chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Two patients received Moderna Bivalent vaccine that had been in the refrigerator for more than 30 days.; Two patients received Moderna Bivalent vaccine that had been in the refrigerator for more than 30 days.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Two patients received Moderna Bivalent vaccine that had been in the refrigerator for more than 30 days.), PRODUCT STORAGE ERROR (Two patients received Moderna Bivalent vaccine that had been in the refrigerator for more than 30 days.) 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)) 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 (Two patients received Moderna Bivalent vaccine that had been in the refrigerator for more than 30 days.), PRODUCT STORAGE ERROR (Two patients received Moderna Bivalent vaccine that had been in the refrigerator for more than 30 days.) and NO ADVERSE EVENT (No adverse event ). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Two patients received Moderna Bivalent vaccine that had been in the refrigerator for more than 30 days.), PRODUCT STORAGE ERROR (Two patients received Moderna Bivalent vaccine that had been in the refrigerator for more than 30 days.) 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 (Two patients received Moderna Bivalent vaccine that had been in the refrigerator for more than 30 days.) and PRODUCT STORAGE ERROR (Two patients received Moderna Bivalent vaccine that had been in the refrigerator for more than 30 days.).    No concomitant medications were reported. Two patients received Moderna Bivalent vaccine that had been in the refrigerator for more than 30 days. At this point in time the phone call was disconnected. The agent called HCP back and left a message with case number. No other information about the patient's or their vaccine history was known.  No treatment medications were reported. This case contains information for the 1st of 2 patients described by the reporter   This case was linked to US-MODERNATX, INC.-MOD-2023-714305 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714305:Patient 2 of 2 Patients
Approximately 12 hours after the vaccine was administered I experienced severe aches- so severe that extra strength ibuprofen and Tylenol did nothing for. I also experienced severe nausea and vomiting that lasted for 6 hours. It is now almost 48 hours post vaccine and I am still very achey and am experiencing chills.
Immediately following administration of vaccine the patient felt lightheaded, nausea, and lost consciousness (for 2 seconds).  She remained sitting and elevated her feet. He blood pressure was 98/60 and pulse 32 immediately following her return to consciousness. The patient remained in observation for about 45 minutes.
This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 57-year-old female patient who received Shingrix (batch number D9P5X, expiry date 18th April 2021) for prophylaxis. On 4th February 2019, the patient received the 1st dose of Shingrix (intramuscular). On 4th February 2019, less than a day after receiving Shingrix, the patient experienced injection site pain (serious criteria hospitalization), fever (serious criteria hospitalization) and shivering (serious criteria hospitalization). The patient was treated with Tylenol. On an unknown date, the outcome of the injection site pain and fever were not recovered/not resolved and the outcome of the shivering was unknown. It was unknown if the reporter considered the injection site pain, fever and shivering to be related to Shingrix. Additional information was reported as follows: At 4 PM, the patient received Shingrix in an unknown deltoid. The patient developed fever (body temperature 102.6 degree F) and shivers. The patient took Tylenol and the fever subsided. The patient then underwent a repeat breast surgery which was not related to vaccination. After surgery, the patient experienced a re-occurrence of the 3rd degree fever. The physician stated that, the patient also experienced pain at the injection site. No additional details were reported.
chills;Soreness (injection site); A spontaneous report was received from a consumer concerning a 62-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events chills/ chills and soreness (injection site)/vaccination site pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 3 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 002A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 3 Mar 2021, the patient experienced Chills and Soreness (injection site).  No treatment information was provided..  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events chills and soreness (injection site) was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
generalized pruritis starting about 3 hours after vaccine and still present more than 3 weeks later
On day 1, within an hour of the injection, she had a hard time lifting her arm. It was extremely painful and it lasted for 2 days. Then, she had a localized swelling which was hot from the shoulder to the elbow, which still persists currently, intermittently every now and then. She was given a Medrol dosepack for the inflammation, but had to d/c it because it made her dizzy and shaky. She took food with it and still experienced these symptoms. She experienced a headache for 3-4 days, but no fever/chills. She did notify the doctor.
Employee received the  Pfizer covid vaccine @ 0752. @ 0800 employee  began to feel flushed, SOB, increased HR. Patient also had some throat tightness and itchiness. BP 147/95. O2 100% HR 149 @ 0755. Symptoms worsened by 0805 and EPI pen given at this time. By 0807 patient was feeling much better- HR 81, BP 134/75, no SOB. Patient chest and face flushed. Taken to ED at 0812.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was reported. On an 06-MAR-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # M034894 with expiration date 11-NOV-2018 or M037771 with expiration date 21-FEB-2019 (not specified by the reported) for prophylaxis (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between 0 to 2 degrees of Celsius for 2 hours 32 minutes. Previous temperature excursion was between 0 to 2 degrees of Celsius for 8 hours 59 minutes. Data logger was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA009362:
tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TINNITUS (tinnitus). At the time of the report, TINNITUS (tinnitus) had not resolved.            No concomitant medication information was provided  No treatment product information was provided  Action taken with mRNA-1273 in response to the event was not applicable.
I was finethrough out the epidemic with no chnage of my PPE precautions, till I got the vaccination and was diagnosed with COVID 19 with PCR test., happened to mtywife too and lot of my MD friends I just hve maet so many of my fiends whio have been diagnossd with covid infection either in betweek 2 injections of after the second doise,. this has to be reported and looked into
Information has been received from a healthcare worker concerning a 52 year old female with allergy to soy products, sulfa, BACTRIM, CIPRO and LEVAQUIN and no illness at the time of vaccination who on 31-OCT-2008 was vaccinated with the first dose of PNEUMOVAX 23 (lot#: 660717/0224X) 0.5ml IM into the left deltoid. Concomitant therapy included flu vaccine and albuterol inhaler. After receiving the vaccination the patient experienced itching on her legs and mouth. Subsequently, the patient recovered from itching on her legs and mouth. Follow-up information was received from the healthcare worker. The healthcare worker indicated that the patient called on 03-NOV-2008 and stated she felt itching and wanted to know if the vaccine contained soy. the patient took BENADRYL to treat itching. The patient's itching lasted 1 day and recovered at the time reporting. Additional information is not expected.
Nauseas , had a fever of 102 for two days , chills, pain all over the body
Information has been received from a certified medical assistant referring to multiple unspecified patients of unknown age and gender.  On unspecified dates, the patients were administered an unspecified number of improperly stored doses of GARDASIL (lot # K006124, expiration date: 02-FEB-2017, route, strength and dose were unknown). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Fever, chills, night sweats, swollen glands under arm, swollen injection site, body aches, headache
I began to have chills and felt achy. This lasted through the night. The next day I still didn't feel 100% but much better.
really bad reaction; left breast swelled up so bad; arm was in a lot of pain; A spontaneous report was received from other healthcare professional concerning herself a 51-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events really bad reaction, left breast swelled up so bad, arm was in a lot of pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 6 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) really bad reaction, left breast swelled up so bad, arm was in a lot of pain, and she was scheduled to get the second dose today 05 Feb 2021. She had to get lab work done to make sure there was no infection; everything so far was ok.  Treatment details included Not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), really bad reaction, left breast swelled up so bad, arm was in a lot of pain were not recovered or not resolved.
Information has been received from a advance registered nurse practitioner concerning a 78-year-old female who on 17-Sep-2007 was vaccinated at 13:15 subcutaneous in the left arm with her first 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (lot # 658194/1095U) for the prevention of shingles instead of zoster vaccine live (Oka/Merck) (MSD). There were no illnesses at the time of vaccination. The nurse practitioner stated that this was not product confusion it was a medication error due to wrong vaccine given. There was no adverse experience related to this event. No diagnostic labs were performed. On 31-OCT-2007 at 13:15, the patient was re-immunized with her first dose of zoster vaccine live (Oka/Merck) (MSD) (lot # 658085/0882U). There was no product quality complaint. Additional information is not expected.
No additional AE reported; PEDVAX HIB was administered after the expiration date of 24-OCT-2021; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  On 10-DEC-2021, the patient was vaccinated with haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot number KP24R was not valid for haemophilus B conjugate vaccine (meningococcal protein conjugate) and did not match any Company product, expiration date reported as 24-OCT-2021; strength, dose and route were not reported) after the expiration date for prophylaxis (expired product administered). The reporter suspected that other administrations might have occurred since the expiration date but could not confirm. It was reported that the haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) had no prior temperature excursions. No additional adverse event was reported.
pt recv vax 27FEB97 & 28FEB97 pt devel fine, red, raised rash on face, stomach & legs;rash was pruritic in nature;
mild flu-like symptoms; soreness in arm shot location; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (mild flu-like symptoms) and VACCINATION SITE PAIN (soreness in arm shot location) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A, 029A21A, 045J21A and 002M21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (mild flu-like symptoms) and VACCINATION SITE PAIN (soreness in arm shot location). At the time of the report, INFLUENZA LIKE ILLNESS (mild flu-like symptoms) and VACCINATION SITE PAIN (soreness in arm shot location) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Reported stated that previous vaccine shots and booster gave mild flu-like symptoms and soreness in arm shot location which all resolved in 2 days.  It was unknown if the patient experienced any additional symptoms/events.  No treatment information was provided.   This case was linked to MOD-2022-687681 (Patient Link).
Localized infection-induration/erythema/warm 1 wk after, Abx-BACTRIM
Pt vaccinated with Pneumovax 23 developed a fever, headache, stiff neck, swollen glands int he lt axilla & swelling w/pain & erythema at the injection site on the upper lt arm.
Had second dose of COVID vaccine on 1/27/21. 5-6 days later had swelling + redness + rash to left arm from shoulder to elbow 6 days later had swollen, painful (L) Breast which lead to appt at Dr + Antibiotics + mammogram + Biopsy
Redness, swelling, itching, heat, pain approx. 2 inches below the vaccination site.  Area of swelling approx. 3 in X 6 in.
0930: Patient complained of itchy throat and difficulty swallowing. Patient is immediately assessed by onsite NP and EMT.  Vitals were taken. BP 154/103, Pulse 100, SAT 99% RA. Benadryl 25 mg IM was given by EMS.  Patient is put on oxygen  0944: Patient is still complaining of same symptoms. a second dose of Benadryl 25 mg IM was given by EMS. Vitals were taken. BS: 110, P:99, BP: 153/107. Fire rescue is called.  0955: Fire rescue arrives, patient reported feeling better.  1000: Patient  transferred for further observation
Patient received vaccine and stated she might pass out as she has with past vaccines  She then immediately fainted with a temporary loss of consciousness. She stirred several times and seemed to wake but then would faint again. She finally regained consciousness and stated she felt okay. I put cold compress on the back of her neck and on her forehead. We had someone move a fan to blow cooler air into the area. Also removed her mask to make sure she was breathing and airway was open. We had her stay an extra 30 minutes for observation. I later called to patient and she stated she felt fine with the exception of a sore arm from the injection.
the door may been left open to long causing IPOL (opened) The highest temperature reached was 48.2F for a total excursion time of 9 minutes with no reported adverse event; A patient was administered IPOL that exceeded extended stability data post temperature excursion with no reported adverse event; Initial information was received on 28-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 16 years old female patient and reporter reported that the door may been left open to long causing ipol (opened) the highest temperature reached was 48.2f for a total excursion time of 9 minutes with no reported adverse event and the patient administered IPV (VERO) IPOL that exceeded extended stability data post temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-Nov-2022, the door may been left open to long causing the highest temperature reached was 48.2f for a total excursion time of 9 minutes with no reported adverse event (product storage error) and the patient received dose 5 of suspect IPV (VERO) at a dose of 0.5 ml (lot U1C571M, expiration date: 17-Jun-2023) via subcutaneous route in the left arm for immunization that exceeded extended stability data post temperature excursion with no reported adverse event (poor quality product administered) (latency: same day).  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Came on suddenly, Nausea, weakness, crazy sweating, and most concerning my arms at my elbows and my legs at my knees were pins and needles on both sides. Breathing was fine as well as my pulse. The entire episode lasted a half hour or so and gradually improved.
PATIENT FAINTED AND  BECAME PALE. RECOVERED WITHOUT ANY HELP IN 10 MINUTES.
pt received pneumovax 0.5cc IM in the R deltoid muscle on 09/13/2006. The patient states that in the evening she noticed redness, swelling, heat, and pain in the right upper arm. She has been applying cold packs to this area.
5 YO female had a physical exam within normal limit, received 4 YO vaccines KINRIX, PROQUAD, Influenza, 3 minutes after vaccines were given the mom called out for help and the patient was on the floor with arm stiffness and then crying. Lock rolled patient to left side, checked pupils they were equal react to light briskly. Patient was moved to an exam table. Patient was breathing spontaneously with no distress. Pulse oximetry showed Pulse 98, BP: 130/91 Glucose via finger stick was 98. Patient was responsive neuro checks at baseline, paramedics were called. Patient was continuously monitored until paramedics arrived. Mother was informed and updated. Parents were advised to have the paramedics take the patient to ED for further evaluation. The father refused and wanted to take the patient home. Father and Mother were both advised on seeking immediate medical care if further signs of seizure or altered neuro status.
no adverse effects reported; improperly stored dose of vaccine was administered to the patient; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 11-APR-2019, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) rHA, lot # R026720, expiration date: 17-MAY-2020 for prophylaxis (dose and route of administration were not reported) reconstituted in sterile diluent (STERILE DILUENT) (lot # and expiration date were not reported). It was unspecified of sterile diluent underwent any temperature excursions. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of 16.6 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported.  This is one of several reports received from the same reporter.  Lot No. R026720 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), expiration date reported as 17-MAY-2020, but upon internal validation established as 17-MAR-2020.; Sender's Comments:  US-009507513-1905USA004595: US-009507513-1905USA011854: US-009507513-1905USA011856: US-009507513-1905USA011857: US-009507513-1905USA011858: US-009507513-1905USA011859: US-009507513-1905USA011860: US-009507513-1905USA011861:
Patient developed a raised firm area about 2 inches in diameter that was red and warm and itchy. She also complained of feeling achy all over and felt "flu-like but fighting it". No fever.
Narrative: He notes having experienced nausea that started about 2 hours after the initial vaccination and spontaneously resolved after about 1-2 hours without intervention. During that time, he was able to eat and drink without difficulty. He denied experiencing other adverse effects including vomiting abdominal cramping and diarrhea.
While waiting in observation room after shot was given, the observation room nurse noted a red circle at the vaccine injection site.  The child had removed a round sticker that she had placed over the bandaid at the injection site.  Hydrocortizone cream and ice were applied.  The child was refered to her pediatrician.  According to mother, after approximately 20 minutes, a red, blotchy rash appeared on both arms and across the chest.  The following day, the child complained of itchiness and was taken to the physician.  She was treated with double claritin and prednisone.
Small rash began to break out on the back of patient's neck.  Over the course of the next week, the rash covered his entire body and was extremely irritation and itchy.  He was later diagnosed with severe eczema.