chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19 Vaccination during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (COVID-19 Vaccination during pregnancy) in a 38-year-old female patient (gravida 4, para 3) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Gestational diabetes (Pregnancy end date: 29-AUG-2002: gestational diabetes was managed by diet 07-MAY-2018: gestational diabetes was uncontrolled by diet and insulin Placenta shut down the day before scheduled C-section asthma). Concurrent medical conditions included Asthma (Patient experiences asthma when she is around allergens like animals with hair/fur/dander) since 1989. Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for Pregnancy, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and IRON for Vitamin supplementation.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 01-Apr-2021. On 14-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (COVID-19 Vaccination during pregnancy). On 14-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (COVID-19 Vaccination during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jul-2020, Pregnancy test: positive (Positive) Positive. On 06-Nov-2020, Ultrasound foetal: normal (normal) normal. On 07-Jan-2021, Blood glucose: abnormal (abnormal) Possibly gestational diabetes, results come back today 15-Jan-2021. On 14-Jan-2021, Blood glucose: abnormal (abnormal) Possibly gestational diabetes, results come back today 15-Jan-2021.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided by the reporter.  The estimated date of conception was reported as 22 to 26-Jun-2020. Date of LMP was reported as  22 to 26-Jun-2020. The patient had no maternal history of subfertility and had established prenatal care. Number of fetuses was reported as 1. The patient had 3 previous live, full term birth on 29-Aug-2002, 30-Jan-2004 and 07-May-2018. The patient had no history of substance abuse.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 38-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Information has been received via field representative from an unknown age male physician referring to himself. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, once, subcutaneously, (lot # and expiration date were unknown) for prevention of herpes zoster. On an unknown date, Six months after receipt of the vaccine, the patient diagnosed himself with shingles (rash and blisters). The rash was treated (topical cream administered unknown) and had since abated (recovering). The patient didn't seek medical attention. The causality was not reported. Additional information has been requested.
Received first Moderna vaccine on 1/4/2021 Continued taking daily consumption of OCP No illness, infection or ABX use during this time LMP 1/15/2021 Positive HPT on 2/14/2021 Experienced episodes of early vaginal bleeding in pregnancy on x2 separate occurrences, primary care and OBGYN notified  ABD pain and cramping present Monitored with hcg levels every 2 days and pelvic ultrasounds Confirmed right ectopic pregnancy 3/4/2021 Diagnosed with a non-viable pregnancy Treatment to end ectopic pregnancy with methotrexate required (other option was surgical management and I declined) Pain/trauma and emotional distress occurred Still being followed with weekly blood draws related to ectopic and methotrexate use
Stomach cramps, diarreah for 2 days. Fatigue, extreme ear ringing, Fever (101.3), chills, hot flashes, cold hands, light headed, tingling in legs and lips. acne on chin, unable to eat for four days, 10/18/19 - migraine. Still ongoing as of 10/22/19.
Mins post vax, pt became lightheaded, devel asthma & exp tight feeling in chest. At ER treated & sent home. Additional info requested.
pharmacist came to provide immunization. pharmacist accidentally drew the pfizer toddler vaccine instead of the pfizer pediatric vacine. pt was given the pfizer toddler vaccine mistakenly. no adverse events were reported.
urticaria - onset at 7:15 (approx 4 hours from time of shot), localized to upper chest and felt hot, right arm sore, had a brief second of dull chest pain (has had before) also had some shortness of breath last night took inhaler and felt better, none currently presented next day over 24 hours from injection - no injection site redness, urticaria on upper chest only, normal airway and lung exam
still bad vision; extremity sleepy; floaties in my eyes; vertigo is much worse than usual; headache; double vision for 1.5 hours; This is a spontaneous report from a contactable consumer. A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 24Apr2021 18:00 (at the age of 58-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included pain (Pain patient), fibromyalgia, post-traumatic stress disorder (PTSD, dermatitis contact), known allergies: Adhesive on band aids, ongoing vertigo (My Vertigo is much worse than usual) all from unspecified date. The patient experienced double vision for 1.5 hours, extremity sleepy, floaties in my eyes, vertigo is much worse than usual, headache on 24Apr2021 18:00 and still bad vision on 05May2021. Outcome of the event double vision for 1.5 hours was recovered on 24Apr2021 and other events were not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
In conjunction the other symptoms I had below: Full arm swelling; Eczema breakout on the arm where the injection occurred
in early July, 2022, I was diagnosed with lichen sclerosis in my pelvic area.  That was followed by extreme tingling/burning sensations  on my wrists, forearms, ankles, lower legs  and at times throughout my body.  It was especially intense at night leading to some terrible long nights.  I was prescribed Gabapentine and am now on Lycria awaiting an appointment with a neurologist.  The lichen sclerosis appears to have clear up.  I have yet to know exactly what is going on with my nervous system.  I was a perfectly healthy 79 year old woman until getting 4 (now 5) COVID shots.
The vial undergo temperature excursions; 13 patients received  an expired vaccine for a booster dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (13 patients received  an expired vaccine for a booster dose) and PRODUCT TEMPERATURE EXCURSION ISSUE (The vial undergo temperature excursions) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer COVID-19 Vaccine (Primary series). Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 Vaccine. Concurrent medical conditions included Food allergy and Allergy to antibiotic (Allergic to Sulfa Antibiotics.).    On 01-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (13 patients received  an expired vaccine for a booster dose). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (The vial undergo temperature excursions). At the time of the report, EXPIRED PRODUCT ADMINISTERED (13 patients received  an expired vaccine for a booster dose) and PRODUCT TEMPERATURE EXCURSION ISSUE (The vial undergo temperature excursions) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
I had severe muscle aches, burning,  head feeling like it would explode, vomiting, severe nausea, extreme muscle weakness, fever 101.6;  constant chills; later sweats.  Called pharmacist and they just keep repeating no oily foods, sweets, fried.   Seriously, I could not even stand up and could not even hold down water.  I feel they should warn you in advance and tell you to have gatorade or something else around as I live alone and this was quite severe.   I thought I was going to have to go to the hospital.   Thank God fever broke, second day in I feel a bit better but still lots of muscle weakness.
This spontaneous report as received from a medical assistant (MA) refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 24-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot#K011562, expiration date 08-APR-2017), dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Case number PHEH2013US020521 is an initial spontaneous report received from a nurse of 30 Sep 2013 with a follow-up received on 25 Feb 2014. This report refers to a 49-year-old female patient. On 27 Sep 2013, she was vaccinated with FLUVIRIN (batch number: 1308401, expiry date: Mar 2014) intramuscularly into her deltoid. It was reported that before vaccination, FLUVIRIN was placed in the shipping container at room temperature for 72 hours and later administered to the patient. No adverse event was reported following this medication error. Follow-up received from a nurse on 25 Feb 2014: Site of vaccination updated. Date of vaccination amended.
Started to feel lightheaded, weak, faint like I was going to pass out, heart rate increased, confusion, trouble speaking, brought to the ED, throat started to swell and started having thick spit and clearing my throat excessively. Diagnosed as anaphylaxis.
The patient presented to the COVID-19 vaccine outreach clinic at We received an email from a clinic who questioned the mixed dose of vaccines that were recorded in DATABASE. After further investigation, it was determined that this 15 year old had previously been given the first dose in the Pfizer series on August 25, 2021, and was in fact give the dose of Janssen (J&J) at the vaccine outreach event on 10/29/2021.   We are continuing to work with our Chief Medical Officer, and continuing to contact the family (left several voicemails).  We will continue to investigate this situation and work towards implementing revised workflows to prevent this from happening in the future.   We are not aware of any symptoms or adverse reactions experienced by the patient at this time.
symptoms consistent with pericarditis; This is a spontaneous report received from contactable reporter (Physician).  A 32-year-old male patient received BNT162b2 (COMIRNATY), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERICARDITIS (medically significant), outcome "unknown", described as "symptoms consistent with pericarditis". Clinical course: the 32-year-old male patient reported to long Covid clinic at a university, with symptoms consistent with pericarditis that has not responded to any standard TMT (NSAIDs, steroids). Autoimmune work up was negative. The patient has not had a Covid illness but received Comirnaty doses in Mar/Apr of 2021.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: A possible contribution role of vaccine BNT162b2 (COMIRNATY) to the onset of pericarditis cannot be entirely excluded, considering temporal relationship and no other risk factors reported in this case, based on current information provided.  This case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
This spontaneous report was received from a pharmacist and refers to a 67 year old male patient. The patient's current conditions included chronic obstructive pulmonary disease (COPD). The patient do not have drug reactions/allergies. On 01-JUN-2016, the patient was vaccinated with ZOSTAVAX. Concomitant therapies included montelukast sodium, SPIRIVA, ADVAIR, PROAIR and omeprazole. On 01-JUN-2016, an unknown time after receiving vaccine, the patient experienced COPD exacerbation. On 16-JUN-2016, as a treatment the patient was prescribed albuterol, levofloxacin, and a 3-day course of prednisone (all manufactures unspecified). On 24-JUN-2016, the patient was prescribed a "16-day high-dose prednisone taper" for an unknown reason. Product quality complaint (PQC) was not involved. The outcome of the event was unknown. The reporter did not provide causal relationship between the event and suspect therapy. Additional information has been requested.
This initial spontaneous report was received from a Registered Nurse male patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX 23. Medical history and concomitant medications were not provided. The nurse stated that the patient got at least two doses of PNEUMOVAX 23 five years apart. She was unsure if he received a dose before that, making it three doses administered if previously given. No adverse events were reported. Additional information has been requested.
She began throwing up is, 2 hours of the shot and continued throweing up for 22 hrs. Cried non-stop from 6;30-10;00 pm, 7/19/02 Ran a slight (100.6) fever, Called dr office to report reaction and they advised to give Tylenol and cut milk in 1/2 2ith water. Fever went up later in the week. (I took her to the doctor's.
56 adults patients received doses after its expiration date 13Jul2022; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13Jul2022) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) 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 EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13Jul2022) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13Jul2022) and NO ADVERSE EVENT (no adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13Jul2022).    Concomitant medications were not reported.  Vial size was 5 ml. The vial did not undergo any temperature excursions. This case contains information for the 16th of 56 adult patients. Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case (1 of 56 patient)
patient fainted for a few minutes. developed blue tinged lips, clamy, slow breathing had to be given epinephrine 0.3mg IM
My son started breaking out in a small rash at 10:45pm, and head was a little swollen on top of his head at soft spot, was having problems breathing correctly at the time, taking random big breaths. Screaming violently in random spurts, not wanting to move head or both legs at all, only arms and hands. Cried for 4 hours straight. Took to urgent care the next day at 3:45pm because he broke out in a full body rash including head and a eyes had bloody looking  broken blood vessel.
Diffuse rash both arms, mild puritis. Home care with Benadryl recommended.
eyes are swelling shut up; face is swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SWELLING OF EYELID (non-serious) with onset Nov2021, outcome "unknown", described as "eyes are swelling shut up"; SWELLING FACE (non-serious) with onset Nov2021, outcome "unknown", described as "face is swollen".  Additional information:It was reported that i got the first dose of the COVID vaccine this week and my eyes are swelling shut up and my face is swollen and I had been reading on the paper works that I got from the pharmacy that might be an allergic reaction. I don't know what to do about it but I wanted it to be noted I am not sure if there is some sort of procedure I should do now."   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Bruising from normal everyday activities.  Left side sciatic pain radiating from lower back to lower leg. Sore joints in left hand, left knee pain.
Patient/healthcare proxy did not mention that patient was not feeling well before vaccine. On the vaccine consent and administration record- patient checked off "no" to the question are you sick today- thus there was no indication that patient was not feeling well at the time. After the vaccine- per healthcare proxy and nearby customer patient seemed to be dizzy while walking out of the pharmacy. Ambulance was called by customer who observed the patient.
This case was reported by a nurse and described the occurrence of extra dose administered in a male patient who received ROTARIX (batch number A41CB426A, expiry date 7th September 2015). Previously administered products included ROTARIX (dose 1) and ROTARIX (dose 2). On an unknown date, the patient received the 3rd dose of ROTARIX 1 ml. On an unknown date, an unknown time after receiving ROTARIX, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown. Additional information received: Nurse reported that a third dose of ROTARIX was given to a patient by mistake today. It was just the third dose given today. Other two doses were given to the patient in the past. No symptoms reported.
On days 1- 4, at injection site: red, sore arm, swelling , hot & itching.  Having fatigue and mild headache.
This spontaneous report was received from a nurse concerning to a 6 months old patient of unknown gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 08-JUN-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # K023534, expiration date: 22-MAY-2016) (strength and dose were unspecified), the route was defaulted to oral. No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
SORE ARM; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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. The 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 sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
acute hemorrhagic edema of infancy. Swollen legs and feet. Severe bruised look of the legs and arms for several weeks. Could not walk for over a week. Low grade fever. Multiple erythematous papillose, merciless and patches on Upper and Lower extremities. There was not a treatment. It resolved on its own in a few weeks.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Concurrent or medical conditions were not reported. On 31-MAR-2015, the patient was vaccinated with VARIVAX (Merck) (dose, strength, route and lot number were not reported), that was improperly stored. No adverse effects were reported. No product quality complaint was reported. Additional information has been requested.
CHIEF COMPLAINT:   Mechanical fall into metal cabinet hitting his nose. (-) LOC, (+) thinner, plavix for a-fib. DM hx. CAO x3. (+) IV. Got 100 mL NS from EMS. Bleeding controlled with pressure. L upper arm fistula. R chest port. BPs on R lower arm   HISTORY OF PRESENT ILLNESS:     75-year-old gentleman with a history of ESRD on hemodialysis, A. fib on Eliquis, CAD, COPD, CHF presenting for the evaluation of a fall and epistaxis. Patient states that he tripped on a chair at work earlier this afternoon and hit his face on a metal file cabinet. He reports pain affecting his face and a nosebleed afterwards. Denies loss of consciousness. Presently reporting pain only in his nose. Has been noting pressure on the nosebleed without significant change. Denies back pain, neck pain, abdominal pain.
7AM awoke crying which is unusual-cried (high pitch) on & off until noon;refused to open eyes-babysitter gave APAP & 45min later checked temp 101;2PM eyes open & improved-slept throughout noc;gave APAP routinely;inj site hard, but not red