chrisvoncsefalvay/vaers-outcomes huggingface dataset:
From initial information received on 4/13/04 from a consumer regarding an adverse event occurring in the USA, it was reported that a 52 year old male patient received an IMOVAX RABIES vaccination, lot number W1419, administered IM in the right arm on the morning of 4/4/04. The patient also received IMMUNOGLOBULIN HUMAN ANTIRABIES on an unspecified date. The indication for the vaccination was not reported. On the evening of 4/1/04, the patient complained of slowed speech described as difficulty getting words out. This has continued since his first injection. He also experienced shaking and felt cold, which lasted for two days. No other information was provided. The patient did not recover from these events. A new version of this case was created to correct the date of administration of IMOVAX RABIES from 4/4/04 to the reported date of 4/1/04. The case was not medically confirmed, as it was reported by the patient. NO new information was reported. From additional information received on 5/20/04, the report has been medically confirmed by a physician where the patient was vaccinated. It was reported that the lot number for this first dose of IMOVAX RABIES (given on 4/1/04) was W1419. The patient received a second dose of RABIES VACCINE and a first dose of IMMUNOGLOBULIN HUMAN ANTIRABIES on 4/7/04. The lot numbers and manufacturers were not reported. On 4/10/04, the patient received a third dose of RABIES VACCINE. He received his fourth dose of IMOVAX RABIES on 4/14/04, a fifth dose on 4/21/04 and a sixth dose on 4/28/04. The lot number for the last three doses was X0581. All doses of IMOVAX RABIES and RABIES VACCINE were given IM. No adverse events were reported following subsequent doses and per the physician there is no additional information. The patient's recovery status was not reported. Further information is not anticipated, this case is considered closed.
A few hours after the vaccine I developed a severe headache, really bad fatigued so I took an  Aleve and went to bed.  When I woke up the next morning my entire body ached causing me to have to stay in bed.  3/17 the symptoms seemed to be getting a little better but all of the sudden my immune system seemed as if it begin attacking all my joints resulting in me not being able to walk for several days.  My knees, ankles and shoulders area were severely swollen.  I reached out to my Rheumatologist after about a week because the symptoms were getting worse.  Because I had just gotten my Remicade Infusion a few weeks prior there was no treatment that could be performed and advised I take OTC pain meds until the vaccine reached full strength first other treatments could be performing.  I did later get the infusion which did improve the symptoms a little and on 4/9 I visit the Rheumatologist in office and my infusions injections were then readjusted from every 8 weeks to now every 6 weeks.
pain and swelling in her fingers and toes; pain and swelling in her fingers and toes; having a bad flare a week after getting first covid vaccine; This is a spontaneous report from a contactable other hcp (clinician). A 53-year-old female patient received bnt162b2 (BNT162B2 formulation; Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient received tofacitinib citrate (XELJANZ XR Prolonged-release tablet), oral from 09Jan2020 (Batch/Lot number was not reported) and ongoing, at 11 mg, daily for rheumatoid arthritis. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced pain and swelling in her fingers and toes and bad flare a week after getting first covid vaccine on an unknown date of Apr2021. Xeljanz was not held during this time. It was reported that MD was aware. The patient prescribed prednisone to help relieve the swelling and pain. The patient would wait a week or two before getting the second vaccine. Therapeutic measures were taken as a result of pain and swelling in her fingers and toes. The action taken in response to the events for tofacitinib citrate was dose not changed. The outcome of event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
No additional AE reported; Pediatric Patient was administered expired VAQTA; This spontaneous report was received from Pharmacist and refers to a pediatric patient (gender not reported).   The patient's concurrent conditions, medical history or concomitant medications were not provided.   On 20-FEB-2023, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (lot #U012007 with expiration date: 18-JAN-2023) administered for prophylaxis (strength, dose and route of administration were not provided). No additional adverse events were reported. No Temperature Excursion reported prior to or at the time of this report.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, in Mar2021 as dose 2, single (Batch/Lot number: unknown), in right arm and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing). Concomitant medication included: NP THYROID, start date: Apr2017. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 12Mar2023 To 16Mar2023 as treatment of COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
6  Hours after the injection I had red pumps on my left arm (injection arm) and red small blisters and pumps on my back. Other than the red rash and pumps I felt fine.  Nothing that would alarm me except the look of the red rash. 2 hour later the rash mostly disappeared. Still feeling fine.
Sore; Tired / Fatigue; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Sore), FATIGUE (Tired / Fatigue), HEADACHE (Headache) and PYREXIA (Fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine. Concomitant products included NAPROXEN SODIUM (ALEVE) for Migraine.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN (Sore), FATIGUE (Tired / Fatigue), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, PAIN (Sore), FATIGUE (Tired / Fatigue), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
3 BRUISED TOES; This spontaneous report received from a patient via a company representative concerned a 66 year old male. 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 was not reported, administered on 16-JUN-2021 for prophylactic vaccination. The batch number was not provided and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced 3 bruised toes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from 3 bruised toes. This report was non-serious.
Pt recvd 2 doses of Hep B vax 25JUN91 & 24JUL91 & following 2nd dose devel severe arthritic sx & lymphadenopathy;
DOSE 1: 23Nov2021; DOSE 2: 04Jan2022; Blisters in mouth and throat; feeling unlike myself consistently since vaccination; rash; Feeling disoriented; Inability to sleep; stomach pain; Excess bruising at injection site; vomiting; extreme fatigue; headaches; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Jan2022 14:00 (Lot number: FF2593) at the age of 36 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Remission from cervical cancer" (unspecified if ongoing), notes: Remission from cervical cancer; "known allergies: Cinnamon" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single; 02:30 PM; Batch/Lot No: FH8028; Location of injection: Arm Left) administration date: 23Nov2021, when the patient was 36 years old, for COVID-19 Immunization.  The following information was reported: (non-serious), outcome "unknown", described as "DOSE 1: 23Nov2021; DOSE 2: 04Jan2022"; BLISTER (non-serious) with onset 04Jan2022 22:00, outcome "not recovered", described as "Blisters in mouth and throat"; FEELING ABNORMAL (non-serious) with onset 04Jan2022 22:00, outcome "not recovered", described as "feeling unlike myself consistently since vaccination"; RASH (non-serious) with onset 04Jan2022 22:00, outcome "not recovered", described as "rash"; DISORIENTATION (non-serious) with onset 04Jan2022 22:00, outcome "not recovered", described as "Feeling disoriented"; INSOMNIA (non-serious) with onset 04Jan2022 22:00, outcome "not recovered", described as "Inability to sleep"; ABDOMINAL PAIN UPPER (non-serious) with onset 04Jan2022 22:00, outcome "not recovered", described as "stomach pain"; VACCINATION SITE BRUISING (non-serious) with onset 04Jan2022 22:00, outcome "not recovered", described as "Excess bruising at injection site"; VOMITING (non-serious) with onset 04Jan2022 22:00, outcome "not recovered", described as "vomiting"; FATIGUE (non-serious) with onset 04Jan2022 22:00, outcome "not recovered", described as "extreme fatigue"; HEADACHE (non-serious) with onset 04Jan2022 22:00, outcome "not recovered", described as "headaches". Therapeutic measures were taken as a result of blister, feeling abnormal, rash, disorientation, insomnia, abdominal pain upper, vaccination site bruising, vomiting, fatigue, headache.  Additional information: The 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. patient been tested for COVID-19 since the vaccination.  Serious: No Seriousness criteria-Results in death: No Seriousness criteria-Life threatening: No Seriousness criteria-Caused/prolonged hospitalization: No Seriousness criteria-Disabling/Incapacitating: No Seriousness criteria-Congenital anomaly/birth defect: No  No follow-up attempts are possible. No further information is expected.
Extreme pain in right arm 1-3 weeks after injection. Sharp pain 7/10 most evenings. Occasional numbness where vaccine injection occurred in right arm. Extreme tiredness as well.
Syncope at approximately 5:20am this morning. I had been awake and active for about 30 minutes getting ready for work. As I was walking to my kitchen, I suddenly became very dizzy with blurred vision, tingling hands, nausea, ringing in my ears, and I felt like I was going to lose control of my bowels. I became very weak in the legs and I made it to the couch before I fell. Episode lasted approximately 2 minutes. As I laid down, my symptoms recovered. My husband gave me some juice and toast. After about 20 minutes, I got up and was able to walk without symptoms. I felt perfectly normal prior to this event. Last night, I ate a full dinner and drank about a liter of water. This event did not seem to be precipitated by hypoglycemia or dehydration. For the rest of this day, I have felt normal.
Face itching, especially around nose, kidney area moderate soreness, apprehension, agitation, general nervousness.
low blood pressure and dizziness, diaphoresis. Taken to medical observation BP 110/60 At 0954 AM BP was 120/70 Patient stable.  Discharged to exit via wheelchair.
Client reported nausea, tingling in her left hand, and slight dizziness at 6:45ish. Vitals obtained at 6:53PM PM were as follows: BP 120/78, HR 71, O2 96%. The client reported a history of nausea when she is nervous. Client was provided an emesis bag. Vitals obtained at 6:58PM were as follows: BP 120/68, HR 65, and O2 98%. The client reported a history of hypotension. The client stated she has to be sure to stay adequately hydrated or she notices a decrease in her blood pressure. Current medications include Avapena. The client denied any s/s of anaphylaxis. At 6:55PM the client reported a headache. The client did eat today. At 7:02PM RN provided the client a cotton ball with peppermint oil on it to smell.. The client stated her headache was very light at 7:05PM. The client left at 07:10PM.
In the middle of the night I had chills, a headache, and body aches as is to be expected. The fatigue and headache lasted two days, but all of those side effects were minor and manageable and are well worth it to avoid covid-19. A couple days after I got the shot, I got my period and it was nine days early. That never happens to me. My cycle is pretty regular and is never early. I additionally experienced much heavier bleeding than usual as well as worse cramps.
Dxed w/ GBS. Currently undergoing tx for increased nerve inflammation & physical therapy. Hospitalized. 60-Day FU states developed post polio syndrome (had polio at age 6). Annual follor-up states that she has not recovered and is still going to physical therapy for hip pain. Discharge summary confirms dx of GBS.
On Friday, January 8 I experienced a headache for the remainder of the day following my vaccination. This headache went away when I woke up the following day.  On Saturday, January 9 I experienced chills, nausea, body aches, and a stiff neck, along with pain in my left arm. The injection site was inflamed and painful. Most of these symptoms were relieved the following day.  On Sunday, January 10 I experienced pain in my left arm that has travelled into my axillary area and my left shoulder. This has yet to be relieved. I am also erythemic at the injection site.
1st symptom was a runny nose. Later that morning, having gone out for tea, I felt weak & felt that I might have chills. I walked home in a light rain but I didn't go into chills. At home I had a fever, so I started drinking fluids & then went to bed. The scariest symptom was a fast heart rate followed by a slow rate. This continued while I was lying down. I had no appetite & also a general stiffness. I started to fell better after the fever broke (after 4pm & my appetite returned. I was still weak & stiff but I felt much better. The next day (Oct. 4) I was back to my normal
Initial report was received from a staff member at a health center on 31 October 2011. A female patient (age not reported) had received an injection of FLUZONE (site and route of administration not reported) lot number UT481AA on 21 October 2011. On an unspecified date, the patient seeked medical attention due to arm pain. Twelve days later after the vaccinations, she was unable to move or lift her arm without pain. The pain worsens at night. No further information was available at the time of the report. The patient's outcome was not recovered/not resolved. Documents held by sender: none.
At 8 weeks pregnancy (2 weeks after first shot) started bleeding and had a subchorionic hematoma. By 10 week subchorionic hematoma resolved.  Received second shot and of Feb.  1 week later,  at 12 weeks pregnancy ,  fetus had no heart beat!  It measured normal size (as expected) and limited normal first trimester anatomy by ultrasound. But NO heart beat. Something insulted this placenta to lead to fetal demise.
Vaccine intake form completed by the pharmacist on duty states the following adverse events: lightheadedness, dizziness within 10-15 minutes of vaccination. cold, clammy feeling, low heart rate. Pharmacist on duty called EMS for patient and noted there were no signs or symptoms of anaphylaxis.
Pain at injection site and progressive arm tenderness that radiated into her shoulder, scapula, left sde of her neck and her head until she developed pain in her jaw on 9/30/14.
This case was reported by a consumer via call center representative and described the occurrence of muscle strain in a 51-year-old male patient who received SHINGRIX (batch number LN9TL, expiry date 30th January 2020) for prophylaxis. On 2nd March 2018, the patient received the 1st dose of SHINGRIX. On 3rd March 2018, 1 days after receiving SHINGRIX, the patient experienced shoulder bursitis, musculoskeletal stiffness, neck pain, headache, difficulty in standing, gait disturbance and general body pain. In March 2018, the patient experienced muscle strain. The patient was treated with Steroid Therapy Nos. On an unknown date, the outcome of the muscle strain, shoulder bursitis, musculoskeletal stiffness, neck pain, headache, difficulty in standing, gait disturbance and general body pain were unknown. It was unknown if the reporter considered the muscle strain, shoulder bursitis, musculoskeletal stiffness, neck pain, headache, difficulty in standing, gait disturbance and general body pain to be related to SHINGRIX. Additional details were provided as follows: Fourteen hours after dose of SHINGRIX, he began to experience hamstring pulls and calf muscle pulls in both legs. He had been seen by several doctors and specialists who could not find a cause at the time of reporting. The patient suspected SHINGRIX. The patient reported a worsening of bursitis in his shoulder. The patient also reported that the muscle pulls were spreading. He described the feeling as muscle pulls below the waist, and his upper body as painful. The patient reported that the pain was in the neck and back of the head. He has had some relief, about 80 percent with oral steroid therapy. He also reported that it was hard to stand from a seated position. He also reported difficulty bending over, such as tying his shoes. He also reported that his gait had been measured as only 8 inches apart. The patient consented to follow up.
This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a 35-year-old female patient who received ENGERIX B (batch number 79ZS7, expiry date 4th June 2018). Co-suspect products included ENGERIX B (batch number A9LB7, expiry date 7th July 2018) and ENGERIX B (batch number A9LB7, expiry date 7th July 2018). On an unknown date, the patient received the 1st dose of ENGERIX B (intramuscular) and the 2nd dose of ENGERIX B (intramuscular) 1 ml. On 21st June 2016, the patient received the 3rd dose of ENGERIX B (intramuscular) 1 ml. On 21st June 2016, not applicable after received ENGERIX B and ENGERIX B and an unknown time after receiving ENGERIX B, the patient experienced drug dose administration interval too short. On 23rd August 2016, the patient experienced therapy non-responder. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the therapy non-responder, drug dose administration interval too short and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the therapy non-responder to be related to ENGERIX B, ENGERIX B and ENGERIX B. Additional details were provided as follows: The reporting pharmacist was the dispensing pharmacist. The age at vaccination was not reported. The regimen used was 3 doses on a schedule of 0, 4 weeks and 12 weeks later. On 21st June 2016, the patient received 3rd dose of ENGERIX B, which led to shortening of the vaccination schedule. The patient who was a healthcare worker at the facility received 3 doses of ENGERIX B in her deltoid. On 23rd August 2016, 63 days after receiving 3rd dose of ENGERIX B, the patient underwent laboratory test, which showed an anti-HBsAg level less than 10 mlU/ml drawn. There were 2 more healthcare workers at the facility (US2016128146 and US2016GSK131990), who had experienced the same outcome after three doses of ENGERIX B.
1 day after receiving COVID-19 booster vaccine, the patient developed dizziness and headache. Symptoms progressed to right facial droop, right ear pain, and hearing loss. She saw ENT and neurology and was diagnosed with Ramsay Hunt syndrome. She received courses of prednisone and valacyclovir . Symptoms improved with the exception of vertigo, which is ongoing.
injection site hurt for a day / last night it started hurting as much as it did right after the injection; This is a spontaneous report received from contactable reporter (Consumer) from medical information team. The reporter is the patient.  A 50-year-old male patient received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), on 05Dec2022 as dose 1, single (Batch/Lot number: unknown) at the age of 50 years for immunisation. The patient's relevant medical history included: "pneumonia", start date: Feb2022 (unspecified if ongoing), notes: got pneumonia last February which put caller in the hospital for 4 days, was on oxygen for a month. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 05Dec2022, outcome "not recovered", described as "injection site hurt for a day / last night it started hurting as much as it did right after the injection". Additional information: The patient stated he received Prevnar 20 two weeks ago and the injection site hurt for a day or so and went away. Patient stated that last night it started hurting as much as it did right after the injection.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
acute fatigue for 4 days & arthralgia. acute Clouding of consciousness for 15+ days
This case was reported by a consumer (also the subject) and described the occurrence of lightheadedness in a 71-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 23 September 2011 the subject received a dose of FLULAVAL (unknown route, right arm). On 23 September 2011, approximately 1 hour after vaccination with FLULAVAL, the subject experienced lightheadedness and tightening in the throat and base of the neck. The next morning, she discovered both sides of her face were red and pimply, as well as her neck, chest and back. She applied BENADRYL cream and the rash resolved after 2 days. On 25 September 2011, the events were resolved.
Within the first 10 mins of getting the shot I started to turn bright red all over it felt like I was on fire from the inside out. Pins and needles feeling all over my body. Itchy feeling all over.
Information has been received from a consumer concerning "friend of a friend" who was vaccinated with ZOSTAVAX (Merck). On an unknown date the patient developed muscle pain at an unspecified area. The outcome of the patient's muscle pain at an unspecified area was not reported. This is one of several reports from the same source. Attempts to identify the existence of an identifiable patient were unsuccessful.
1/14/2021-1/15/2021: moderate nausea - no treatment needed 1/22/2021: 3-inch severe rash distal to injection site noted overnight, topical treatment (antibiotic/steroid ointment) applied twice during day gave mild relief, diphenhydramine 50 mg taken PO that evening, rash gone within 24 hours