chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via call center representative and described the occurrence of upward deviation of eyes in a 3-year-old male patient who received ENGERIX B Pediatric (batch number 44DF2, expiry date 25th May 2018). Concomitant products included SINGULAIR. On 5th January 2017, the patient received the 1st dose of ENGERIX B Pediatric .5 ml. On 7th January 2017, 2 days after receiving ENGERIX B Pediatric, the patient experienced upward deviation of eyes (serious criteria GSK medically significant) and tremor. On an unknown date, the outcome of the upward deviation of eyes and tremor were recovered/resolved. It was unknown if the reporter considered the upward deviation of eyes and tremor to be related to ENGERIX B Pediatric. Additional details were provided as follows: The patient received ENGERIX B Pediatric on a Thursday. On the Saturday, the patient experienced a seizure like symptoms. He was shaking, his eyes rolled back in his head and he did not speak for 20 minutes.
I began experiencing side effect about 7 hours after I got my second dose of the moderna vaccine. The side effects included: Full body chills,  joint aches that did not allow me to sleep, headache, lightheaded ness, cramping
This case was reported by a consumer via call center representative and described the occurrence of cough in a female patient who received DTPa (batch number U57866AA ?, expiry date October 2019). The patient's past medical history included low blood pressure. Previously administered products included Influenza vaccine with an associated reaction of influenza (received in past and experienced flu (refer case US2017GSK149422)). Concurrent medical conditions included tetanus. On 8th September 2017, the patient received dTpa vaccine. On 8th September 2017, less than a day after receiving dTpa vaccine, the patient experienced cough and documented hypersensitivity to administered product. On 9th September 2017, the patient experienced swelling arm, fall and elbow fracture. In September 2017, the patient experienced vomiting. On an unknown date, the outcome of the cough and vomiting were recovering/resolving and the outcome of the swelling arm, fall and documented hypersensitivity to administered product were unknown and the outcome of the elbow fracture was not recovered/not resolved. The reporter considered the cough, swelling arm, fall, vomiting and elbow fracture to be related to dTpa vaccine. Additional details were reported as follows: The age at vaccination was not reported. The patient only weighed 108-110 lbs. The patient received Tdap vaccine on right deltoid and that evening she developed a terrible cough. One day after the vaccination, the patient was doing gardening when she suddenly fell and broke her elbow. The patient was allergic to tetanus and received Tdap vaccine, which led to documented hypersensitivity to administered product. She went to the emergency room, but was told her arm was too swollen for them to do anything, so she had to make an appointment with a surgeon for the next week. Less than a month after vaccination, the patient experienced vomiting. While waiting to see the surgeon she went to the hairdresser's to get her hair done. While there she started coughing so bad that she began throwing up. The cough seemed to be improving, but her husband was now developing a cough as well. She was scheduled to see the surgeon on the next day. As the patient had an allergy to tetanus, so when she was at the emergency room after she fell she was told she should not get the Tdap vaccine. She had not noticed a rash since receiving Tdap, but her past reactions had also included very low blood pressure, and she wondered if that could have been why she fell during normal gardening. The reporter thought these problems were related to her getting the Tdap vaccine.
Received the shot at 11am, by mid afternoon I have a severe headache-worst I have ever experienced.  It felt like my brain was loose inside my skull and even things like my ponytail brushing the back of my head caused stabbing pain. The next morning when I woke up, both arms began having tremors. My body felt weak, shaky, and like I was vibrating from my jaw, through my kneck and chest and down to my lower abdomen. My calves also felt shaking. My hands would rotate between tremors and shaking with joint pain. I also had diarrhea for a week following my injection.  I sought Urgent Care on 8/9/2021. The doctor did not know how to treat me, told me to take Tylenol and Benadryl and rest. I spent the next week trying to follow up with my primary care doctor without much success. I was finally seen by a doctor from my health network on 8/18 who told me I had neuro inflammation caused by the vaccine.  He told me to take 400mg of Ibprofen 3 times a day until the tremors and shaking stop.  Although the symptoms have lessened, as of today, 8/20/2021 I still have mild shaking.
I received a flu vaccine on Oct 3, 2014 in my right arm.  Since then I have had progressively worse pain in my shoulder at the site.  My bicep muscle is so sore it wakes me up at night.  I have tried heat; I have tried ice. These decrease the pain by about 5% maybe although not all the time and this lasts only for a short time - about an hour.  I cannot lift my arm to put plates away in the cupboard and my arm becomes fatigued when I write. I have tremendous pain many times throughout the day especially when I lift the arm or stretch to reach for something.  It's like someone knocked the breath out of me.  Other times it's a dull ache.  I have reported this to my PCP although he is sending me to physical therapy for an unrelated problem in my shoulder as he theorizes the two situations are related to possibly degenerative spondylosis in my neck area.  The pain there appears unrelated to the arm pain although I trust my PCP; he is very good. I wanted to report this to the appropriate persons.  If you are not the correct contact please let me know.  I don't want someone else to go through this pain.  It is very painful. No swelling at the site.  I had shoulder pain prior to this although ONLY shoulder involved - not the entire arm and bicep muscle.  I received the vaccine through my husband's work health provider.  It was given by persons from the pharmacy.
Heart beating fast when lying down. 30 minutes later I experienced difficulty breathing. I took my asthma puff but that only provided some relief.; Heart beating fast when lying down. 30 minutes later I experienced difficulty breathing. I took my asthma puff but that only provided some relief.; Heart beating fast when lying down. 30 minutes later I experienced difficulty breathing. I took my asthma puff but that only provided some relief.; This is a spontaneous report from a non-contactable consumer (patient) or other non hcp. A 34-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8729 and expiry date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 15Apr2021 at 11:00 as DOSE 2 (age at vaccination: 34-years-old), SINGLE, dose 1 via an unspecified route of administration, administered in Arm Left on 25Mar2021 at 11:00 (Batch/Lot Number: ER2613) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient had no known allergies. Concomitant medications included bupropion (BUPROPION), lamotrigine (LAMICTAL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced heart beating fast when lying down. 30 minutes later I experienced difficulty breathing. I took my asthma puff but that only provided some relief on 15Apr2021 at 17:00. The event resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. Outcome of the events was not recovered.  No follow-up attempts are possible: information about lot/batch number/expiry date cannot be obtained.
redness and swelling in left arm medical side extending past the elbow. increase warmth no fever
nausea, vomiting, loss of appetite Mother contacted health department, RN advised to see MD if symptoms persist
Moderna COVID-19 Vaccine EUA  1.) Diffuse muscle pain/stiffness over entire body (most notably in neck and back) 2.) Severe lethargy/fatigue 3.) Intermittent nausea  Symptoms lasted 48 hours and required no medical intervention aside from an OTC NSAID which only mildly improved symptoms.
Awoke with swelling of left arm which increased over the course of a day.  Developed redness and a bruised area.  Injection site and swelling on arm distal to site very red and warm, tender to palpation.
This spontaneous report was received from a female patient of unknown age reporting on herself, with no know drug reactions or allergies. On 12-AUG-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (route, dose, lot number and expiration date were not provided). Concomitant medications were not reported. On the same date, the patient's injection-site arm had been painful and difficult to move. It was reported that the patient sought medical attention by calling the county health clinic. There has been no product quality complaint involved. The outcome of the events was unknown. The causal relationship between PNEUMOVAX 23 and the events was not rated by the reporter. Additional information is not expected as there is no contact information.
Faintness to the point of dropping to floor on her knees; Dizziness; A spontaneous report was received from a Healthcare Professional concerning a female patient who received Moderna COVID-19 vaccine (mRNA-1273) and experienced events faintness to the point of dropping to floor on her knees and dizziness.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) via an unknown route for prophylaxis of COVID-19 infection.  On an unknown date in Jan 2021, the patient experienced the events faintness to the point of dropping to floor on her knees and dizziness.  The event faintness to the point of dropping to floor on her knees was considered serious with criteria of important medical event and dizziness was considered to be non-serious.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was unknown.   The events faintness to the point of dropping to floor on her knees and dizziness were considered recovered/resolved on an unknown date in Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start  of the events, a causal relationship cannot be excluded.
I started having menstrual cramps on Tuesday, 4-27. I had some spot bleeding yesterday and seem to have actually stayed menstruating today. I have always been very regular and even more so on Larissia. The cramps started 11 days after my first shot, 13 days before it was expected. This is really unusual for me.  I have been tracking my period for a few years and the only time it has been irregular was when my body was adjusting the last time I quit birth control. I have no tests or treatment to report other than the usual ibuprofen if the cramps get bad. I also have had headaches on and off, but it was the extremely early period that drove me to report.
high pitched scream x 1 hr p/vax; then cried intermittantly nl cry for 4-5 hrs, taking sm amts of formula; no fever; inj site sl reddened & swollen; was unable to console for 1st hr; was given APAP p/inj; resolved p/several hrs;
I am breastfeeding and while I did not have any side effects, it appeared my 4 month old was very sleepy and unwilling to take breast milk for a day.
Severe nosebleed on 6th day that lasted for 2 hours without slowing-stopped  after nasal pack procedure fainted the same morning had to be rushed to ER by paramedics; BP dropped to 88/68; bouts of dizziness from day 2 until now, unusual heartbeat recorded on holter monitor,  unusual rise of BP 182/117.   Blood test from Aug. 28 showed low haemoglobin.
No adverse event; lower than authorized dose of Moderna bivalent vaccine administered to patient.; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (lower than authorized dose of Moderna bivalent vaccine administered to patient.) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 27-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (lower than authorized dose of Moderna bivalent vaccine administered to patient.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (lower than authorized dose of Moderna bivalent vaccine administered to patient.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (lower than authorized dose of Moderna bivalent vaccine administered to patient.).    No concomitant medications were provided. It was reported that 18 elderly patients received 0.25 mL dose instead of 0.5 mL dose The patients have not reported any adverse reactions at this time.  No treatment medication was provided. This case contains information for the 2nd of 18 elderly patients described by the reporter.
Rash/ red rash/patch on below the injection site that is red; is tender to touch; Pain; flu-like symptoms; Fevers and Chills; chills; felt fatigued; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of feeling abnormal (for tolerance of 1st dose refer case US2020AMR165271).   On 14th August 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 14th August 2020, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, fever, chills and fatigue. On 15th August 2020, the patient experienced red rash, tenderness and pain. On 15th August 2020, the outcome of the influenza-like symptoms, fever and chills were recovered/resolved and the outcome of the fatigue was recovered/resolved. On an unknown date, the outcome of the red rash, tenderness and pain were not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, red rash, fever, chills, fatigue, tenderness and pain to be related to Shingrix.  Additional details were reported as follows: The patient received 2nd dose of vaccine in right deltoid. The patient received his second dose and noticed that day he felt fatigued, had fever and chills ,flu-like symptoms that resolved. The reporter did noticed a patch on below the injection site that was red but not itchy. He stated each day since the rash has formed that it had gotten larger and noticed that it was tender to touch but unsure if its due to the rash or the injection.  The lot number and expiry date not provided. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR165271:same reporter
No additional AE details.; a patient received an expired dose of PROQUAD.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies, historical drugs and concomitant medications was provided.  On 06-JAN-2021, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, 0.5 milliliter (ml), lot # S021324, expiration date: 05-JAN-2021 (dose number, route of administration and anatomical location were not reported) for prophylaxis. The nurse was not aware of any temperature excursions for the vaccine administered. No additional adverse event was reported.
After injection felt dizzy and diaphoretic.  Hx of needle phobia.  Monitored vitals and extended monitoring.  Recovered without intervention.
Sore throat; Diarrhea; Headache; She also has a body ache; Throwing up; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the parent.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 26Apr2021 (Batch/Lot number: unknown) 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: OROPHARYNGEAL PAIN (non-serious) with onset 27Apr2021, outcome "unknown", described as "Sore throat"; DIARRHOEA (non-serious) with onset 27Apr2021, outcome "unknown", described as "Diarrhea"; HEADACHE (non-serious) with onset 27Apr2021, outcome "unknown", described as "Headache"; PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "She also has a body ache"; VOMITING (non-serious) with onset Apr2021, outcome "unknown", described as "Throwing up".  Additional Information: The patient had a side effect after the first dose of the vaccine. The reporter was asking if she should get the second dose. Tuesday (27Apr2021), she developed a sore throat, diarrhea, headache but no fever. She also had a body ache and was throwing up. The reporter was asking if these symptoms were associated with the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
fever on day 1 and 2 after vaccine 99.5 and 102.5
site is a large red welt; site is a large red welt; site is a large red welt and hot; This case was reported by a consumer via interactive digital media and described the occurrence of injection site wheal in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site wheal, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site wheal, injection site erythema and injection site warmth were unknown.   It was unknown if the reporter considered the injection site wheal, injection site erythema and injection site warmth to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-MAY-2022 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient's injection site was a large welt red, hot and red. The patient wanted to know if this was normal. Additional Supportive Information: The follow up would not possible as no contact details were available.
My ears started ringing about three days after the vaccine. I did not connect the ringing to the vaccine until after I had my second vaccine dose and the ringing got louder.
11:20 - pt observed post vaccine, states she's feeling "shaky". Asked by nurse if she ate breakfast which she had not. Provided snack and water. 11:30 - no improvement, vitals WNL, 11:32 - pt states "trouble breathing", SpO2 98%, RR WNL, c/o nausea, no vomiting. 11:34 - d/t anaphylaxis hx, SOB and nausea, first dose of epi given. Called 911. 11:39 - continues to have symptoms (SOB, diaphoretic, shaking), second dose of epi given d/t no improvement. continued to monitor vital which were stable with the exception of tachypnea. 11:50 - EMS arrives, pt remained A&Ox4, report to EMS given by RN. Two used epi pens given to EMS.
Information has been received from a registered nurse concerning a 15 year old female with no known drug allergies, who in June 2007 was vaccinated with Gardasil.  There was no concomitant medication.  There was no illness reported at the time of vaccination.  The patient began to feel dizzy and light headed after receiving her second dose of Gardasil (lot# 658554/0928U) on 27-AUG-2007, while still in the physician's office.  No laboratory/diagnostic tests were performed.  The patient was diaphoretic and given a wet wash cloth to place on her forehead.  There was no other symptoms or treatment.  The reaction lasted 15 minutes following the injection, also reported as the patient was recovering as of 27-AUG-2007.  Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 9/17/2007. Initial and follow-up information has been received from a registered nurse concerning a 15 year old female with no known drug allergies, who in June 2007 was vaccinated with a first dose of GARDASIL (lot# unknown). There was no concomitant medication. There was no illness reported at the time of vaccination. The patient began to feel dizzy and lightheaded at 1:02 PM after receiving her second dose of GARDASIL (lot # 658554/0928U) IM in the left deltoid on 27-AUG-2007 at 1:00 PM, while still in the physician's office. No laboratory/diagnostic tests were performed. The patient was diaphoretic and given a wet wash cloth (also reported as a cool compress) to place on her forehead and neck. There was no other symptoms or treatment. The reaction lasted 2-3 minutes. The patient waited 15 minutes and felt fine to go home. Additional information is not expected.
5MAY devel chest pains, tightness of breathing, swelling in rt ankle & knee, sore shoulder;20MAY saw MD in ER dx allergic rxn rx DPH & Pred
pt states about a week after getting her 2nd dose of the covid vax that she started having severe shortness of breath.  She saw her PCP about this and she was prescribed anxiety medication lorazepam.   Pt states that she feels like her breathing was compromised after getting her vaccine.
received both doses of the Pfizer Covid vaccine (2nd dose rec'd 16Mar), and tested positive on 8Apr after symptoms began 6Apr; received both doses of the Pfizer Covid vaccine (2nd dose rec'd 16Mar), and tested positive on 8Apr after symptoms began 6Apr; having been miserable the last week; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on an unspecified date and received the second dose on 16Mar2021; both dose via an unspecified route of administration at SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received both doses of the Pfizer Covid vaccine (2nd dose rec'd 16Mar), and tested positive on 8Apr after symptoms began 6Apr. The patient also reported that she completely understood that the vaccine would not prevent her from contracting, rather protect against serious illness. The patient also mentioned that her purpose in reaching out was that she was very willing to participate in any research to help further understand breakthrough cases. If she could even provide a small amount info to further science, it out weighs having been miserable the last week. The outcome of the events was unknown.  Information on the lot/batch number has been requested.