chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine was stored in refrigerator on 04-Jun-2022 and administered on 14-Jul-2022; No adverse event; Administered the vaccine to patient after the 30 day use by date; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day use by date), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered on 14-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered on 14-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day use by date), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered on 14-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day use by date) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered on 14-Jul-2022).    No concomitant product use was reported.  Patient received half dose.  Vial did not undergone any temperature excursions.  No treatment information was provided.
Headaches, difficulty breathing, muscle spasms, eyes rolling back, unable to communicate. Patient was taken to hospital. Given various tests, stayed in the hospital for three nights.11/18/09 Medical records and discharge summary received for DOS 11/12-11/13.  Final DX: Influenza  Immediately s/p vaccine c/o SOB, leg weakness, leg muscle spasms, then developed HA malaise, lower back pain by next day. Febrile. Tic like movements. Eyes rolled back. No LOC. Body aches. Mental status changed confusion.  Hyper-reflexic LEs. Hyperesthesia, LP neg.  Mild encephalopathy possible. Antiviral med as tx. Improved.
7 BLOOD CLOTS; This spontaneous report received from a consumer through social media concerned a 5 decade old male of unspecified race and ethic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient ended up with 7 blood clots after the vaccination and It was reported that luckily the clots were identified before it leads to stroke, or death. The patient's friend mentioned that the patient's life was changed as the patient had to take the blood thinning shots daily. The patient's friend commented that this seemed to be a big secret on the deaths & injuries caused by the shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of 7 blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210915668- Covid-19 vaccine ad26.cov2.s- 7 blood clots. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
She was having very bad chest pain. It last for days and he (her husband), he told her to go lay down for a while. She took something for heartburn. She went to see her PCP and to the ER and they ran some test and they didn't see anything. She has had to go to the hospital a few times before January 2022. The doctor did a stress test and they didn't found anything on it as well. She is pregnant and is 20 weeks. Her doctor has referred her to see someone else but he couldn't remember who or when.
I got my Dose 2 on 04/17/2021 and I started to experienced adverse event on 04/19/2021 in the evening while I was trying to sleep I had little of fever it was normal for me. I had 100 degree of fever. My head was buzzing. I thought it was a just simple thing just like a flu. The buzzing thing started and never went away. I thought it was going to go away but it kept bothering me. I couldn't sleep at night. I scheduled to see my doctor he said there wasn't nothing in my ears. I was hearing fine. My doctor recommended me to go to an ENT. They couldn't tell if that was from the vaccine. My hearing was good for my age. They gave me nasal spray to cleared it up but it didn't really helped. It's been 1 year am experiencing tinnitus. I am looking for procedures to get better. I hope something will work for me. It's in my right. It's been extremely consisting of the buzzing sound in my ears.
shallow breathing, cold & clammy,  briefly lost consciousness several times (eyes rolled back in head and lost consciousness, then would recover), periods of incoherence, could answer questions sometimes and at other times  no comprehension, nausea, lethargic, contracting muscles in arms where they would draw up against body, said her legs and arms felt numb. treatment continuous monitoring, gave sip of water and cold compress on face/forehead.  EMS was called--monitored blood pressure and vitals.  Did not transport, she went home with her dad
1 day following vax inject was responding slowly-vomiting blue around mouth; 02 given by ambulance crew-relief in 30 mins;
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 52-year-old female patient who received Shingrix for prophylaxis. In June 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In June 2018, less than a month after receiving Shingrix, the patient experienced injection site pain, pain and injection site erythema. On an unknown date, the outcome of the injection site pain, pain and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site pain, pain and injection site erythema to be related to Shingrix. Additional information was received as follows: The patient received the Shingrix vaccine on the left arm. The patient experienced soreness at injection site, achy feeling and redness at injection site. This has been linked to the case US2018157107 and US2018GSK162355, reported by the same reporter.
Patient experienced pain and weakness in the arm, in the area of the injection. Pain and limited mobility are still a factor at this time. She is going to physical therapy to try to improve movement and pain.
Developed fever, chills, body aches evening after receiving 2nd dose. Fever improved this morning, but still with body aches and chills.
5 minutes after vaccine administration, patient experienced brief loss of consciousness and fall from seated position. Momentarily regained consciousness. Suspected convulsive syncopal episode
Pt recvd vax p/laceration to hand.Next day pt exp spreading painful erythema @inj site. Pt seen in ER & tx w/one gram ceftriaxone IV & cold packs & observation.
Patient experienced tingling/loss of feeling in her arm(s).  Was admitted to hospital and diagnosed with Miller-Fisher Syndrome and has been receiving immunoglobulin.
Case number PHEH2014US005295, is an initial spontaneous report received from a medical assistant on 12 Mar 2014. This report refers to an 11 years old female patient. She received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: X13014), intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component on 10 Mar 2014. No adverse event was reported following this administration error.
After about 15 Minutes after the injection, My Hands and Feet broke into a sweat, about 1 minute after that the top of my head  started to tingle ( like pins and needles) after about another minute it felt like I had to keep breathing on purpose. ( what I mean by that is I was aware of my breathing and had to knowingly take breaths it was like I had been under water and just come up for air) I don't remember the exact time maybe another minute or so, my heart started to race. This All went on for about 45 Minutes. When this first happened the Pharmacist told me that what was happening was common with vaccinations and had nothing to do with the covid 19 vaccination, I asked for the nurse that had provided the vaccine to me and was told she went to lunch. So there was no healthcare professional there to help me. The pharmacist just had me sit in a chair and told me to sit there until I felt better. This happened for both injections. I have never experienced this type of reaction with any other vaccine in my life.
Hives began at injection site on right upper arm, and extended across neck and back, then down left arm. Few scattered hives on face. Tingling of lips. Sent to ER next door to clinic where they administered Benadryl and steroids.
chills/fever/ nausea/ headache symptoms started around 9:30pm and were gone by morning
5/2/12 11:00 infant woke from nap after receiving vaccines at 9:00 AM. Child had 2 episodes of convulsing, mother reported child's legs were "jerking." Happened twice, one episode after another. Lasted 10 seconds each. Child saw physician 5/2/12. Referred to clinic neurology dept, appointment 5/9/12.
Shingles 10 days after 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included kidney transplant. Previously administered products included Shingrix (received 1st dose on an unknown date). Concurrent medical conditions included immunosuppression.   On 24th January 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 3rd February 2022, 10 days after receiving Shingrix, the patient experienced shingles. The patient was treated with mycophenolic acid (Mycophenolate) and valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received her second Shingrix dose on her arm and ten days later she developed shingles. The patient was treating the shingles with Valtrex 1 gram daily. The reporter consented to follow up with her and her physician.
No side effects at all for the first 7 days. Tonight (night 7) at injection site developed red, hot, bumpy (hives?) itchy rash in a large circle, roughly twice the size of a quarter.
This spontaneous report as received from a physician (M.D.) via a company representative refers to a 22 year old female patient. On unknown dates the patient was vaccinated intramuscularly with dose of GARDASIL, 3 doses respectively, (date, dose, frequency, lot# not provided). The patient had tested positive for high risk HPV after completing the 3 doses series of GARDASIL. The patient had her annual pap smear done at the physician's office on 20-MAY-2013 and also had  a colpo biopsy done on an unspecified date and location. The patient was not hospitalized and alive. Her adverse event improvement and present status was unknown. Therapy with GARDASIL was reported as not discontinued. Additional information has been requested.
Developed transverse myelitis. She began to develop numbness in her feet starting 4/30 which worsened over several days.  She presented to the emergency department and had a normal CBC, CMP, TSH.  Normal vital signs.  However on her exam she had decreased but not absent sensations in bilateral lower extremities to the mid calf, lack of positional sense of her bilateral toes.  She had a lumbar puncture which showed 160 white blood cells with an 83% lymphocyte predominance but without elevated protein or glucose alteration the numbness found a ascending to just below her breasts at that time she was having no sensory or motor symptoms in her arms, no visual disturbance speech or swallowing difficulty.  She was aware of bowel and bladder sensation but unable to sense her self urinating or defecating.  She was listing to the left while walking. Her B12 was noted to be low at 232 and she was started on a B12 supplement. She is negative for Covid, RSV, influenza A and B. She also had her cerebrospinal fluid evaluated for IgG and oligoclonal bands.  She was after having MRIs of her brain, C-spine, T-spine with and without contrast she was started on Solu-Medrol for 5 days. Imaging had no specific findings suggesting the diagnosis, Dr felt that she likely had some mild myelitis.  She did improve with the Solu-Medrol.   Since returning home patient has been feeling better but still has some limitations.  Still has some limited sensation from her abdomen downward, gait is a little unsteady.  The balls of her feet still feel numb, and she is to be very cautious about her footwear and how she walks.
Vaccine was administered at 11 am on 4/19 without event. Around 3pm moving my arm became painful. This worsened as the evening progressed.I could not get the arm in a comfortable position. I applied heat for a few minutes. This made the pain worse. I took 800mg of Ibuprofen which provided little relief. I could not sleep and at midnight took my temperature which was just over 101. I began having diarrhea and feeling faint. The diarrhea and fever subsided on Sunday morning. My husband called the ER and was given a nurse help line number to call. She reported that if my fever went over 105 or if I became dehydrated to go to the ER. Sunday I was very tired and did not use my arm very much. The pain has lessened, but I still have pain when I move it in certain directions. It prevented me from  sleeping in my normal positon and from going out of the office today.
On 11/8/2021 noticed redness below injection site. Became very itchy.  Redness travelling down arm.
Patient with 3 Moderna COVID vaccinations who admitted to the hospital with hypoxia and COVID detected PCR.  Provider d/c note below:  "93-year-old female with history of peripheral artery disease, osteoporosis, anxiety, who presented to the emergency department on 07/01/2022 with intractable nausea and vomiting.  There were also some concerns hemoptysis/hematemesis at home, which was about the size of a half-dollar.  In the emergency department, vital signs were stable.  Lab workup was reassuring.  Chest x-ray and CT abdomen pelvis were all reassuring.  She was initially admitted to the emergency department under observation status for nausea.  On the emergency department, patient developed hypoxia on ambulation requiring 2 L of oxygen.  She tested positive for COVID, she was noted to have some shortness of breath and productive cough.  She was admitted to inpatient status for further evaluation.   Patient was started on remdesivir and Decadron for treatment of COVID pneumonia.  Patient became agitated with altered mental status a few days into her treatment.  This was thought to be secondary to steroid induced delirium, Decadron was stopped and she was continued on remdesivir.  Patient's mental status and agitation improved 1-2 days after stopping steroids.  Patient's highest oxygen requirement was 4 L, and she continue to wean down with time and remdesivir treatment.  PT/OT recommended skilled nursing facility.  Patient was accepted at a Hospital for continue rehabilitation.  On day of discharge, patient was at her baseline level of mentation and was satting well on 2 L nasal cannula.  She was discharged in stable medical condition and transported out of facility."
drew up vaccine incorrectly in syringe; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (drew up vaccine incorrectly in syringe) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (drew up vaccine incorrectly in syringe). At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (drew up vaccine incorrectly in syringe) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Drug details were reported.  No Treatment information was provided.
Pt. states she had trouble breathing. Pt. received vaccine on 04-06-11, and did not have any trouble breathing until 04-09-11. She had a local reaction at the injection site on 04-07-11. Pt. went to ER on 04-09-11 and was treated for rash and allergic reaction. She was given (1) BENADRYL IM 25 mg, (2) Prednisone PO 60 mg, (3) PERCOCET PO 10 mg. Pt. recovered from rash/allergic reaction.
Sore arm after the Covid-19 vaccine; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (Sore arm after the Covid-19 vaccine) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriasis.    Concurrent medical conditions included Psoriasis, Tobacco user, Alcohol use and Penicillin allergy (manifested by swell up and bumps all over the body). Concomitant products included HYDROCORTISONE for Adrenal disorder NOS, LEVOTHYROXINE for Thyroid disorder NOS.   In 2017, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram every two weeks. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. In February 2021, the patient experienced VACCINATION SITE PAIN (Sore arm after the Covid-19 vaccine). At the time of the report, VACCINATION SITE PAIN (Sore arm after the Covid-19 vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Full blood count: no significant results found Inconclusive. On an unknown date, Mycobacterium tuberculosis complex test: no significant results found Inconclusive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VACCINATION SITE PAIN (Sore arm after the Covid-19 vaccine) to be probably related.    No treatment medications were reported.
Initial report received from a health care professional on 24 September 2007. A 38 year old, female patient (with no medical history) complained of pain in her left arm and neck, and fever, 2 days after she received Menactra (lot number U2379BA) intramuscularly in the left deltoid on 20 September 2007. She did not have any illness at the time of vaccination. The fever has resolved, however it was reported the other symptoms were still resolving.
day after injection noticed approx 1/2 inch diameter hard lump at site oozing clear liquid. Has since almost disappeared but leaving small longitudinal scab.
Patient reports feeling dizzy, heart racing, slight shortness of breath. had an egg for breakfast today.
Headache; head is killing me, it is stressing me out; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EN6202; Expiration date was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included traumatic Brain Injury, seasonal allergies from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced headache on an unspecified date. Therapeutic measures were taken as a result of headache. Patient had the Covid shot the day before this report (19Mar2021) and got a headache that couldn't get rid of. Patient asked what to do to get rid of the headache (manufacturer not clarified, hence is this a Pfizer product tab left unchecked). Stated to get a bit of a headache then and it does not go away. Consumer was informed about Pfizer Medical Information department. Consumer further stated to transfer as quick as you can do it because patient head was killing patient, it was stressing patient out. Patient stated that between the allergies and the TBI and this Covid shot got a terrible headache patient couldn't get rid of it. And headache was causing patient a lot of stress right then. Consumer stated, got a TBI that was number 1. Got Traumatic Brain Injury (Intent: History) and number 2 was that patient take medications for allergy (Further not clarified over the call hence captured as unspecified medication). So, between the allergies and the TBI and this Covid shot patient got a terrible headache patient couldn't get rid of it. Patient took Tylenol the day before this report. Consumer informed about Pfizer Medical Information Department and about the role of Pfizer Drug safety. When asked about LOT#: Consumer stated, "I can't understand you it's hard to me to understand you because of you accent I am not trying to be rude I just don't understand when you, the second was EN6204." (unclear, so retained as EN6202). Consumer stated that he/she was going to take Ibuprofen or Advil, the headache was killing. Product details (NDC# UPC# and Treatment) and Pharmacy details could not be probed as consumer was unwilling to share further information. Hence further probing could not be done. Limited information available over the call. Clinical outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Evening of vaccination patient developed a "playing card" sized" rash between her shoulder blades, just below the neck. Denies any other symptoms. Rash was itchy only rarely. Rash has improved slowly, and not fully resolved as of today 6/19/08
Within days of receiving flu shot, experienced pain in back, shoulder and upper left arm. Muscle spasms of rhomboid muscle. Saw chiropractor 2 times w/no relief, received muscle relaxer from GP, didn't help. Got 2 massages, no relief, saw GP again and got steroids-Didn't last, GO gave more muscle relaxers and prescribed P.T.