chrisvoncsefalvay/vaers-outcomes huggingface dataset:
gave 0.25 mL to an older adult; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (gave 0.25 mL to an older adult) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) 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) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (gave 0.25 mL to an older adult) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (gave 0.25 mL to an older adult) 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 ACCIDENTAL UNDERDOSE (gave 0.25 mL to an older adult).    No concomitant medication was reported.  It was reported that they gave 0.5 but initially charted 0.25 and changed it afterwards to 0.5. There was over a milliliter left of vaccine still in the vial after supposedly 5 full doses might have been withdrawn.  The vial fill volume was possibly too high. The vial was punctured 5 times. 5 doses were extracted from the vial.  No treatment medication was reported.  This case was for Adult patient 2.   This case was linked to US-MODERNATX, INC.-MOD-2022-673533, US-MODERNATX, INC.-MOD-2022-673578, US-MODERNATX, INC.-MOD-2022-673580.   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2022: Additional follow-up received was added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-673533:Same reporter US-MODERNATX, INC.-MOD-2022-673578:Same reporter US-MODERNATX, INC.-MOD-2022-673580:Same reporter
Around mid-September I started having severe headaches before getting up from bed. I also felt nauseous. I checked my blood pressure and it was high compared to my normal one. I went to see my doctor, and he couldn't find anything wrong with me or what was causing the high blood pressure. He started me on Amlodipine 2.5 mg/daily. I have been taking this medication for approximately 10 days and I started feeling a little bit better, but I am still having sporadic headaches. Some days I have stomachaches.  My stomach feels bloated. Today I got up with a headache again. Later in the day developed a fever (100F). I felt very hot in the face and head. Now (7 pm) my temperature is normal.
Menveo mixed with sterile diluent; Menveo with sterile diluent administered; This case was reported by a nurse via sales rep and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 29-Jul-2022 Reporter's comment: The nurse reported that one of them gave Menveo to a patient but it was mixed with sterile diluent instead of the Menveo diluent. Additional supportive information: The patient received Menveo which was mixed with sterile diluent instead of the Menveo diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The follow-up could not be possible as no contact details were available.
Patient received FLUZONE HD, PREVNAR 13 and ADACEL on 11/6/17. FLUZONE & PREVNAR both given in left arm. Pt developed 6 in by 4 in redness and swelling on left arm, lower injection site, that did not respond to Benadryl. Patient called pharmacy to report on 11/13. rph advised patient to contact PCP or go to urgent care for further treatment. VAR does not clearly state which vaccine was lower admin site. Rph suspects PREVNAR 13 was lower admin site, based on practice habits.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On unspecified dates, improperly stored doses of GARDASIL lot # H020901 expiration date 05-JUL-2015 (strength, dose number, dose, frequency and indication were not reported) was administered. No concomitant medication reported. Outcome and causality was not reported. This is case has been linked to MARRS # 1406USA000382, 1406USA000549, 1406USA000551, 1406USA000552, 1406USA000550, 1406USA008391 and 1406USA008418. Additional information has been requested.
Approximately 21 days after receiving vaccine I started to have symptoms of what was later diagnosed to be shingles.  My skin was very sensitive to even wearing clothes and I thought I had bites on the back of my neck into my hairline because we had been on Nantucket.  But I could not see it.  I was feeling very fatigued and had pain from my left ear down my left arm and side.   I did not think it could be shingles because  I received the Shingrix vaccines in 2019.  Finally I had my husband take a picture of it and sent it to me PCP ON 4/8/2021.  She informed me it was shingles and put me on a prescription (not sure of name for 1 week).  Because nerve pain in neck and ear still continues I was prescribed Gabapentin which I am still taking.
I had no idea I had high blood pressure until I went in for my regular prenatal check up. My blood pressure has been running normal during my whole pregnancy. Yesterday my blood pressure was 142/88. It was high enough that my doctor and I have decided that it would be best not to wait for my due date of August 31, 2022 and opt for a cesarean on August 11, 2022.
Provider ordered MA to give DTap due to the patient not ever having vaccines. The patient was to get TDap. I helped with these vaccines and entered them into the chart.  The provider was notified, this event was reported and there were NO adverse reactions.
Vaccine that had been more than 30 days in the refrigerator was given to 16 patients, vaccinate past its expiration date of 10/1/21; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients, vaccinate past its expiration date of 10/1/21) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients, vaccinate past its expiration date of 10/1/21). On 07-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients, vaccinate past its expiration date of 10/1/21) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant use were reported No Treatment were reported
This spontaneous report has been received from a licensed practical nurse referring to a patient of unknown age and gender. No current of historical conditions were reported. On 18-MAY-2016 the patient was vaccinated with PEDVAXHIB (lot # L051122, expired date of 12-OCT-2018, dose and route unknown) and ROTATEQ (Lot # L028645, expired date of 25-MAY-2017, oral, dose unknown). The vaccines were improperly stored under 9.1 celsius degree for 30 minutes. No previous temperature excursion. Data logger was involved. No adverse effects was reported. This is one of several reports received from the same reporter. Additional information has been requested.
DOES NOT FEEL LIKE EATING; BONES HURTING; NOT FEELING WELL; This spontaneous report received from a patient concerned a 37 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies and no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced does not feel like eating. On 09-APR-2021, the subject experienced bones hurting. On 09-APR-2021, the subject experienced not feeling well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from not feeling well, does not feel like eating, and bones hurting. This report was non-serious.
Patient received shot, walked to waiting room and fainted. Brought back into exam room. HA and ST occurred at time of feeling faint. No SOB, BP 115/50
experiencing her arm still hurting until now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 28Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "experiencing her arm still hurting until now".  Additional information: NDC number of Pfizer Covid-19 Vaccine Booster Shot was not provided. Reason for no lot number of Pfizer Covid-19 Vaccine Booster Shot was caller unwilling to complete the report. Expiry Date of Pfizer Covid-19 Vaccine Booster Shot was not provided.  This follow-up is being submitted to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Didn't feel good Friday afternoon, then achy by the evening and by Saturday, noticed swelling and redness to injection site; unable to take temp at time of onset.
lt deltoid site-warm, erythematous & indurated 15cm x 10cm;
patient stated she was dizzy and nauseated and needed to lay down. after she lay down, I continued talking to her and she never blacked out.
This is a spontaneous report from a non-contactable female Pharmacist via a Company representative reporting for herself. An adult female patient of an unspecified age (in her mid to upper 50s) and ethnicity  received PREVNAR 13, via an unspecified route of administration on an unspecified date 0.5ml, single for immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced swelling in arm and pain in arm on an unspecified date with outcome of unknown.  The pain and swelling lasted about 4 to 5 days. Reporter pointed to her right arm when reporting the event, but caller is not sure if the injection was administered in her right arm. No follow up attempts possible. No further information expected.
Pt devel urticaria w/in 1 hr or 2 p/the initial immun;
local rxn ecchymotic nodule 3mm in diameter, tender, fever X 48 hrs (100 F), lt ear painful X 5 days. S/T, systemic lymphadenopathy
Patient received PNEUMOVAX as ordered and had a local reaction (cellulitis), called to report next day.
headache, fever, chills, muscle aches, nausea-  lasting 48 hours
Dark purple bruising starting on his arms. Noticed red splotches on arms, legs and back which turned to bruises overnight. Diagnosed with ITP related to MMR. Course of prednisone.
Patient does not meet criteria for administrations of Modern COVID Vaccine as patient is under recommended age for the same. Patient was administered vaccine in error. No adverse event reported during time of visit. None reported during follow up phone contact.
Patient woke up this morning 11/18/2021 with a headache and a fever of 101.1.
Heaviness on chest; woke up and had heart palpitations or heart was racing; This is a spontaneous report received from a contactable consumer (Patient). This 59-year-old female patient reported for herself that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8733; Expiration Date: 31Jul2021) via an unspecified route of administration into the upper left arm on 01Apr2021 16:30 (at the age of 59-year-old) at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that she woke up and had heart palpitations or heart was racing on 02Apr2021 (late night) to early morning 03Apr2021. On 03Apr2021, she felt heaviness on chest and was fine and went on about her business. Patient woke up and had heart palpitations or heart was racing, on 04Apr2021, she reported that it happened again for a shorter period of time around 05:00 in the morning and again on Sunday night and Monday morning. She called the General Practitioner on Monday and went in and had an EKG done and it didn't show anything and made an appointment with the Cardiologist. On 07Apr2021, it happened again and she went to the Emergency room 08Apr2021 at 02:00 and had an EKG done and there was nothing. On 09Apr2021, the Cardiologist ran a battery of tests including complete work up, heart monitor, a stress test and echocardiogram, but nothing had happened since the 07Apr2021.  The patient believes it is directly related to the Pfizer Covid Vaccination and stated she never had any heart problems and prior to this for the last two months, caller has exercised daily on the elliptical for an hour.  It wasn't as if she exerted herself and something happened but she did exercise the Thursday before the Vaccination. She was scheduled to receive the second dose Pfizer Covid 19 Vaccine on 22Apr2021 and she was not keen on doing this given the situation. No prior vaccinations within four weeks. The patient took German Measles Vaccine and had high, high fever and a seizure at the age of 6. Caller does not have NDC/lot/expiration to provide and states this was a long time ago. Outcome for the events was unknown.  No Follow-up attempts are needed. No further information is expected.
FEVER, Wheezing, Shortness of Breath DX  Fever, unspecified fever cause R50.9 Pulmonary infiltrate R91.8  New Prescriptions   DOXYCYCLINE HYCLATE (VIBRAMYCIN) 100 MG CAPSULE    Take 1 capsule by mouth 2 (two) times daily for 10 days.
No adverse reaction for the patient as of yet. She completed 2 doses of Shingrix back in 2019 and received a 3rd dose at this time.
Case number PHEH2013US0325475, is an initial spontaneous report received from a pharmacist on 09 Dec 2013. This report refers to a 20-year-old male patient. He received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: M12097), intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component on 05 Dec 2013 No adverse event was reported following this administration error.
Vaccine was administered on 12 Jun 2023 and was expired on 17 May 2023.; No adverse event; 12 adult patients received expired Bivalent Moderna COVID-19 vaccine beyond MFG expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (12 adult patients received expired Bivalent Moderna COVID-19 vaccine beyond MFG expiration date), PRODUCT STORAGE ERROR (Vaccine was administered on 12 Jun 2023 and was expired on 17 May 2023. ) 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. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jun-2023, 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 12-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (12 adult patients received expired Bivalent Moderna COVID-19 vaccine beyond MFG expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was administered on 12 Jun 2023 and was expired on 17 May 2023. ) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (12 adult patients received expired Bivalent Moderna COVID-19 vaccine beyond MFG expiration date), PRODUCT STORAGE ERROR (Vaccine was administered on 12 Jun 2023 and was expired on 17 May 2023. ) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (12 adult patients received expired Bivalent Moderna COVID-19 vaccine beyond MFG expiration date) and PRODUCT STORAGE ERROR (Vaccine was administered on 12 Jun 2023 and was expired on 17 May 2023. ).    No relevant concomitant medications were reported. Vial size was 2.5 ml. Date the vial was initially stored in the refrigerator was on 12 Jun 2023. The vial haven't undergone any temperature excursions. No treatment medication reported.  This case contains information for the 12th of 12 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-729389 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2023: Follow-up information included no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729389:Master case
Pt starts received flu and pneumonia vaccine in left arm 10/23/01. Later that day arm became painful, swollen and unable to raise arm. Seen by Dr. on 10-24-01. Prescribed 10d course of Cephalexin and Zyrtec. Pt has completed meds. Pt states swelling is down, gets out of breath, feels weak sometimes.
Numbness in left arm and redness 24 hrs after shot given. I was seen by doctor he said to report this.
1348 RECIEVED VACCINE 1410 VERBALIZED NAUSEA REPORTS NAUSEA MAY BE RELATED TO PASTA AND CRAB THAT HE ATE EARLIER  VITALS 136/85 HR 74 O2 98 %  ON ROOM AIR R 16  REPEAT VITALS 129/80 HR 73 O2 98%  ON ROOM AIR R 18  DENIES SOB, NO DIFFICULTY BREATHING, NO SWELLING IN THROAT, NO CHEST PAIN, NO ITCHING  PT DISCHARGED HOME WITHOUT COMPLICATION EDUCATED TO FOLLOW UP EMS IF SOB, SWELLING, HIVES, DIFFICULTY SWALLOWING OR BREATHING PT VERBALIZED UNDERSTANDING
Physician is fully vaccinated with Pfizer vaccine/ but both physician and mother contracted COVID-19.; Physician is fully vaccinated with Pfizer vaccine/ but both physician and mother contracted COVID-19.; His O2 saturations were 92-93%. It started mild but got worse; This is a spontaneous report from a contactable physician. A adult male patient received BNT162B2 (Formulation: Solution for injection: Batch/Lot number: unknown), dose 2 via an unspecified route of administration on an unspecified date 2021 as dose 2, single and dose 1 via an unspecified route of administration on an unspecified date of 2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date of 2021 the patient (physician) is fully vaccinated with Pfizer vaccine. His wife was pregnant and not vaccinated, contracted Covid-19. Her mother was also fully vaccinated, but both physician and mother contracted COVID-19. Physician stated that his symptoms were worse than his wife, mother and lasted for weeks. His O2 saturations were 92-93 percent. It started mild but got worse. No one needed to be hospitalized, but he is very apprehensive on the efficacy of vaccines against the variant and is a bit worried we are letting our guard down too fast with re-opening and removing mask mandates. He believes the efficacy of Pfizer vaccine is in 50 percent for variant based on information he is seeing from another country. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included oxygen saturation as 92-93 percent on an unspecified date of 2021, sars-cov-2 test as unknown on an unspecified date of 2021. The events drug ineffective and COVID-19 considered as medically significant. The outcome of the event was recovered.  Information on the lot/batch number has been requested.; Sender's Comments:  The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.
Muscles in legs ached, developed a respiratory infection over the next day, and unable to sleep for two nights because of pain in my legs. Felt like a bad cold. My son who is thirty three came to visit me on 11/21/2011 the next day and slept in my bed and on 11/24/2011 develop a rash on his face, back and chest. On 11/26/2011 he went to emergency room and they diagnosed his rash as consistent with herpes zoster infection and it looks exactly like the chicken pox.