chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 21-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown demographic patient who was vaccinated with a dose of IPOL lot number not reported via unknown route in unknown administration site on an unspecified date. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. It is an actual medication error case due to incorrect product storage. It was reported that the patient injected with IPOL that was exposed to temperatures outside of recommended temperatures. At the time of report, the patient did not had any adverse event. 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.
Information has been received from a Nurse Practitioner concerning an "about 2 month old" patient who in December 2008, was vaccinated with the first dose of ROTATEQ 2ml, PO.  In December 2008, after receiving the vaccine, the patient experienced diarrhea for 7 days and vomiting.  Subsequently, the patient recovered from diarrhea and vomiting.  Additional information has been requested.
Immediately following vaccination:  Flu like symptoms. 24 Hours after vaccination:  Very severe headaches started and continued. 12 Days after vaccination severe Stroke/Hospitalization/ICU
This spontaneous report was received from a medical assistant refers to a patient of unknown gender and age. Information regarding the patient's medical history, concurrent condition, drug reactions/allergies and concomitant medications were not provided. On 26-SEP-2016, the patient was vaccinated with an expired dose of VARIVAX (lot # 010440, expiry date: 22-JUL-2016). Medical assistant reported that the vaccine was always stored properly. No adverse effects were reported. Additional information has been requested.
Breakthrough case admission after 2 vaccines Pfizer 4/20/21 Lot# Ew0171;  Pfizer 5/11/21 Lot# Ew0182
The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 30-MAY-2023; She states that no adverse reactions have been reported by any patients; Doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 30-MAY-2023) and NO ADVERSE EVENT (She states that no adverse reactions have been reported by any patients) 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. 019H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-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 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 30-MAY-2023) and NO ADVERSE EVENT (She states that no adverse reactions have been reported by any patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 30-MAY-2023) and NO ADVERSE EVENT (She states that no adverse reactions have been reported by any patients) 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 (She states that no adverse reactions have been reported by any patients) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired) and PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 30-MAY-2023).    Concomitant medications were not reported.  Suspect product dosage text was reported as unknown. It was reported that no adverse reactions have been reported by any patients. The vial was initially stored in the refrigerator on 4-JUN-2023 and did not underwent any temperature excursions.  Treatment information was not reported.  This case is reported for patient 46 out of 50 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:Master case
Patient is complaining about soreness and tenderness at site of injection.  Patient stated he has iced site, applied moist heat to site, taken Ibuprofen and Tylenol to help with complaint.
Per Client received first COVID 19 vaccine in left deltoid on 2/1/2021 and had mild discomfort at site for one day. Received second COVID 19 vaccine in left deltoid on 2/22/2025 and next day notice a reaction. Per Client left arm, vaccine site was hot to touch, tender, red raised whelps and swollen. Per Client left arm is still with all the previous descriptions. Per Client did take Tylenol for tenderness and has not seek any medical attention. Client also report to receiving both vaccines in left arm only due to already existing complication with right arm. Writer suggested that Client follow up with PCP and continue to monitor left arm, client verbalized plan to follow up with PCP or emergency attention if needed.
Very difficult to breath at times, Shortness of breath, Heart palpitations, extreme bloating and gas, inflammation of entire body
Extra heavy flow at start of mensuration cycle (roughly 2x the normal volume of blood); This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0183) via an unspecified route of administration in the left arm on 12May2021 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 21Apr2021 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. On 16May2021, the patient had extra heavy flow at start of mensuration cycle that was roughly two times the normal volume of blood. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event extra heavy flow at start of mensuration cycle that was roughly two times the normal volume of blood was resolved on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
When rec'd injection on 12/23, it hurt more than any I've ever had and expected discomfort for several hours. By evening on 23rd my upper arm and shoulder were very painful and deltoid area swollen.  By 24th, the pain was affecting entire left arm, shoulder, left back and neck.  Then had pain/discomfort throughout body through the 25th, Ibuprofen taken as needed, by end of 26th I was feeling a bit better, and the 27th near all symptoms resolved.  I do still have a good sized bruise around injection site.
Influenza- like disease; injection site reaction, migraine - information has been received from a registered nurse concerning a 38 year old female patient who on approximately 19 apr 2000 was vaccinated with a second dose of varicella virus vaccine live.  On 20 apr 2000 the patient experiened flu like symptoms, a local injection site reaction that is red, swollen and the size of a quarter.  It was noted that the patient also had a migraine headache.  Unspecified medical attention was sought.
13SEP93 joint pain & edema of feet & ankles & hives ER MD dx as gout;
Diagnosed with Achalasia; He also lost about 40 pound; Chills; Fever; Throwing up Has trouble keeping food and water down; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OESOPHAGEAL ACHALASIA (Diagnosed with Achalasia) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A 2(Z)1A and 041L(C)20D) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Gastroesophageal reflux disease in 2020.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OESOPHAGEAL ACHALASIA (Diagnosed with Achalasia) (seriousness criterion hospitalization), ABNORMAL LOSS OF WEIGHT (He also lost about 40 pound), CHILLS (Chills), PYREXIA (Fever) and VOMITING (Throwing up Has trouble keeping food and water down). At the time of the report, OESOPHAGEAL ACHALASIA (Diagnosed with Achalasia), ABNORMAL LOSS OF WEIGHT (He also lost about 40 pound), CHILLS (Chills), PYREXIA (Fever) and VOMITING (Throwing up Has trouble keeping food and water down) outcome was unknown.            Concomitant product use was not reported. The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable. The causality assessment was not provided.  Patient called on 03MAY2021 to report that on 20JAN2021 he received his 1st dose of the Moderna vaccine and 23FEB2021 he received his 2nd dose. After the 2nd dose he experienced chills, fever and had been throwing up. He said he had been having trouble keeping food and water down and it has gotten worse. He also lost 40 pounds. Patient saw a gastroenterologist and had tests done April, 2021. The specialist said patient's esophagus is not functioning well and diagnosed him with Achalasia. Patient is scheduled for further consultation and potential surgery in August 2021 with a Specialist. Patient also stated he had GERDS Reflux about a year ago (2020).; Sender'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.
My arm was severely hurting after 2 to 3 hours of getting the vaccine.  I started getting slight bodyaches Around eight or 9 PM. Things started getting worse and around 11 PM to midnight I reached a fever of 102.2. I also had a severe headache and worse bodyaches.
Anxiety aggravated; Rash worse and bright red arms, legs, back; Rash started little itchy inside arm inner; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Anxiety aggravated), RASH PRURITIC (Rash started little itchy inside arm inner) and RASH ERYTHEMATOUS (Rash worse and bright red arms, legs, back) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism, GERD, Seasonal allergy, Anxiety and Allergy to antibiotic (Erythromycin + tetracycline of moderna.). Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA 24 HOUR) for Allergy, ALPRAZOLAM (XANAX) for Anxiety, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for GERD, LEVOTHYROXINE SODIUM (L THYROXINE) for Hypothyroidism, ASCORBIC ACID (ESTER C [ASCORBIC ACID]) and SALBUTAMOL SULFATE (PROAIR DIGIHALER) for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced RASH PRURITIC (Rash started little itchy inside arm inner). On 18-Mar-2021, the patient experienced RASH ERYTHEMATOUS (Rash worse and bright red arms, legs, back). On an unknown date, the patient experienced ANXIETY (Anxiety aggravated). The patient was treated with CORTISONE for Rash, at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYTREC) at an unspecified dose and frequency and METHYLPREDNISOLONE (MEDROL DOSEPAK) from 20-Mar-2021 to 25-Mar-2021 at an unspecified dose and frequency. At the time of the report, ANXIETY (Anxiety aggravated) and RASH ERYTHEMATOUS (Rash worse and bright red arms, legs, back) outcome was unknown and RASH PRURITIC (Rash started little itchy inside arm inner) had not resolved.            Treatment information included Allergy pill for general allergies, but nothing specific Rash.   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Follow-up information will be processed at the same time as the initial report. Follow-up provided patient details, medical history, concomitant medications, treatment information and details surrounding the events.
CHILLS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills. This report was non-serious. This parent/child case is linked to 20210503989.
I began having fasciculations that have now lasted 4 months and caused great distress. I?ve never had a fasciculation in my life, am very active. There are entire message boards of people that developed these after the vaccinations. I am very grateful for the vaccine but I need to understand what is happening to my body. Like my central nervous system is on HIGH alert. Please help.
28 hours after shot given to me , my heart rate plummeted to around 40 beats per minute, causing   Inadequate amount of air to the brain causing slurred speech and dizziness and fear of dying.
45 yo MALE presents today for side effects from J&J covid vaccine. Patient reports he had received the vaccine 11/16/2021. He reports within a couple hours he got redness/rash all over his body, next day right leg rash which cleared then left leg he developed a rash left leg with sores, he reports he put ointment on it and it went away after a few days. Patient reports he then developed a lymph node in the L armpit painful to the touch for 3 weeks. He reports he has since then had bilateral neck lymph nodes which swell and have continued to do so and is nonpainful. Patient reports pain in his bilateral hands/feet and he reports continued nausea and problems eating, especially meat. Patient reports he has had 30 lb unintentional weight loss since he received the vaccine. Patient reports his paternal grandfather passed of lung cancer and his biological father passed away from colon cancer a few weeks ago. Patient does not endorse any blood in his stools, he does endorse non consistent bowel patterns over the past 6 mos. He is also endorsing night sweats since the vaccine, waking up with wet shirt about 3 times/week.
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Pt recvd vax  & devel moderate generalized itching; recvd no treatment & recovered w/in 3 hrs; No further details were provided;
child had missed Ipol dose between the age of 4-6, no adverse event; Initial information received on 27-Nov-2019 regarding an unsolicited valid non-serious case from a nurse.  This case involves a child patient (age and gender not reported) who missed a dose of vaccine IPV (VERO) [IPOL], which the child was supposed to get at age of 4 to 6 (month or year not specified).  This was a potential medication error case due to missed dose.  No adverse event was reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Received 2nd Maderna vaccine on March 20.  On March 23 my upper left arm was very red, hot to touch, and slightly swollen.  This extended from the injection site down to just above my elbow.  I had a scheduled doctor?s appointment that day.  My PCP said it was cellulitis from the vaccine injection  and that would need antibiotic to get rid of it.  I was prescribed cephalexin 750 mg, one  capsule 2X aday for seven days.
Red itchy bumps few at a time. First on the upper body and then on entire body. Appeared for almost two weeks. Treated with 150 mg/day doses of Diphenhydramine HCl tablet
COVID arm. Rash showed up earlier today on the vaccine site, it is firm and itchy. Diameter is 2 inches.
PT GIVEN IPV AND MMR RIGHT ARM ON 08/05/209, RETURN BACK 8/06/20009 C/O TENDERNESS AND WARM TO THE LEFT ARM. BENADRYL, KEFLEX AND TYLENOL RX TO PT BY DR. ASK TO F/U IF SYMPTOMS PERSIST OR WORSEN. PT RETURN BACK TO CLINIC 08/07/2009 MOTHER CONCERNED CHILLS HAD SLIGHTLY INCREASE AREA OF INDURATION MOTHER SEND TO ER FOR FURTHER EVALUATION.
I was diagnosed with Raynaud's syndrome after receiving my first booster. I noticed it happening a couple of days after receiving my vaccine. The capillaries in my fingertips became numb and tingled and lost color/sensation. I contacted my doctor who told me I was suffering from Raynaud's. I've never had any problems or complications similar to this prior to receiving my booster. Now, it's become difficult to work in my computer job with constant cold and numb sensations in my fingers at least 10 times a week.
This spontaneous report as received from a 68 years old female consumer refers to herself with shingles in March and drug allergy to unspecified drug. The patient had shingles originally in March 2012 subcutaneously the patient was vaccinated with a dose of ZOSTAVAX (lot number not provided) subcutaneous on 25-MAY-2012. No other co-suspects were reported. Concomitant medications included CRESTOR. On 15-JUL-2012, a few weeks later the patient developed the shingles. The patient felt the vaccine lessened the severity of this case. The patient had sought medical attention and acyclovir was given as a treatment for the adverse event. The outcome of shingles was unknown. Additional information is not expected.
Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) 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) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) 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 (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster).    No concomitant product reported by reporter.  It was reported that 100 patients were administered an invalid dose of Moderna COVID-19 bivalent booster. The nurse had no standing order other than what they had for second booster, when administering bivalent boosters, so they assumed same dose as second booster and administered 0.25mL to uncompromised adults.  This case was for one of the patient among the 100 patients who were administered an invalid dose of Moderna COVID-19 bivalent booster.   It was reported that CDC had recommended to revaccinate the patients with full dose of 0.5mL.  No treatment medication reported by reporter.
Was having headache and pain in my leg.  The pain became so bad that I went to see me PCP.  At time in office, my blood pressure was high, which she believes is why I was having headaches.  She put me on Medrol dose pack for 7 days.  After seven days, my leg started to swell and arm.  She made me go to emergency room. At emergency room, they were concerned because my blood pressure was rising.  I also had a ultrasound done to see if I had a DVT or PE, which was negative.  It has been 1 month since my booster and my blood pressure is slowing coming down with double the Lisinopril and the pain is getting better as well as the swelling but it has not completely gone away.  My PCP recommend I talk to the Pharmacist and the Pharmacist recommend that I report it to you.
pt recv comvax & hep b instead of ped HIB & hep b; there was product confusion;pt sought unspecified medical treatment;
Within one week of both Moderna Covid vaccination shots I began to develop left leg pain and swelling. I was checked by my doctor on both events. Both times I was sent to the hospital to have my leg ultrasound. Following the first shot there was no finding of blood clots. I was able to treat my leg swelling with compression socks and rest. Following my second dose of the Moderna Covid vaccine a blood clot was discovered. My doctor has been treating it with Eliquis. Both events of leg swelling happened within a 10 day period of the vaccine. No prior history of like swelling or blood clots prior to the vaccine shots.