chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse concerning a female grandmother of a child who received the second dose of VARIVAX (Merck) (Lot # 654756/13335F) on 18-JUN-2008. Grandmother spent 10 days with the child and 3 days later went to the emergency room for the rash. The child did not have a rash. The emergency room physician thought that the grandmother contracted the chickenpox naturally. VZV analysis offered but the nurse declined since she did not think that it was related to VARIVAX (Merck). No further information is available.
4 patients were administered doses of a vial 4 days after the 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 patients were administered doses of a vial 4 days after the 30-day Use By Date) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011f21a) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 patients were administered doses of a vial 4 days after the 30-day Use By Date). On 14-Dec-2021, EXPIRED PRODUCT ADMINISTERED (4 patients were administered doses of a vial 4 days after the 30-day Use By Date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Date when the vial was initially stored in the refrigerator: 10 Nov 2021.  No treatment information was reported.   This case was linked to MOD-2021-413275, MOD-2021-413238, MOD-2021-413267 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Dec-2021: Significant Follow-up : Reporter address updated, patient Information added and batch/Lot information added. On 14-Dec-2021: Follow-up contains no new information.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 27Apr2021 (Lot number: EW0176) at the age of 37 years 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: HEADACHE (non-serious), outcome "not recovered", described as "Headache".  Additional information: Patients Headache was Ongoing. The reporter reports on herself then handed the phone to her husband who then provided the details for his experience in this report. The patient said he does not had a primary care provider right now. The patient said the headache started the day he had the shot and then afterwards it was on and off. He says it started within 3 or 4 hours after the first dose. Patient received Second dose on 18May2021, Lot number EW0176, right arm, NDC number unknown, expiration date unknown. Vaccine did Administered at a Facility. Patient received First and second doses Pfizer vaccine received. Time of Onset was (24-hour clock) within 3 or 4 hours after the first dose. Event did not result into Emergency room and Physician office visit. patient was not hospitalized. Prior Vaccinations, patient did not received any other medication within 4 weeks. patient did not experience any prior vaccinations. The patient denies being sick a the time of either dose. Patient did not have any Allergies and did not undergo any Surgery. Patient did not have any family medical history relevant. The patient asked what is next in this process, what's the next action. He asks if the headaches become worse should he be going to regular doctor any other place and He asks what Pfizer recommends.  Follow-up attempts are completed. No further information is expected. .
Bilateral Tinnitus; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 17May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  MANUFACTURER UNKNOWN.), for Covid-19 immunisation; Covid-19 vaccine (Dose 3 (booster); MANUFACTURER UNKNOWN.), for Covid-19 immunisation. The following information was reported: TINNITUS (non-serious) with onset 24May2022, outcome "unknown", described as "Bilateral Tinnitus".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No adverse effects; Expired vaccine used; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication.  On 13-JUN-2019 the patient was vaccinated with a properly stored, expired dose of hepatitis a vaccine, inactivated (VAQTA) lot number R006342 and expiration date of 21-APR-2019, at a dose of 1 ml./once, intramuscularly for prophylaxis (anatomical location was not reported). No adverse effects were reported.
My arthritis in my left knee has flared up considerably and my right knee is nearly non functional now, and I haven't had arthritic issues in my right knee until I received the vaccine. It's very hard to move, stand, balance,  walk, stay awake, focus..remember..
This is a spontaneous case, initially received on 30-Jan-2018, was reported by other non-health professional and concerns a 03-year-old female child. The patient had no medical history or concomitant medications. On 30-Jan-2018, the patient was administered FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid batch number: 195240A, expiry date: 30-Jun-2018). It was reported that, the patient had no adverse event following the vaccination. The reporter assessed the case as non-serious.
Information has been received from a health professional concerning an 82 year old white male who on 04/09/2003 was vaccinated with a 0.5ml dose of pneumococcal vaccine 23 polyvalent (Lot # 644218/1027M).  On approximately 04/09/2003 the patient developed a fever, swelling, a sore area hot to the touch that was hard with bruising and a big lump.  On approximately 04/11/2003, "a couple days later", the patient recovered after being treated with unspecified antibiotics.  It was also noted that a 60 year old female patient was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot # 644218/1027M) and developed the same symptoms (WAES # 0304USA01253).  No further information is expected.
swelling began 3hr p/vax & by evening shoulder to fingers were swollen;circumference 2X nl size;blotchy rash on arm & chest;given DPH x 1;rash disappeared by next AM looked better;
Feet and hands were cold; Tested positive for COVID; A spontaneous report was received from a consumer concerning a female patient of unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and tested positive for COVID (COVID-19) and feet and hands were cold (peripheral coldness).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unspecified date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: unknown) for prophylaxis of COVID-19 infection.  On an unspecified date, after the vaccination, the patient was tested positive for COVID and feet and hands were cold. No treatment information was provided.  Laboratory information included SARS-CoV-2 test (positive).  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, tested positive for COVID and feet and hands were cold, were considered as unknown.
Patient had multiple seizures that were treated with 5 mg Versed intranasally and 5 mg IVP. Seizures broke and weas transferred to Hospital
1mL instead of 0.5mL; 18 years patient was given 1mL; This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 18-year-old female patient who received HBV (Engerix B) for prophylaxis.   On 12th July 2022, the patient received the 1st dose of Engerix B (intramuscular) 1 ml. On 12th July 2022, unknown after receiving Engerix B, the patient experienced overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the overdose and inappropriate age at vaccine administration were unknown.   Additional Information: GSK receipt date: 15-Aug-2022 Reporter's comments: The pharmacist reported that another pharmacy in her chain gave an overdose (1mL instead of 0.5mL) of  Engerix-B vaccine. The pharmacist reported that 18 years old patient received dose of Engerix-B vaccine on an unknown arm. Transferred to medical information for further assistance. The reporter consented to follow-up. Additional Supportive Information: The Engerix-B was administered 1ml instead of 0.5 ml to 18 years patient, which led overdose and Inappropriate age at vaccine administration.
Pruritic rash on arms. Rash not on trunk. Rash developed within 2 hours of receiving vaccines. Pt given 7.5 ml of of diphenhydramine in office.
Burning under skin at injection site Wednesday evening followed next day by large red patch. Arm warm to the touch. Still experiencing some burning under the skin. This side effect was not experienced with previous COVID-19 vaccines/boosters or flu vaccines.
This case was reported by a nurse and described the occurrence of injection site cellulitis in a 5 year old male who received Infanrix for prophylaxis. On an unspecified date in July 2003, the pt received the fifth injection of Infanrix (583A2) packaged in a prefilled syringe. The injection was made IM into the right deltoid. The pt also received an injection of MMR II into the right deltoid. On 7/30/03, "within a couple of days" post-immunization, the pt developed redness at the injection site. The pt was seen by the physician, who noted 3-ich by 4-inch area of erythema on the right deltoid. The physician made a diagnosis of injection site cellultiis and prescribed a 10-day course of Omnicef. The event resolved on 8/10/03. The nurse considered the event to be serious (OMIC) because it jeopardized the pt or required intervention. The nurse considered the event was possibly related to vaccination with Infanrix.
Pt developed severe headache, myalgias and fever 102. He had chills, nausea as well as pain and swelling at the site. On exam 26x16cm area of erythema, warmth and swelling. HA and fatigue persisted. Pt treated with antihistamine and prednisone. Symptoms recovered by 1 month.
She has a diagnosis of CLL; This is a spontaneous report from a Pfizer sponsored program, from a contactable female consumer (patient). A female patient of unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route on an unknown date, as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route on an unknown date, as a single dose for covid-19 immunization. On an unknown date, after taking both doses of the Pfizer covid-19 Vaccine, patient was diagnosed with CLL. She mentioned that she was not immune. The patient underwent lab test and procedure which included antibody test and it came back negative because of her Lymphoma & T-Cells and doctor recommends getting third shot of the covid vaccine and wanted to know if Pfizer can approve for her to receive a third Pfizer Covid 19 Vaccine. The clinical outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
3 + inch in diameter swelling and redness in left deltoid.  Onset 24 hours after injection.  Numbness, cramping of left hand that lasted 3-4 days.  Site is still sensitive today.
I do not know if anything I am saying was a cause of the two shot I received, but in trying to look up information I figured I would report the result I had, since I feel like it could be a relatively new idea to receive these two shot simultaneously.  I received the Moderna Covid-19 vaccine and the Seasonal Flu shot at the same time. First the Moderna then the Flu. Left arm first then right arm. The lady at the pharmacy said that was normal and safe, and I?m sure she is most likely correct.   However, I felt terrible the next day, which I know is expect but I felt very feverish all day and when I finally decided to take me temperature, it had reached 103.3.  I took Tylenol and the fever reduced to around 100.1 in about 20 - 30 minutes.   I have already had Covid-19 (January 2021).  I just didn?t know if this was a result of taking both of these vaccination at the same time.   I did feel a lot better the next day however.
Bivalent vaccine was administered the vaccine was beyond the BUD; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine was administered the vaccine was beyond the BUD) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 062F22A) for COVID-19 prophylaxis.   No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine was administered the vaccine was beyond the BUD) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine was administered the vaccine was beyond the BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine was administered the vaccine was beyond the BUD).    No concomitant medications were reported.  No treatment information was provided.
fussy, elevated temp, cried for 2hr, lt leg silver dollar size redness involving knee, lower leg discolored;t102;
Pt received Moderna Magenta Label 6mo-5y as dose number 1. He was given Pfizer Maroon 6m-4y as dose number 2.
No adverse event; Given an expired vaccine; Given the monovalent vaccine as booster dose; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given an expired vaccine), WRONG PRODUCT ADMINISTERED (Given the monovalent vaccine as booster dose) and NO ADVERSE EVENT (No adverse event) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013B22A, 029H21B, 025B21A and 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Nov-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given an expired vaccine) and WRONG PRODUCT ADMINISTERED (Given the monovalent vaccine as booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Given an expired vaccine), WRONG PRODUCT ADMINISTERED (Given the monovalent vaccine as booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Given an expired vaccine) and WRONG PRODUCT ADMINISTERED (Given the monovalent vaccine as booster dose).    The concomitant medication was not reported by reporter. The Medical assistant reports that a co-worker accidentally administered an expired vaccine. They wanted to know if there were certain risks if patient was revaccinated. Vial for 5.5 ml. On 15-Nov-2022, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. The treatment medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-681148 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-681148:Same reporter
Mom called to report , pt developed congestion, fever up to 103 degrees right, and irritability following vaccine administration.
Abdominal distress, including diarrhea, abdominal cramps and gas. Frequent visits to the bathroom  even after drinking only water. Lasted for 3-4 days after which I took an anti-diarrheal /anti-gas medicine. This brought relief and mostly ended the adverse event.
Patient received a dose of Moderna COVID-19 at age 17. At the time of this report, he had not reported any adverse effects.
This case was reported by a pharmacist via call center representative and described the occurrence of blistery rash in a 60-year-old male patient who received SHINGRIX (batch number 524S7, expiry date 12th February 2021) for prophylaxis. On 25th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In August 2018, less than a week after receiving SHINGRIX, the patient experienced blistery rash and spot-like rash. On an unknown date, the outcome of the blistery rash and spot-like rash were recovered/resolved. It was unknown if the reporter considered the blistery rash and spot-like rash to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported the case for the patient. The patient received SHINGRIX in the left deltoid. Within 1 week (reporter was not sure of exact time) the patient developed a rash on his body in a few spots and a rash on his leg that was in a straight line. The patient reported to the reporter that the rash was blister-like and the patient did report the event to his physician. The reporter was not sure if a visit to the physician was required or if the patient just called the physician.
~10 seconds after administering the shot into the left deltoid, patient's eyes started to roll back, became unresponsive, and started falling back in the chair. This lasted for ~15 seconds. After this, the patient immediately regained consciousness, had no issues breathing, and was able to talk. Patient reported light-headed. 911 was called immediately upon reaction, first responders came in and took patient's BP and glucose. Glucose 91 mg/dL, BP was low (forget exact value), but returned to normal (~117/80) after about 10 minutes. Patient seemed fully conscious and aware, opted to not go to the hospital and signed a declination form of transport. First responders deemed that the patient was aware and did not necessarily need transport to the ER. Patient requested a ride home from friend/family member and is going home to rest.
erythema & swelling medical left arm-axilla to wrist; pt applied heat-MD recommended observe;
Patient said that the second dose caused redness at the injection site and was warm to the touch.  This did not happen to her with the first dose.
Initial two days of injection site redness and soreness resolved, but on day 9, the injection site became inflamed, with hives, heat, itching and redness. Center of inflammation was numb. These symptoms peaked at 12-24 hours and were resolved within 60 hours.
Case number PHEH2014US026092 is an initial spontaneous report from a pharmacist received on 23 Dec 2014. This report refers to a 19-year-old male patient. He was vaccinated with FLUVIRIN (batch number: 1414001) at a dose of 0.5 ml intramuscularly on 23 Dec 2014. It was reported that the patient received vaccine which had a temperature excursion of 65 F. No adverse event reported following this medication error.
Pain, Redness, Swelling, High Fever, Chills, Stomach Pain, Neck Pain, Headache Pain, General Tiredness and Weakness
I have just completed the hepatitis AB-A-AB shot program. My last AB shot was 4/28. Midday on 5/1 I was suddenly unable to breathe properly -SOB- and felt very weak, voice hoarse and wheezing with a phlegmy cough developed. So why am I writing you. I had my first AB shot on 9/14, my second A shot on 10/15. On 12/2 I woke up unable to breathe properly and my health declined. I presented myself to the free clinic - I have no insurance/job- and they have been trying to determine what is wrong with me. A chest XRay ruled out lung problems, now they are focusing on my heart. When I got that shot and 2 days later my health further declined & repeated what had happened in December - I didn't think it a coincidence! My persistent but almost gone cough reappeared and I found myself stumbling around...I thought I would investigate adverse reactions to Hep B. Sure enough, I have those reactions!! This realization probably won't help my health any but I hope it will bring this to your attention.
This spontaneous report as received from a registered nurse via field representative refers to a 15 year old female patient of unspecified ethnicity (nurse niece). On 19-JAN-2015, the patient was vaccinated with her first dose of GARDASIL (lot #, batch #, expiration date, dose, route of administration and indication were not provided) in the pediatrician's office. In the evening of 19-JAN-2015, the patient experienced shakiness, headaches and "uncomfortable reaction". The patient sought medical attention. The pediatrician was contacted on the following day, 20-JAN-2015. No treatment was given to the patient, however, the pediatrician stated that the patient should not receive any further doses of GARDASIL in the future. Action taken with GARDASIL was not reported. The outcome of the events was not reported. Relatedness between GARDASIL and the events was not provided. Additional information is not expected. It was reported that the physician could not be contacted.
Patient received her tetanus booster on Monday, and last night noticed some red splotches on her upper arm near injection site. She also has had a headache, had a headache Tuesday, no headache Wednesday, and then the headache came back today. Patient spoke to PCP as well as Clinic Pharmacy staff and was given treatment advice. Will follow-up with Neurologist. Monitor closely for now, can try cold pack on upper arm, and splotches if they feel itchy or uncomfortable. Ibuprofen for headache. If headache or splotches persist tomorrow though, she will call back to check in.  08/3/2019 Seen in injections office. States that she is having no more effects from the vaccine.