chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 2013, the patient was inoculated with ZOSTAVAX by a physician 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. On or about 2014, the patient was treated the same 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.
Swelling and redness of entire bicep region of right arm from shoulder to elbow. Flu-like symptoms for one day and then cellulitis type infection as described above.
Severe insomnia only able to sleep 2 - 3 hours and wake and remain awake. Had severe insomnia after other shots but didn't connect it to vaccine at that time. Insomnia waned over the summer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Oct2021 11:15 (Lot number: 30155BA) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing); "coconut, onions" (unspecified if ongoing); "known allergy-Sulfa" (unspecified if ongoing); "if covid prior vaccination: Yes" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Ibupropfin, reaction(s): "Known allergy-Ibuprofin". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP7534, Location of injection: Arm Left), administration date: 18Mar2021, when the patient was 62 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6203, Location of injection: Arm Left), administration date: 25Feb2021, when the patient was 62 years old, for Covid-19 Immunization. The following information was reported: INSOMNIA (non-serious) with onset 20Oct2021 12:00, outcome "unknown", described as "Severe insomnia only able to sleep 2 - 3 hours and wake and remain awake. Had severe insomnia after other shots but didn't connect it to vaccine at that time. Insomnia waned over the summer". Therapeutic measures were not taken as a result of insomnia.  Additional information: The most recent COVID-19 vaccine was administered at public Health Clinic/ facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination included prescription for blood pressure. Reported Event: Severe insomnia only able to sleep 2 - 3 hours and wake and remain awake. Had severe insomnia after other shots but didn't connect it to vaccine at that time. Insomnia waned over the summer. Started the night after patient received 3rd dose. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
I woke up on March 4th gasping for air with severe chest pain and I could not catch a breath. I was in severe pain, so my husband took me to the emergency room. They did x-rays, cat scans, bloodwork and couldn't figure out what was going on. They sent me home and said if it doesn't get better come back or follow-up with my PCP. It was getting worse, so I went back the next morning to the main hospital not the smaller branch of the main hospital I went to the first time. Again, they ran bloodwork, cat scans, x-rays. They found, which they thought was based on pneumonia based on my lab work. They admitted me and started treated me immediately for pneumonia 3/5-3/8 discharged with antibiotics to continue at home. That was the first episode. I continued to have some shortness of breath and pain and it went on until April 10th, and on that morning, I woke up again and I was feeling okay and then all of a sudden started having sharp chest pain with shortness of breath. I went to the restroom and coughed up blood and went back to the hospital. They did CT scans, chest x-ray, bloodwork and they found pretty large pulmonary embolism in my right lung. They transferred me to the main hospital, and I was admitted from 4/10-4/12. I was discharged with a blood thinner and told to follow-up with pulmonologist, hematologist and PCP. Hematologist told me the blood clot in my leg from 2014 means I would be on blood thinners for the rest of my life and this blood clot episode was unprovoked. I am also seeing a rheumatologist to see if there is an autoimmune disorder that could have put me at a higher risk of clotting. So far, they haven't come up with anything.
Patient had 1st 2 series of Pfizer Covid-19 vaccine but was given the Moderna COVID-19 as the 3rd dose because pharmacist mistakenly thought if the Pfizer COVID-19 vaccine was not available the Moderna one can be given as a 3rd dose
Rotavirus 2nd dose given. 20 min later, unconscious, stopped breathing, eyes rolling in back of head.  5/9/08 Reviewed hospital medical records of 1/14-1/16/2008. FINAL DX: cyanotic episode; sacral dimple; heart murmur. Records reveal patient experienced 3-4 min episode of decreased responsiveness w/pallor & circumoral cyanosis.  Returned to normal state w/n 15-20 min.  Stable throughout hospitalization w/o further episode of apnea.
MATERNAL EXPOSURE TO VACCINE DURING PREGNANCY; This spontaneous pregnancy report received from a consumer concerned multiple patients. 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: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced maternal exposure to vaccine during pregnancy. The date of the subject's last menstrual period and expected delivery date were not reported. On an unspecified date, the pregnancy resulted in an other. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of maternal exposure to vaccine during pregnancy was not reported. This report was non-serious. This parent/child case is linked to 20210760520.
Near syncopal episode immediately after the immunization. Back to normal w/i 15 min after immunization.
Patient presented to clinic after work (around 3:45 pm) with noted erythema, swelling and heat to left upper arm and shoulder area. Patient reports that it is also painful to touch. Patient advised to try benadryl 50 mg along with ice for 15-20 minutes at a time and report back to this office for further observation in the next day or 2.
Tingling and numb feeling at back of tongue immediately after injection Weird sensation of lump in throat without anaphylaxis that got better with time
This case was reported by a consumer via call center representative and described the occurrence of shivering in a female patient who received SHINGRIX for prophylaxis. On 4th October 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shivering, headache and tiredness. On an unknown date, the outcome of the shivering, headache and tiredness were unknown. It was unknown if the reporter considered the shivering, headache and tiredness to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The patient declined to answer any questions or provide her address or phone number. The patient did not consent to follow-up.
Severe arm pain in injection site, fever (100.2), horrible leg aches and muscle pain.  Felt like I had the worse case of the flu in my life.  Very tired and little energy.   This lasted about 36 hours.
11/18: pt complained of swelling, redness, pain, inability to move arm, fever, chills, HA, armpits sore. Began within 12 hours. 11/19: condition worsens. 11/20: pt. received Rx for KEFLEX 500mg.
-lightheaded -weakness in legs  -tingling in the head, face and strange sensations that would go from the top of my head and go down my body  -heart palpitations -general cloudiness in the head one night I woke up and had to concentrate very hard to think and to speak like having a stroke  -numbness in face -face felt swollen for a day or two  -itchy for a day  3 weeks later and some of these have subsided, but I still feel off and on tingling, strange sensations, lightheaded and weakness at times.
Moderna COVID-19 Vaccine EUA Low-grade fever (100.3), headache, chills. Onset around 2:30 pm on March 13, 2021. Unresolved as of 9:45 am on March 14, 2021.
9/13/21 2:30 PM VACCINE ADMINISTERED. 9/14/2021 8 AM ERYTHEMA, WARMTH, MUSCLE PAIN, NAUSEA, REDNESS OF ENTIRE UPPER ARM, HARDNESS, 100.2 FEVER.  9/15/2021 SAME SYMPTOMS AS 9/14/21 BUT FEVER 99.5.  ON 9/15/21 MD PRESCRIBED 3 ADVIL X3DAILY AND KEFLEX 3X DAILY FOR 5 DAYS (PATIENT REFUSED PRESCRIPTION FOR STEROIDS AND OPTED TO TAKE ADVIL FOR INFLAMMATION). 9/16/21 REDNESS CONTINUED BUT REDUCED. 9/17/21 SYMPTOMS RESOLVED. SEPTEMBER 18,19,20 DIZZINESS (NOT SURE IF THIS IS RELATED TO VACCINE)
I had body aches, sore arm, headache, nauseated, flu like symptoms. That lasted February 24th, 25th, 26th and when I woke up the 4th day, I had nothing all symptoms were gone. I had gone to the doctor on 7/26/21 because I was extremely weak, shortness of breath, and coughing. I had a chest X-ray and everything was normal. I followed up with my cardiologist and he put me in the ER. They did blood pressure check, ultrasound with contrast, COVID test, it came back negative. They did bloodwork. They could not find anything wrong. The ER MD gave me albuterol because he couldn't find anything wrong but thought I was at the start of a bronchial infection, but he didn't think I needed antibiotics. All the symptoms and sickness eventually cleared up. I was at hospital for about 3 hours or so and then was discharged.
5-26-2022, I started noticing a sore throat, fatigue and head congestion and I took a home Covid test that was negative. I retook another home test on 5-27 and it was negative as well. On 5-30, 2022, I took another home test and it was positive. I called the doctor on 5-30 and went to the urgent care. They prescribed a cough medicine with codeine and told me to come back if it got worse. I am much better today. I am reporting my breakthrough case of Covid.
Headache, Fever, CHILLS, WEAKNESS  Narrative:  Other Relevant History:
with dose 1given on 1/7/21 - within 5 mins -flushing, headache, chills, back pain., high blood pressure in 150's,  fatigue. Headache and backache lasted for 4 days. Fatigue for a week. I was monitored for 2 hours after injection.   With dose 2 on 1/29/21- immediate - nausea, headache, lightheadedness, chest discomfort, very sleepy like I just wanna go to sleep right away. I was monitored for 2 hours until Chest discomfort subsided.  nausea took more than 3.5 hours. headache is still on today the next day. Midnight -I had severe severe joint pains like my bones were ripping apart. very sleepy. i slept 12 hours straight.  still have headache.
Pt states very loose bowel movements, diarrhea, nausea, general GI problems.
Information has been received from a health professional concerning a female patient (age unknown) who on 15-NOV-2006 were vaccinated with Pneumovax 23 (lot # 651406/0620F), intramuscularly.  Subsequently, "one hour after vaccination", the patients developed pain, swelling and redness at the site and all around her upper arm.  The patient also developed splotchiness in the arm in which they were vaccinated.  Itching soon followed along with bruising.  The symptoms increased over the next few days.  The patient saw her doctor who stated that since she was allergic to the flu preservative she should not have been given the Pneumovax 23 since it had the same preservative.  She said she told the nurse she was allergic to the flu vaccine.  The doctor told her she had an allergic reaction and placed her on ZYRTEC.  The symptoms went away after 5 days.  Additional information is not expected.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Medium, Additional Details: About 5 minutes after the shot, the patient lost conciousness, fell face forward on the ground. Face appeared grey, was unresponsive, but was making grunting sounds. His body appeared to be shaking lightly, possible seizure, was not responsive. Oral benadryl was not possible at this point. Turned patient on back/side in order to adminster the epipen. Patient quickly became alert and responded. No injection site reaction. Paramedics arrived shortly to check vitals and transfer him
Patient states she started having a headache, sore arm, and feeling generally unwell the day after the vaccine. She stated she had "little red dots" in her mouth that were fluid filled which appeared the day after her second dose. No adverse events reported after the first vaccine dose.
pt died @ home per death certificate; cause of death COVID pneumonia; unable to obtain medical records from physician who signed the death certificate
Day of vax pt felt trouble breathing/fluish, day after she felt lots of pressure on lungs and felt like she couldnt get enough air, chills, fever, cough, sinus issues, headache. Went to er and they said she was having and allergic reaction
Patient arrived in critical care with subdural hematoma per Head CT on 12/28/2022.  Patient was subsequently intubated.  Patient was later extubated on 1/5/2023 and coded that evening, and unfortunately died.
Information has been received from a physician concerning a 63 year old female pt with drug hypersensitivity to Bactrim, codeine, lisinopril, comeprazole, Zantac, ragweed allergy, mold allergy and rhinitis allergic who on 07OCT2003 was vaccinated in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine. There was no illness at the time of vaccination. Concomitant medication included estradiol. Metro cream and famotidine. On 08OCT2003 the pt experienced injection site hives and hives up arm and onto shoulder; total of 13-15 cm. It was noted that there was no relevant diagnostic tests or laboratory data. It was also noted that the pt recovered. Additional information has been requested.
Fever, Muscle Aches, Severe Headache, Severe Chill w/entire body shaking,
COLD SYMPTOMS/COUGH; This spontaneous report received from a consumer concerned multiple patients. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number is not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced cold symptoms/cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of cold symptoms/cough was not reported. This report was non-serious.
"ringing noise in his brain"; not able to sleep; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Apr-2021 and was forwarded to Moderna on 10-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS ("ringing noise in his brain") and INSOMNIA (not able to sleep) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 027A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced TINNITUS ("ringing noise in his brain") and INSOMNIA (not able to sleep). At the time of the report, TINNITUS ("ringing noise in his brain") and INSOMNIA (not able to sleep) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
swollen arm , tender to touch and move, nausea vomiting, diarrhea, dizzy, weakness,  lost 55 lbs, since second vaccine symptoms began and still ongoing
This spontaneous report as received from a pharmacy student refers to a 60 years old female patient with none known pertinent medical history and drug allergies to OMNICEF and CELEXA. The patient was vaccinated with ZOSTAVAX (lot # not reported) on an unknown date. No concomitant medications were reported. "Three days later" (exact date unknown) the patient began prednisone therapy ("40 mg daily for four days") for a "mosquito bite or bug bite she experienced while camping." The patient sought for unspecified medical event attention via an office visit. The outcome was reported as not recovered. Additional information has been requested.
Awoke in early AM with chills; in morning 96.6F temp, fingers and toes numb with cold, tearful, whole body aches; no s/sx of infection at injection site.
Patient had syncopal episode within 15 minutes of vaccination.  Patient fell out of chair and had a cut on her forehead (from sunglasses).  Patient recovered and was released to home.
On 2nd day after vaccine I had terrible body aches, splitting headache, low grade fever and chills for 24 hours, on 3rd abnd 4th still experienced headache and fatigue- I took Advil once on day 2- that is the only medication I took
feeling funny; anxiety attacks; nervous; Headache; Nauseous; This is a spontaneous report from a contactable consumer(patient).  A patient of unspecified age and gender received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1283), via an unspecified route of administration on 16Jan2021 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. Patient experienced feeling funny, anxiety attacks and nervous on 16Jan2021, and went to emergency room due to feeling funny, anxiety attacks and nervous, patient also experienced headaches, went to physician office visit and a little nauseous in Jan2021. It was reported that patient received the first shot on 16Jan2021. Immediately after the shot went in(16Jan2021), patient started feeling funny. So, patient was right in the hospital anyway, patient just went to the emergency room and they checked patient up and they just gave patient prednisone, patient do not know why they gave patient Prednisone thinking patient was having anxiety attacks or something and they did an Electrocardiogram(EKG) said patient was fine. Patient took the Prednisone a couple of days because it made patient nervous but patient was still having headaches and a little nauseous and its since Saturday, last Saturday. Treatment received for all events. Outcome of headache and nauseous was not recovered, of other events was unknown.
pt was inadvertently given MenB instead of MenactraACWY -- no adverse reactions.
The pt experienced a butterfly shaped rash at injection site, and a papular rash as well.  Follow up: "Vaccine recipient recovered from adverse events."
On 5 Jul 00, the vaccinee received her first dose of Engerix-B. Within 48 hours, she experienced flu-like symptoms which resolved. On 7 Aug 00, the vaccinee received her second dose of Engerix-B. Within 48 hours, she again experienced flu-like symptoms which resolved. No treatment was given. As of 8 Jan 01, the outcome of the events is resolved.
MD reports inc number of inj site rxns (induration, erythema, & swelling) following vax w/a particular lot;normally receives 1-2 complaints per wk;w/this lot 3-4 per day;some required MD visit; 1 of these pt was @ 15mo old vaxed 26SEP94;
Muscle ache at injection spot, fatigue, nausea, high-grade fever (102 degrees), inability to move arm.
Client returned to clinic due to red and swelling Right arm. She reports it was very painful and the day after getting the vaccine it. She put a heating pad on it which didnt improve it. Today when she got up she noted it was red and swollen. It is warm to the touch today also.
Extreme pain and difficulty raising arm for thet full days 10 days after injection Some pain at site for two days.
unable to make a fist with both hands for 3 days and muscle aches in legs that still persist and fatigue
Arm pain I was very tired for 3 days; Arm pain I was very tired for 3 days; fell back asleep for 3 days; Like pain and overall discomfort every where; Like pain and overall discomfort every where; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 17 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Apr2021 15:00 (Lot number: Er8735) at the age of 17 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious), FATIGUE (non-serious) all with onset 29Apr2021 18:00, outcome "recovered with sequelae" and all described as "Arm pain I was very tired for 3 days"; SLEEP DISORDER (non-serious) with onset 29Apr2021 18:00, outcome "recovered with sequelae", described as "fell back asleep for 3 days"; PAIN (non-serious), DISCOMFORT (non-serious) all with onset 29Apr2021 18:00, outcome "recovered with sequelae" and all described as "Like pain and overall discomfort every where". Therapeutic measures were not taken as a result of pain in extremity, fatigue, sleep disorder, pain, discomfort.  Additional information: patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination nor been tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
Pt received MMR as school requirement on Tues 6-16-08.  Nausea 6-17-08 - increased N/V 6-18-08 - hives 6-19-08 to date confluent hives L face - blister on lip.  Discomfort with L eye - rash R shoulder & L lower ribcage.  Has had hives both arms.  C/O feels like face is on fire today unable to take BENADRYL & work.  Advised to see MD - no insurance.
ringing in my ears, started in June and was worse in July. August had ringing and dizzy spell so scheduled doctors appointment.
She had the vaccine on Thursday and no visible side effects. On Saturday she was very weak and had to be lowered to the ground. She was drooling and staring vacantly and was not responding to questions. This lasted for a bit. I called the ambulance which took her to the  hospital. They hydrated her and sent her home with no idea what caused it. The next day she was sitting on the toilet and passed out with her eyes closed. She started drooling. I again called the EMTs and they came. She had come to and they said she fainted and it was probably because she was having a bowel movement. This has not happened before or since these two episodes. I do not know if she should get the next shot.