chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3 year old patient inadvertently received the Kinrix; 3 year old patient inadvertently received the Kinrix; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old male patient who received DTPa-IPV (Kinrix) (batch number 7DY4, expiry date 22-AUG-2025) for prophylaxis.   On 28-JUL-2023, the patient received Kinrix (left thigh). On 28-JUL-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 3 year old patient inadvertently received the Kinrix) and inappropriate schedule of vaccine administered (Verbatim: 3 year old patient inadvertently received the Kinrix).  The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were 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: 28-AUG-2023 Medical physician called to inquired that the dose of Dtap and IPV count with the patient and asked how to proceed with series. The reporter declined to follow-up from safety. The case is linked with US2023117322, by same reporter. The patient inadvertently received the Kinrix (this is the patient's 5th dose of Dtap and IPV) due to the patient being mistaken for 4 years of age, which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered.; Sender's Comments:  US-GSK-US2023117322:Same reporter
pt had a positive COVID test on 9/5/21 at Medical Center; transferred to other hospital on 9/6/21 with respiratory acidosis; on BiPAP; given Dexamethasone, not a candidate for Remdesivir;  DNR with limited intervention; Vapotherm/BiPAP supported; transitioned to Comfort Care and passed away in the hospital
On March 2nd I received the first dose of the vaccine.  On March 5th I began to feel poorly and run low grade fever.  On March 6th, I suddenly developed double vision.  The low grade fever and feeling poorly (other than fatigue) subsided around March 7-8; however, the double vision persists.  It is very difficult to focus at times and drive and perform some other activities that require visual focus at medium to far distances.
He has had gout at other times, but he has never had it as hard as this/awaken with pain in the middle of the night; He was awaken with pain in the middle of the night; This is a spontaneous report from a contactable consumer (wife) who reported for her husband (patient) that a 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899) via an unspecified route of administration on 05Jan2021 08:40, at single dose for COVID-19 immunization. Medical history included gout, using timolol maleate to control the pressure in his eye. Concomitant medication included ongoing timolol maleate (5ml eye drops) to control the pressure in his eye. He uses eye drops that are prescribed. He keeps them on the counter to remember to take them. He has been using it for 3 years. Patient previously had the shingles vaccine on 14Dec2020 for immunization at the age of 65 years old. It said as long as the vaccine was given two weeks prior. The patient received COVID vaccine at outdoor park on 05Jan2021. The wife reported that the next day after the first dose of the vaccine (06Jan2021), her husband developed gout. He got it at the same time she did. He has had gout at other times, but he has never had it as hard as this. He awaked with pain in the middle of the night, it started from 06Jan2021 and is ongoing, slight improvement. She was not sure if that was reportable. Patient did not visit emergency room or physician office for any adverse events. Outcome of the events was recovering.
Within 5 minutes of recieving the vaccine, patient broke out in severe hives on his scalp, face, neck and arms and seemed to be progressing toward difficulty swallowing.  His face became beet red.  Doctor administered Benadryl immediately and withing 15 minutes, the reaction subsided.
NO ADVERSE EVENT OCCURRED.  I was advised by the reporting system to report this due to the following. Pt received 1st dose of Moderna on  3/4/21.  About 1 week later his wife developed Covid so he was advised to get antibody testing which indicated positive for antibodies. He did NOT have an adverse effect to Moderna either. Family member advised pt to not get second dose of Moderna (due to positive antibody test) and to wait about 90 days and get the Janssen vaccine instead. Pt did NOT disclose to me upon administration of Janssen vaccine that he had recieved a first dose of Moderna about 3 months prior. Realized this when entering in the reporting system. Follow up call to pt on 6/8/21-no adverse events or problems.
Slight itching. Light redness. Little warm. No pain. Started at about 9am. Not growing/developing in reaction.
1982 I was given vaccines for Typhoid and Cholera. I was allergic to them. In less than 24 hrs I had difficulty moving and was taken to ER at hospital. I was given a shot of ?. I had arthritic symptoms for one year. In 1988 I had developed RH Arthritis and later Lupus.1/12/09-records received for DOS 2/26/08-diagnosed with RA many years ago, treated with alternative medicine. Diagnoses with SLE and Class IV. Lymphadenopathy. This treating physician did not provide vaccines to patient.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided. On 10-APR-2018, the patient was vaccinated with one dose of expired VAQTA intramuscularly, lot number N01234, expiration date 05-APR-2018 (exact dose was not reported). No adverse effects were reported.
I, MA, accidentally administered Varicella to the patient but intended to administer Zoster. I did not witness any adverse reaction to the vaccine however.
The evening of the vaccine I had severe chills, headache and I threw up. The next day the chills were gone but I still had a headache which I had to take off work, it lasted a week. One week after the shot I experienced shortness of breath and my Reynaud?s symptoms were bad. My fingers and toes were blue. I had leg pain and I was concerned for a blood clot. I returned to the ER a week later because I had shortness of breath and chest pressure. I continued to have sharp chest pain for four weeks. I also saw a Pulmonary specialist six weeks after the vaccine and tests were normal. I am scheduled to see a Rheumatologist.
Patient received the immunization and roughly 5 minutes later he passed out.  Patient hit his nose on our bench and had to go to the hospital to get stitches.  Patient didn't have a concussion. Patient went to urgent care and was taken care of and released the same day.
In so much pain at the base of the neck; she has enlarged lymph nodes on the side of the injection; Pain in legs; swollen legs; Tired; Swollen lymph node/she has enlarged lymph nodes on the side of the injection, and is now having them on the other side. Consumer stated her health care providers have stated it is due to the vaccine; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Pain in legs), PERIPHERAL SWELLING (swollen legs), NECK PAIN (In so much pain at the base of the neck), FATIGUE (Tired) and LYMPHADENOPATHY (Swollen lymph node/she has enlarged lymph nodes on the side of the injection, and is now having them on the other side. Consumer stated her health care providers have stated it is due to the vaccine) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in legs), PERIPHERAL SWELLING (swollen legs), FATIGUE (Tired), LYMPHADENOPATHY (Swollen lymph node/she has enlarged lymph nodes on the side of the injection, and is now having them on the other side. Consumer stated her health care providers have stated it is due to the vaccine) and CHILLS (Chills). On an unknown date, the patient experienced NECK PAIN (In so much pain at the base of the neck) and VACCINATION SITE LYMPHADENOPATHY (she has enlarged lymph nodes on the side of the injection). At the time of the report, PAIN IN EXTREMITY (Pain in legs), PERIPHERAL SWELLING (swollen legs), NECK PAIN (In so much pain at the base of the neck), FATIGUE (Tired), LYMPHADENOPATHY (Swollen lymph node/she has enlarged lymph nodes on the side of the injection, and is now having them on the other side. Consumer stated her health care providers have stated it is due to the vaccine), CHILLS (Chills) and VACCINATION SITE LYMPHADENOPATHY (she has enlarged lymph nodes on the side of the injection) outcome was unknown.            Unspecified cancer medication was used by the patient as concomitant mediction. Patient was asked to take unspecified pain medication  as treatment drug. Health care provider stated that the side effects were due to the vaccine and was asked to take ultrasound and blood tests.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Significant Follow-up
Patient received Moderna vaccine on 5/20/2021 and his first vaccine was Pfizer. He should've received the Pfizer vaccine and not Moderna. No adverse effects, signs, or symptoms occurred.
Entire face numb within one hour of receiving second vaccine.  I could feel pressure on my face but no heat or cold.  I try putting a frozen entee and couldn't feel my face.  This included my lips.  By the next morning feeling has returned from my nose down. The next day I could feel from my top lid down.  It took a total of 4 days for the feeling to return to my whole face. I also have serve headaches and belly aches (flu like) the next day until 1;00 p.m.  After that I had belly aches off and on for 2 weeks. Head aches were gone after the day after the vaccine.
Swelling and redness all around site of injection about 4" X 9" in size. Puffy gradually reduced in size, but lasted approximately 9 days altogether. (Still reddish)
Time of shots none noted. 9-10-07 to MD - diagnosis of shingles. Rash started 9-6-07.
Immediately after shot dizzy, rapid heartbeat, chest pressure, shortness of breath, followed by panic attack due to physical symptoms. Up until present: brain fog/unable to concentrate or focus, insomnia, occasional rapid pulse, shortness of breath, off and on dizziness, spatial awareness completely off,  short term memory problems, freezing cold feet, strange menstrual period?.
Pt reported sore spot and and rash on left arm and received rx prednisone and Famvir on 9/18. Rash spread to right inner arm and back. Pt also started Toprol xl 25mg on 8/11 2015. Dermatoligist felt rash was not shingles. Toprol stopped and rash subsided as of last report.
Site: Swelling at Injection Site-Medium, Additional Details: The shot may have been given too high on the arm.
Sharp chest pain, shortness of breath, Extreme fatigue, pain with deep breath, lasted about five days. Took about 10 to 12 days to feel fully recovered
Pt recv vax on 10/16/98; 7 min post vax pt exp shakiness, nausea, hyperventilating, red face, anxiety
Patients arm has a large, red, itchy rash below where vaccine was administered. Warm to touch and showed up day after vaccine administered.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 9:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 9:00 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 26.32 No concomitant medications were reported. On 03-Apr-2021 at 09:00 A.M., the temperature recorded was 34 degree Fahrenheit and vial was initially moved to the fridge on 30-Mar-2021 and beyond use date was 29-Apr-2021. Product moved to clinic on 03-Apr-2021.  Vial was stored on cooler 1, on 03-Apr-2021, Excursion duration At 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM : 41, 3 PM: 40, 4 PM: 40 and 5 PM : 41.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. No treatment medications were reported.
On 11/27/2021 I ended up in the ER with a lot of kidney pain, I was diagnosis with diabetes, and when I wen to see my primary she ran a test and my diabetes came back as type one , official date of diagnosis was December 2nd or 3rd. I had blurry vision, extreme fatigue, headache, extreme thirst, frequent urination.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 76-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Nov2022 as dose 5 (booster), single (Lot number: GLO446 5450), in left arm for covid-19 immunisation; BNT162b2 (COMIRNATY), on 15Mar2021 as dose 1, single (Lot number: EP6455), in left arm, on 05Apr2021 as dose 2, single (Lot number: ER8732), in left arm, on 27Oct2021 as dose 3 (booster), single (Lot number: FF2593), in left arm and on 11Jul2022 as dose 4 (booster), single (Lot number: FP7150), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on the available information, a possible causal relationship cannot be excluded between the suspect vaccines (bnt162b2 and bnt162b2, bnt162b2 omi ba.4-5) and both events Vaccination failure and COVID-19.
ICK FEELING; ARM SORENESS; TIREDNESS; This spontaneous report received from a patient via a company representative 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported. On an unspecified date, the subject experienced ick feeling, arm soreness, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm soreness, tiredness and ick feeling was not reported. This report was non-serious.
cold symptoms, achy bones, joint/muscles pain, cough, lasted 6+7 days
No adverse effects reported; patient inadvertently received a second dose of VARIVAX at 15 months; This spontaneous report was received from a registered nurse referring to a 15 month old patient of an unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions and allergies.  In approximately July 2019, at 12 month old, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (dose, route of administration, anatomical injection site, lot number and expiration date were not reported). On 10-OCT-2019, at 15 months, the patient inadvertently received a second dose  of varicella virus vaccine live (oka/merck) (VARIVAX) with lot # S006021 and expiration date on 27-FEB-2021, for prophylaxis (dose, route of administration and anatomical injection site were not reported) (wrong product administered). The vaccines were reconstituted with a sterile diluent(STERILE DILUENT). No adverse effects reported.
a little skin crawling; sore arm; fatigue; menstrual cycle changes- 8 days late and only 3 days of flow (cycle is typically very regular at 24 days and 5 days of flow; This is a spontaneous report received from a non-contactable reporter (Consumer). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 10Apr2021 09:45 (Lot number: Ew0153) at the age of 37 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Chronic migraines" (unspecified if ongoing); "post-herpetic neuralgia" (unspecified if ongoing); "allergies" (unspecified if ongoing); "iga deficiency" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "known allergies: Pineapple" (unspecified if ongoing), notes: known allergies: Pineapple. Concomitant medication(s) included: ALLEGRA 24 HOUR; FLONASE [FLUTICASONE PROPIONATE]; ALBUTEROL [SALBUTAMOL]; CONCERTA. Vaccination history included: Bnt162b2 (Dose 1, Single, Lot number: EP7534, Administration time: 09:45 AM, Vaccine Location: Left arm), administration date: 20Mar2021, when the patient was 37 years old, for COVID-19 immunisation, reaction(s): "Crawling skin and scalp", "headache", "fatigue", "sore arm", "general malaise". The following information was reported: FORMICATION (non-serious), outcome "unknown", described as "a little skin crawling"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; MENSTRUATION IRREGULAR (non-serious), outcome "unknown", described as "menstrual cycle changes- 8 days late and only 3 days of flow (cycle is typically very regular at 24 days and 5 days of flow". Therapeutic measures were not taken as a result of formication, pain in extremity, fatigue, menstruation irregular. Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID Vaccine. It is unknown if the patient has been diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021446464 same patient, different drug dose/event
little soreness in her arm at the injection site (as for the first dose); This is a spontaneous report from a contactable consumer (patient).A 78-year-old female patient received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On unknown date, the patient experienced a little soreness in her arm at the injection site. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Patient called our office to report the following information (per encounter note to Triage):  PATIENT HAS CALLED TO INFORM US OF AN ALLERGIC REACTION TO HER COVID SHOT. PATIENT STATES THAT SHE WAS RUSHED TO ER AFTER BREAKING OUT IN HIVES, SHORTNESS OF BREATH, LIP AND THROAT SWELLING. PATIENT ALSO STATES THAT SHE TESTED POSITIVE FOR STREP AS WELL. ER PHYSICIAN TOLD HER IT WAS DUE TO HER VACCINE AND NOT TO RECEIVE ANY MORE DOSES.
Narrative: COVID infection following COVID vaccine series 02/03, Pfizer, dose #1 02/24, Pfizer, dose #2 08/30 COVID swab, result: detected 08/27 pt cc: cough, diarrhea, fatigue, headache, myalgias, rhinorrhea, sore throat exposure; unknown 08/30 SARS-COV-2 Variant Sequencing result: pending
sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2020, the patient received the 1st dose of Shingrix. In March 2020, 12 hrs after receiving Shingrix, the patient experienced pain in arm. On an unknown date, 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 case details were reported as follows: The patient had his 1st dose either the 10th or the 15th of March 2020 in his left arm. The patient experienced a sore arm for a couple of days. No other symptoms were reported. The reporter consent to follow up. For tolerance after 2nd dose of Shingrix, refer case US2020139466.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020139466:2nd dose
Pt received Engerix-B 10 days later experienced severe hoarseness, transient tingling of arms & legs.  No treatment was given for the events.
Patient came in to clinic and received a COVID19 (Pfizer-BioNTech) vaccination on 06/23/22, she then came in for a second office visit on 06/24/22 and received another COVID19 (Pfizer-BioNTech) vaccination. Patient was not due for another Pfizer Covid 19 vaccine until 07/24/22