chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Delirious; Chills; Nausea; Aches; Could not get out of bed for toilet unassisted; Trouble sleeping; No appetite; Lost 10 pounds in 10 days; This is a spontaneous report from a contactable consumer (patient). An 81-year-old male patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6200) at single dose via an unwon route in left arm on 18Feb2021 at 81-year-old for Covid-19 immunization. Medical history included Pacemaker since 30Aug2017, right Total Hip Replace on 04May2020, ongoing antiseizure, ongoing bladder (as reported), ongoing swelling ankles. Concomitant drugs included levetiracetam (KEPPRA) for anti-seizure, tamsulosin hydrochloride (FLOMAX) for bladder, hydrochlorothiazide (MICROZIDE) for swelling ankles, all ongoing. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9262) on 28Jan2021 in left arm at 81-year-old for Covid-19 immunization. Patient had no other prior vaccinations (within 4 weeks). Relevant tests included MRI on 04May2020: RT. Hip Replacement.  blood test was taken on 04May2020. On 20Feb2021 (reported as day 1 reactions; also reported as "02Feb2021"), patient experienced delirious, chills, nausea, aches, could not get out of bed for toilet unassisted. Following 9 days, patient experienced trouble sleeping, continued nausea, aches, no appetite, lost 10 pounds in 10 days. No treatment was received. COVID-19 Swab on an unknown date: negative. Outcome of the events trouble sleeping, no appetite, lost 10 pounds was resolve on 02Mar2021. Outcome of the events was resolved on 02Mar2021 with duration of 10 days. Seriousness criteria was reported as "1".  No follow-up attempts are possible. No further information is expected.
Patient received vaccine around 10:25 am, within a minute of receiving vaccine, patient fainted. After 15 minutes of laying down she was able to sit in a chair. She later felt nauseated and vomited around 10:47 to 10:50. She felt well enough to leave with parents around 11 am
3 days fatigue- stayed in bed the entire day 09.15.22 after shots/ big red blochey spot where injections were administered - also arm extremely sore for 4 days / nausea/headache 3days/muscle pain all over body/shivering, couldn't warm up 09.14.22 night/took Advil and Tylenol (intermittently) to help ease symptoms
I  tested positive for Covid 19 in November. 10 hrs after vaccine is had chills, fever, muscle  aches, head aches for 12+ hours.  My vaccinated arm was extremely painful and itchy
pt received a Hep B inj. IM RD at approx. 2:15PM. Left with parent approx. 2:30 mother noted jerking movements of arms and legs, eyes rolled back and child collapsed in mothers arms. Was taken by private auto to city hospital ER (3:55PM) EKG and Blood work done. Loss of sensation elbow to fingertips per mother.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX, (dose: 0.25 ml) (lot # expiry date and route were not reported). The reporter stated that an unspecified patient experienced an "anxiety attack" during administration of ZOSTAVAX resulting in delivery of a partial dose. Also stated that "the patient could not tolerate the dose and she only got about 0.25ml of the vaccine" (anxiety and underdose). The outcome of the event anxiety was not reported. The reporter did not provide the causality assessment between the event anxiety and ZOSTAVAX. Additional information has been requested.
Headache/migraine: 3 days Fatigue, in a fog : 2 weeks Chills : 3 days RSV on October 14, 2021
the evening of day vax given pt devel achiness;the next morning had a fever around 99.5;reported a sore arm as well;w/in 24hr was back to nl;
Paralysis of right arm for hours same day as shot in opposite arm,.. week later shocks throughout arms when lifting objects, numbness in legs, knees, fingertips, and toes. Arms and legs go numb at random times. Feelings similar to vertigo.
First shot, experienced anxiety at site. Second shot, experienced daily anxiety and some joint discomfort.
16 y/o male, with no past medical history, who presents with complaint of a weird feeling to the front of his throat post vaccination administration. Patients mother states that patient with an allergic reaction to Probiotics in the past (rash and throat discomfort0. This is the patients 1st vaccination which was applied to the left deltoid. ). NP and Paramedics at the patients side. Patient vitals within normal limits (110/56 BP, 56 HR, 99% O2, 14 Resp). Patient provided with a bottle of water and 25mg Benadryl PO x1 administered. It was explained to patient that if symptoms do not improve with Benadryl then we would have to administer EPI and seek further emergent evaluation. Patient and mother agreed. Patient with resolution of symptoms within 20 minutes of medication administration. Patient discharged home in stable condition.
Tingling in both hands and arms, more on the left side; Numbness in both hands and arms, more on the left side; Moderate pain; A spontaneous report was received from a consumer concerning a 59-year-old, female patient who developed tingling in both hands and arms/ paraesthesia, numbness in both hands and arms/ hypoesthesia and moderate pain/ pain in extremity.   The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.      The patient received their first of two planned doses of mrna-1273 (Batch number not provided) on unknown.  On 15 Feb 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mrna-1273 (Batch number: 012MZ0A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.    On 15 Feb 2021, patient received second dose of vaccine and experienced events tingling in both hands and arms/ paraesthesia, numbness in both hands and arms/ hypoesthesia and moderate pain/ pain in extremity.  Treatment information was not provided.    The patient received both scheduled doses of mrna-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events tingling in both hands and arms/ paraesthesia, numbness in both hands and arms/ hypoesthesia and moderate pain/ pain in extremity were not reported.
PNEUMOVAX administered 1/25/2010. Patient called to report adverse reaction on Monday night-complained of pain, redness and swelling. Was asked about allergic reactions including shortness of breath and hives etc. (reported none of these symptoms Monday night). Suggested applying cold compresses to the area and to take BENADRYL in case of allergic reaction and TYLENOL or ibuprofen for pain. Followed up with patient on Tuesday morning-patient reported that her condition had improved. Patient reported site reactions including pain, redness, swelling, soreness (all listed in package insert). She has been applying cold compresses to the area and taking BENADRYL (though she still reports no itching or shortness of breath). Asked if patient was planning to see her health care professional and she said no, she was planning to rest her arm and willl continue to use cold compresses. Followed up with her this afternoon and she still complains of pain in the arm. Stated that her sone was coming to check on her shortly. Suggested seeing a healthcare professional or going to the ER.
This spontaneous report as received from 3 healthcare workers (1 medical assistant, other not specified) refers to an unspecified number of patients. No demographic information was provided. GARDASIL (lot number not provided) was exposed to 29-35 degrees Fahrenheit multiple times over a period of 3 months. The improper storage started on 29-DEC-2012. The improperly stored GARDASIL was administered to an unspecified number of patients on unspecified dates. Reportedly GARDASIL was "still not supported by in-house stability data". No adverse symptoms were reported. This is one of several reports received from the same source (other case IDs 1307USA008944, 1307USA008945, 1307USA008946, 1307USA008947, 1307USA008948 an d1307USA008949). Additional information has been requested.
Patient was given last year's flu vaccine, flu vaccine expired 30 JUne 2022
Patient is under the age of 18 and a booster was administered at a Booster clinic at off site booster clinic. Upon discovery, Mom was contacted and informed. Patient does not have any symptoms or adverse reactions reported.
This case was reported by a nurse via sales rep and described the occurrence of welts in a male patient who received MENVEO. Co-suspect products included FLUZONE. On an unknown date, the patient received MENVEO and FLUZONE. On an unknown date, unknown after receiving MENVEO, the patient experienced welts and erythema. On an unknown date, the outcome of the welts and erythema were unknown. It was unknown if the reporter considered the welts and erythema to be related to MENVEO. Additional details were reported as follows: The age at vaccination was not reported. The patient received MENVEO and FLUZONE in the same arm. The patient developed a large red almost welt on the arm. The reporter
Information has been received from a physician concerning a 5 yr old white female, with no medical history and no allergies, who on 31Jan01 was vaccinated with a 0.5ml SC first dose in the left leg of varicella virus vaccine live (lot 636571/0928K). Concomitant vaccines administered on the same day included a third IM dose in the right leg of poliovirus inactivated (Ipol), a first IM dose in the right leg of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot 637423/1512K) and a first IM dose in the left leg of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (crm197) (PREVNAR). There was no illness at the time of vaccination and no adverse events following prior vaccinations. It was reported that the pt as brought into the office on 16Apr05 complaining of leg pain. The pt was brought back into the office on 10Apr05 with the same complaint. The physician then diagnosed the pt with herpes zoster and prescribed acyclovir. It was noted that as of last evening the physician did not have any follow up on the pt. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information from a physician indicated that the onset of severe right thigh pain was 15Apr05. The pt experienced continuous pain over 2-3 days. Then there was an onset of a rash on her right calf. A Tzanck smear of the right calf showed no evidence of malignancy and the cell findings were consistent with a herpes cytopathic effect. The pt responded to acyclovir. It was reported that on 21Apr05 the pt recovered. Additional information is not expected.
Woke up in the middle of the night with convulsions, was freezing, body burning up, migraine. Still can barely move and it?s been 24 hours
Case number PHEH2013US005583 is an initial spontaneous report received from a consumer on 06 Mar 2013 with the follow-up received from Quality Assurance Department (reference number: 215380) on 09 Apr 2013: This report refers to a 64-year-old male patient. His current condition, medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: unknown) on an undetermined date in Oct 2012. On 02 Jan 2013, he was diagnosed with flu. He had fever, diarrhea and body aches. His doctor prescribed him TAMIFLU and he felt better within four to five days. The events abated on 07 Jan 2013. No further information about causality and seriousness was provided. Based on the Annual Product Review (APR) of FLUVIRIN, it was concluded that FLUVIRIN manufacturing process was operated at a good level of overall control and the supporting systems are effective in supporting the complaint production, testing and supply processes for FLUVIRIN. From this conclusion there was no reason or explanation to account for the reported adverse event. Follow-up received from Quality Assurance Department on 09 Apr 2013: Updated batch review report.
16-year-old patient was vaccinated with a Menveo reconstituted without the proper diluent; 16-year-old patient was vaccinated with a Menveo reconstituted without the proper diluent; This case was reported by a nurse via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA733A, expiry date 30th November 2023) for prophylaxis.   On 8th November 2022, the patient received Menveo. On 8th November 2022, unknown after receiving Menveo, the patient experienced inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   Additional Information: GSK receipt date: 08-NOV-2022 Reporters comment:  The patient received Menveo vaccine reconstituted without the proper diluent.  The reporter consent to follow-up via email Additional Supportive information: The patient received Menveo vaccine reconstituted without the proper diluent which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.    which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Passed away; A spontaneous report was received from a consumer concerning a male patient of unknown age, who was received Moderna's COVID-19 vaccine (mRNA-1273) and died.  The patient's medical history was not provided. No concomitant medications were reported.   On an unknown date, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  It was reported by the patient's wife that the patient died.  She was calling to cancel his second dose of mRNA-1273.  No additional details, including the date of death, were reported.   Treatment information was not provided.  Action taken with the mRNA-1273 was not applicable as the patient died.  The cause of death was not provided.  Plans for an autopsy were not provided.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  No further information is expected.; Reported Cause(s) of Death: Unknown cause of death
About 12 hours after the vaccination I had diarrhea and then again about 3 hours later.
Genital herpes; This non-serious case was reported by a consumer via call center representative and described the occurrence of genital herpes in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In NOV-2022, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced genital herpes (Verbatim: Genital herpes). The outcome of the genital herpes was not resolved.   It was unknown if the reporter considered the genital herpes to be related to Shingrix.     It was unknown if the company considered the genital herpes to be related to Shingrix.   Additional Information: GSK Receipt date: 3-APR-2023. Patient reported that she had recently experienced a case of genital herpes and might have to postpone Shingrix 2nd dose. Patient did not want to provide any additional information. Adverse event filed with limited information. The reporter did not consent to follow-up.
Information has been received from a health care worker concerning a 40 year old female healthcare consultant with penicillin allergy who on 08-MAY-2007 was vaccinated IM with a dose of PNEUMOVAX 23 lot # 655766/0038U. The reporter reported that patient had very large local reaction and possible cellulitis. She was treated with 1 gram ROCEPHIN and 500 mg CEFTIN twice daily x 7days. She was also advised to keep arm elevated and apply ice. The patient recovered. Additional information has been requested.
swelling at site, headache, fatigue, body ache, chills, nausea
Patient received second dose of Pfizer mRNA covid-19 vaccine on Thursday,  4/1/2021 at 2:25pm. After administration, patient reported tightening in her chest and was negative for difficulty breathing, change in heart rate, and had normal cognitive functioning. After approximately 5 minutes of being observed, the patient reported further tightness in chest and started feeling short of breath, but was negative for change in pulse or cognitive functioning. At that time, the pharmacist provided the patient with dexamethasone 4mg, which was self administered, and after 5 minutes hydroxyzine 10mg when the patient's symptoms did not resolve. An Epipen injection was administered around 2:35pm by the pharmacist after the patient's tightness in chest worsened despite dexamethasone and hydroxyzine and the patient was feeling cold and started shaking uncontrollably. 911 was called at that time and EMS services evaluated the patient around 2:45. The patient was transported to the emergency department at the local hospital around 2:50pm.
Day 7 since I recieved the vaccine a red mark started to develop on my left arm near the original injection site. By 1/29/2021 (day 8) I had a welt/rash looking red mark about 3 inches in length and 1 inch in width. It itches on and off and appears to follow the guidelines for "covid arm" caused by the moderna vaccine. I have an appointment with my dermatologist on monday for an examination.
Around the first week of November 2022, I initially had diarrhea every other day in the morning. This lasted for about a week to two weeks before it started to improve. I then gradually made my back to having normal, regular bowel movements by the fourth week of November 2022. At some point in around mid-December 2022, I began to have gastrointestinal symptoms like burping, acid reflux, and intermittent abdominal pain. I would drink water and take TUMS occasionally, and they would help with the burping and abdominal discomfort. I then noticed that these symptoms normally occurred in the evening, about three hours after I had eaten dinner. These symptoms continued pretty much daily, and the symptoms would worsen with certain foods, such as citrus fruits, kiwi fruit, and lemon juice used in cooking, so I began to avoid those things. However, the symptoms continued and became worse. I occasionally would take a Prilosec and Bioclinic Naturals DGL licorice root extract, which would help some, but the symptoms would return the next evening. I then began chewing fennel seeds, which also helped with symptoms, so I ceased taking Prilosec and began taking the licorice root extract less often. Over time, the symptoms began to come earlier in the day. I then started taking L-glutamine, which helped more than anything else I had tried. I began taking it twice a day, and I ceased taking the licorice root extract and chewing fennel seeds. At the time of this writing, I have been taking L-glutamine for at least a month. On 4/4/2023, I had an appointment with my NP. The NP and I went over a timeline of symptoms. We then discussed microbiome health, and she suspected that there had been a disturbance in the microbiome in my gut. We also discussed the possibility of whether the symptoms could have been caused by the COVID-19 vaccine, or if maybe the vaccine had exacerbated an already existing issue. She advised me to continue taking L-glutamine and eat a low FODMAP diet. She informed me about an app I could use to assist me in the diet. My NP also suspects that I have irritable bowel syndrome, and she said that the low-FODMAP diet should help with that. I am to adhere to the low-FODMAP diet for about a month. Afterwards, I can try gradually reintroducing certain foods back into my diet to see if there is a negative reaction. I will also return to the NP's office for a follow-up visit. She has ordered a lab test for me that I will receive through the mail in the very near future. A fecal sample will be tested to see if there is any imbalance in the microbiome.
Client complained of not feeling well 12/18/14 after school. Complained of sore throat, and had a fever of 102.9. Parent contacted nurse on 12/19/14, and was advised to have client seen by a Dr (at that point client had taken ibuprofen and consumed popsicles). Nurse called mother 12/29/14 for an update, and was informed that client began to feel better on 12/23/14, and is no longer feeling ill at this time.
Patient fainted after he got his shot. It took about 10 seconds for the patient to be oriented. Patient was with older brother who said he was not surprised(he expected it) since it happens when he get shots or anything with needles.  But he is also fine after a short period.  No epipen given and no EMS called
This spontaneous report as received from a nurse via a company representative refers to a 12 year old female patient. On approximately 10-APR-2014, "3 weeks ago", the patient was vaccinated with GARDASIL (dose, lot # not reported). Concomitant therapies included DIPHTHERIA TOXOID (+) PERTUSSIS ACELLULAR VACCINE (UNSPECIFIED) (+) TE) and TUBERCULIN PURIFIED PROTEIN DERIVATIVE. On an unknown date in 2014, the patient experienced dizzy and was going to faint, but did not fall. The outcome is unknown. Additional information has been requested.
arm has been hurting ever since receiving the second dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 81 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 15:00 (Lot number: EP7534) at the age of 80 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing); "anti-inflammatory" (unspecified if ongoing). Concomitant medication(s) included: TELMISARTAN taken for blood pressure measurement (ongoing); MELOXICAM taken for antiinflammatory therapy (ongoing). Vaccination history included: Bnt162b2 (Dose: 1, Lot: EN6198, NDC: Unknown , Expiration: Unknown , Anatomical location: left arm), administration date: 24Feb2021, when the patient was 80 years old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 19Mar2021, outcome "not recovered", described as "arm has been hurting ever since receiving the second dose". The event "arm has been hurting ever since receiving the second dose" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity.  Additional information: It was reported that patient had a reaction and is still having a problem after receiving the second dose Pfizer Covid 19 Vaccine. He went to the doctor about the arm hurting and he went to the orthopedic doctor and the family doctor. The orthopedic doctor took x-rays. He was sent to rehab section, did rehab exercise stuff and believe it or not it may have helped a little, doing exercise and went to physical therapy, everything and not seen a lot of improvement. Reporter stated figured the arm pain would go away. The patient is worried about, it has been 4 months since the caller received the Pfizer Covid 19 Vaccine. Some days the arm pain does not bother the caller as much and only hurts when moves arm or not normal, lifting arm above head, trying to put on his belt or something like that, raising his arms above his head, brushing his hair or pulling his hair, sticks arm behind back or something like that. If the caller has his hands Infront he feels the arm pain but it does not hurt that bad. Sometimes the arm hurts worse than others. He clarifies the arm pain is in his left arm, not his primary arm. The patient is not overweight and takes a little bit of blood pressure medicine, a low dose and also takes an anti-inflammatory medicine. No additional Vaccines administered on same date of the Pfizer Suspect and no prior Vaccinations (within 4 weeks).   No follow-up attempts are possible. No further information is expected.