives on 2/21/06. The pt remained in the physician's office for thirty minutes post/vax for observation. No treatment medications were given. The date of recovery was not provided. No additional info was available at the time of this report.
Tinnitus -- loud squealing noise in both ears. Headach, body ache, low-grade fever.
Vomiting and diarrhea, swelling and soreness at the puncture area (left arm) , on and off chills.
lt arm 60% swelling, erythema & warm area extending from mid bicep to mid forearm; t101.4;
experienced the extreme fatigue after second dose vaccination; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (experienced the extreme fatigue after second dose vaccination) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (experienced the extreme fatigue after second dose vaccination). At the time of the report, FATIGUE (experienced the extreme fatigue after second dose vaccination) outcome was unknown.            Concomitant product information was not provided. The cardiologist does not know what it is and could only prove that it wasn't a heart problem.  Treatment information was not provided.
Extensive swelling reaction after 5th dose of DTaP vaccine. Swelling on day after vaccination=60x80mm. In addtion, redness of 50x75mm. All reactions in left arm.
feel crummy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Jun-2021 and was forwarded to Moderna on 22-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feel crummy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jun-2021, the patient experienced FEELING ABNORMAL (feel crummy). At the time of the report, FEELING ABNORMAL (feel crummy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.
Pt woke with vertigo and nausea. Today has pain at injection sight and in r hand with swollen and tender L ant cervical lymph node.
My arm hurt, it got big, my head hurt, by Monday water was coming out of my mouth and I look in the mirror and I saw that my face had turned to the right side. I called my children and they took me to the doctor, and the said it was a side effect of the vaccine. He gave me medicine to reduce the inflammation of the face and antibiotic. Yet I have a turned face and a small eye.
sharp pain in stomach and back; sharp pain in stomach and back; faint; soreness at injection site; diarrhea; nausea/vomiting; nausea; dizziness; chemical feeling in her stomach; This case was reported by a consumer via call center representative and described the occurrence of faint in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th October 2021 10:00, the patient received the 1st dose of Shingrix (intramuscular). On 11th October 2021, 6 hrs after receiving Shingrix, the patient experienced faint (serious criteria GSK medically significant), injection site pain, diarrhea, vomiting, nausea and dizziness. On 14th October 2021, the patient experienced stomach pain and back pain. In October 2021, the patient experienced stomach discomfort. The patient was treated with hyoscine (Scopolamine Patch). On an unknown date, the outcome of the faint, injection site pain, diarrhea, vomiting, nausea, dizziness, stomach pain, back pain and stomach discomfort were not recovered/not resolved.   It was unknown if the reporter considered the faint, diarrhea, vomiting, nausea, dizziness, stomach pain, back pain and stomach discomfort to be related to Shingrix. The reporter considered the injection site pain to be related to Shingrix.  Additional details provided were as follows: The case was reported by patient herself. The patient received a dose of Shingrix in right arm and about 4 hours later she experienced diarrhea, nausea/vomiting, dizziness and a sore arm at the injection site. The patient reported that approximately 6 hours after the Shingrix injection she began to feel faint while laying by the pool. The patient reported that all the previous symptoms had continued in waves for the past 10 days and was not resolved. The patient reported that she called her health care professional, who gave her the vaccine, and she told her to use a scopolamine patch behind her ear and the patient reported which helped with the dizziness. The patient reported that 3 days after receiving the Shingrix vaccine she began to experience sharp pains in her stomach and back, they come and go in waves. On 15th November 2021, the health care professional took a blood sample and told her that her sodium was low and suggested to increase her salt intake. The patient reported that for the past 10 days she could only eat bland food because of the nausea and vomiting. Less than 2 weeks after vaccination, the patient reported that her stomach feels like there was chemicals floating in her stomach. The patient did not give permission to contact health care professional. The reporter did not consent to follow-up.
Almost immediate tachycardia and palpation (beating hard). Dizziness and slight headache at the same time (~2/3 mins after shot). After 30 mins it resolved.
pt recv vax & later that day 4-8hr later devel fever 103, also mild stomachache;no rash or resp problems;fever resolved by next day;
Patient asked for extra monitoring in the observation area due to Sulfa and other antibiotic allergies. Patient states tongue was swelling. No difficulty breathing, no airway obstruction. Assessed by on site provider, 25 mg po Benadryl liquid ordered and given without difficulty BP elevated to high of 151/95. 911 call placed. EMS on site. Patient refused transport to hospital and was picked up by her mom after signing AMA documents. Advised to not drive, not be alone and was being monitored by mom who was a physician. Patient states tongue swelling improving on discharge to mom. Last BP 140/90. Patient is obese.
not feeling well; not feeling well; This is a spontaneous report from a contactable consumer. A 83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on 09Apr2021 as DOSE 2, SINGLE (at the age of 83-years-old) for covid-19 immunisation. The patient's medical history included hypertension, drug hypersensitivity (allergic to Penicillin). The patient's concomitant medications included lisinopril (LISINOPRIL) taken for blood pressure measurement. The patient had hip surgery 11 years earlier and was now an inch shorter. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The reporter's brother died after getting the second shot. It was reported that, the patient was not feeling well and the reporter talked to him on the 07Apr2021 and then on 11Apr2021. The patient didn't complain and didn't sound well and didn't feel well when the reporter spoke to him. By 15Apr2021 the patient died. It appears the patient had some kind of reaction to the vaccine. The patient was well before he took any vaccines. The patient had his blood pressure under control, low cholesterol, and walked every day. The reporter tried to get an autopsy but was unable because of the condition of the body. The reporter had a welfare check done on the patient on 06May2021 and that's when they found his body in his home. The patient was alive until the 15Apr2021. The reporter knew this because the patient wrote on his calendar daily but it abruptly stopped on 15Apr2021. They did not have the official cause of death for the patient, the reporter will have to look at the patient's death certificate. Everything about the patient was healthy and had his blood pressure under control for a while. The patient died on 15Apr2021. An autopsy was not performed. The outcome of the patient was reported as fatal.  Information about Lot/Batch number has been requested.; Reported Cause(s) of Death: not feeling well
lowgrade fever of 99.9; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (lowgrade fever of 99.9) and VACCINATION SITE PAIN (arm was sore) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced PYREXIA (lowgrade fever of 99.9) and VACCINATION SITE PAIN (arm was sore). On 17-Jan-2021, PYREXIA (lowgrade fever of 99.9) and VACCINATION SITE PAIN (arm was sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Tiredness; sore throat and ears such; sore throat and ears such; low grade fever; Nauseous; This is a spontaneous report from a contactable consumer or other non hcp. A non-pregnant female patient of unspecified age received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL8982) via an unspecified route of administration on 23Jan2021 10:00 as DOSE 1, SINGLE, second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL9269) via an unspecified route of administration on 13Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Patient didn't receive other vaccines within 4weeks prior to vaccination. The patient medical and concomitant medications were not reported. Patient had no allergies. on 25Jan2021 02:00 the patient experienced tiredness, sore throat and ears such, low grade fever, nauseous. No therapeutic measures were taken for the events. Patient was not tested to covid to post vaccination. The outcome of the events fatigue, oropharyngeal pain, ear disorder, pyrexia, nausea was recovering.  Follow-up attempts are completed. No further information is expected.
A week after the shot, my upper arm became red, sore, and itchy.  My gland in the left armpit also seems to be swollen.  It has been this way for three days.  Other than a little sore at the site of the injection for a day, my arm was fine until a week following the injection.
PATIENT FELT DIZZY, NAUSEA AND VOMITTED A COUPLE OF TIMES. PT ADVOCATE REPORTED THAT PATIENT FELT NAUSEA PRIOR TO COMING TO THE PHARMACY FOR HER VACCINATION.
flu; Initial information received on 01-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult  patient who had flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer, with (unknown dose, strength, lot number, route, administration site expiry date).  On an unknown date the patient had flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.
PATIENT WAS A TRANSPLANT PATIENT AND SHOULD HAVE RECEIVED AN ADDITIONAL DOSE 0.5ML, INSTEAD IN ERROR RECEIVED A BOOSTER 0.25ML.
February 2021, I had blood drawn and it came back perfect. Then I had my normal physical done on November 11, 2021. My blood work had came back with high liver enzymes. I had got more testing did and it came back with high liver enzymes still. I went to see a gastroenterologists. They said I have high enzymes. I have follow up appointments. I will have a blood panel done sometime at the end of April at or around the 26th. I will have a hepatic functional's panel on May 10, 2022. I will have a fibroscan on May 17, 2022. I have a follow up with the gastroenterologist for those results. For many, many years my blood work has been perfect. Nothing has changed except for taking those vaccines. I don't drink. I had my last alcohol about 10 years ago. I haven't had a cold or sickness since the 6th grade. I never missed a day of work my whole life for being sick, but now all of a sudden I have elevated liver enzymes. December 6, 2021 was the follow up appointment I had with my doctor. January 25, 2022 was the appointment I had with the gastroenterologist. When I had got the results of my blood work, I had changed my diet considerably. I also increased my activity levels as well. My doctor told me to continue what I was doing. They are going to do more testing to see if anything is changing.
No adverse event; 2 adults patients received expired first primary dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 adults patients received expired first primary dose of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 042C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Apr-2023, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 04-Apr-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (2 adults patients received expired first primary dose of Moderna COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 adults patients received expired first primary dose of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (2 adults patients received expired first primary dose of Moderna COVID-19 vaccine).    No concomitant medications was reported. Those were intact cartons and size of the vial was 2.5 ml. The vial was initially stored in refrigerator on 29-mar-2023. The vial did not undergo any temperature excursions. No treatment drug details was reported. This case contains information patient 1 out of 2 adult patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-718682 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718682:(Patient 2 out of 2)
Tingling and rash on both arms started on 11/09/2021 Topical treatment was having limited success. Symptoms subsided about 11/23/2021 but then started again by 11/29/2021 and rash and itching spread up both arms and to neck, chest and ears. Topical cortisone cream started on 11/13/2021. Saw MD on 11/22/2021. Contacted MD again on 12/13/2021 and started on prednisone
Sore arm, it resolve after 2 days  Narrative: sore arm that resolved after 2 days by itself
Kinrix administered to a 12 months old; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-month-old patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-SEP-2022 Reporter's Comments:  The reporter stated that the Kinrix to a 12 months old patient. Reporter asked how to proceed with patient. The reporter mentioned that actually there were 2 patients who received the Kinrix vaccine, since these patients were twins. The reporter did not consent to follow up. Additional Supportive Information: The Kinrix to a 12 months old patient which lead to Inappropriate age at vaccine administration. This case has been linked to the US2022137221 case reported by the same reporter.; Sender's Comments:  US-GSK-US2022137221:Same reporter
Narrative:  PATIENT WAS IMMUNIZED IN A TIMELY MANNER WITH PFIZER MRNA VACCINE ON 1-30 AND 2-20-21 RESPECTIVELY.  PATIENT PRESENTED TO THE ED 11-5-21 WITH SOB AND FATIGUE AFTER TESTING POSITIVE OUTSIDE OF THE FACILITY ON 11-1-21. PT REQUIRED 02 SUPPORT AND RECIEVED REMDESIVIR, DEXAMETHASONE AND BARICITINIB TREATMENT. PT WAS TREATED, IMPROVED AND DISCHARGED WITH OXYGEN