chrisvoncsefalvay/vaers-outcomes huggingface dataset:
individual less than 18 YO receives 0.25mL of Moderna as first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (individual less than 18 YO receives 0.25mL of Moderna as first dose) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (individual less than 18 YO receives 0.25mL of Moderna as first dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (individual less than 18 YO receives 0.25mL of Moderna as first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
06/01/2021 PATIENT EXPERIENCED LEG PAIN AND SWELLING, ON 06/05/2021 PATEINT WENT TO THE ER WITH SEVERE LEG PAIN AND WAS ADMITTED TO THE HOSPITAL WITH A DVT.  ON 06/07/2021 PATIENT WAS RELEASED FROM THE HOSPITAL AFTER A VASCULAR DOCTOR REMOVED A SUBSTANTIAL CLOT. PATIENT IS CURRENTLY TAKING XARELTO.
Pt came to ER c/o: fatigue, nausea, decreased appetite, generalized weakness, loss of appetite, body aches, occipital headaches, dry cough with occasional sputum for 1 week prior. Some non bloody vomiting as well.
Swelling and redness area of injection 4" wide by 3" long area (R) deltoid.
ears plugged with fluid (cannot hear well); ears plugged with fluid (cannot hear well); ears plugged with fluid (cannot hear well); loss of balance; unstable walking around; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received the first dose of BNT162B2 (BNT162B2, lot number: EN6201), via an unspecified route of administration, on 05Feb2021 03:00 PM at a single dose on the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to receiving bnt162b2. Prior to vaccination, the patient was not diagnosed with COVID-19. Medical history included diabetes, high blood pressure, pancreatic cancer in 2012 and fully recovered no treatment since 2013 and NED all scans have been clear. Concomitant medications included ondansetron (ZOFRAN), prochlorperazine (COMPAZINE SPANSULE), and oxycodone (OXYCODONE). The patient previously took Zocyn and experienced migraines (Allergies to medications, food, or other products: The antibiotic Zocyn causes migraines). On 06Feb2021 at 12:45 AM, the patient woke up in the middle of the night with ears plugged with fluid (cannot hear well) and had a loss of balance. He was unstable walking around. Since the vaccination, the patient has not been tested for COVID-19. It was unknown if patient received treatment for the reported adverse events. Outcome of the events was not recovered. The patient assessed the events as non-serious.   No follow up attempts are possible. No further information is expected.
This spontaneous report as received from a physician refers to unspecified number of patients of unknown age and gender. Patients' medical history, concurrent conditions and concomitant therapy were not reported. On an unknown dates, unspecified number of patients were vaccinated with a dose of improperly stored GARDASIL (lot number, Expiry date, dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
About 5 minutes after the patient received their injection, they fainted. After about 10 minutes, they fainted again. EMS was called on the scene for evaluation, pt was escorted to the ambulance. Prior to leaving the patient mentioned he was fasting and had not had anything to eat or drink. Patient denied the use of any medications, any health conditions, and past adverse reactions to vaccines. SCRT report was filed with Walmart concerning the . incident. Patient denied any injuries, only dizziness was reported post-event. BP was checked prior to him being take for evaluation in an ambulance.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On 12-APR-2016, the patient was vaccinated with an improperly stored dose of RECOMVIBAX HB injection (lot # K026666 with expiry date: 22-OCT-2016; strength, dose, route and site of administration were unspecified). The administered vaccine underwent the temperature excursion at 53 degree Fahrenheit during 12 hours and 15 minutes. It was not the case of a "data logger". No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
On 11/23/2022 the patient was given Pfizer Monovalent Vaccine when they should have received Pfizer Bivalent Vaccine. Patient reported no adverse effects.
He started feeling nauseated right after the injection but could eat with no problem. Within 1 hour, he started feeling cold with chills and then the mild fever over 100 degrees followed by vomit and eyes swollen. Fever went away the next morning. He had stomachaches and couldn't eat for 24 hours. And as soon as he took Benadryl the next day, he got better within 30 minutes, while his eyes are still swollen.
My left arm after the 2nd shot had gotten 100% worse. I had gotten my booster in the right side because my left arm had not resolved. I ended up having to go back to the orthopedic clinic on March 30, 2022. On April 5, 2022 was when I received steroid shots in both shoulders, but they never worked. I was in horrible shape at this point. The left arm had gotten worse so for physical therapy, we concentrated a lot on the left arm. I was in more pain in the right shoulder, but I could barely move the left arm as well. I had the evaluation on April 7, 2022. I went for 8 weeks to PT after that twice weekly again. The doctor did not x-ray me for the right shoulder because I wasn't sure if I had another frozen shoulder. I was unsure at the time if I overworked the right shoulder or if it was a different issue. So I did 8 weeks of physical therapy. I went from April 4, 2022 and straight through until 06/01/2022 which was the last day of my physical therapy. I continued for another month and a half doing my shoulder exercises at home because I was determined to get my shoulders better. My right shoulder got worse, and I went back to the orthopedic clinic on September 20, 2022. I got an x-ray for my right shoulder and I received another steroid shot for my right shoulder. I went back for more physical therapy 09/22/22 - 10/19/2022. My left shoulder feels healed now, but now I'm working on the right shoulder because it just feels terrible. I was determined to get my left shoulder better because at the time I had right side mobility, but then my right shoulder had gotten worse. I'm doing my exercises to continue getting better. I'm much improved.
she continues to have high levels after the booster dose.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ARMOUR THYROID; PLAQUENIL [HYDROXYCHLOROQUINE PHOSPHATE]. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 08Mar2021, when the patient was 53-year-old, for Covid-19 Immunization, reaction(s): "showing 1.06 high creatinine levels"; BNT162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right), administration date: 09Apr2021, when the patient was 53-year-old, for Covid-19 Immunization, reaction(s): "on 28Apr2021 1.06, on 05May2021 1.03, on 19May2021 1.16 High, on 05Aug2021 1.10 High, on 16Aug2021 1.13 High, on 08Sep2021 1.29 High". The following information was reported: BLOOD CREATININE INCREASED (non-serious), outcome "not recovered", described as "she continues to have high levels after the booster dose.". The event "she continues to have high levels after the booster dose." required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of blood creatinine increased.  Additional information: Elevated levels of Creatinine following dosing. I reported this previously, but she continues to have High levels after the booster dose. Hoping to find out if this is related to vaccination prior to receiving additional booster doses. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient was not tested for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Case number PHEH2013US021607 is an initial spontaneous report received from a nurse on 15 OCT 2013 with a follow up information received from a nurse on 15 OCT 2013. This report refers to an 18-year-old male patient. He was vaccinated intramuscularly with MenA lyophilized powder of MENVEO (batch number: A12100, expiry date: SEP 2014) reconstituted with sterile water instead of MenCYW-135 liquid conjugate on 14 OCT 2013. No adverse event was reported following the maladministration. Follow up information received from a nurse on 15 OCT 2013. Expiry date of vaccine and DOB and age updated. The event inappropriate age at vaccine administration was deleted.
pt only 10 was given trumenba instead of menactra in error  pt had no reaction  ? do we need to call back and give menactra  anything we need to call the parent about regaring the trumenba
Arm pain from shot. Fever, chills muscle aches, exhausted and headache.
Initial and follow up information has been received for the Pregnancy Registry for GARDASIL from a health professional concerning a 25 year old female patient with allergic reaction to codeine, allergic reaction to antibiotics, genital herpes (onset 2006) and a history of d pelvic inflammatory disease (2005) who on 18-MAY-2007 was vaccinated IM with a first dose of GARDASIL (lot #657621/0387U). Concomitant therapy included VALTREX. The reporter mentioned that they found out that patient was pregnant one day before her second injection was due (LMP= 14-JUN-2007). The second dose of GARDASIL was not administered. Patient had cervical smear test and enzyme immunoassay HIV antibody screen laboratory tests were done. On 11-OCT-2007 the patient had a normal serum alpha fetal protein and on 26-NOV-2007 the patient had a normal ultrasound. On 09-APR-2008 (41 weeks from LMP) the patient delivered a normal male infant (weight 9 pounds, 0 ounces). Apgar score were 8 and 9. There were no congenital anomalies, complications or abnormalities. Follow-up information was received via medical records. The baby developed jaundice on 14-APR-2008. On 23-APR-2008 bilirubin test was performed the result was 14.7. On 02-MAY-2008 the baby's skin looked good. On 27-MAY-20087 the baby vomited twice. There was no fever, cough etc. The patient subsequently recovered from the jaundice and vomiting. No further information is expected.
headache; hard to sleep; This is a spontaneous report from a contactable consumer (patient herself). A 78-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9262), via an unspecified route of administration in left arm on 26Jan2021 (at the age of 78-years-old) as single dose for covid-19 immunisation. On an unspecified date, the patient started receiving lisinopril (LISINOPRIL) Dosage text: 20mg, 1 tablet, oral for blood pressure measurement, cardiac disorder and was Ongoing. No lot number was provided for Lisinopril due to Product dispensed in pharmacy vial. The patient was taken Covid vaccine due to her age and heart issues. Relevant medical history and concurrent conditions included pacemaker inserted on Oct2011 and ongoing, had it replaced Jan2020. No further details provided. Pertinent Details include surgical procedures and dates were Pacemaker inserted Oct2011 and Jan2020. No other AE following prior vaccinations. No family Medical history relevant to AEs. Relevant Tests were none. History of all previous immunization with the Pfizer vaccine considered as suspect was None. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No other Prior Vaccinations were taken within 4 weeks prior to the first administration date of the suspect vaccine. No Other Products were reported. No Investigation Assessment. On an unspecified date in Jan2021, the patient experienced headache and felt hard to sleep. It was reported that patient getting a bit of a headache almost every day for almost 2 weeks. Patient reported about 2 weeks ago she got the first dose of the Pfizer Covid vaccine. She wants to know if this was expected and if it will be worse on the second dose. She had a question about the side effects. It's not serious, but she just had like a headache every day and wondered how long side effects supposing to last. Patient got the vaccine on Tuesday, 26Jan2021 and the headaches started like the next day. It was still there sometimes worse than others and at night it had bothered her more. She doesn't have them nightly and it's hard to sleep. No further details provided. Patient Mentioned she did see the cardiologist and her medication Lisinopril was increased to 20mg once daily. Does not know if that had anything to do with the headaches. Patient clarified the headaches were before she had the medication increase. Not visited Emergency Room due to events. Event headache caused Physician Office to visit. Outcome of the events was not recovered.  Follow-up (08Feb2021): This is a follow-up Spontaneous report from a contactable consumer. New information included patient details, RMH, Outcome of the events.  Description of Product Complaint: Did see the cardiologist and her medication, Lisinopril was increased to 20mg once daily. Clarifies the headaches were before she had the medication increase. Unable to provide NDC, Lot or expiry from pharmacy bottles. Product strength and count size dispensed: 20mg  Follow-up attempts are completed. No further information is expected.
Fever reaching 102.8. Severe headache. Stomach ache. All over muscle and body aches. Tiredness. Chills. Sore joints. Pain at injection site. Fever lasted two days.
Patient received pneumonia vaccine. Local reaction, redness and swelling in a semi circular shape, anterior of arm toward armpit.
Patient developed rash about 2 months ago, that began with red bumps, that look like raised dots or zits, with no pus on top of head that has developed behind ear and neck, forehead and has spread to areas on back and legs also. Patient said the only newer things  prior to the rash developing were: he used a new lotion, he received his second covid vaccine by Moderna 6 months ago; he began Imbruvica about 5 to 6 months ago .
Patient post Johnson and Johnson vaccination and in observation period when EMS and Nursing staff noticed patient to be unresponsive with 10-20 seconds of mild jerking movements. Patient able to regain consciousness and state that he has a history  of seizures Blood pressure124/80, blood glucose 63. Patient transported by EMS to hospital.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Hypertension-Medium, Systemic: Hyperventilation-Medium, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Shakiness-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Medium, Additional Details: Patient was given the vaccination and she moved from the immunizing chair to the waiting area. While in the waiting area, the patient passed out briefly (less than 15 seconds), revived and was complaining of blurred vision and that her brain felt "funky." She then broke out in full body hives and was administered 2x25mg benadryl tablets orally. 911 was called. Patient then began complaining that her face and body felt numb and tingly all over. Paramedics arrived and took patient to the hospital.
Information has been received from a physician concerning a 17 year old female who was vaccinated with the third dose of GARDASIL vaccine (yeast) (lot#, therapy route and dose not reported). On the same day of vaccination of the third dose, the patient had arm pain and achiness down the length of the arm from the shoulder down to the hand. Which arm unspecified. The patient's arm hurt a couple of days after vaccination then it went away and then came back. The patient did not have any problems with the first and second doses of GARDASIL vaccine (yeast). The patient came into office to seek medical attention. The patient was prescribed unspecified medications for the achiness. As of 15-JUL-2008, the arm pain persisted. Additional information has been requested.
COVID but I had a very mild case because of the fact that I had been inoculated; COVID but I had a very mild case because of the fact that I had been inoculated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received bnt162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "bottom teeth are temporary" (unspecified if ongoing), notes: waiting for recombinant replacement. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID but I had a very mild case because of the fact that I had been inoculated". Clinical course: Consumer stated, "He was just calling to report a side effect because he had never had one and up and till now, he had 4 shots for COVID (suspect captured as Pfizer Covid Shot), the two initials and then two boosters last year". Since, he had, his wife was living in a rehab hospital and nurse that gave her and him COVID but he had a very mild case because of the fact that he had been inoculated and unfortunately his wife passed away on the Mar of this year. He took it because he saw the add suggesting that they got a new one for this year. The last one he got was in 2022.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300321269 same patient/vaccine, different dose number/event;US-PFIZER INC-202300321110 same patient/vaccine, different dose number/event;
Information has been received from a consumer concerning her friend a 68 year old female with a history of shingles who in approximately March 2010 or April 2010, was vaccinated with a single dose of ZOSTAVAX (Merck) (no lot number provided). Reporter stated that her friend had a prior case of shingles and after receiving ZOSTAVAX (Merck) experienced a mini stroke on 02-APR-2010. The patient was hospitalized and had to have a surgery. Around May 2010, the patient recovered from mini stroke. The reporter considered the mini stroke to be an other important medical event. Additional information is not expected.
Information has been received from a physician for the pregnancy registry for Gardasil concerning a female who was vaccinated with an unknown number of 0.5 mL doses of Gardasil. "A few weeks ago," the patient developed a miscarriage in the first trimester. The patient's outcome was unknown. Upon internal review, the patient's spontaneous abortion was considered to be an other important medical event. Additional information has been requested.
Dad took infant via EMS to ER at 03:00 on 5/12/01 with vomiting, dry heaves, fever of 101.4F, fussy, pale and apparent difficulty breathing. When EMS arrived, infant had short, shallow breathing per dad. Had shots on 5/11/01. Information taken over the phone.
Initial report received from a consumer on 18 September 2013. A male patient (age at the time of event was not reported), with a history of sulfa drug allergy, had received a dose of Flu vaccine (manufacturer unknown, batch number, dose in series, route and site of administration was unknown) on an unspecified date. On an unspecified date, after vaccination the patient had injection site reaction and tiredness for a few days. medical history included sulfa allergy, laboratory test and corrective treatments were not reported. At age 75-year-old patient received intramuscular dose of FLUZONE HD vaccine (batch number: U4713AA, expiry date: unknown and site of administration was left deltoid) on 11 September 2013. It was reported that on 11 Sep 2013, the patient had no reaction and was worried that he did not really received the vaccine. The events were recovered at the time of report. List of documents held by sender: None Follow up information received from consumer on 25 November 2013. Updates made to product details, suspect drug and event outcome changed. Follow-up information received from non-healthcare professional on 31 March 2014. The patient received FLUZONE HD in left deltoid and had no reaction (Previously captured as suspect). The patient did not experience any adverse event within 4 weeks prior to vaccination.
tested positive for Covid afterward; tested positive for Covid afterward; This is a spontaneous report from a contactable healthcare professional. This healthcare professional reported same events for two patients. This is the first of two reports. A 67-year-old male patient received his first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date), at unknown vaccination age via an unspecified route of administration on Feb2021 as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The healthcare professional from a Pediatrician's office reported in behalf of patient's parents, she believes them to be 67 years old. The reporter mentioned that they received first dose of Pfizer vaccine at the end of Feb2021 and then tested positive for Covid afterward (2021). They are due to receive second dose of vaccine this next Tuesday (Mar2021). The reported inquired on the guidelines to receiving the second dose if testing positive for Covid between the first and second dose. The outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. The case will be reevaluated should additional information become available.,Linked Report(s) : PFIZER -2021328881 same reporter/drug/events, different patient