chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache back of neck; Slept for 14 hours; This case was reported by a consumer via other manufacturer and described the occurrence of occipital headache in a 71-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   Co-suspect products included treprostinil (Orenitram) for pulmonary arterial hypertension.   Concurrent medical conditions included pulmonary arterial hypertension.   In November 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season and Orenitram at an unknown dose and frequency. In November 2019, less than a month after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced occipital headache and sleep excessive. On an unknown date, the outcome of the occipital headache and sleep excessive were unknown.   It was unknown if the reporter considered the occipital headache and sleep excessive to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional case details were reported as follows: The patient had flu shot and slept for 14 hours and missed one dose. The patient occasionally got headache back of the neck. He had minimal health improvement since starting PO Orenitram. The orenitram dose was not changed due to the events of therapeutic response decreased, headache and hypersomnia. Action taken with Flu dose due to the events of therapeutic response decreased, headache and hypersomnia was not reported. At the time of reporting, the outcome of the events of therapeutic response decreased, headache and hypersomnia were unknown. The reporter assessed the causal relationship between the PO Orenitram and the event of therapeutic response decreased as possible. The reporter did not provide causality for the events of headache and hypersomnia.
Shot area itched. The second day I had chills and a rash. The third day in the pm I experienced dizziness, difficulty breathing, nausea, and hoarseness. The fourth day in the am I still experienced dizziness and nausea. It finally went away in the afternoon. The next couple of days I have still had a feeling of lightheadedness but am able to work. I took Benedryl for the rash.
late second dose and a late third dose; late second dose and a late third dose; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 30-year-old female patient who received HBV (Engerix B) (batch number N4GA4, expiry date unknown) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (received 1st dose on September 2020).   In October 2021, the patient received the 3rd dose of Engerix B. In May 2021, the patient received the 2nd dose of Engerix B. In May 2021, not applicable after receiving Engerix B and unknown after receiving Engerix B, the patient experienced drug dose administration interval too long. In October 2021, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long and drug dose administration interval too long were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient had been given a late second dose and a late third dose of the Engerix-B vaccine, which led to lengthening of vaccination schedule.  The reporter consented to follow.
Patient had immediate swelling of immunization site on L leg of MMRV Vaccine. Swelling remained localized and did not spread. Patient's provider was notified and was given a cold pack to reduce swelling. Patient was monitored for 20 minutes and swelling decreased over time. Patient was seen with her provider and was released to go home with her mother and sister.
Child received vaccine 05/12/2006 had redness and blisters to area between dtap and mmr not in direct line with vaccine 2 large blisters ruptured and appeared dry 05/16/2006. Child in no distress.
diabetic wounds; end stage heart failure; He tested positive for COVID; He tested positive for COVID; This is a spontaneous report from a contactable consumer. A 78-year-old male patient received first dose of bnt162b2 (reported as COVID-19 vaccine), via an unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received his first dose of the COVID-19 vaccine on 07Jan2021. He tested positive for COVID on 27Jan2021. Patient was in hospice care. He went to the hospital for treatment of diabetic wounds on 20Jan2021. In addition to diabetes he had end stage heart failure on an unspecified date. Event took place after use of product. The event outcome was unknown.  Information about batch/lot number has been requested.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021 at 4:05 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Oct-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications was provided by the reporter.    Patient received vaccine which was stored in an ultra cold freezer at minus 82 degrees Farenheight. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No Previous temperature excursions was reported.   This case was linked to MOD-2021-402935 (Patient Link).
Week of 1/23/2007 pain at site of GARDASIL injection #2 5 week past GARDASIL. Myalgias, hip pain, elbow, wrist, hand, finger, knee, foot pain, fatigue, petechiae legs, decreased ROM, lab NL. Seen by rheumatology, resolved completely 4/3/08. Followed by rheumatology no reoccurrence as of 1/09.  1/29/09 Received PCP medical records which included Rheum & Ortho consults. FINAL DX: Polyarticular reactive arthritis Records reveal patient experienced usual state of good health on 5/18/07, day of HPV#1 & Varicella vaccinations.  RTC 8/23/07 with symptoms x 3 days of pain & swelling of multiple joints; gen aching; fatigue; decreased appetite; difficulty standing, walking & making fist or extending fingers; low grade fever; oral ulcers; scattered petechiae of LEs; searing pain where HPV#2 given 7/18/07.  6/20-23 had illness w/cough, sore throat, fatigue, HA, fever, pain in hips/ankles, stiff joints.  Rheum consult of 9/5/07, 4/3/08, 7/10/08 & 1/5/09.  Ortho consult of 7/30/08.  Referred to pulm & ID on 1/5/09.
Came down with a mild fever Sunday evening.  The next day it seemed to subside, but the fever returned again Monday night and was higher--around 102 to 103 degrees.  Fever broke again in the morning and returned Tuesday evening.  For three days she had fever, difficulty sleeping, decreased appetite, and generally seemed not to feel very well, though she was still active.  Wednesday morning she seemed to have trouble swallowing (she was rolling her tongue around in her mouth as if uncomfortable all morning), and she vomited three times during meals.  Took her to see the pediatrician.  She was given a strep test (negative).  The doctor said during the exam that her ears and lungs looked good, but her throat appeared red.  Was advised to keep watching for another 48 hours to see if symptoms persisted.  The fever did not return that night. However, she developed a rash that evening and continued to feel poorly (lack of appetite, rubbing eyes, crankiness).  The rash and other symptoms (except for fever) lasted another 4 days.
Within 40 minutes approximately of getting the vaccine, my face became numb at the tip of my nose and the area above my upper lip. By one and a half hours later after the vaccine, the numbness had expanded from right below my eyes down to my jawline. This numbness lasted a few hours and by the following morning, the numbness had returned to just my nose and area above my upper lip. This numbness lasted about an extra day. Nausea lasted 15 minutes beginning approximately 40 minutes after getting the vaccine. Lightheaded and feeling somewhat disoriented began about 40 minutes after getting the vaccine and lasted two days. While I received the injection in my left arm, my right arm was actually sore, which started within a couple of hours after getting the vaccine and lasted about three days. Severe muscle aches beginning from my waist down to my ankles, which began about four days after getting the vaccine and lasted about three days total. No muscle aches above my waist was experienced. Soreness in my left arm at injection site as well as itchiness was observed about 8 days later. All side effects fully subsided about 9 days after the injection.
On the second morning after my second COVID shot, I woke up to find three visibly swollen lymph nodes that were not there the night before, one in each inguinal lymph node and one in the left axillary lymph node. I called Dr. and asked if these might be normal side effects of the vaccine. She said the vaccines were so new that it was hard to say. Nothing changed in the size over the next four months, when I went for my annual check up. The swelling was suspicious enough that she referred me to an oncologist.
I received my second dose of the covid Pfizer vaccine on April 24 of 2021. The day of, and after I got the dose, I started my menstrual cycle and experienced extreme pain and nausea. I had never experience period cramps to that degree before receiving the second dose. I still experience bad pain to this day. I believe that the vaccine had something to do with the new period symptoms, my period was irregular but I got it hours after getting the vaccine.
Left sided facial paralysis (Bell's palsy) began on 3/7/21 and was still present when I contacted the patient by phone one 3/9/21.  Problem has so far not resolved.  Seen at urgent care and diagnosed as Bell's palsy.
extreme dizziness ringing in ears vomiting elevated heart rate elevated blood pressure headache itching sensation under skin nystagmus  transported by ambulance from home to the emergency room treated via IV, benadryl, meclizine, anti-nausea medication
Temperature Excursion; Initial Report Received on 05-Jan-2023 and 09-Jan-2023  A medical assistant and a pharmacy purchaser reported that a 51-year-old male patient (race and ethnicity unknown) [Patient 4] received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that had a temperature excursion issue.   Medical history, concomitant medications, and allergies at the time of vaccination were not reported.  On 23-Dec-2022, there was a power outage at 04:00 AM at the health center. There was no backup generator to the vaccine refrigerator. When the medical assistants came into work, they heard the vaccine refrigerator's alarm go off. The refrigerator was warm with a temperature of 54.5°F at 06:45 AM. All the vaccines were removed and put into coolers with ice. Pharmacy was notified, and all the vaccines affected by the power outage were counted.   On 03-Jan-2023, 12 days later, the patient received a dose of HEPLISAV-B (Lot # 939305, expiration date 29-Mar-2024, and NDC # 43528-003-01) in the right deltoid (route not reported) by a medical assistant. It was discovered the next day on 04-Jan-2023 that a couple of boxes were missed being removed after the power outage, and the patient had received the HEPLISAV-B vaccine that had the temperature excursion of 54.5°F for 2 hours and 45 minutes.  No further information was provided. Additional information was requested.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Red itchy swollen patch on upper arm a little below injection site, hot to the touch. About 4" when first noticed (because of itch). Next day less itchy but more sore, still red, swollen and hot. Two days later in the morning, about 6" across, itchy again, still hot to touch, red rim around edge of patch. Two days later in afternoon (now), red patch overall less swollen, but raised redder patch at bottom of main patch, still hot.
Information has been received from a physician concerning a 12 year old female with no pertinent medical history and no drug reaction/allergies who on 13-MAY-2008 was vaccinated IM with the first dose of GARDASIL. There was no concomitant medication. On 13-MAY-2008, the patient experienced jerky movements in the upper torso. On an unspecified date. an electromyography was performed (no results provided). The patient sought unspecified medical attention. At the time of the reporting, the patient had not recovered. Additional information has been requested. 10/16/08-records received-neurology consult:Assessment-Suspect akathisia. presented for evaluation of abnormal movements described as muscular twitching occurring diffusely throughout her extremities. Twitching became more prominent after Gardasil injection several weeks ago. Normal neurological exam.  9/8/08-office visit for congenital pes planus. Twitching has not progressed, changed, worsened or gone away.
Pain at shot location for several days, tender to the touch. Extreme fatigue for two days. Shivering, chills two nights. Possible fever, two days. Achy for two days. I am not sure if it is Zoster SHINGRIX or ZOSTAVAX - the paper I was given did not specify.
patient has a giant bruise on her upper arm and shoulder, and this bruise appeared after her second vaccine dose.  The bruise is getting bigger/spreading.; This is a spontaneous report from a contactable consumer. An elderly non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on an unspecified date (Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not known. It was unknown if the patient had allergies to medications, food, or other products. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination and if the patient has been tested for COVID-19 since the vaccination. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on an unspecified date (Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient had a giant bruise on her upper arm and shoulder, and this bruise appeared after her second vaccine dose. The bruise was getting bigger/spreading. It was unknown if the patient received treatment for the events. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Arm was sore after injection until the pain got so bad I had to go to the ER. Ibuprofen and oxycodone where given in the ER
Had a low grade fever for 48 hours after vaccines. On 1/7 the fever went up to 103.4 and mom treated with TYLENOL and ibuprofen. On 1/8, he broke out in hives from the neck up.
pt recvd vax; pt exp redness & raised hot area; area of vax was swelling; pt taken to PHNA advised warm compress x3- 4x5/days;
This spontaneous report was received from a nurse refers to a patient of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On 30-AUG-2015, the patient was vaccinated with first dose of GARDASIL, K016966, 10-MAY-2017. The patient received a second dose of GARDASIL 9 lot # L019297, 18-AUG-2017 on 30-DEC-2015. The patient received the third dose of GARDASIL 9, lot# L024993 17-OCT-2017 on 29-FEB-2016. No adverse effects were reported. Additional information has been requested.
Patient reported to feel his left arm becoming numb from elbow down to fingers after 45 minutes of shingrix vaccine. The numbness lasted 1 hour later, and then patient felt sensitivity of his middle finger and ring finger. I described the sensation like when he had a burn on those 2 fingers. The numbness from elbow down went away 1 hour after the shot, but his sensitivity on the 2 fingers is still there at the time of reporting. Patient went to PCP to check up, and PCP recommended patient to make appointment with neurologist.
Accidently used a wasted extra dose  that left in a Pfizer vial  and mixed it  with 1.8 ml  Normal Saline. Thinking i was mixing an intact vial. A dose was withdrawn from the affected vial and administered to the patient.
LOSS BOWEL CONTROL; LOSS BLADDER CONTROL; FALL OFF HER SEAT; WEAK MUSCLES IN ARM AND LEGS/ DID NOT HAVE ANY MUSCLES STRENGTH IN THE ARM AND LEGS; PAIN AT SITE OF INJECTION; EXTREMELY WEAK; COULDN'T GET UP FROM CHAIR; This spontaneous report received from a patient concerned an 89 year old female.  The patient's height, and weight were not reported. The patient's past medical history included: shoulder replacement surgery (date not specified), and hip replacement, and concurrent conditions included: orthopedic problems, and failed meniscus in right knee. The patient reported that she was young and healthy.  The patient was previously treated with influenza vaccine for prophylactic vaccination in SEP-2021.  On 03-APR-2021, the patient was previously treated with covid-19 vaccine ad26. cov2. s for prophylactic vaccination (dose series 1).   The patient subsequently received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811 expiry: UNKNOWN) dose was not reported, 1 in total, administered on 27-OCT-2021 around noon for prophylactic vaccination on her right arm (dose series 2). No concomitant medications were reported.  On 27-OCT-2021,around 23:30 that night the patient couldn't get up from her chair and had no muscles strength in the arm and legs/ weak muscles in arm and legs. She felt extremely weak. The patient fell off her seat and experienced loss of bladder control and bowels control. The patient pressed her emergency button to call paramedics who arrived right away and they were able to get her up. The patient was not taken to the hospital as she wasn't hurt. The paramedics helped the patient to get her walker from the garage. The patient had some problem in the past but never felt that weak.  The patient reported she had shoulder replacement surgery recently and was sleeping on a mechanical chair. The patient got up several times during the night but she felt weak.  By the morning she was better but reported it was almost four days for her "to return to normal self". The patient also experienced pain at the site of injection that was shadowed in the morning on 28-OCT-2021 (dose series 2).   The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient recovered from loss bowel control, loss bladder control, and weak muscles in arm and legs/ did not have any muscles strength in the arm and legs on an unspecified date, and recovered from pain at site of injection on 28-OCT-2021. The outcome for  extremely weak, of fall off her seat, and couldn't get up from chair  was not reported.  This report was non-serious.
I got Covid about a month after injection, then was sick multiple times after then with Covid being one the sicknesses again.
This case was reported by a consumer and described the occurrence of narcolepsy in a adult male patient who received BOOSTRIX. Concurrent medical conditions included foot infection (coral infection on foot). Concomitant products included antibiotics nos.  On 13th April 2016, the patient received BOOSTRIX. On 15th April 2016, 2 days after receiving BOOSTRIX, the patient experienced migraine headache. In April 2016, the patient experienced tremor limb. In 2016, the patient experienced narcolepsy (serious criteria GSK medically significant). On an unknown date, the patient experienced sleep excessive. On an unknown date, the outcome of the narcolepsy, migraine headache and tremor limb were not recovered/not resolved and the outcome of the sleep excessive was unknown. The reporter considered the narcolepsy, migraine headache, tremor limb and sleep excessive to be possibly  related to BOOSTRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient was in his late 50s. This case was not previously reported to anyone. The patient visited the hospital emergency room due to a coral infection on foot and was given BOOSTRIX along with IV antibiotics. The vaccination was administered sometime before noon that day. The patient did not experienced migraine headaches in 30 years. The leg tremors began about a week after receiving the vaccination and the patient described them as feeling like gremlins crawling around in legs. The patient stated that it is harder to pinpoint when the narcolepsy began but described it as sleeping for more than 12 hours, needing to nap (which never had in the past) and just falling asleep randomly. The patient did not want to provide further details for this report.
Headache-- 11:00 PM ongoing Dizziness-- 1:00 AM ongoing Body aches-- 1:30 AM ongoing Muscle and joint pain: 1:30 AM ongoing Chest pain: 2:30 AM ongoing Nausea: 3:00 AM receded after taking zofran Vomiting: 4:00 am, 6:00 am currently receded
Redness and soreness. Treated took cetirizine and cortisone cream applied the evening after. This happened hours after vaccine administration.
Facial tingling- was on the bottom half of face, mostly around mouth; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 30Mar2021 at 12:30 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not receive any other medications within 2 weeks of COVID-19 vaccine. On 30Mar2021 at 12:45, the patient experienced facial tingling on the bottom half of face, mostly around mouth, which came and went for a few days and very sporadically after that. The patient had no swelling or any other concerns. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the event facial tingling around mouth was resolving at the time of report.  No follow-up attempts are needed. No further information is expected.