chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu like symptoms severe chills, fever of 102, headache, body aches, fatigue. Had second COVID, had fever about 100, chills, body aches, chills, headache that lasted for two days.
Itchy rash directly below injection site -- approx. 4 inches x 2 inches -- appeared on 8th day after vaccination
Pregnancy at 6 weeks 1 day on date of vaccination.   Approximately 9 hours after vaccine administration, I experienced sharp rhythmical abdominal cramps with equivalent intensity of full child labor with extreme pain, lasting  approximately 5 minutes, followed by 2 hours of rhythmical abdominal cramps 2-3 minutes apart.  A large amount of clear fluid that was blood tinged was found at 8:30pm.  Then there was bright red blood visible in the toilet and when wiping until approximately 10pm.  From there forward, discharge turned rust colored.  Rust colored discharge was in decreasing amount, but still visible for the next 24 hours (10pm on 2/6/21).  No further discharge on 2/7/21 forward.
Diarrhea ? Generalized Body Aches ? Cough ? Fatigue
Severe local pain at vaccine site on arm. Very severe muscle spasms entire right side of back with deep inflammation around lumbar vertebrae #3. 2 months duration of event treated with trigger point injections. Physical therapy & deep tissue massage.
Bell's palsy; After second shot, 102 fever for 76 hours; vomiting; diarrhea; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 36-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (batch/lot number: unknown) via an unspecified route of administration on 12Mar2021 (36-year-old at vaccination) at a single dose for COVID-19 immunisation. Medical history was reported as the patient did not test positive for COVID, but did have a respiratory illness preceding the bell's palsy. Known allergies: sulfa and tetracycline. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medications the patient received within 2 weeks of vaccination was reported as none. The patient was not pregnant at time of vaccination. The patient experienced adverse events after second shot, was reported as 102 fever for 76 hours, vomiting and diarrhea; all with onset date in 2021. On 30Apr2021, the patient was diagnosed with bell's palsy in emergency room. She was not sure that they were related, just reporting for your tracking purposes. The adverse event result in emergency room/department or urgent care. Treatment received for the adverse event included steroids. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was not resolved.  Follow-up attempts are needed. Further information is expected.
My 13 year old daughter, not sexually active, seems to have a herpes zoster breakout. First ever, blister like breakout on her labia.
onset might have been in Sept. -- I am unsure.  joint/muscle pain...over time worsing with more and more fatigue.  Saw my doctor finally and he did blood work and consulted rheumatologist and belief is my body is reacting to a virus with internal system-wide inflammation.  Given the shot was a live virus to prevent Shingles, I wonder if this is the cause.
Patient under age 18 was vaccinated with Moderna 031A21A, which is a vaccine error, on 4/2/2021. He received his second vaccine  Moderna  008C21A on 4/30/2021, Troubleshooting: Neither original dose vaccinator/screener nor second dose vaccinator validated birthdate.  Unreported as error, found in data mining. He was eligible for the second vaccine per standing orders. A policy requiring vaccinators/scribes to check age was instituted shortly after his first vaccine to prevent this from occurring again.
Administered 0.25ml doses; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (Administered 0.25ml doses) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 dosage form. On 25-Mar-2021, the patient experienced UNDERDOSE (Administered 0.25ml doses). On 25-Mar-2021, UNDERDOSE (Administered 0.25ml doses) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  This report refers to a case of Underdose for mRNA-1273, lot #  017B21A, with no associated AEs.; Sender's Comments: This report refers to a case of Underdose for mRNA-1273, lot #  017B21A, with no associated AEs.
Patient received the vaccine on 9/6/18. Patient stated that on 9/7/18 the area looked like a mosquito bite. Then on 9/8/19 the redness has increased to a large portion of her arm, it is tender to touch, the area is very warm and itchy with a raised, hardened bump. Patient is afebrile. She has tried ibuprofen and did not notice a difference. She stated it doesn't look like it's getting better and it isn't getting worse. Patient was instructed to try a cold compresses to the area and instructed to take Benadryl in the evening. Patient also instructed to contact her prescriber on Monday for further direction.
The mother of this patient was concerned about the persistant swelling at the site of injection on 10/30/00. Swelling noted the day after immunizations received. The mother feels it has gotten "larger", firm, moveable swelling (4cm x 4cm) anterolateral aspect left thigh. No erythema, no tenderness, full range of motion, no medical evaluation sought to date.
In the early evening, I could not raise my arm - very painful when taking off my over-the-head blouse. I felt somewhat chilled. Was just not feeling good - no energy, etc. During the night I woke up 5 to 6 times to urinate. The next morning, the arm still was painful and continued to be to the touch or when trying to lift my arm. About 10 am that morning, Dr. recommended ice, Benadryl, 1 Aleve. I slept for 4 hours and when I was awaken at 3 pm, most of the pain was gone. I felt much better - was even able to play in a "fun" golf scramble in the evening. So the discomfort was certainly short- lived.
4 days after the vaccine I started having periodic sharp pains in my uterus which made me think my period was coming. 6 days post vaccine I started bleeding lightly and the periodic sharp pains continued. 8 days post vaccine I woke up in the most excruciating pain of my life. It was the most severe menstrual type cramps I have ever experienced. I also had a severe headache which I never get. I took 600mg of ibuprofen. The pain continued for hours and I tried my best to breath through it. When I went to the restroom there was only a little blood but large amounts of fleshy tissue began discharging from me. Later that day when the tissue seemed to slow down the pain began to subside to a tolerable threshold (although still more severe than normal). I then began to bleed heavier than any other previous cycle. Normally I have a medium bleed for 2.5 days. This heavy bleeding lasted 6 days. I felt extremely dizzy and weak. Finally when the bleeding stopped I started to feel myself regain strength over the next few days although the sharp intermittent jabs of pain in my uterus lasted about three days after the bleeding stopped. I now am feeling back to normal and recovered. I never went to the ER but came very close to going during that time.
Morning of 7/27/11 fever of 102.6, erythema, tenderness to site, headaches, muscle aches, and fever of 101.4 on 7/28/11 also. Pt took TYLENOL to help with symptoms.
3 days after receiving 1st shot, I woke up as usual & after putting on coffee I returned to dressing room to put in my eye drops...a morning ritual, and as doing so I completely 'blacked out' & fell against the dressing room counter and floor. I have fainted before and this was nothing like that. I don't think I was 'out' long nut when I cam to I was on the floor afraid I had had a stroke or heart attack..ruling that out I slowly got up and after sitting for a minute, called my neighbor and then she called 91. I was taken to the emergency at  Hospital where they ran all kinds of test
Feeling like my shingle are coming on; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Feeling like my shingle are coming on) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced HERPES ZOSTER (Feeling like my shingle are coming on). The patient was treated with PARACETAMOL (TYLENOL) for Hypersomnia, at an unspecified dose and frequency and VALACICLOVIR HYDROCHLORIDE (VALTREX) for Shingles, at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Feeling like my shingle are coming on) outcome was unknown. Not Provided          No concomitant medications were provided.
Severe chest pain woke me up around 3 am on 11/11/21.  Chills.  My husband got me an aspirin.  I went back to sleep until about 8 am.  I didn't feel well all day but the chest pain was mostly gone.  11/12/21, today, I still had some mild chest pain.  I didn't contact my PCP.  This report wouldn't let me change the date from 11/13/21.
This spontaneous report was received from a nurse refers to patients of unknown age and gender. The patients were vaccinated with GARDASIL. No concomitant medications were reported. The nurse reported that unknown number of patients received improperly stored GARDASIL (lot# dose and route not reported). The vaccine was exposed to 0 degree Centigrade (0 C) for 60 days. No adverse effects reported. No further information is available. This is one of the several reports from the same source. Additional information has been requested.
Right after vaccine injection site was extremely itchy. After a few minutes of vaccine my whole body was itchy .  Left arm was extremely sore warm to touch and bruised 45 minutes after vaccine I bleed as if I was getting my period (Bright red blood) spotted until the next day then it was done. I was due for my menstrual cycle on 05/22/2021 which never came I am regular on my cycle.  Topical rash on neck developed after 24hrs , redness, itching and burning
I had received a text message from my father on 9/15/2021 after his first vaccine dose that said "Yeah that shot was not fun Never had a shot that made me feel so bad so quick "I felt bad with in a minute 4 hrs ago and breathing is still difficult it sucks" On 10/23/2021, my father called 9-1-1 and was taken & he passed away 10/24/2021 from what is listed as Massive upper gastrointestinal hemorrhage on his death certificate. I have spoken to people that knew him and said he was feeling sick for the past few weeks, he started taking antacid and Imodium in the days leading up to his death.
Patient reports that since receiving the second dose of shingrix, her upper arm muscle "catches" describing it as the muscle dislocates. She reports that this causes a sudden and sharp pain and that sometimes she can "push the muscle back in place". This condition has lasted since receiving the vaccine and that it is ongoing.
Fever; Weakness; Dizziness; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th November 2020, the patient received Shingrix. On 10th November 2020, 1 days after receiving Shingrix, the patient experienced fever, weakness and dizziness. On an unknown date, the outcome of the fever, weakness and dizziness were unknown.   It was unknown if the reporter considered the fever, weakness and dizziness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported.  The age group was not reported but was captured as adult as per vaccine indication. After receiving dose of Shingrix, the patient experienced fever and weakness some dizziness. The reporter said how long does this last. The reporter did not consent to follow up.
A three inch area surrounding injection site became red, raised and sore 20 hours after the injection. Aches and nausea 36 hours after injection. Soreness and aches resolved 46 hours after injection. Arm continued to be red but no longer sore.
nightmares; joint pain; This is a spontaneous report from a contactable consumer (patient). A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient on an unspecified date experienced nightmares and joint pain. The clinical outcome for the events was unknown.  Information on Lot /Batch Number has been requested.  Follow-up attempts are completed. No further information is expected.
On day 1 I had a fever of 100.7 degrees. On day 2 101.1 degrees, headache, congestion, and fatigue, and  a runny nose. On day 3 I didn't record the fever but I had one as well as headache, congestion, cough, and frequent urination. I also had lightheadedness and weakness. I remember my cough was so bad that I went back to urgent care. I lost my taste and smell. I was put on prednisone. I also had nausea. I took TYLENOL for the fevers. The urgent care doctor told me to take zinc, vitamin B, vitamin C and SUDAFED for the congestion.
little shingles outbreak; "Normal Side effects the first evening (fever & chills)"; "Normal Side effects the first evening (fever & chills)"; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0167) via an unspecified route of administration in the left arm on 07May2021 at 11:45 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. The patient did not receive any other medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8731) via an unspecified route of administration in the left arm on 16Apr2021 at 11:45 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07May2021, the patient experienced "normal side effects the first evening (fever & chills)". On 15May2021, the patient experienced little shingles and was specifically writing about the little shingles outbreak which the patient was having, likely due to the vaccine. It was reported that the patient was 25 years old and an active individual and have never had a shingles outbreak previously. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with valacyclovir (MANUFACTURER UNKNOWN). The clinical outcome of the events "normal side effects the first evening (fever & chills)" and little shingles outbreak were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Missed period for 3 months, then upon return my period went from 6-7 days to about 10-11 days with two of those days very heavy making it difficult to even work bc the flow is so heavy. I have to set my alarm for every two hours to change my ultra tampon(the most absorbent on the market) to ensure I don't have an accident and sometimes two hours is pushing it. The onset of my PMS, fatigue , lower back pain, and headaches seems to start much sooner than before. I have never had easy periods , but these changes are huge compared to before and have yet to subside.
This spontaneous case was reported by an other and describes the occurrence of MIGRAINE (very severe migraine) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. #046B21A) for COVID-19 vaccination.     Concomitant products included ORAL CONTRACEPTIVE NOS.   On 18-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 19-Apr-2021, the patient experienced MIGRAINE (very severe migraine). At the time of the report, MIGRAINE (very severe migraine) outcome was unknown.            Patient took Tylenol to treat symptoms.
R THIGH CELLULITIS, URI. COUGH, CONGESTED, FUSSY. R THIGH WARM, RED. TEMP 101(R). TREATED WITH MOTRIN.
This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Moderna and Bivalent vaccines have undergone several temperature excursions and administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna and Bivalent vaccines have undergone several temperature excursions and administered to patient) and NO ADVERSE EVENT (No adverse event) in a 5-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Moderna and Bivalent vaccines have undergone several temperature excursions and administered to patient) and PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna and Bivalent vaccines have undergone several temperature excursions and administered to patient).    No concomitant product use was reported.  It was unknown whether the patient was diagnosed/tested positive for COVID-19.  The vaccination site was reported as deltoid.
Got first Covid vaccine on 12/31/20.  That night ran a fever>101 and had a headache.  Stated she felt fine after about 10am the next morning and did not have a fever.  On Saturday 1/2/21 she developed a rash on her trunk and arms that itched.  On Sunday 1/3/2021 she developed petechiae on her trunk.  States the rash lasted 2-3 days and they remain on her trunk dark red.  On Sunday 1/10/21 she developed a rash again on her trunk and arms that itched a little and some new petechiae on her trunk.  States she had no other symptoms.
Vomited blood in early am. Was extremely nauseous and unable to keep anything down until around 2pm.
receiving covid vaccine/ and 3 days recently due to covid; receiving covid vaccine/ and 3 days recently due to covid; pain in left calf since 05Jan2022; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a sponsored program (141003).  A 53 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 53 years as dose number unknown, single for covid-19 immunisation; tofacitinib citrate (XELJANZ), oral since Aug2021 (ongoing) (Batch/Lot number: unknown) at 5 mg 2x/day for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "receiving covid vaccine/ and 3 days recently due to covid"; PAIN IN EXTREMITY (non-serious) with onset 05Jan2022, outcome "recovered" (Jan2022), described as "pain in left calf since 05Jan2022". The action taken for tofacitinib citrate was unknown. Clinical Course: It was reported that missed therapy for 3 days (date unknown) prior to receiving covid vaccine, and 3 days due to covid (resumed Xeljanz today). No adverse events due to the missed doses of Xeljanz. Prescription per dispensing system states to take Xeljanz 5 mg two tablets by mouth one time a day, however patient was advised by md to take one 5mg tablet twice a day and no adverse events reported.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided, the events COVID-19 and drug ineffective are assessed as possibly related to BNT162B2 and are unlikely related to tofacitinib. Given the current SARS-COV-2 pandemic in the country of incidence, there is an inherently higher risk of COVID-19 infection regardless of tofacitinib treatment. The case will be reassessed when additional information becomes available.
extreme nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (extreme nausea) in an elderly female patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No medical history was provided by the reporter.  Concomitant products included SERTRALINE for an unknown indication.    In April 2022, the patient received fourth dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (extreme nausea). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) at an unspecified dose and frequency and ACETYLSALICYLIC ACID (ALKA SELTZER [ACETYLSALICYLIC ACID]) at an unspecified dose and frequency. At the time of the report, NAUSEA (extreme nausea) outcome was unknown.            The patient was over 65 years old. The patient received the second booster dose in Apr2022 and experienced extreme nausea but no vomiting. The patient took Pepto Bismol or Alka Seltzer for the side effects.   This case was linked to MOD-2022-640742 (Patient Link).
pain/swelling under arm on side of vaccine, later felt swollen lymph area in arm pit. occasional numb sensation down left arm into wrist and fingers.
Immunocompromised recieved a dose of 0.25 ml; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised recieved a dose of 0.25 ml) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Immunocompromised recieved a dose of 0.25 ml). At the time of the report, ACCIDENTAL UNDERDOSE (Immunocompromised recieved a dose of 0.25 ml) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided. No treatment medication was provided.
Information has been received regarding a case in litigation from a lawyer referring to a currently 66 years old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 02-NOV-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) in a Family Care for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by a provider for the following injury resulting from the patient's zoster vaccine live (ZOSTAVAX) use: postherpetic neuralgia. The outcome of the event postherpetic neuralgia was unknown.