chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dose administered greater than 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post puncture) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017f21a) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post puncture). On 07-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.  The patient received dose from vial that was first punctured on 30 Nov 2021 and put on the refrigerator since then.It was reported that, date the vial was initially stored in the refrigerator was 30 Nov 2021. Date the vial was first punctured was on 30 Nov 2021 time was assumed around 8 AM.
After about 5 minutes I started getting hot and cold flashes and feeling light headed. If felt like I  would faint, but I didn't faint. This lasted for over 30 minutes. I then left the store. For the next hour I felt lethargic and started feeling nauseous. After 1 hour I had severe uncontrollable nausaea and vomitting, this continued until I went ot sleep 3 hours later. After 2 hours I experienced dry heaves and could not hold down any liquids. After 3 hours I was extremely tired and needed to sleep, I slept for 6 hours until 11pm and then felt better. The following day I had a sore arm, felt sick and needed to rest, then felt better the day after that. My left arm was sore for 3 or 4 days.
Vaccine was administered on 7/7/2021.  On 7/9 pt woke up feeling like something heavy was sitting on her chest and said it was hard to catch her breath. She would get winded walking up a flight of stairs. Symptoms worsened throughout the day and was taken to the ER around 2am on 7/10/2021. Upon arrival at the ER, she rated her chest pain a 6/10. A CXR and EKG were completed and returned normal. She was diagnosed with inflamed tissue around her sternum and told to continue to take Motrin at home.
Moderna COVID-19 Vaccine EUA.  Sore arm and headache the evening of 2/4.  Chills and malaise the evening of 2/5.  Took ibuprofen the evening of 2/5.  All symptoms gone the morning of 2/6.
Today, 11/7/23, pt came for visit to see me and reported severe left upper shoulder pain since flu vaccine above on 10/24. Felt like vaccine was placed too high and had instant pain and felt like something wasn't right. Gave it a few weeks to resolve but had persistent pain subacromial/upper deltoid, especially w/ movement. On exam, no swelling, redness, increased warmth, effusion. full passive range of motion, normal internal rotation, pain w/ adduction and cross arm movement. normal sensation, warmth to left arm, hand.
patient says that she fell sick after few hours of getting the flu shot this time  and she had vomiting vast. this happened later in the night after getting her vaccination. She feels that while she has never felt sick after getting flu shots for many years, this year has very different and she is not feeling very well still.  She also headache after for few days which is now better as she took aleve for treating her headache. She says that she has never had any reaction to any vaccines in the past and therefore this was a little abnormal
Pt was given a Hep-B and MMR on 8/16/01. On 9/26/01, she developed a unilateral blurry vision and was subsequently dx'd with retrobulbar neuritis. This was transient (about 2 weeks).
fever, chills, body aches within one hour.  Unable to move right arm.  Symptoms worsening throughout next 48 hours to include chest pain, chest tightening, weakness, nausea, dry heaving,  diarrhea, elevated heart rate, tremors, blurred vision and confusion,  inability to swallow leading to trip to urgent care for allergic reaction and transport to ER by ambulance  for tachycardia and allergic reaction to flu shot. ER DR advised upon DC to follow up with PCP and said each reaction would become more severe and not to take the flu vaccine ever again
Patient had onset of chills, flushing, tearing of eyes, runny nose and fatigue
DTaP was given 2 days ago, Patient presented to clinic with redness and swelling on 2/3 of the anterior left thigh where the shot was given.
No additional AE reported; temperature excursion VARIVAX has been administered; This spontaneous report was received from a medical assistant referring to a 16-month-old (also reported as 14-month old) female patient. The patient's illness at vaccination and pre-existing allergies, birth defects and medical conditions were reported as none. The birth weight was 9 lbs. The patient had 1 sister. Concomitant therapy included sterile diluent (manufacturer unknown) and hib vaccine conj (tet tox) (HIBERIX).    On 26-MAY-2022, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot number U025790 (also reported as U02590), expiration date: 19-AUG-2023) (The vaccine underwent a temperature excursion of 5.5 Celsius degree for 5 hours and 6 minutes on 26-MAY-2022 (vaccine was moved to refrigerator to deforest freezer at 07:49, returned to freezer at 12:55, min temperature in fridge: 4.46 Celsius degree, max temperature in fridge: 5.55 Celsius degree, the excursion occurred as a result of digital data logger)) 0.5 ml subcutaneously at right thigh for prophylaxis (product storage error) at a private doctor's office. No adverse event was reported (no adverse event). The vaccine was used according to the instruction leaflet. The vaccine was no longer in office and no longer available for return or evaluation.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA007524:MSD US-009507513-2206USA007508:MSD US-009507513-2206USA007509:MSD US-009507513-2206USA007511:MSD US-009507513-2206USA007512:MSD US-009507513-2206USA007513:MSD US-009507513-2206USA001254:MSD
This spontaneous report as received from a registered nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX, lot # L010144, expiration date- 24-MAR-2017, lot # L017144, expiration date- 13-MAY-2017, lot # L013827, expiration date- 21-APR-2017, lot # L001333, expiration date- 13-JAN-2017, and lot # L013827, expiration date- 21-APR-2017. No concomitant medication was reported. No adverse event was reported. No product quality complaint (PQC) was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient did not have any pertinent medical history, concurrent conditions, drug reaction/allergy neither was taken any concomitant medication. On 28-DEC-2017, at pharmacy, the patient was vaccinated with PNEUMOVAX23, intramuscularly, lot # N023651, expiration date on 20-MAY-2019, for pneumonia (strength and dose were not reported). On 28-DEC-2017 (also reported as 28-DEC-2019), the patient experienced facial flushing, lower back pain, erythema on both hands and complained of feeling faint. The patient sought medical attention; thus, the paramedics were called to the scene and the patient's vitals were taken. Then, she said that she felt fine. The episode lasted for 15 minutes and the pharmacist instructed the patient to take TYLENOL and to apply a heating pad to her lower back. Finally, no laboratory studies were performed. On 29-DEC-2017, at morning, the patient called the pharmacist and said that all her symptoms have resolved at an unspecified time after TYLENOL and heating pad were used. The causality assessment between the events and vaccination with PNEUMOVAX23 was not provided.
2 episodes of shingles on my right upper arm. First episode was 2/26/21, second episode was 7/4/21. Both episodes cleared after 10 day course of valacyclovir HCL 1gm
4 x 6 inch redness, swelling, (L) anterior thigh within 48 hours of vaccination.
Localized area of erythema and med heat 8-10 cm right buttock, surrounding injection site.  No fever or systemic signs.
feels very very itchy at sight of injection; soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (feels very very itchy at sight of injection) and VACCINATION SITE PAIN (soreness) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (feels very very itchy at sight of injection) and VACCINATION SITE PAIN (soreness). At the time of the report, VACCINATION SITE PRURITUS (feels very very itchy at sight of injection) and VACCINATION SITE PAIN (soreness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.
got shot, have shingles/Suspected vaccination failure; had shingles; painful shot; pain in my rear; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, injection site pain and pain. On an unknown date, the outcome of the vaccination failure, shingles, injection site pain and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, injection site pain and pain to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had shingles got shot which was painful, had shingles again and pain in rear. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.
This spontaneous report as received from a pharmacist refers to a 58 years old male patient with no pertinent medical history and drug reactions/allergies. On 15-JUL-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot# J000783, expiration date: 30-APR-2014), unspecified dose and route at an unspecified location. No concomitant therapies were reported. On 16-JUL-2013 the patient developed a red, itchy area, warm to the touch, about 6 inches below the injection site of the ZOSTAVAX vaccination (no rash reported). The patient had sought medical attention via contacting pharmacy. No lab diagnostics studies were performed. At the time of report, the outcome of the events was not recovered. This is one of several reports received from the same source. Additional information is not expected.
Red island like rash around site of immunization. Fever that abated with use of Ibuprofen, and rash was warm and caused pruritus.
On 11/18/21, the patient complained that since receiving her second shot, she had decreased range of motion in her left shoulder causing difficulty with ADL's and the range of motion never improved.
pt rcvd 3 doses of vax; BC was positive for H. influenzae; was admitted to hosp w/ dx of sepsis;
Information has been received from a physician concerning a 33 year old female who in January 2000 was vaccinated with one dose of varicella vaccine. Concomitant therapy included one dose of tetanus toxoid and one dose of MMR vaccine. It was noted that the pt received these vaccinations "just prior to conceiving." Approximate LMP 02/07/2000. On 06/26/2000, the pt was seen by a physician and an ultrasound was performed. The results indicated "a singleton fetus growing appropriately for gestational age at the 50-75th percentile. Amniotic fluid volume is normal. The placenta is anterior and unremarkable in appearance. No anomalies are identified." The reporting physician noted "would also like to see her follow-up ultrasound evaluation in 6 weeks, specifically to look at fetal limb lengths and to assess the appearance of the lens of the fetal eyes." Follow-up info received from a physician, indicated that on 08/07/2000 the pt had an ultrasound which revealed the following :weight 885 grams, gender: female, no anomalies, limbs, eyes and heart all OK. Follow-up information received from a physician revealed that on 09/23/2000, at 33 weeks, 2 days gestation,t he pt delivered a baby weighing 3lb. 15 oz. The physician's notes indicated that the baby was healthy and normal. It was also noted that the pt had a previous preterm delivery as well. No further information is available.
Client called EIPHD on 8/27/09 reporting symptoms of fever, body aches, redness and tenderness at site of injection. Visited EIPHD on 8/28/09 stating fever subsided yesterday. Redness on upper arm extending along back of arm from below injection site to elbow. Red area on arm was warm. Patient reports shoulder joint stiffness in right limb.
This case was reported by a consumer via other manufacturer and described the occurrence of nasal stuffiness in a 29-year-old female patient who received BOOSTRIX for prophylaxis. On an unknown date, the patient received BOOSTRIX at an unknown dose. On an unknown date, unknown after receiving BOOSTRIX, the patient experienced nasal stuffiness. On an unknown date, the outcome of the nasal stuffiness was unknown. It was unknown if the reporter considered the nasal stuffiness to be related to BOOSTRIX. Additional details were provided as follows: The initial information received by other manufacturer on an adverse event report associated with GlaxoSmithKline's BOOSTRIX. The age at vaccination was not reported. No additional information was available.
First dose was given 12/21/20 and second dose was given 1/6/2020 at day 16.
After the injection Patient had uncontrollable screaming fits, and restlessness for just over 1 week. Email sent to Doctor. See below: Dtap This message is being sent by lady on behalf of Patient I forgot to mention in our last well check for Patient that he acted strange following his dtap shot that he received a few weeks ago. Initially he didn't get a fever or scream but that evening and the following 4 days he would just scream all the time. It wasn't crying, just screaming. I tried to figure out what was going on but he wasn't able to sit and play or sleep like he usually did. The screaming finally let up and now I am attributing this behavior to the dtap shot. His sister had a horrible reaction to dtap when she was his age resulting in inconsolable crying for 3 or more hours after the shot a very high fever and huge red circle on the injection site. The vaccine insert warns that an infant with these types of reactions should not continue to receive that particular vaccine. I know my son, and I know that wasn't normal behavior for him. I wanted to let you know. Like I said I forgot to mention at his well check. Thank you.
Initial report was from a health care professional on 26 September 2011. A 72 year-old male patient with no reported past medical history had received FLUZONE HIGH-DOSE (lot number, route, site and date of administration not reported) and an unspecified amount of later, experienced a high fever of 103 and chills. The patient was hospitalized overnight and was told it was a "reaction from the flu vaccine". No further information was available at the time of the report. The patient's outcome was not reported. Follow-up information was received from a health care professional on 24 October 2011. The patient had received the FLUZONE HIGH-DOSE, lot number UH457AA on 22 September 2011. He was admitted to the hospital and kept overnight. The patient was reported to have died on 22 September 2011 but was also reported to have recovered. No further information was available at the time of the report. Documents held by sender: none.
Chest tightness; The caller's chest burned yesterday; Shortness of breath; The caller has been taking deep breaths; This is a spontaneous report from a contactable consumer (patient) reported for herself that. A 47-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 06Apr2021 (Batch/Lot Number: ER8737) as DOSE 1 SINGLE for covid-19 immunization. The patient medical history included slight heart murmur from an unknown date and unknown if ongoing, Blood pressure high Diagnosed about 20 years ago and Allergic to sulfa from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The caller had shortness of breath last night 06Apr2021 and her chest was tight this morning 07Apr2021. The caller has been taking deep breaths, the tightness is gone but she is still having to have deep breathe on Apr2021. The patient underwent lab tests and procedures which included sars-cov-2 test negative on unspecified. The event outcome was recovering for Chest tightness, Unknown for Chest burning and breathing abnormally deep and Not recovered Shortness of breath.  No follow-up attempts are possible. No further information is expected.
Right thigh erythema, swelling and itching - seen in ER given BENADRYL and MOTRIN. Fever 103 degrees.
Fever 100.4/body aches/headache 24 hours-ibuprofen x 2 doses
pt exp hives over entire body -swelling of eye lids-anaphalactic rxn
Patient was vaccinated Thursday, May 27, 2021. Patient indicates that from the day after, Friday, May 28, 2021, he lost taste and does not feel hungry.
Breakthrough COVID Case. This patient completed covid series in January. Tested positive for covid 5/4/21 after cohabitant (wife) had covid
I went into Atrial Fibrillation four weeks after the third dose of the vaccine. I have a history of Atrial Fibrillation, but it has been stable since an Ablation five years ago. I recognized that I was having Palpitations and abnormal Heartbeat because I have gone through it before. I went to the ER and they did a Cardioversion. It seems to be back under control. I also had elevated Thyroid levels. I was prescribed a higher level of Levothyroxine and I was prescribed Xarelto.
I got horrible hives 1wk after the first Moderna vaccine.  It's been  3 weeks now and they still haven't gone away. I'm on prednisone, high doses of antihistamines, Pepcid, singular. And have now started on Xolair.
First shot(04/21/21) on Left Arm. Left arm still hurts a lot every day, muscle soreness and hot at injection site sometimes. 2nd shot on Right arm, not sore but day after (04/30) had extreme dizziness, heart palpitations, Head-Ear ache-EMT homecheck, diagnosis adverse reaction from 2nd shot on 05/06/21 dizziness, fever 101, went to urgent care, given antibiotics for probable ear infection..07/30 more extreme dizziness with nausea, heart palpitations, went to ED.
I had an allergic reaction over night; I was a bit sleepy after getting my vaccine but that seemed normal; my left eye had swole up; throat was scratchy; This is a spontaneous report from a contactable consumer (patient). A 19-years-old non pregnant female patient received BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number was not reported) via an unspecified route of administration on 26Apr2021 13:30 (Age at vaccination was 19 Years) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history included known allergies: I am allergic to a few different types of fruit and also most pets, covid-19 from an unknown date and unknown if ongoing covid prior vaccination. The patient had been diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications the patient received within 2 weeks of vaccination. Concomitant medication was not reported. On 27Apr2021 07:30, it was reported that the patient had an allergic reaction overnight. I was a bit sleepy after getting my vaccine but that seemed normal. I went to bed a little late that night and when I had woken up on the morning of the 27th my left eye had swole up and my throat was scratchy. I took some allergy meds and waited to see if it would help. It got better throughout the day, but the swelling still is not fully gone. Allergy medication had been taken for allergic reaction while no treatment received for rest of the events. The outcome of the events was recovering.  This follow-up was being submitted to notify that the lot/batch number was not available despite the follow-up attempts made. Follow-up attempts completed. No further information was expected.
Approx. 30 minutes, post vax, pt notes swollen eyes and difficulty breathing. The PE noted wheezing throughout lung fields. Rx'd Benadryl 50mg IM X 1, then 25mg; albuterol; Epinephrine 1:1000 0.3ml SC X 1; Solu-Medrol IV; Ranitidine 50mg IV.