chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Unexpected menorrhagia (heavy menstrual bleeding) with large (larger than half dollars) clots within 12 hours of receiving both the 1st and the 2nd Pfizer covid vaccine shots. (My periods are typically mostly normal and even though I have had heavy bleeding in the past on a few occasions, I've never experienced anything like this before.) After the 2nd shot, in addition to the menorrhagia, I also woke up the next morning with a large (about the size of a dime) subconjunctival hemorrhage in my right eye, at the top center portion of the sclera. It is mostly hidden underneath my eyelid, but is visible when I pull my eyelid back or when I look down or to the sides. (I have never had one of these before and it scared me, so I made an appointment to have it checked out.) Also, after the second shot, I have been experiencing bleeding gums when I brush or floss my teeth, which is also something new and unexpected and not something I typically or have ever experienced. It has now been 6 days since the second shot and I am still bleeding (heavy period bleeding with large clots), my right eye still has the large bloody spot (about the size of a dime), but thankfully my gums have stopped bleeding.
More than recommended interval from the first dose on 21 May 2021; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than recommended interval from the first dose on 21 May 2021) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than recommended interval from the first dose on 21 May 2021). On 21-May-2021, PRODUCT DOSE OMISSION ISSUE (More than recommended interval from the first dose on 21 May 2021) had resolved.        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.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
felt poorly since shot on 18OCT on 24OCT felt large welt on lt arm which had extended in AM lt upper arm 5" by 7" erythematous warm, non-indurated area of erythema; sl ax adenopathy; tx w/E-Mycin 333 tid x 10 days, DPH & ice PRN;
CDC RECOMENDATION IS TO DISCARD VACCINE 70 DAYS AFTER STORAGE IN THE REFRIDGERATOR. PATIENT RECIEVED VACCINATION ON DAY 71.
Swollen lymph nodes on neck. Itchy upper back, possible hives. No fever.
a rash that is on her torso/Body Rash; This is a spontaneous report from a contactable other hcp.    A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 intramuscular, administered in Deltoid Left on 05Mar2021 16:00 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hypertension She is hypertensive, and her cholesterol is on the high side, blood cholesterol abnormal from an unknown date and unknown if ongoing She is hypertensive and her cholesterol is on the high side. Concomitant medication in not reported.  Caller received the second dose of the Covid vaccine and reports a week and a half after administration, she is experiencing a rash that is on her torso. Caller states that she has never had it on her face and consulted with her doctor. Caller states that she does not have discomfort, the rash is only an annoyance. Caller asked if there has been any report of body rash after receiving the Covid vaccine. ER or physician's office required.  She was concerned because it did not get better.  She made an appointment with her PCP yesterday.  They gave her a Steroid injection.  She does not remember the name of the steroid injection and did not have a dose, lot or expiration.  She was using topical ointment to see if it helped, and it did not. It was Triamcinolone 0.1%.  She does not have a dose, lot or expiration.  They were just getting it ready for her at the pharmacy.  There was no dose, just put thin coating on area twice daily.  She used it all and does not have a sample to send. Description of complaint: She does not remember the name of the steroid injection and did not have a dose, lot or expiration.  She was using topical ointment to see if it helped, and it did not. It was Triamcinolone 0.1%.  She does not have a dose, lot or expiration.  They were just getting it ready for her at the pharmacy.There was no dose, just put thin coating on area twice daily.  She used it all and does not have a sample to send. Outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received regarding a case in litigation from a lawyer regarding a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history. In 2009, the patient was vaccinated with ZOSTAVAX, (dose, route, anatomical location, lot number and expiration date were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) as recommended by the healthcare professional. On unknown date, the patient experienced shingles (herpes zoster) and in approximately 13-DEC-2016, the patient was treated for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX (vaccination failure) and suffered serious physical, emotional, and economic damages (emotional distress), as a result of patient's injuries. The patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffered (emotional distress, pain); extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (condition aggravated); lost wages; loss of earnings capacity; and other losses and damages. At the time of the report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased, and the pre-existing unspecified conditions aggravated was unknown. The reporter considered all aforem entioned adverse events to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-threatening and medically significant.
Chest Pain  Shortness of Breath Cough Epigastric pain Nausea Vomiting Diarrhea Arthralgias Myalgias Ansomia Dysgeusia Headache
On January 12 I noticed some pain on L arm at injection site. It became itchy. I noticed redness and swelling. approx 3 inches in length and 2 inches in width .I took some Ibuprofen before bed and it relieved the discomfort. Today the redness , swelling and itchiness is unchanged.
I started feeling twinges, like weird feelings in my chest. It spread to my arms as well. At one point, my left arm was hurting pretty bad one night and I know that's a heart attack type thing. I went to the doctor and have done blood tests and am wearing a heart monitor currently. The palpitations have gone from being very rare to so frequent that they are almost constant. I can't have caffeine at all. I had a cup of coffee and my heart freaked out for the next three days. I'm doing a bit better now, but my resting heart rate is like 103 and it's not WPW syndrome, the doctor told me. So it may be something due to the vaccine, I don't know. I am scheduled to have an angiogram and a CT scan of the chest area. Hopefully we will figure out what's wrong with me, but I can tell you, it started right around getting the vaccine.
4 hrs after injection, site red, hot, itchy, swollen. C/o HA, N/V.
After 6 to 7 days patient went to urgent care w/dark red rash around injection site (3 inches x 1.5 inches). Dx: Cellulitis and given course of KEFLEX. Strength and frequency not known.
No adverse effect; Received both doses of proquad and varivax; This spontaneous report was received from a Nurse referring to a 14-month-old patient of an unknown gender. The patient's concurrent conditions, medical history, drug allergies/reactions and concomitant medications were not reported. On 03-FEB-2020, the patient had subcutaneous administration of a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose/frequency were unknown, lot # S003866, expiration date reported as 08-AUG-2020, but upon internal validation established as 08-AUG-2024) and varicella virus vaccine live (oka/merck) (VARIVAX) (dose/frequency were unknown, lot# R033660, expiry date: 20-NOV-2020) for prophylaxis (inappropriate schedule of product administration). No adverse events were reported. The outcome of the events was unknown.
1 day after receiving the MMR she developed redness around the (L) eye and it deviated medially. She was diagnosed by ophthalmology as a 6th nerve palsy. 4d later developed diarrhea.
Case number PHEH2014US025134, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 56-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 19 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursions began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event reported following this medication error.
Patient states that she has developed a rash on both wrists and wanted to check if it's okay for her to take Benadryl. No other adverse events reported.
The day patient received vaccine, her arm became swollen, tender, red, and painful. Pt iced her arm, symptoms improved. Recommend pt take TYLENOL (cannot take NSAIDS), continue icing, and BENADRYL at bedtime.
SORE ARM; HEADACHE; A SMALL DOT AT INJECTION SITE; This spontaneous report received from a parent concerned a 21 year old male. The patient's weight was 190 pounds, and height was 73 inches. The patient's concurrent conditions included: hay fever, and other pre-existing medical conditions included: The patient did not have past medical history and was not on medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816027, expiry: Unknown) dose was not reported, administered on 08-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced a small dot at injection site. On 09-SEP-2021, the patient experienced sore arm. On 09-SEP-2021, the patient experienced headache. Treatment medications included: acetylsalicylic acid/caffeine/paracetamol/salicylamide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and headache on 10-SEP-2021, and had not recovered from a small dot at injection site. This report was non-serious. This case, from the same reporter is linked to 20210926070.
Narrative: Vaccinated, not boosted pt admitted for cellulitis with incidental, asymptomatic COVID
The nurse stated that while attempting to attach the needle, she cut her finger; The nurse stated that while attempting to attach the needle, she cut her finger; The nurse stated that while attempting to attach the needle, she cut her finger; The nurse stated that while attempting to attach the needle, she cut her finger; VAQTA pre-frill syringed that is missing the finger flange; This spontaneous report was received from a nurse of 51-year-old reporting on herself. The patient's pertinent medical history, concomitant medications, concurrent conditions and drug allergies or reactions were not reported.  On an unspecified date in December 2019 (reported as "a few days ago"), while attempting to attach the needle to hepatitis a vaccine, inactivated (VAQTA)( lot number S019435, and expiration date 23-AUG-2020) for prophylaxis, the nurse cut her finger (limb injury and injury associated with device), and then noticed the finger flange was broken off of the barrel of the syringe. Also, she noticed that the hepatitis a vaccine, inactivated (VAQTA) pre-frill syringed that is missing the finger flange (product container issue). The medication was still in the syringe with no leaking of liquid (occupational exposure to product and circumstance or information capable of leading to medication error). No patient received this dose, no missed doses. The patient did not received medication for the event, and don't sought for medical attention.  It was reported, that there was no crack on the syringe, but it was broken into two or more pieces, near the purple plunger. Also, the entire finger flange was missing all the way around the vial leaving a jagged edge.   The outcome of limb injury was reported as recovering/resolving. The outcome of injury associated with device, circumstance or information capable of leading to medication error, occupational exposure to product and product container issue was unknown.  The causality between the aforementioned events and hepatitis a vaccine, inactivated (VAQTA) was not provided.
WOKE UP SICK JUST BEFORE MIDNIGHT. SEVERE CHILLS, HEADACHE, NAUSEA, VOMITING, DIZZINESS, FEVER UP TO 102, BODY ACHES, TIREDNESS, DIFFICULTY BREATHING, FAST HEART BEAT, SLIGHTLY SWOLLEN LYMPH GLANDS.  SYMPTOMS LASTED 3 DAYS (SEVERE AT FIRST, PROGRESSIVELY EASING BY THIRD DAY).  HEADACHES KEPT RECURRING AND WERE EXTREMELY PAINFUL.  IBUPROFEN DIDN'T HELP.  MIGRAINE MEDS (IMITREX) EVENTUALLY HELPED.
Brief neurosurgery consult note   History:  34 yo woman with extensive VP shunt history, myelomeningocele now with cellulitis over her right breast overlying shunt tubing. I reviewed imaging and it appears that cellulitis is involving old shunt catheter on the right side, potentially tracking up from its origin in the pelvis. Patient is at neurological baseline, head CT and shunt series appear stable on my review. No fevers. WBC elevated.    A/P: 34 yo woman, myelo, vp shunt, cellulitis overlying old right shunt catheter. Potentially tracking from pelvis.  -recommend evaluation and treatment of cellulitis -recommend evaluation by general surgery given fluid collection in pelvis  -no immediate plans for shunt externalization or revision given patient does not have any signs of shunt failure or infection
Within 5 minutes of injection pt felt like she was on fire, syncope, nausea, injection site warm to touch, sweating.
Redness, swelling, warn to touch 24 p receiving infuenza/pneumovax in L arm. Deltoid.
Glaucoma; This case was reported by a physician via sales rep and described the occurrence of glaucoma in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced glaucoma (serious criteria GSK medically significant). On an unknown date, the outcome of the glaucoma was unknown.   The reporter considered the glaucoma to be probably related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient was diagnosed with glaucoma soon after the injection. The patient wanted it reported to the company fearing there could be a relationship with the vaccination.
This man was given his Covid 19 vaccinations at a drive thru clinic held at a local fairgrounds event. He was given the vaccine by a RN. The adverse reaction was an extremely sore arm and neck that this man states happened immediately after he got the vaccine and cont to hurt up his neck.  It continues to hurt today 4-23-21.  His wife is the person to report this and she has been giving him ibuprofen, muscle spray, and using cold and heat on the site to help the pain.
Breakthrough case admission after two vaccines 3/24/21 Pfizer Lot# ER8727 4/14/21 Pfizer Lot# Ew0158
I had 2 shingles vaccines, I have shingles now/suspected vaccination failure; shingles; extreme sinus headache; head on fire; face on fire; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, sinus headache, burning sensation scalp and burning sensation in face. On an unknown date, the outcome of the vaccination failure, shingles, sinus headache, burning sensation scalp and burning sensation in face were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, sinus headache, burning sensation scalp and burning sensation in face to be related to Shingles vaccine and 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 2 shingles vaccines as instructed by doctor.  The patient had shingles at the time of reporting. It was started as an extreme and the patient thought was sinus headache on Friday, today on the day of reporting the patient's head on fire, face on fire went to doctor and sure enough shingles. This case was considered as suspected vaccination failure as the details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting. No contact details were available.
Side effects; This case was reported by a consumer via call center representative and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was not recovered/not resolved.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient experienced side effects after receiving the dose of Shingrix. The reporter wanted to know how long do side effects last after second shingles shot.
Dizzy, refused EMS, Gave water, symptoms resolved. Observed for 30   minutes
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with improper stored ROTATEQ (lot # R003111, expiration date: 12-SEP-2019, strength, dose and frequency were unknown) orally for prophylaxis. The vaccines had temperature excursion of 32 F to 35 F (34.9) for 1 hour 10 minutes and 47 F to 77 F (51.6F) for 1 hour 5 minutes. Previous temperature excursion was 32 degree F up to 35 degree F for 3 hours 12 minutes. The call was due to the digital data logger. No adverse event was reported. No product quality complaint involved.
Hep A given instead of Hepatitis B.  Medical Assistant handed the wrong vaccine to the administering MA.
Seeing dots in my vision.; high blood sugar; Dizzy; Felt jittery; felt weird; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), FEELING JITTERY (Felt jittery), FEELING ABNORMAL (felt weird), VISUAL IMPAIRMENT (Seeing dots in my vision.) and HYPERGLYCAEMIA (high blood sugar) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN and ERTUGLIFLOZIN PIDOLATE (STEGLATRO) for an unknown indication.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced DIZZINESS (Dizzy), FEELING JITTERY (Felt jittery) and FEELING ABNORMAL (felt weird). On 07-May-2021, the patient experienced HYPERGLYCAEMIA (high blood sugar). On 15-May-2021, the patient experienced VISUAL IMPAIRMENT (Seeing dots in my vision.). On 14-May-2021, HYPERGLYCAEMIA (high blood sugar) had resolved. At the time of the report, DIZZINESS (Dizzy), FEELING JITTERY (Felt jittery), FEELING ABNORMAL (felt weird) and VISUAL IMPAIRMENT (Seeing dots in my vision.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-May-2021, Blood glucose: 178 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
This spontaneous report has been received from a healthcare worker (also reported as clinical manager) refers to a patient of unknown age and gender who on 06-MAY-2014 was vaccinated with a dose of ZOSTAVAX (strength, dose and route not reported, lot # J008802, expiration date: 19-OCT-2014), that had been improperly stored. The temperature during the excursion was unknown, as it was not monitored. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Experienced 103 fever, delirious stumbling, falling, site was raised, red, and feverish occurred 48 hrs after administered.
Become ill; 1st dose of Shingrix on August 2018 and has not completed the schedule/because of the pandemic, the patient did not receive the 2nd dose; This case was reported by a pharmacist and described the occurrence of illness in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In August 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced illness and social problem. On an unknown date, the outcome of the illness and social problem were unknown.   The reporter considered the illness to be unrelated to Shingrix.  Additional information was provided as follows: The age at vaccination was not applicable for 2nd dose. The patient did not complete the schedule.  The patient become ill a time later after receiving the 1st dose (he said it was not related to the vaccine, did not specify which illness) and then because of the pandemic, the patient did not receive the 2nd dose. The reporter did not have vaccination details but agreed to follow up.
15 hours after receiving immunization in the left arm the patient became swollen and painful with  red splotchy rash. Within 48 hours symptoms subsided.