chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 12-DEC-2017 and 27-MAR-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength were unknown) (lot# N004815 and expiration date 07-OCT-2018; lot# M022173 and expiration date 15-MAR-2019) orally for prophylaxis, respectively. The MERCK STERILE DILUENT (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments:  US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
Raised red nodules that are painful and itchy.   These bumps come and go.  Have been occurring since second vaccine.
received COVID-19 vaccine while pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (received COVID-19 vaccine while pregnant) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 08-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY. At the time of the report, EXPOSURE DURING PREGNANCY (received COVID-19 vaccine while pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  Treatment medications were not provided.
Red  spot size nickel.  No pain in arm.   Flu like aches. Woke up vomiting violently that night approximately 2:00am, headache
Patient felt fine until time of first vaccine on 1/4/2021 after which he developed fatigue and fever and then developed a cough. Started cefpodoxime x 3 days, further work up included chest xray with no findings on 1/11/21 and a chest CT on 1/13/21 with large lower lobe consolidation. He was directly admitted on 1/13/21 for pulmonary abscess. On admission he had leukocytosis and fever of 103. Workup did not identify an infectious cause but raised concerns for an auto immune cause such as Wegener Granulomatosis. Remained febrile for about 14 days
Developed severe and persistent tinnitus approximately one week after first injection. Did not have any tinnitus before vaccine. Tinnitus present in both ears but worse in left ear. No other side effects except for sore arm and fatigue.
Red, swollen, heated and painful area 2 inches around the injection site and it lasted 4-5 days.
Moderately severe abdominal pain and bloating, Jan 19 - Jan 28 (10 days) Moderate chest/lung pain Jan 26 - Jan 31 (6 days) Fever hovering around 101 (highest 102.1) Jan 29 - Jan 31 (3 days) Extreme fatigue Jan 28 - Jan 31 (4 days) Severe headache Jan 29 - Jan 31 (3 days)
Mild itching about 9:00 AM that escalated to a rash on my upper arms, stomach, thighs and feet.  The itching  sensation increased considerably throughout the day.
4 days of giant hives. Used BENADRYL to control them. I have had yearly flu shots all my life and never had a reaction before.
Non-viable due to temperature excursion of refrigerator and vaccine was too warm. It was not reported right away and that is why the bad vaccine was given. All the pt.'s have been found, told, and awaiting either the 1 month or 6 month return for repeat vaccine. No actual adverse events reported.
slight ache at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (slight ache at the injection site) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concomitant products included APIXABAN (ELIQUIS), LATANOPROST, BRINZOLAMIDE (AZOPT), NETARSUDIL MESILATE (RHOPRESSA), FLUTICASONE, LOSARTAN, ROSUVASTATIN, METFORMIN, GLIMEPIRIDE, PARACETAMOL (TYLENOL), FISH OIL, COD LIVER OIL, CINNAMON [CINNAMOMUM VERUM], VITAMIN D3, CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) and MELATONIN for an unknown indication.    On 05-Feb-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 PAIN (slight ache at the injection site). At the time of the report, VACCINATION SITE PAIN (slight ache at the injection site) 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.   This case was linked to MOD-2021-045572 (Patient Link).
Patient has experienced arm, shoulder and upper back pain since injection. She has also lost range of motion in the arm and neck.  Patient has attributed it to the last vaccine of moderna, the first two doses were pfizer (patient did not experience these symptoms with pfizer).
Information has been received from an office medical assistant concerning a female patient who on an unspecified date, was vaccinated with a dose of GARDASIL (which specified dose was unspecified). Subsequently the patient experienced a delayed period by one month. At the time of reporting, the outcome was unknown. It is unknown if the patient sought medical attention. Additional information has been requested.
Pain; Dizziness; cannot walk safely; This is a spontaneous report from a contactable consumer report self. This 74-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at right arm on 12Jan2021 15:30 at single dose for covid-19 immunization. Medical history included ongoing diabetic diagnosed about 5 years ago or longer, had COVID back in Nov2020, he was in the hospital for 3 days with pneumonia and was sent home and he could not keep his oxygen levels up, then he was put on oxygen and he just got off oxygen 2 weeks ago. Concomitant medication included ongoing Metformin for diabetes for years. No prior vaccinations within 4 weeks. No additional vaccines administered on same date. The patient received the first dose of Pfizer covid vaccine on 12Jan2021 and had a reaction. His pain started around 12:30 to 1am last night (13Jan2021). He took Aleve this morning for the pain. The pain is now getting close to where he would have to take another Aleve. The pain was probably getting worse. He started experiencing dizziness on 13Jan2021 afternoon and he cannot walk safely, the doctor is aware. He will try to get to the bedroom to get in bed. The outcome of events was not recovered.  Information on the lot/batch number has been requested.
INCORRECT STORAGE OF VACCINE; VACCINE ADMINISTERED AFTER STORAGE OUTSIDE OF RECOMMENDED STORAGE CONDITIONS; This spontaneous report received from a health care professional concerned a 31 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809 expiry: 04-AUG-2022) dose was not reported, administered on 11-JAN-2022 for prophylactic vaccination. Age at time of vaccination 31 years old. No concomitant medications were reported. On 11-JAN-2022, the patient experienced vaccine administered after storage outside of recommended storage conditions. On an unspecified date, the patient experienced incorrect storage of vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered after storage outside of recommended storage conditions and incorrect storage of vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20220558451, 20220558511, 20220558390, 20220558439, 20220558823 and 20220558598.
Date and time adverse event started: From 1st dose ADE started same day (3/10/2021) at unknown time. From 2nd dose ADE started (4/2/2021) approx. 8:30pm Adverse events experienced and are they still occurring now:  From 1st dose: patient reported that on same day vaccine was administered (3/10/2021) she had some pain in her left arm so she took Motrin one time same day. The next day (3/11/2021) her left elbow and arm were swollen, sore, painful and she had muscle hardness, patient reported those symptoms subsided 6 days later without taking or applying any treatment. From 2nd dose: approx. a few minutes from rcvding the vaccine on (3/31/2021) she had experienced headache and dizziness, which she reported went away before leaving the vaccine administration site. Then on (4/2/2021 approx. 8:30pm), patient reported that the entire right side of her body from the foot, ankle, leg, armpit, shoulder areas there's burning sensations, and swelling. The left calf is also swollen and hard to the touch. Right arm red rash developed, hot to the touch, swollen, painful and burning sensation. Her left knee gotten red. Stomach pain/cramps. From last night until today, mild headache to right side of her head.    What happened as a result of the adverse event? Patient reported for 1st vaccination ADE, she took Motrin one time on 3/10/2021. For her 2nd vaccination ADE, she took only 2 tablets of Bendaryl on 4/2/2021, and stated her swelling went down a little this morning when she woke up. She also reported that the right arm rash, swelling, pain and burning sensation subsided and that the redness on her left knee also went away. As of 4/3/2021, patient reported that her right leg, armpit and shoulder is still swollen, existing burning sensations, still extremely red, hot and hard to the touch. She reported she felt like her pain is not getting better.   ***NOTE*** Recommended patient to go to urgent care or the hospital to get her symptoms check out as soon as possible since she stated that her pain and swelling is not getting better on the right leg, armpit, and shoulder.
new employ had too much time between vaccines primary series- approx 10 months inbetween; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (new employ had too much time between vaccines primary series- approx 10 months inbetween) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (new employ had too much time between vaccines primary series- approx 10 months inbetween) and NO ADVERSE EVENT (no adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (new employ had too much time between vaccines primary series- approx 10 months inbetween) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (new employ had too much time between vaccines primary series- approx 10 months inbetween).    No concomitant medication was reported.    New employ had too much time between vaccines primary series- Approx 10 months in between. No treatment information was reported.   Reporter did not allow further contact
Information has been received from a consumer concerning her 11 year old son with allergies to egg, peanuts and tree nuts who on 14-SEP-2009 was vaccinated with a 0.5ml dose of VARIVAX (Merck) (lot#, route and site of administration not reported). There was no concomitant medication. On 14-SEP-2009, several hours later, the patient experienced chest pain and felt like someone was sitting on his chest. A few hours after that, his throat started swelling. Medical attention was sought and he was given BENADRYL (manufacturer unknown) and was fine. There were no laboratory diagnostic studies performed. On 14-SEP-2009 the patient recovered. No further information is available.
13 hours after the second vaccine was received I developed chills, shivering, fever, body, and joint pain.  After taking Tylenol 1000mg the symptoms went away for 5 hours. The same symptoms came back two more times overnight.
The right deltoid upper arm has a red spot, tender, and hot to touch. Area size of a small orange on 01/25/01 at 10:23 PM.
My face turned very red 20 minutes later with no additional symptoms and went away over the next hour. Almost 24 hours later, I noticed a rash on my lower left back (the side I received injection).  The rash continued to spread for 2.5 weeks and has been quite itchy. I have been using hydrocortisone cream to ease the itching.
Patient received Pfizer 5-11yrs, no adverse event noted while observed for over 30min after administration, also nothing reported by family as of 7/21/2022 when assessed by phone 9:15am.
Presented with acute respiratory failure; found to be COVID-19+; tx w/remdesivir, steroids, zinc, abx, O2;
I was on day 3 of my period and I had very heavy bleeding. I passed a blood clot the size of the palm of my hand. I felt extremely tired and thought I may pass out, so I called the advice line, and they suggested I go into the emergency room.  When I went into the emergency room, they did a vaginal ultrasound, and they found a polyp.  They also did some blood work and a pregnancy test.  They gave me an IV with Tranexamic acid. The doctor referred me to my OBGYN for follow up.  I went to see my doctor on 3/2/23. She did an endometrial biopsy, and the results came back normal.  I was diagnosed with Adenomyosis. I was prescribed Tranexamic acid for when I experience heavy bleeding.
Warm, pink/red tender area.  No fluctuance.  Temp 99.1.
Pt. stated he received Flu vax Tues 10/4/11 and noticed rash on forehead with Rt. sided jaw pain later that day, but no reaction at injection site.
suffered with fatigue. headache all day long. I feel like im getting the flu. Im hot and cold, i have chills. at the injection site its all red ad hard and hot. sleep all day
covid-19 positive; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (covid-19 positive) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (covid-19 positive). At the time of the report, SARS-COV-2 TEST POSITIVE (covid-19 positive) outcome was unknown.            No concomitant medication provided by the reporter no treatment information reported by the reporter   This case was linked to US-MODERNATX, INC.-MOD-2021-155098 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-155098:Crosslinked case of reporter friend case
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 18-APR-2016, the patient was vaccinated with an improperly stored does of ZOSTAVAX lot L034724, expiration date 09-DEC-2016 (dose and route of administration were not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
shingles; This spontaneous report has been received from a lawyer regarding a case in litigation, referring to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant medication were not reported.    In 2015 the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, strength, batch/lot# and expiration date were not reported) for the long-term prevention of shingles and/or zoster-related conditions. At the time of the patient's vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through the patient's healthcare provider(s) that zoster vaccine live (ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced the patient to be vaccinated. Alternatively, in 2015, the patient's healthcare providers relied on the warning label affixed to the zoster vaccine live (ZOSTAVAX) vaccine, believed that it was effective in preventing shingles on a long-term or permanent basis that it did not carry any significant risks of adverse effects.   On an unknown date, reported as subsequent to the patient's zoster vaccine live (ZOSTAVAX) inoculation, the patient experienced shingles and was treated. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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 include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was unknown. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered the event shingles to be serious due to hospitalization and life threatening.
some fluctuation in blood pressure; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE FLUCTUATION (some fluctuation in blood pressure) and FATIGUE (tiredness) in a 78-year-old female patient who received mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2023, the patient received dose of mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (unknown route) 1 dosage form. In 2023, the patient experienced BLOOD PRESSURE FLUCTUATION (some fluctuation in blood pressure) and FATIGUE (tiredness). At the time of the report, BLOOD PRESSURE FLUCTUATION (some fluctuation in blood pressure) and FATIGUE (tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: some fluctuation.         Concomitant product use was not provided by the reporter. Treatment information was not provided.
Initial symptoms were chills, low grade fever, nausea and fatigue.  GI symptoms progressed to extensive gas for 10 days and stool that was pale and soft.
Received immunizations Friday. By Saturday evening, arm hot, swollen, tender. Went to ER due to SOB - received Nebulizer treatment and allergy meds and sent home. Sunday - swelling increased to hand; back to ER, admit. In hospital Sunday - Monday receiving IV Rocephin q 12, took 1 pain pill starting to improve. Fever presented Saturday and Sunday. Monday 5 PM, swelling and minimum fever - no SOB. Follow-up: Recipient describes bouts of pruritis in area of administration on arm. Recipient has been stricken with excessive fatigue since event. Physicians are investigating possible causes. Recipient will be participating in sleep study to rule out sleep apnea. Recipient has history of asthma. Recipient has not identified further swelling or range of motion problems since his hospitalization and treatment.
Expired vaccine used; Product administration error; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.
(unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE RASH (rash at the injection site). At the time of the report, VACCINATION SITE RASH (rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Batch / lot number of vaccine was unknown  No concomitant medications were reported Treatment medications was not provided   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 event, a causal relationship cannot be excluded.
I started loosing weight and lost 25 lbs in Sept. My thyroid was bad with night sweats and pain. I went an urgent care and was told it could be allergies. I went to an endocrinologist and had a blood panel, ultrasound, and was prescribed steroids which was 2 months of Prednisone. That ended in January. I have had monthly visits and they said everything was back to normal. My doctor did state that it could be due to the vaccine. I have no family history of thyroid disease.