chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within about a week or two, I experienced Vertigo.  I have n ver experienced this before.   I have been experiencing this for 1 year and 8 months. It?s very sporadic and very intense causing nausea, vomiting (1 time) and falling 2 times). There is no forewarning and I can go a month or two without a ?bout?.   It happens when I am in bed sleeping & I turn over on my left side; if I bend over when sitting or standing, and walking. It just hits out of the blue with no rhyme or reason - nothing I have been able to pinpoint as to the pre-curser of cause.
Headache, Myalgia, CoughWheeze, Syncope, Fatigued, chills, night sweats, mild shortness of breath, cough. Takes coumadin for protein s deficiency. Tested + for COVID on 1/4/21 Narrative:  Fatigued, chills, night sweats, mild shortness of breath, cough. Takes coumadin for protein s deficiency, sees hematology. Currently taking prn tylenol, scheduled to see hematology. Tested positive for COVID on 1/4/21.
Pt had recent history of Guillain Barr about 4 months prior to receiving pneumococcal vaccine. Was admitted to hospital with complaints of weakness. Possible relapse of Guillain Barr. Pt was admitted about 5 days after receiving vaccine. Discharge summary states diarrhea, bacterial infection. Information received from 60 day follow-up states patient experienced residual weakness and continues to slowly recover.
Vomited for an hour; light headed; broke out in a cold sweat; body cramped up; nauseus; Sore left Arm; convulsions; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SEIZURE (convulsions) and VOMITING (Vomited for an hour) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2. On 06-Apr-2021, the patient experienced SEIZURE (convulsions) (seriousness criterion medically significant), VOMITING (Vomited for an hour) (seriousness criterion hospitalization), DIZZINESS (light headed), COLD SWEAT (broke out in a cold sweat), MUSCLE SPASMS (body cramped up), NAUSEA (nauseus) and VACCINATION SITE PAIN (Sore left Arm). The patient was hospitalized from 06-Apr-2021 to 08-Apr-2021 due to VOMITING. On 08-Apr-2021, SEIZURE (convulsions), VOMITING (Vomited for an hour), DIZZINESS (light headed), COLD SWEAT (broke out in a cold sweat), MUSCLE SPASMS (body cramped up), NAUSEA (nauseus) and VACCINATION SITE PAIN (Sore left Arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood lactic acid increased: increased (abnormal) increased. On an unknown date, Blood potassium: decreased (abnormal) decreased. On an unknown date, Blood pressure decreased: decreased (Low) decreased. On an unknown date, Body temperature: decreased (Low) decreased.  No concomitant medications were reported.  No treatment medications were reported.  Company Comment  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.
Varicella erythema-8-10 lesions in varied stages.  Patient's father has shingles currently.
This spontaneous report was received from a nurse practitioner regarding a patient of unknown age and gender. The patients concurrent conditions, medical history and concomitant medications were not reported. On 01-AUG-2008, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX  dose 1 , (dose unknown) from lot # 661445/0525X with expiry date of 27-MAR-2010. No adverse effect were reported.  The reporter stated that inconsistencies in storage temperature were identified on extensive review of records. The reporter stated that the vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
She got the vaccine, was fine and went to bed.  She sleeps in a fetal position with her legs curled and when she woke up she was not able to get up and was stuck in the fetal position.  She was in excruciating pain, and had a dog to let out as she lives by herself.  This went on for about 3 days.  Then she went back to work and worked 2 days and then she woke up the next morning 3/28/21 and every joint in her body including her toes was throbbing and aching like she had arthritis.  Since then she has continued with these symptoms, and aching all the time in her feet, shoulders and other areas.   She saw her stomach doctor who she told him about her side effects and he advised her not to take the 2nd vaccine.  She took her normal pills and Tylenol arthritis.  She did notify her regular provider of her reaction as well.  She went and got x-rays of her knees and legs at healthcare facility that said that they did not find anything other than some arthritis.  It also affected her arms, legs and feet and had x-rays again and showed nothing but some arthritis in her hips.  She still continues with the same symptoms.  It will ease up, she will go about her business and then will wake up with throbbing pains.
Hasn't gotten it in years, got it one time for sure; Supposed to get it every year; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination and product label confusion. On an unknown date, the outcome of the incomplete course of vaccination and product label confusion were unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. The reporter stated that, till the time of reporting, the patient did not receive 2nd dose of shingrix, which led to incomplete course of vaccination. The reporter stated that, she knows that she was supposed to get it every year, which led to product confusion. The patient got it one time for sure, but is unsure if she actually ever got a second dose. Agent called in an attempt to learn vaccination dates, but could not find any record (locally or system wide) of consumer ever having any prescription filled or vaccine being administered. Agent informed consumer. Gave medical disclaimer.  The reporter consented to follow up.
Red rash and swollen at site of injection (subcutaneously part of upper left arm) about 3 inches long and 1.5 inches width.
Sudden sweat and  almost blacked out up for  few minutes  couldn't walk had to be carried to my bedroom
Headache, Chills, Fever, Sweating, Shaking, Aches and pain in joints/muscles all over the body. Treatment: Motrin and Tylenol. Patient received telephone consult with RN.  Patient still has the symptoms but they lessening.
Received KINRIX and PROQUAD on 1/13/15. Wed. morning mom noticed large red, raised spot at injection site on Rt thigh with redness all around it. It was hot to touch. Mom gave her BENADRYL for itching. Was bigger by Fri 1/16 when she was seen.
I have red blotched over my hips,lower back and in between my breasts; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (I have red blotched over my hips,lower back and in between my breasts) 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 RASH MACULAR (I have red blotched over my hips,lower back and in between my breasts). At the time of the report, RASH MACULAR (I have red blotched over my hips,lower back and in between my breasts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Received last vaccination on April 14th, about a month later Patient has  red blotched over  hips, lower back and in between breasts.  Concomitant product use was not provided by the reporter.   Treatment information was not provided.
RASH ON ARMS AND HANDS; EXTREME PAIN IN BOTH HANDS AND ARMS; SEIZURE; HEADACHE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient is not on any medication and has no known drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. patient got the Janssen Covid shot on March 9th Tuesday and then experienced headache started same day and Wednesday10th march, took Tylenol and headache recovered, then seizure on 11th mar, went to the ER and spoke to the doctor on reporting day. consumer also started patient experiencing rash and extreme pain on both arms and hands on reporting day 12th mar and getting worse. On 09-MAR-2021, the subject experienced headache Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from seizure, and headache, and had not recovered from rash on arms and hands, and extreme pain in both hands and arms. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210325468 - Covid-19 Vaccine Ad26.Cov2.S - Seizure. This event is considered Unassessable. The event 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.
redness, hard lump, 7cm x 9cm, warm and tenderness. ICU and Ice x 5 days
May 10 muscle pain over all of body,,,, May 11 Fever 99 to 100.6 for 4 days,, May 12 thru May 21 nausea and sever joint pain,,,,  Higher than normal blood pressure,,,May 18 extreme ankle pain could not put pressure on foot for 4 days,,, Saw Doctor on May 25 and received medication to relieve pain,,, now May 29 can walk but still joint pain in both feet and knees....
While administering the vaccine to gthe patient, the vial burst and vaccine liquid was splashed all over the patient face, including into her eyes.
Benadryl and Tylenol b/4 shot.Woke up 3-4 times crying during nite, ? fever. Next am felt warm, temp 102R, tylenol given no reduction in temp, lethargic, wouldn't move legs. Alternated Advil and Tylenol and temp reduced. following day at 3pm feeling better, playing & walking, 08-22 noted red & hard area on left leg, not warm, child again cranky. Redness increased, today 08-25 redness almost gone, child still cranky but not as bad.
Fever, chills, teeth chattering, headache, muscular weakness, dry mouth, diarrhea.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2014, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. Later in 2014, the patient was treated by a physician for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
PATIENT RECEIVED A SMALLPOX VACINE IN LEFT DELTOID AND A SMALL OUTBREAK HAS SPREAD TO LEFT AC SPACE.  BOTH SITES ARE BANDAGED. PT EDUCATED
pain in injection site; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and VACCINATION SITE PAIN (pain in injection site) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus. Concomitant products included INSULIN GLARGINE (TOUJEO), METFORMIN and DICLOFENAC for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (sore arm). On 16-Apr-2021, the patient experienced VACCINATION SITE PAIN (pain in injection site). At the time of the report, PAIN IN EXTREMITY (sore arm) and VACCINATION SITE PAIN (pain in injection site) outcome was unknown. Not Provided          Other concomitant medicine included other Heart medication. Treatment medication was not provided.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-079297 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079297:Case for dose 1
3 pulmonary embolisms; he started having really bad headaches; he was complaining of the back of his leg hurting; his left shoulder started bothering him and it was radiating from his shoulder up to his chin as well as; This is a spontaneous report from a contactable consumer.   A 42-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EW0172, Expiration Date 31Aug2021) via an unspecified route of administration, on 28Apr2021 at 09:00 (at the age of 42-years-old) as a single dose in the left "shoulder" for COVID-19 immunization. The patient's medical history and concomitant medications were denied (reported as "He has no medical conditions and does not take any regular medications"). The patient did not receive any other vaccinations within four weeks prior to the vaccine. The reporter says she is reporting on behalf of her husband with regard to the Pfizer COVID vaccination. She just wanted to report that her husband got the first shot 28Apr2021 and Friday 07May2021 he was admitted to the hospital with 3 pulmonary embolisms. When asked when the pulmonary embolism began she says the week before the hospitalization, so the week he actually got the first dose, he was complaining of the back of his leg hurting, in the upper calf area. She says it was either the day after the shot or the next day that he said his leg hurt but he did not think too much about it and it resolved after a couple days and then Wednesday, 05 May 2021 he started getting discomfort in his left upper quadrant, she clarifies his abdomen and rib cage area, and he started having really bad headaches Thursday that continued and during the night  Thursday night his left shoulder started bothering him and it was radiating from his shoulder up to his chin as well as he had the severe headache so the doctor told him to go to the ER. The patient experienced three pulmonary embolisms on an unspecified date with outcome of not recovered. The patient was hospitalized for 3 pulmonary embolisms from 07May2021 to 08May2021. He also started having really bad headaches on an unspecified date with outcome of unknown and he was complaining of the back of his leg hurting on an unspecified date with outcome of recovered, his left shoulder started bothering him and it was radiating from his shoulder up to his chin on an unspecified date with outcome of unknown. The reporter commented that she and her husband wanted to report this because of the timing of getting the shot and they are waiting now to go see his primary care they are supposed to be calling to set up an appointment because he is supposed to be having the second dose 19May2021 so they do not know what is going to happen. Therapeutic measures were taken as a result of pulmonary embolism and included Eliquis which he would be on for at least 3 months.
Extremely faint, headache, body ache, shivering, fatigue, accelerated heartbeat, loopy
lip tingling; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported), dose 1 via an unspecified route administration on unspecified date as dose 1, single for covid-19 immunization (at the age of 50years). The patient medical history was not reported. The patient's concomitant medications were not reported. On unspecified date the patient experienced lip tingling that lasted for 15 minutes following the first dose. Consumer received the first dose of the vaccine and is expected to receive the second dose tomorrow. It was explained that lip tingling may be associated to an allergic reaction. Patient HCP and vaccination provided to discuss this before receiving the second dose. The outcome of the event was unknown.  Information on lot number/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Overnight I was awakened by chills and body sweats breaking into a102.3 fever. In the morning I woke up to an intense headache, body pains and stronger chills. I was bed ridden for two days before I had the strength to actually get up and walk to the kitchen. I would try to eat or drink but it made my nausea and headache stronger. The headache lasted a week and I was unable to focus on completing any schoolwork. Two weeks later, I started with a sore throat, mild fever, and headache, but was written off as just a cold. Three days later, my left eye grew sensitive to light. It became more red and more swollen throughout the day. I went to the school doctor who wrote it off as a side effect of catching a cold and was instructed to avoid contact with anyone until the redness faded. Over the next week , my sore throat got worse to the point where I couldn't speak and hardly swallow.  The infection spread to my other eye, both eyes were now swollen, extremely irritated. It took about four days to see any improvement. Before the vaccine, I didn't have any health problems, I had years without experiencing any cold or flu symptoms despite being around other sick students around campus.
Case number PHEH2015US026859 is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 24-year-old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501 and expiry date: May 2016) into left deltoid on 29 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and  when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information provided. Follow up information received from the nurse on 26 Jan 2016: Reporter's comment updated.
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Fever 100.1, 6 cm swelling (R) lat arm. No cellulitis. Pruritus. Mild pain.
On 6/17/2022 I developed severe burning in nose and sore throat. Nasal congestion and headache followed. No fever, no body pains and no fatigue. Loss of smell and taste followed next day and home test positive. I am a speech pathologist for facility and unable to get care at Employee Health nor reach my PCP at facility until 6/21/2022.  Spoke with Teladoc on 6/19/2022 , as knew care would be delayed and wanted to see about Paxlovid. He refused to prescribe as "may cause cancer later in life" (nowadays what doesn't?)PCR done at facility for Health on 6/21/2022 and reported to Dept of Health as positive. NP would not prescribe Paxlovid and asked me to reach my PCP. I called into facility PCP on 6/22/2022 and only able to speak to receptionist. She wished me luck and glad that my case was mild and no return call for Paxlovid. I now seem to have chronic loss of taste and smell, no change since onset.
sore arm; red arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and ERYTHEMA (red arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and ERYTHEMA (red arm). At the time of the report, PAIN IN EXTREMITY (sore arm) and ERYTHEMA (red arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications are provided. treatment to the events not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Fever of 101.6 degrees F at 0400 the day after 2 month vaccines. Fever resolved after TYLENOL and did not reoccur.
Patient received a Moderna Vaccine on 3/19/2021. Patient then went to pharmacy on 5/4/21 and 5/25/21 and received Pfizer on those dates. Unsure if the pharmacy used the immunization reconciliation system in place. Patient is not exhibiting any adverse effects at this time.
Vaccine Error. Patient was given a TDAP on 12/22/21 and we gave him a TD.  Second vaccine: He was given his meningococcal MCV shot on 12/22/21 and we gave him another one on 8/29/22. No adverse reactions reported.