chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; 9 adult patients (Not pregnant) received expired Bivalent Blue Cap booster doses of Moderna COVID-19 vaccine on 10JUN2023 through 24JUN2023/Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (9 adult patients (Not pregnant) received expired Bivalent Blue Cap booster doses of Moderna COVID-19 vaccine on 10JUN2023 through 24JUN2023/Dose administered after 30-day Use By Date) 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. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-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 11-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (9 adult patients (Not pregnant) received expired Bivalent Blue Cap booster doses of Moderna COVID-19 vaccine on 10JUN2023 through 24JUN2023/Dose administered after 30-day Use By Date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (9 adult patients (Not pregnant) received expired Bivalent Blue Cap booster doses of Moderna COVID-19 vaccine on 10JUN2023 through 24JUN2023/Dose administered after 30-day Use By Date) 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 (9 adult patients (Not pregnant) received expired Bivalent Blue Cap booster doses of Moderna COVID-19 vaccine on 10JUN2023 through 24JUN2023/Dose administered after 30-day Use By Date).    Pharmacist was called to report that 9 adult patients (Not pregnant) received expired Bivalent Blue Cap booster doses of Moderna COVID-19 vaccine on 10JUN2023 through 24JUN2023. The dose administered after 30-day Use By Date.  The product was Bivalent BA.4-5 Blue Cap Lot number Lot-  AS7642B  and Exp. Date: 13JUL2023). The individual vials or intact cartons, the vial size was 2.5 ml. The date of the vial was initially stored in the refrigerator was 10MAY2023. The vial did not undergo any temperature excursions. This case contains information for the 2nd patient out of 9 patients described by the reporter. Concomitant medications were not reported.  No treatment information was provided by the reporter.    This case was linked to US-MODERNATX, INC.-MOD-2023-732805 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732805:Same report Patient 2
3/29/08-site of Tdap immunization red, hot to touch and swollen---3/30/08-developed fever (temp unknown), chills, headache, joint pain---3/31/08-developed rash around site of immunization, PMD advised ER visit, where client was given Benadryl and an antibiotic---4/1/08-systemic symptoms resolved, site still red and warm to touch but swelling has decreased
administered expired Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired Moderna COVID-19 vaccine) in a 20-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.  No Medical History information was reported.  On 18-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired Moderna COVID-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired Moderna COVID-19 vaccine) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Concomitant medication of the patient was not reported.  Date the vial was initially stored in the refrigerator was approximately 26-Dec-2021 and the vial did not undergo any temperature excursions.  No treatment information was provided by the reporter.
First symptom was on 6/10/2015 a stabbing pain in same hand vaccine (rabies immunoglobulin) were given and then developed into muscle spasms in legs then arms throat. It is now July 14 and I have been hospitalized 3 times and have suffered tremendously and still am. I now to date have worsening cramps & stabbing pains in extremities to the point I can barely function.
All periods (starting 24 May) have been predominantly blood clots; atypical to see any.  Sudden onset of banana allergy. Itchy ENT, swollen/watering eyes, full-body itch.
Heavy period flow and severe acne on the face and neck.  My period lasted twice a long.  Acne lasted for several weeks. It was like going through puberty again.
Pt began throwing up bile 7 hours after the vaccination was administered. He was healthy before leading up to shot. Continue to throw up bile for 36 hours following. No temp.
Information has been received from a physician concerning a male who was vaccinated with varicella virus vaccine live (Oka/Merck). Subsequently, the patient experienced a rash around the injection site. The patient sought medical attention and has recovered. No product quality complaint was reported. Additional information was not available. Follow up information from the physician indicated that they did not recall an event and were unable to provide additional patient information. Additional information has been requested.
Patient fully vaccinated with Moderna. Tested positive for COVID 19 on 01/08/2022. Patient was admitted to hospital on 1/8/2022. Patient expired on 1/15/2022 while still hospitalized.
Narrative:  Pt reports soreness at shoulder/arm near injection site x 3 days.
Initial and follow-up information has been received from a physician and a medical assistant, concerning a female who on an unspecified date last  year, in 2007 was vaccinated with the third dose of GARDASIL. It was reported that the patient experienced seizure. The patient was walking out of the office and went down. In follow-up information received from the nurse, she reported that the patient did not have a seizure. She passed out and recovered while in the office. This is one of two patients concerning the same source. Additional information has been requested.
This spontaneous report as received from a registered nurse reported a patient was administered the first dose of RECOMBIVAX HB (1 ml, intramuscular, lot # and exp date were not reported) in December 2011 and was in the office on 05-SEP-2013, to receive the second dose of RECOMBIVAX HB (1 ml, intramuscular, lot # and exp date were not reported). No adverse effects reported. Additional information has been requested.
This case was reported by a other health professional via call center representative and described the occurrence of vomiting in a 4-month-old patient who received ROTARIX. On an unknown date, the patient received ROTARIX. On an unknown date, immediately after receiving ROTARIX, the patient experienced vomiting and underdose. On an unknown date, the outcome of the vomiting and underdose were unknown. It was unknown if the reporter considered the vomiting to be related to ROTARIX. Additional details were provided as follows: The healthcare professional reported that the patient spit out majority of the ROTARIX vaccine during administration. This led to an underdose. The healthcare professional reported not having access to further product details. No further information was reported regarding the event.
I'm not sure which type of pneumonia vaccine it was. Fatigue lasting 2-3 days and pain and swelling at injection site lasting 6+ days. Still have a hard lump at the injection site that is uncomfortable and itchy.
Red flushed face.  And numb/tingling on end of tongue.  Sore, red, and hard bump at injection site.
Initial report was received from a healthcare professional on 31 October 2013. This reporter is the same for a cluster of patients who experienced events post-vaccination with FLUZONE, lot number UH907AC, which were captured in case number 2013SA113890. An 8-year-old patient (gender not reported) had received an injection of FLUZONE, lot number UH907AC (route, site and date not reported) on or after 19 October 2013 and within 24 hours had an asthma attack and was hospitalized for three days. The patient had known history of asthma. Outcome was unknown. Documents held by sender: None.
pt devel rash like mosquito bites on knees w/in 2 hrs of vax; they spread over body; The next morning ankles, hands, & face were swollen; taken to clinic; By evening swelling & rash had disappeared;
Vomiting 40 hours after dose 2; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 5 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 03Dec2021 17:00 (Lot number: Fl0007) at the age of 5 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Fk5127, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 12Nov2021, for COVID-19 Immunization. The following information was reported: VOMITING (non-serious) with onset 05Dec2021 09:00, outcome "recovering", described as "Vomiting 40 hours after dose 2". Therapeutic measures were not taken as a result of vomiting. Additional Information: The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. patient did not received any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Patient still is experiencing some post herpatic neuralgia pain from the shingles.  Not sure if the vaccine affected this or if she was not symptom free at the time of the vaccine.
Information has been received from a physician via a field employee referring to a 13 year old male patient. The patient's pertinent medical history, concomitant medication or drug allergies/drug reactions were unknown by the reporter. On an unknown date, the patient was vaccinated with a second dose of GARDASIL 9 (dose, lot # and expiration date unknown; intramuscularly to prevent anal cancer and genital warts) and had a syncopal episode following the administration of the vaccine. The physician stated he kept the patient in the office for 30 minutes after the syncopal episode to monitor the patient and unspecified treatment was given for the event. The patient recovered before he left the office. The causality assessment was not reported. Additional information is not expected since the reporter did not wish to be contacted.
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE MASS (Developed two lumps), ERYTHEMA (Redness), INJECTION SITE INFECTION (Infected), INJECTION SITE PRURITUS (Itchiness at the injection site) and VACCINATION SITE INDURATION (Induration that is getting bigger) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 13-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 MASS (Developed two lumps), ERYTHEMA (Redness), INJECTION SITE INFECTION (Infected), INJECTION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE INDURATION (Induration that is getting bigger) and INJECTION SITE PAIN (Soreness at the injection site). The patient was treated with DOXYCYCLINE at a dose of UNK, bid. At the time of the report, VACCINATION SITE MASS (Developed two lumps), ERYTHEMA (Redness), INJECTION SITE INFECTION (Infected), INJECTION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE INDURATION (Induration that is getting bigger) and INJECTION SITE PAIN (Soreness at the injection site) 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. No concomitant medications reported by investigator. Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Follow-up received and Patient provided email and confirmed that she is a physician.
Administered undiluted Pfizer Biv 5-11, 0.2ml
Diarrhea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and VOMITING (vomiting) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.    Co-suspect product included non-company product TREPROSTINIL SODIUM (REMODULIN) injection for Pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included TADALAFIL (ADCIRCA), WARFARIN SODIUM and AMBRISENTAN for an unknown indication.   On 29-Nov-2007, the patient started TREPROSTINIL SODIUM (REMODULIN) (Subcutaneous) .112 microgram/kilogram. On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced DIARRHOEA (Diarrhea) and VOMITING (vomiting). At the time of the report, DIARRHOEA (Diarrhea) and VOMITING (vomiting) was resolving.            No treatment drugs were reported
Patient received second Moderna COVID injection on 2/27/2021. Patient admitted to the ICU on 3/15/2021 with shortness of breath and fever.  Was hypoxic on room air and ultimately transitioned to Optiflow.   Symptoms positive for cough, shortness of breath, chills, fever,
flu-like symptoms; 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 INFLUENZA LIKE ILLNESS (flu-like symptoms) 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, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms) outcome was unknown.            No concomitant medication nor treatment provided by reporter.
Received Tdap vaccine IM (L) deltoid 11/14/12 lump at injection site on 11/15/2012 and not feeling well. Felt achy, short of breath and tired. Small red area at injection site 11/19/12. 11/20/12 Increased redness, swelling, warmth and pain at injection site. Seen emergency room for IV antibiotics.
Between 2 - 3 years had ear infections and tubes in ears. Very sensitive to sounds, would cover ears. Years of different treatments for autistic behaviours. Then started with a doctor. Started vitamins, supplements and a lot of tests. Recent tests provided showing very high strep in blood. She has never had strep.  9/25/2007 VAERS report received with medical records and vax record attached.  TC to parent for additional info.  Parent is unable to give AE onset date "sometime between age 2-3". Medical records from MD reveal Dx:  Unspecified Disorder of Immune mechanism. Obsessive-Compulsive Disorder.  Autoimmune Disease NOC. Encephalopathy unspecified.  DX of Autism on vax record. Per 60 day follow up: She is severly autistic. Follow-up: Patient is severely autistic with major deficits in language and social skills. We continue to see obsessive/compulsive issues. Patient will never be able to live alone. She will always need a caregivers.
905am patient states left shoulder pain, Lightheadedness, shakiness, headache, and tachycardia.    Placed patient on gurney, monitored vital signs.    Patient stated headache was worse and felt restriction while breathing.   Called Rapid response 916-AM    Vitals : 910- BP 147/101, HR 94, 02 100% 913-BP 130/89, HR 98,  02 100% 914- BP 135/87, HR 97,  02  100% 920- BP 141/92, HR 100, 02 99%  921- BP 133/93, HR 94, 02 100%
Child develops rash on 5/7/06 child has approximate 10-15 pox.
I was first just blaming it on stress. I would not sleep well, could not get comfortable. Had a lot of anxiety. I would wake up in the middle of the night, gasping for breathe. I was at work a few days later, and my heart rate was really high. They did an EKG on me and it was abnormal. They scheduled me for an echo and a stress test. Both came back abnormal. I had a problem with the blood flow to my heart. They referred me to a heart specialist, who thought I had a electrical problem. But after all the tests came back and they said it was normal but I still feel that my heart is stopping and my blood pressure is still higher. I feel weak and my heart rate is all over the place.
This spontaneous report was received from a doctor of pharmacy concerning an approximately 71 year old female patient with no drug reactions/allergies. On 28-DEC-2012, the patient was vaccinated with 0.5 milliliter (ml) PNEUMOVAX 23 (lot number and expiry date reported as 1947AA and 20-OCT-2013 respectively) intramuscularly. Concomitant medication included unspecified medications and FLUVIRIN received in the opposite arm on the same day (28-DEC-2012). Approximately on 29-DEC-2012 (reported as 1 or 2 days after vaccination), the patient experienced a rash 1 or 2 inches below the injection site. There was no fever and the rash was not itchy. The patient sought medical attention for the event by visiting the pharmacy. The pharmacist told the patient to take BENADRYL. No lab diagnostic tests were performed. There were no symptoms in the arm that received FLUVIRIN. The outcome of a rash 1 or 2 inches below the injection site was unknown. The relatedness for rash 1 or 2 inches below the injection site was unknown for PNEUMOVAX 23. Additional information is not expected.
Moderna COVID-19 Vaccine EUA moderate injection site soreness not yet relieved at time of reporting 12/16/17 7:30 p.m. chills starting 12/14/2021 2 p.m. lasting until after going to sleep that night slight flushing not known if fever-related during the period of chills relieved by sleep mild headache 12/15/2021 and 12/16/2021 relieved by tylenol
I had the pfizer vaccination administered in my left arm and the flu vaccination administered in my right arm at the same time. Within 10 minutes of my injection, the under side of my tongue began to swell. This only lasted 5-10 minutes. Throughout the afternoon/evening I was frequently lightheaded and imbalanced on my feet. My left arm was difficult to lift which was normal for a shot. The next morning I woke up very light headed and thought that if I could just get some food and fluid in me I would be ok. I began to pass out twice while moving about my kitchen, taking a break to sit after the first instance, and having to move all the way to the floor with my legs in the air on the second instance. I laid on the floor for roughly 10 minutes before being able to move to the couch. I was unable to take more than a few steps on my own for the next 2-3 hours without feeling severely lightheaded again. I also noticed from the time I woke up that my left arm (pfizer) hurt significantly worse than my right arm (flu) and that something was wrong with the lymph nodes in my left armpit. Throughout the day I would take my right hand and try to massage my lymph node from my left elbow down to my left ribs to encourage lymph fluid mobility. By early afternoon 10/9 the lightheadedness and arm pain had decreased and I was able to move freely around the house; however, around 6pm I noticed myself feeling hot and lightheaded running a 99.9 degree fever (my standard temperature is close to 97.5 degrees). I spent the rest of the evening in bed, lymph node pain worsening, and my temperature reached 100.3 degrees. My fever broke between 1-5am on 10/10. On 10/10 the only persistent symptom was the lymph node pain at which point I noticed my lymph node in the left armpit was visibly swollen. As of 3pm 10/10 my lymph node is still swollen despite my efforts (massage, stretching, and heat therapy) to reduce the swelling.
Received first dose of vaccine on 8/6/21. By 8/12/21, I noticed lesions on my left elbow as well as lesions on the palm-side of my fingers, bottoms of feet and toes. These became increasingly painful, enlarged and additional sores appeared over the course of the next few days, on my right elbow, both knees, both thigh/buttocks regions, and tops of hands followed. Sores/lesions are red, inflamed, tender to touch, blistered feeling, burning sensation, and mild itchiness.
Has varicella about 10 vesicles to each arm about 3 vesicles to face (rash began 7 days after receiving varivax).
muscle aches; Diarrhea; Headache; She experienced insomnia since she had the 2nd dose of the vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Apr2021 (Lot number: ER8733) at the age of 66 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First Dose, EN6198, LEFT arm), administration date: 15Mar2021, when the patient was 66 years old, for COVID-19 immunization. The following information was reported: INSOMNIA (non-serious) with onset 05Apr2021, outcome "not recovered", described as "She experienced insomnia since she had the 2nd dose of the vaccine"; MYALGIA (non-serious) with onset 06Apr2021, outcome "not recovered", described as "muscle aches"; DIARRHOEA (non-serious) with onset 06Apr2021, outcome "recovering", described as "Diarrhea"; HEADACHE (non-serious) with onset 06Apr2021, outcome "not recovered", described as "Headache". Therapeutic measures were taken as a result of insomnia.  Additional information: She had very bad insomnia since the second dose of vaccine. Patient's stated that last week was really horrible and then she had diarrhea and a headache and muscle aches and had been taking melatonin to help with the insomnia, does not like doing it because she does not like drowsiness.  No follow-up attempts are possible. No further information is expected.
loss control of my right arm,   said it was a mini stroke  was treated with TPA shot
Severe migraines that don't go away, ongoing fatigue, frequent menstrual spotting that used to be less frequent, frequent abdominal cramping, GI issues causing upset stomach out of the blue and diarrhea.
Patient fully vaccinated tested positive for COVID 1/28/2022 admitted to hospital 1/28/2022 patient expired 2/5/2022.