chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 14-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 10 months old female patient who was administered 0.5 ml dose as the second dose in series for routine vaccination, while she received vaccine FLUZONE QUADRIVALENT instead of 0.25 ml. The patient received first dose of FLUZONE QUADRIVALENT 0.25 ml on 17-Oct-2018. The patient's past medical history, medical treatment(s), and family history were not provided. No concomitant vaccines were given. On 14-Nov-2018, the patient received a dose of 0.5 ml suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: U6260BA and expiry date: 30-Jun-2019) via intramuscular route in the left thigh. It was a case of actual medication error due to overdose. It was not reported if any adverse event occurred. 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 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. List of documents held by sender: none.
Heaviness in chest, at times, sharp pains with deep breaths. Has lasted >24hrs
I woke up the day after my 2nd Moderna vaccine shot with loud ringing in both ears and it has continued for 4 straight days. Sudden onset that morning - had never experienced this ringing sensation before. Possible tinnitus.
Pt had flu like symptoms (chills, lethargy, feeling generally bad/achy) the evening following the shot and for a about a full day after getting the shots.
No adverse event reported. Reconstituted vaccine with expired sodium chloride diluent. Diluent was expired by 3 or 4 days. Awaiting instructions from Pfizer.
Pt arrived for her COVID vaccination.  Dose received and during monitoring period she reported throat tightness and difficulty swallowing.  VS WNL with BP 130/88, HR 90, O2 sats 98% on room air.  Pt ambulatory and escorted by staff to ED for further monitoring.
Pt complains of redness & swelling to injection site of lt arm, problem began the day after receiving injections & is still present. Pt using cold compresses to reduce swelling.
Temp 104(ax) during the night of 14FEB91; Fever lasted into 15FEB91; Seen by MD; Tx w/Bactrim 3/4 tsp BID on 18FEB91 for cold & congestion;
Site of injection reddened and swollen. Warm to the touch. Reddened area approximately 60 x 60 cm. No blistered or broken skin.
Patient started to feel "tightness in throat" before leaving observation area.  VS Stable.  Patient felt it was anxiety and was educated on all follow up options. No evidence of distress noted.
Upon reviewing the patient questionnaire with the patient she indicated that she has fainted with past immunizations about "2yrs ago".   The patient indicated that she has had vaccinations since then and tattoo's without incident.  After administering the Covid-19 vaccination, the patient stated she felt fine and didn't feel like there would be any problem.  I escorted the patient to the post vaccination area for the 15 minute recovery time.   After a few minutes I checked on the patient and she looked fine without signs or symptoms (pale face) of possibly going to faint.  After a few more minutes I heard the patient fall out of her chair.  Upon reaching patient she was laying on the ground and was still out.  After about 5 seconds she awoke and was aware where she was and that she had just received a vaccination.  She stated she felt fine and after about 5 minutes we had the patient sit up when she felt comfortable.  In the mean while a 'Code White' was called and store management had arrived.  After about another 5 minutes and when the patient was comfortable we had her sit upon a chair.  Patient had a very minor bump on her fore-head but was not bleeding.  Patient stated she felt fine but I had the patient remain in the post vaccination area for 45 minutes just to make sure.  The whole time the patient waited she was accompanied with store management.  After 45 minutes I assessed the patient.  The bump on her head looked the same and the patient indicated she felt fine, so I released her to go.
Patient reports that he does not know of anyone who received the Moderna Covid-19 vaccine who did not complain of malaise.I know a Medical Doctor who reported malaise after  the Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Patient reports that he does not know of anyone who received the Moderna Covid-19 vaccine who did not complain of malaise.I know a Medical Doctor who reported malaise after  the Moderna Covid-19 vaccine) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Patient reports that he does not know of anyone who received the Moderna Covid-19 vaccine who did not complain of malaise.I know a Medical Doctor who reported malaise after  the Moderna Covid-19 vaccine). At the time of the report, MALAISE (Patient reports that he does not know of anyone who received the Moderna Covid-19 vaccine who did not complain of malaise.I know a Medical Doctor who reported malaise after  the Moderna Covid-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Patient showed up for an appointment  on the wrong date, since this was supposed to be a pediatric dose the patient was nervous and a bit upset. In all of the commotion I grabbed the adult dose and gave that to him. I realized that I had done this after the patient left the store with his grandparents. I called them and spoke to the grandmother about the potential for increased side effects of the adult dose as compared to the pediatric dose. I assured her that she could call me (I gave her my personal phone number for any questions) I will follow up with her in a day or two to check on the patient.
There was an excrusion from freezer on 1 Oct 2021; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excrusion from freezer on 1 Oct 2021) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excrusion from freezer on 1 Oct 2021) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excrusion from freezer on 1 Oct 2021) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided.   This case was linked to MOD-2021-387514 (Patient Link).
This spontaneous report was received from a certified medical assistant and refers to a 11 year old female patient. Information on the patient's concurrent conditions, medical history or concomitant medications was not reported. On 16-APR-2016 at 12:00 PM, the patient was vaccinated with GARDASIL 9 (lot # L044475, expiration date: 12-MAY-2017) dose 1, intramuscular in the left arm. On unspecified date, the vaccine that was administered to the patient had been improperly stored by being exposed to temperature: 34F for a total time of 65 hours. There were no previous temperature excursions. No adverse event, signs or symptoms were reported. The patient had no illnesses at the time of vaccination. This is one of several reports received from the same source. Additional information is not expected as all available information was obtained.
I got a break through infection from my son; I think without your vaccine I would have been much worse; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (I got a break through infection from my son) and THERAPEUTIC RESPONSE UNEXPECTED (I think without your vaccine I would have been much worse) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFECTION (I got a break through infection from my son) and THERAPEUTIC RESPONSE UNEXPECTED (I think without your vaccine I would have been much worse). At the time of the report, INFECTION (I got a break through infection from my son) and THERAPEUTIC RESPONSE UNEXPECTED (I think without your vaccine I would have been much worse) outcome was unknown.            Concomitant product use was not provided by the reporter.    Treatment information was not provided.  The patient stated that he/she went through break through infection from his/her son after vaccination. The patient also stated that, it would have been worsen, if he/she would not been fully vaccinated.
She Had bumps and Rash all over body especially on her Torso and arms. She said it was itching all over
After administering the 2 vaccines for the patient (covid vaccine and Flu vaccine) the patient stated she feel dizzy and gonna stay in the immunization room till she feels better, then she started to have body stiffness and like black out for 45 seconds , I held her not to fall and injure herself . the pharmacy associates called ambulance and called for code white. customer was still alert , I put her on the floor on her side as instructed by ambulance team .she started vomiting, I cleaned her mouth and made sure she can breath. the ambulance team came, she was alert and communicated with them. they identified the situation as panic attack. the customer stayed in the immunization room with a member of management  to take her statement till someone of family members came for her.
This case was reported by a pharmacist and described the occurrence of adverse event in a subject of unspecified age and gender who was vaccinated with influenza virus vaccine (manufacturer unspecified).  On an unspecified date the subject received unspecified dose of influenza virus vaccine (unknown).  At an unspecified time after vaccination with Influenza virus vaccine, the subject experienced adverse event.  The reporter stated that he did not know the specifics of the type of events that were experienced by this subject as a consumer reported to the pharmacist that her co-worker experienced "similar problems" after he or she received a flu vaccine (unknown which manufacturer).  This particular subject had experienced arm soreness at the injection site, arm tenderness at the injection site, arm muscle weakness, especially at night, could not use her arm very well and arm weakness.  Details of this case are found in case number A0709413A.  At the time of reporting the outcome of the unspecified event was unspecified.
Frequent periods.  More than three times / every two months, sometimes 2 times a month (used to 29days or31days a cycle:  once a month).  It started when I got Moderna, so I changed to pfizer for 3rd shot since the symptom had not been improved. However, I still have same issues.  My doctor said, maybe I am going to have menopause soon, but I still feel it's not normal.
The day after I received my vaccine I developed flu-like symptoms and heart palpitations.  The heart palpitations subsided on 10/1 but then returned much worse on 10/4.  I went to the doctor and received an EKG.  The palpitations have mostly resolved.
Area of erythema and induration, also warm on left thigh, about 4x5 cm.
Pt developed fever, vomiting, diarrhea 5 days after vaccines given. Pt observed and monitored.
Pt recvd dose of Engerix-B felt lightheadedness & exp severe hypertension & irregular heartbeats; went to ER; tx Solu-medrol & IV DPH; in ER could not hear (sounded muffled) & had shakes; laryngoedema suspected;
Arm soreness followed by severe pain and bruising of right arm/shoulder and lateral chest wall.
Patient came in on the 10/13 to show me that his arm about 4 -5 inches below the injection site was red and a little swollen. He said he noticed it at first the night before and he hadn't tried anything yet. I suggested that he try icing the area and taking ibuprofen and benadryl to see if it helped.  He was considering going to the dr if those interventions didn't help
a lot of heat; a pretty significant site reaction that's just getting worse; it is very raised; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (a lot of heat), VACCINATION SITE ERYTHEMA (a pretty significant site reaction that's just getting worse) and VACCINATION SITE SWELLING (it is very raised) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (a lot of heat), VACCINATION SITE ERYTHEMA (a pretty significant site reaction that's just getting worse) and VACCINATION SITE SWELLING (it is very raised). At the time of the report, VACCINATION SITE WARMTH (a lot of heat), VACCINATION SITE ERYTHEMA (a pretty significant site reaction that's just getting worse) and VACCINATION SITE SWELLING (it is very raised) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient presented to the Emergency Department with shortness of breath. He had recently tested positive for COVID-19 on 01/03/2022. He had an infusion of the monoclonal antibody Regeneron earlier in the day. Upon EMS arrival to his home, we was found unresponsive and in asystole. He was intubated in the field and CPR started. ROSC was obtained while enroute to the hospital however it was lost prior to arrival. He arrived to the ED with active CPR in progress. He had no neurological signs on evaluation and skin showed evidence of poor circulation. CPR had been in progress for more than an hour so CPR terminated due to futility.
Patient reports starting with a small rash on her back and her eye swelled. She says eye swelling went down, but the rash spread to her left arm and ear.
Caller states that after receiving the Moderna vaccine, she developed blood clots in her brain; This spontaneous case was reported by a consumer and describes the occurrence of CEREBRAL THROMBOSIS (Caller states that after receiving the Moderna vaccine, she developed blood clots in her brain) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBRAL THROMBOSIS (Caller states that after receiving the Moderna vaccine, she developed blood clots in her brain) (seriousness criterion medically significant). At the time of the report, CEREBRAL THROMBOSIS (Caller states that after receiving the Moderna vaccine, she developed blood clots in her brain) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was reported.  After receiving the Moderna vaccine, patient developed blood clots in brain. Patient was working with MD at hospital to research trial associated with her condition. Caller did not disclose any other information as to when she received this information on her circumstances.  No treatment information was reported.  Company Comment: This spontaneous case concerns a female patient, of unknown age, with no medical history reported, who experienced the unexpected, serious (medically significant) AESI of cerebral thrombosis. The event occurred unknown number of days after receiving an unspecified dose of the mRNA-1273 vaccine. Of note, the vaccination date and event onset date were not provided; hence, the onset latency could not be assessed. It was reported that after vaccination, the patient developed blood clots in the brain. Treatment information was not provided. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jul-2022: Additional follow-up document received contains no new information.; Sender's Comments: This spontaneous case concerns a female patient, of unknown age, with no medical history reported, who experienced the unexpected, serious (medically significant) AESI of cerebral thrombosis. The event occurred unknown number of days after receiving an unspecified dose of the mRNA-1273 vaccine. Of note, the vaccination date and event onset date were not provided; hence, the onset latency could not be assessed. It was reported that after vaccination, the patient developed blood clots in the brain. Treatment information was not provided. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Patient recieved their first dose of the Moderna vaccine. We advised patient to wait around for 15 minutes atleast to make sure no reaction would occur, about 5 mins later the patient had difficulity breathing on her own. The RPh had administered a dose on epinephrine in the patients left leg, the patient improved right away.
Pt developed a large erythematous 10cm blanchable area over DTaP injection site. Non-tender, mildly pruritive. Rippened to local case and obvious
Became ill with flu like symptoms for approximately 20+ hours.  Achy and very tired.  Stayed in bed most of the next day after 2nd dose.
Days Later, my left arm was extremly soar, fever in it, hot to the touch, swollen arm, sever soar throat, sick to my stomach & swollen lymph nodes. I went to the doctor & got antiobotics, taken over a number of days, my lymph nodes went down & I begin to feel better.
muscle ache; vaccination site pain; vaccination site swelling; Headache; joint ache; Fever; Chills; tired; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via unspecified route of administration in the right arm on 22Mar2021 at 14:30 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, hypertension and osteoporosis. The patient had many unknown allergies to medications, food, or other products. Concomitant medications included olmesartan (MANUFACTURER UNKNOWN), dulaglutide (TRULICITY), insulin glargine (TOUJEO) and insulin lispro (HUMALOG 200) all taken for unknown indications from unknown start dates. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6205) via unspecified route of administration in the right arm on 01Mar2021 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Mar2021, the day of vaccination, the patient was tired. On 23Mar2021 at 08:00 (reported as next day), the patient experienced headache, joint ache, fever, chills and tired. On 24Mar2021 (reported as following day), the patient also had muscle ache. On the same day (reported as third night), the patient experienced pain (vaccination site pain) and swelling at injection site (vaccination site swelling). The adverse event did not result in doctor or other healthcare professional office or clinic visit or emergency room visit. The patient did not receive any treatment for the adverse events. The clinical outcomes of the events tired, headache, joint ache, fever, chills, muscle ache, pain at and swelling at injection site were recovering. No follow-up attempts are possible.  No further information is expected. No follow-up attempts are needed. No further information is expected.
Patient got light headed, started sweating and passed out. She got rigid and body tensed up a few times and then she came to and repeated this cycle about 3 times then she didn't remember what had happened. She sat in a chair for about 25 minutes and was able to leave the immunization room on her own with guidance from her mother.
Moderna covid 19 vaccine EUA. 0.5ml given instead of 0.25ml.
fell; Hurt her wrist; itchy; large round redness; a little bit of swelling and looked like she got hit in the arm with a baseball; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of FALL (fell), INJECTION SITE PRURITUS (itchy), INJECTION SITE ERYTHEMA (large round redness), INJECTION SITE SWELLING (a little bit of swelling and looked like she got hit in the arm with a baseball) and JOINT INJURY (Hurt her wrist) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.  Concomitant products included CENTRUM VITAMINTS, VITAMIN D NOS, METOPROLOL, GABAPENTIN, ROSUVASTATIN, WARFARIN, LEVOTHYROXINE and FISH OIL for an unknown indication.   On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced INJECTION SITE PRURITUS (itchy), INJECTION SITE ERYTHEMA (large round redness) and INJECTION SITE SWELLING (a little bit of swelling and looked like she got hit in the arm with a baseball). On an unknown date, the patient experienced FALL (fell) and JOINT INJURY (Hurt her wrist). At the time of the report, FALL (fell), INJECTION SITE PRURITUS (itchy), INJECTION SITE ERYTHEMA (large round redness), INJECTION SITE SWELLING (a little bit of swelling and looked like she got hit in the arm with a baseball) and JOINT INJURY (Hurt her wrist) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment: Medrol for hurting wrist.  No treatment for the rest of the events.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.