chrisvoncsefalvay/vaers-outcomes huggingface dataset:
menstrual cramps; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558).  A 25 year-old female patient received bnt162b2 (BNT162B2), administration date 26Apr2021 (Batch/Lot number: unknown) as dose 1,single for covid-19 immunisation. Relevant medical history included: "pre-existing down syndrome" (unspecified if ongoing). Concomitant medication(s) included: ACETAMINOPHEN; IBUPROFEN. The following information was reported: DYSMENORRHOEA (non-serious), outcome "unknown", described as "menstrual cramps". Therapeutic measures were taken as a result of dysmenorrhoea.  Additional Information: Caller, consumer is scheduled to take the 2nd dose of the Pfizer Covid-19 vaccine today at (3:45pm) with her daughter (patient). Daughter has a condition of down syndrome and currently has menstrual cramps. To relieve that, consumer gave her daughter 2 (pcs.) of Acetaminophen 500 mg today at 10:00 am and 1 (pc.) Ibuprofen 200 mg at 10:30 am. However, upon checking the fact sheet she read that these medicines (Acetaminophen and Ibuprofen) should not be given before getting the Covid-19 vaccine. She wanted to know if she needs to reschedule the 2nd dose for her daughter because there might be an interaction with the vaccine or will it be fine to proceed. The 1st dose was given 26Apr (21days schedule).  Created Manual AE Form.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt had fever (100-101), cranky, dec appetite since got shot; sx escalated on 10OCT92 temp noted 102, rapid raspy breathing, twitchy, jerking motions, unable to walk; seen @ hosp t105;
feeling that he worked out hard and that his left arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (feeling that he worked out hard and that his left arm was sore) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced PAIN IN EXTREMITY (feeling that he worked out hard and that his left arm was sore). The patient was treated with GABAPENTIN for Adverse event, at an unspecified dose and frequency and BACLOFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (feeling that he worked out hard and that his left arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided.
Expired moderna vaccine mistakenly administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered). On 02-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was reported.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of MMR II injection, lot # L028273, expiry date 28-JUL-2017 (dose, route of administration and administration site were not specified). Administered doses of MMR II underwent temperature excursion at 75 Fahrenheit degrees for 1 hour and 10 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
( after </=12 hours, myalgia, fevers, chills, HA.  24 hrs: HA, but improving. )  At approx 48 hrs post vaccination, urticaria.  Seen in clinic.  no other organ system involvement/anaphylaxis.  treated with diphenhydramine 50 mg po.
Feels hot, dizzy, passed out . transported by medics to observation area. BP low, Pulse  stable. In observation for 30 minutes recuperate and went home on her own.
Lightheaded about one hour after vaccines.  Later chills , aches, tiredness.  It was gone the next day.
At 4:45 pm, I developed hives on the left side of my face and blotches on my neck. At 5:30 pm, my lower lip and chin began tingling. By 6:00 pm, my face and tongue were numb, my throat was sore, my head and eyes hurt, and my chest was tight. Through November 5, I am continuing to have intermittent sore throat, facial numbness, headache, eye pain, and chest pressure with shortness of breath from normal daily activities. I am still very fatigued and my arms and legs feel heavy and weak. 11/10/09 Medical records received for date 10/27/09. DX: acute allergic reaction. Presented to ER with c/o chest pressure, sensation of throat closing, rash, itching, red, tongue numbness/swelling. Assessment: (+)rash on neck 11/9/09 OV pt feeling better.  Diagnostics/Labs: PPD(-).
Onset of fever (101 degree Fahrenheit occurred at approximately 3:30 pm (3.5 hours following vaccination. The fever was accompanied by significant fatigue and joint discomfort. Over the counter analgesic (acetaminophen) was taken. The symptoms lasted until approximately 8:30 pm, when the fever broke. Joint pain and fatigue remained through evening and night. No symptoms were present the following morning.
Received 1st dose of Hep B vaccine in left deltoid on 3/31/04 at 12 Noon. On 4/1/04 noticed an itchy rash on both shoulders. No soreness or redness at site of injection. Sent to Dermatologist. Given Triamcinolone 0.025% cream and Doxepin HCP 10mg at bedtime.
Blood in urine. Happened after both shots. Didn?t think much of it after the first dose, but definitely happened after the second. Also had a fever (peak at 102.2). Blood in the urine does happen for me occasionally when sick in the past.
On 1/28/21, resident complained of "itching" on her trunk. Upon assessment by R.N., resident was found to have a rash, suspicious of shingles. A telehealth visit was performed with her primary care physician's office Dr. wherein she was diagnosed with shingles. She was prescribed Valacyclovir HCl 1 gm 1 bid x 7 days and Gabapentin 300 mg 1 q day.
Client received a combo vaccine (vaxellis) which included ipv and an additional single IPV dose.
Approximately 13 hours after receiving vaccine I began to feel sick (headache, slightly nauseous, feverish). I went to get ibuprofen at 5:30 am. Without any indication it was coming on, I passed out. I hit my face on our kitchen counter and then fell face first into the floor. I fractured my nose, split open the skin on my nose, completely ripped apart my upper lip, and damaged all four upper front teeth. This resulted in a trip to the emergency room, a CT scan, multiple stitches, root canals, and possible dental implants. I will also most  likely need speech therapy because the muscle around my mouth was torn in two and I will need  orthodontic devices to reposition my teeth. I have never passed out from a vaccine before . I have undergone many surgeries without passing out. I continued to feel flu like symptoms for 3-4 days after receiving the vaccine.
I received the vaccine at 9:00am on October 15th.   Early in the morning on October 16th, I had chest pains and rapid heartbeat.
Pt devel hives/wheals on back 10-12 hrs p/DTP & OPV given; this was reported today @ 5yr PE;
later that day pt exp soreness in arm & motion sickness feeling;the next AM motion sickness feeling worsened, nauseated, trembling, weak;Dexadrine med was also started this day but was stopped p/2 doses that day;motion sickness following da
The client stated the day after receiving vaccinations developed raised areas on his left wrist surrounding the wrist and extending about 4 inches above the wrist. Had some itching and redness in color.  States it did not cause much discomfort and he did not seek medical assistance States symptoms lasted serveral weeks slowly improving over this period.  It has resolved.
After 5+ years of not getting my period (using NuvaRing) now have very heavy periods, strong cramping, etc.
Myalgia, NauseaVomiting, rigors, chills Narrative:  reportedly bedridden with rigors, chills, headaches, body aches and nausea for 36 hrs after second vaccine administration
This spontaneous report as received from a health professional refers to a 6 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 21-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Several days after administration, patient states experienced flu-like symptoms including headache, fatigue, fever, muscle weakness and aches. States muscles in legs were very weak and had a difficult time getting out of bed.
Caller believes that the MMR vaccine and Tetanus shot made both her and her mother sick and that vaccines cause cancer; This spontaneous report was received from a consumer via Pfizer, referring to her mother, a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) and tetanus vaccine (manufacturer unknown) (strengths, vaccination schemes, anatomical sites of vaccination, routes of administration, lot numbers and expiration dates were not reported) as prophylaxis.  On an unknown date, the consumer reported that the shots made her mother sick (illness).  The outcome of illness was not reported. The causal relationship between the event and the suspect therapy was related.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA005734: US-009507513-2109USA005991:
The day of I felt my throat closing off a little about 45 minutes after the vaccine, it lasted about 30 minutes and then slowly resolved.   The location where I got the vaccine Swoll up to the size of a Silverdollar and was raised in very red.  That resolved over a two week period.  I had a bad frontal headache for about a week, my joints eight particularly anywhere I had injured previously, and I was exhausted.   And I had what felt like allergy symptoms in my sinuses.    By the 11th I felt like I had a sinus infection in the mucus I was blowing out of my nose was turning yellow-ish.   My sinuses in my cheeks and forehead hurt, I had drainage.  I did my best to treated at home using saline nose spray.   By 9/30/21 I had been blowing green mucus out of my nose for two weeks.   The sinus pressure and pain was much worse. I went to the walk-in clinic and received antibiotics. They said because I have a history of several sinus surgeries I am more susceptible to sinus infection.
Information has been received from a nurse practitioner concerning a 16 year old female who on 06-NOV-2006 was vaccinated with GARDASIL. In May 2007 the patient completed the dosing schedule. Concomitant therapies included LAMICTAL and birth control. Subsequently the patient was diagnosed with the following HPV strains despite receiving GARDASIL: 16 18 31 33 35 39 45 51 52 56 58 59 68. The patient had sought unknown medical attention. The lab diagnostic test performed: pap smear. At the time of report the patient' s status was not recovered. Follow-up information has been received from a nurse practitioner concerning the 19 (previously reported as 16) year old female patient. The patient had standard pap smear test in February 2006 and the result was all normal. On 06-NOV-2006 the patient was vaccinated IM with the first dose of GARDASIL (Lot# 653736/0689F). On 06-JAN-2007 the patient was vaccinated IM with the second dose of GARDASIL (lot # 655619/1427F) and on 10-MAY-2007 the patient was vaccinated IM with the third dose of GARDASIL. Pap smear were all normal until June 2009. The patient can back to the office in December 2009 and a pap smear test showed Ascus and that the patient was positive with following HPV strains: 16 18 31 33 35 39 45 51 52 56 59 68. In March 2010 the pap smear test was normal again. Additional information is not expected.
infected with covid within 10 days of 1st Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (infected with covid within 10 days of 1st Moderna vaccine) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (infected with covid within 10 days of 1st Moderna vaccine). At the time of the report, COVID-19 (infected with covid within 10 days of 1st Moderna vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) COVID-19 Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient has received 3 hour antibodies infusion and doctor suggested not to take second dose of Moderna until 90 days but when the patient scheduled for the second dose they are told that patient can receive second dose within a time frame of 41 days of their first dose.  No concomitant medications were reported.
About 9:00 pm I tried having sensitivity in my left eye to light and a headache. I came home and went to bed. I got up the next morning and could not stand to have light near my eye and it was swollen. I went to work and my boss a doctor told me to go home and take Benadryl and Duexis for inflammation. I went to bed and woke up about 3:00 pm that day and was running a fever of 102.8 and had pain under my arm and into my breast area. My eye felt better but I was still running a fever, headache and pain under my arm and in my breast. I continued to take Tylenol for the fever over night. The next morning my fever had went down to 100.4. Later in the day the fever broke and I felt better, except for the pain still under my arm and into my breast.  I was able to return to work the next day. I continued having the under arm and breast pain until the end of the week and then it went away. I have not had any other symptoms beside headaches since then.
Chills, shaking, alternating between freezing and unable to get warm, and becoming too warm/sweaty--this occurred the night I received the vaccine. The day after the vaccine I was weak and incredibly fatigued, it was briefly difficult for me to stand without feeling like I was going to fall over/needed to lay down. These symptoms largely subsided after 24 hours. A headache occurred intermittently for at least 3 days. Sore arm lasted about 48 hours.
Extreme GI issues (started pooping every 9-10 days instead of 3-5 times in one single day), Rib breathing for at least 1 month very consistently especially at night time, came down with fever and flu symptoms within a day after, and started scream crying consistently during day and night for no reason and was inconsolable (which had never happened before and with no other lifestyle changes)
Nausea, vomiting, joint aches, muscle weakness, headache, mild fever around 100, 6cm very hot and tender swelling around injection site lasting 3 days (Benadryl applied), now just hard knot around site.  Physical symptoms occurred approx 24 hours after receiving vaccine.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 06-APR-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml, (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 48 hours with the lowest recorded temperature of 32 Fahrenheit degree. The total cumulative excursion time of the second time was 24 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Urticarial rash, non anaphylactic reaction at site and generalized urticarial rash.
Several days after receiving my vaccination with the Moderna product I developed a significant rash of both hands on the dorsal side. It is non-blanching and it's only mildly tender and itchy. It was on my neck a little initially, but that has cleared.
This case was reported by a pharmacist via call center representative and described the occurrence of nausea in a adult female patient who received HAVRIX adult (batch number M252Y, expiry date 17th August 2018). On 17th August 2016, the patient received HAVRIX adult. On an unknown date, less than a year after receiving HAVRIX adult, the patient experienced nausea, fever, diarrhea and vomiting. On an unknown date, the outcome of the nausea, fever, diarrhea and vomiting were recovered/resolved. It was unknown if the reporter considered the nausea, fever, diarrhea and vomiting to be related to HAVRIX adult. Additional details were reported as follows: The patient received HAVRIX adult on left arm. It was reported that, the exact onset date of the events was unknown.
Patient experienced swelling the night of which grew, the day following administration it was very swollen and sore, continued to grow in size expanding to her neck and causing neck pain until she went to the ER 2 days after administration.  Reported numbness in arm and neck, redness of the entire area.  Was given steroids in hospital and 5 day course of PO prednisone 40mg daily + Keflex.  she reports that pain and swelling has decreased and that she experiences more relief after taking the daily steroid.
This spontaneous was received by a Healthcare Worker. The report refers to a patient of unknown age. On 14-OCT-2013, patient was vaccinated with GARDASIL. On 14-OCT-2013, patient was vaccinated with GARDASIL. 03-JAN-2014, patient was vaccinated with GARDASIL. On an Unknown date, the patient came into the office to receive a third dose. No further information was provided. Outcome of inappropriate dose schedule unknown. Additional information is not expected.
8/6 pt noticed injection site of ZOSTAVAX was swollen, red, warm to touch. The area measures 2.5 x 3" swelling and redness 2 x 3". Pt had shot administered on 8/5 at 4pm. Pt is currently self treating w/ BENADRYL at home.
Tightness and pressure in chest from top of shoulder to lower rib cage. Isolated to left-side. Also dizziness and diarrhea. Tingling and numbness in left arm and leg.
cold; Fever 101.00 - 101.7 range; She feels wiped out; Body feels achy; This spontaneous case was reported by a patient and describes the occurrence of NASOPHARYNGITIS (cold), PYREXIA (Fever 101.00 - 101.7 range), FATIGUE (She feels wiped out) and PAIN (Body feels achy) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20M) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced NASOPHARYNGITIS (cold), PYREXIA (Fever 101.00 - 101.7 range), FATIGUE (She feels wiped out) and PAIN (Body feels achy). At the time of the report, NASOPHARYNGITIS (cold) was resolving and PYREXIA (Fever 101.00 - 101.7 range), FATIGUE (She feels wiped out) and PAIN (Body feels achy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported.  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.   This case was linked to US-MODERNATX, INC.   Reporter did not allow further contact; 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.
This spontaneous report was received from a registered nurse and refers to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 14-JUL-2017, the patient was vaccinated with an improperly stored VARIVAX at a dose of 0.5 (units not specified) from lot # N012488 with expiry date: 20-APR-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA004945.
Increasing chest pain and colon discomfort.  I went to hospital on Friday April 9th because of this.  Troponin levels were normal.  Symptoms have been coming and going and are still present.  At times I feel like I am going to black out.  I feel generally unwell and the chest pain is concerning.
CLEAR FLUID FILLED BLISTERS (NOT PUSTULES) ON RIGHT  HAND AND FORARM, LEFT HAND AND FORARM, RIGHT LOWER LEG.  ITCHING, REDNESS.  SCARRING.
low-grade fever; chills; headache; body aches; sore arm; This is a spontaneous report from a non-contactable consumer. A 44-years-old female patient received second of BNT162B2(Formulation: Solution for injection; Batch/Lot number), dose 2 via an unspecified route of administration, administered in Arm Right on 05Mar2021 09:00 AM as 2ND DOSE SINGLE DOSE for covid-19 immunisation. Medical history included allergy with Penicillin from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient received first dose of BNT162B2 (Formulation: Solution for injection; Batch/Lot number), dose 1 via an unspecified route of administration, administered in Arm Right on 11Feb2021 02:00 PM as 1ST DOSE SINGLE DOSE for covid-19 immunisation. Patient did not received any other vaccines within 4 weeks. On 05Mar2021 21:00 AM patient experienced low-grade fever, chills, headache, body aches, sore arm. Since the vaccination, patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.