chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 09-Oct-2018 regarding an unsolicited valid non-serious case received from an office staff on behalf of physician. This case involves 20 year old female patient who received FLUBLOK QIV (batch number, expiry date, route and site of administration were not reported) on 12 Sep 2018 and again on 08 Oct 2018. It was a case of actual medication error due to extra dose administered as 20 yo female got the FLUBLOK twice. Caller said a patient got it once on September 12 and again yesterday, October 8th. The patient has not reported having any adverse reactions to this. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Vaccine booster received too soon. 2nd dose received 2/10/22, 3rd dose received 3/11/22. Interval is 5 months for general population. No further adverse reaction/event noted.
double vision whenever he moved his head; vision was disrupted when he would move his head; equilibrium was totally off; Head felt wobbly, head was in a fog type haze; The felling was scary; This is a spontaneous report from a non-contactable consumer (patient). A 54-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 1 at vaccination age of 54-year-old via an unspecified route of administration in the left arm on 22May2021 16:00 (Lot Number: EWO179) as dose 1, single for covid-19 immunisation. Medical history included Covid-19 in Nov2020 to Nov2020 prior to vaccination. The patient has no known allergies. Concomitant medications included duloxetine hydrochloride (CYMBALTA) and alprazolam (XANAX), both indications, start and stop date were not reported. The patient received the most recent COVID-19 vaccine in a public health clinic or facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that 2 days after the vaccination (24May2021 08:00), the patient's vision was disrupted when he would move his head. He saw almost what you would call double vision whenever he moved his head, like while driving or looking from one side to the other. He couldn't drive for about 3 days because the movement of one car would look like 2 cars. This didn't happen when head was still and looking straight. His equilibrium was totally off, his head felt wobbly, his head was in a fog type haze for about 2 weeks. The feeling was scary. He mentioned that he did have covid Nov2020. He added that he made phone call to his doctor and they said to give it 2 weeks before coming in which is exactly when symptoms started to subside but still feel a little off. The patient did not received treatment for the adverse events. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Fever\chills\headache\body aches\nausea\vomiting. Same reaction as Moderna Dose #2. Very ill. Durations of reactions 16 hours with ongoing soreness\swelling\redness at injection site following Moderna Dose #3. 10 days following Moderna Dose #2 developed COVID Arm with redness and warmth around injection site that was not bothersome.
Patient received the Moderna Covid Vaccine at 1700.  By 1725, patient complained of tingling in his RUE, posterior neck, and frontal head.  He also reported lightheaded and dizzy.  VS were WNL.  Rapid Response Team ( RRT) called 1804.  RRT arrived at 1808.  PO Benadryl 25mg  given and symptoms began subsiding.  The patient no longer felt lightheaded or dizzy.   Dr. visited the patient at 1810.  No new orders.  Patient left at 1830.
Suddenly not feeling well, severe headache lasting 24 hours, 102.5 fever that lasted all night and into the next day, vomiting that night
On Friday my body was achy, sore all over and I slept a lot.  I also had a slight headache. Today, Saturday I feel much better. I?m still a little sore but not achy and no fever.
Horrible head ache the same night as vaccine and the next day. Achy muscles from 4/17 until it peaked (where I felt like I got hit by a bus) on 21st and 22nd.  Let up a little but sick and sleeping most of the day on 4/24 and part of day 4/25. today (4/26) slight headache and a little muscle aches but not as bad as in the past.  Temperature was normal but felt feverish.
Arm muscle soreness for 48 hours,  ping pong ball size lump with redness, hot to the touch and tenderness at injection site for 72 hours, red circle patch on skin started as ping pong ball size and increased to softball size with redness and itching persisting until February 4 (13 days later).
This spontaneous report was received from a physician and refers to an unspecified group of children of unknown age and gender. There was no information about the children's concurrent conditions, concomitant therapies or medical history provided. On unknown dates,  the children were vaccinated with PROQUAD for prophylaxis (dose, route of administration and anatomical location were not reported). The physician recalled reading that, among the vaccinated children an increase of diseases they were vaccinated against was noted (mumps, rubella, measles and varicella) (onset dates were not provided). The outcome of the events was unknown. The relatedness between the events and PROQUAD was not reported. Upon internal review the event of measles was determined to be medically significant. This is one of several reports received form the same reporter.; Sender's Comments: US-009507513-1709USA006164: US-009507513-1709USA007573:
cant wallow good food gets stuck my arms and legs hurt feet and hand hurt go nub head aics face go's nub
A week after taking the vaccine her left started going numb. She had a tingling feeling and she went to the dr and they informed her that it might be the nerves. She started physical therapy but it never went away. They did a vascular test and she had some abnormal readings. She was diagnosed with having a Vascular Artery Disease.
PC to patient after receiving vm that he was feeling "deathly ill" following his vaccination. He states that he really didn't do anything for a couple days and his mental capabilities were affected. He states he received his vaccination thurs and fri morning he called his friend to have him check on him every couple hours since he just didn't feel right. His friend told him by 2pm that he had a hard time having a conversation with him as he was only able to get out a few words and they didn't make sense. He had shaking, vomiting, weakness, fatigue, staggered when he walked and really doesn't have much memory of friday. He states his friend called the walk in clinic to see if he should go in and was told those were just normal side effects. Patient believes he had covid in the past month as he had altered taste and his friend had covid and was hospitalized with similar sx. He states his sense of taste is back to the saltiness that it was when he had covid. He reports that still on day 4 post vaccine, he doesn't feel he is mentally at baseline and is struggling to pull words out. He plans to make an appointment to see his physician today.
14 yo vaccinated, vaccinator verified DOB but did not realize patient was under 16 yo of age.  No adverse reactions reported by parent
pt stated she was gasping for air and she felt her tongue swelling.  911 was called. Nurse administered Epi-pen,  placed O2 at 8L, took vitals every 3 times until EMS arrived. time course was within 15 min.
Area of induration, erythema, warmth and pain; was 11x13cm central cluster of blisters was 3x5cm.
Redness and swelling at injection site on day after immunizations given. No fever or discomfort. Area is hard and warm to touch. Area is the size of a silver dollar.
pt rcvd vax; pt failed to seroconvert following 6 doses of vax in 92; series repeated in jan93; pt subsequently seroconverted;on 11mar93 pt gave blood & was told he was pos core antibody;
vaccine almost killed my dad; This case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced near death experience (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the near death experience was unknown.   It was unknown if the reporter considered the near death experience to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-NOV-2022 Reporter's Comments:  This case was received from consumer via interactive digital media. The reporter stated that this vaccine almost killed his dad The follow up would not possible, as no contact details were available.
patient woke up next morning, fever,sweats,arm very sore even numb for a few hrs  states today she is not feverish, only mild pain
Initial report received from a healthcare professional on 21 October 2014. A female patient, whose age, medical history and concomitant medication was not reported, had received a dose of INFLUENZA VACCINE (manufacturer unknown) (batch number, dose, dose in series, route of administration and site of administration was not reported) on unspecified date in 2008. On unspecified date in 2008, after vaccination, the patient experienced increased heart rate and BP. Laboratory investigation was not provided and corrective treatment was not reported. On an unspecified date the patient was recovered from event. Documents held by sender: none.
Vial initially stored in the refrigerator on 14 Mar 2022, manufacturer date of expiry was on 02 Apr 2022; Expired dose administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered) and PRODUCT STORAGE ERROR (Vial initially stored in the refrigerator on 14 Mar 2022, manufacturer date of expiry was on 02 Apr 2022) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 13-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial initially stored in the refrigerator on 14 Mar 2022, manufacturer date of expiry was on 02 Apr 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered) and PRODUCT STORAGE ERROR (Vial initially stored in the refrigerator on 14 Mar 2022, manufacturer date of expiry was on 02 Apr 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.  The vial was initially stored in the refrigerator on 14 Mar 2022. Expiration date of the vial  was on 02 Apr 2022. The vial did not undergo any temperature excursions.  No treatment medication details reported.
day 8 patient awoke with red, swollen, warm, nausea, tiredness and  itchy arm progressed the next day to increasing redness, warmth, and swelling along with induration and pain in arm.  patient seen seen by health care provider and put on Keflex and steroid cream
On 4/25/99, 5/14/99 and 2/23/00, the vaccines received his 1st, 2nd and 3rd doses of Lymerix, respectively. Within hours after the 3rd vaccine, he expeerienced uncontrolled shaking and fever. He was seen in the ER "some" hours after the 3rd shot, was treated (NOS) and released on 2/23/00. He complained of shortness of breath with exercise. He was referred to a cardiologist. The pt reported the dx as 2nd degree heart block. As of 7/9/00, the outcome of the event is unknown.
3 minutes after vaccination the patient began to feel a tingling and pain in his arm where the vaccine was placed.  Within minutes the patient began to feel faint and proceeded to faint as he was gently laid to the ground by the healthcare provider to initiate an emergency response.  The patient was alert and oriented at 5:30 but felt nausea and a tingling sensation in the tongue.  The patient stated that he had been fasting for 2 days and we determined low blood sugar likely played into his response to the vaccine.  Glucose gel was placed in mouth and patient felt better within 15 minutes.
unable to eat; feels very weak/ weak; lack of appetite; Tired; This spontaneous case was reported by a nurse and describes the occurrence of FEEDING DISORDER (unable to eat), ASTHENIA (feels very weak/ weak), DECREASED APPETITE (lack of appetite) and FATIGUE (Tired) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 025L20A) for COVID-19 vaccination.     The patient's past medical history included Cancer (Cancer survivor) and Back surgery. Concomitant products included GABAPENTINE, RETINOL (VITAMINE A) and ASCORBIC ACID (VITAMINE C) for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEEDING DISORDER (unable to eat), ASTHENIA (feels very weak/ weak), DECREASED APPETITE (lack of appetite) and FATIGUE (Tired). At the time of the report, FEEDING DISORDER (unable to eat), DECREASED APPETITE (lack of appetite) and FATIGUE (Tired) outcome was unknown and ASTHENIA (feels very weak/ weak) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient states that there was no reaction to the 1st dose, only with the 2nd dose.  No Treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Additional information received captured patient demographics, product details, concomitant medications, events and outcome.
dizzy; could not move for 30 hours; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy) and HYPOKINESIA (could not move for 30 hours) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LATANOPROST, AMLODIPINE, VITAMIN 15 and DORZOLAMIDE HYDROCHLORIDE, TIMOLOL MALEATE (DORZOLAMIDE/TIMOLOL ACTAVIS) for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 27-Jan-2021, the patient experienced DIZZINESS (dizzy) and HYPOKINESIA (could not move for 30 hours). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizzy) outcome was unknown and HYPOKINESIA (could not move for 30 hours) had resolved. Unknown    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, Body temperature: 102 (High) 102 degrees Fahrenheit.         Patient had a temperature of 102 degrees Fahrenheit and patient could not move for 30 hours.   Reporter did not allow further contact
Sore on injection site as well as all over the body; feeling tired; Sore on injection site; Sore on injection site as well as all over the body; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (feeling tired), INJECTION SITE PAIN (Sore on injection site), MYALGIA (Sore on injection site as well as all over the body) and VACCINATION SITE PAIN (Sore on injection site as well as all over the body) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced FATIGUE (feeling tired), INJECTION SITE PAIN (Sore on injection site) and MYALGIA (Sore on injection site as well as all over the body). On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore on injection site as well as all over the body). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at a dose of UNK UNK, qd and IBUPROFEN for Adverse event, at a dose of UNK, qd. At the time of the report, FATIGUE (feeling tired), INJECTION SITE PAIN (Sore on injection site), MYALGIA (Sore on injection site as well as all over the body) and VACCINATION SITE PAIN (Sore on injection site as well as all over the body) had not resolved.            The patents wife stated that there were no such symptoms for first two shots No concomitant medications were reported
I started getting nausea, chills, and sweats. Then the long term, I had mild bilateral neuropathy in both feet. It has been getting worse now. I went to my doctor about this. He thinks it is from the vaccine. He thinks I had an autoimmune disease before the vaccine and when I got the vaccine it is making it worse.
This spontaneous report was received from a physician referring a 65 year old male patient. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 08-NOV-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # L035687 and expiration date: 16-FEB-2017, intramuscular. (Dose was not reported). On an unspecified date in November 2016, the patient experienced injection site swelling, injection site pain and injection site erythema. At the time of reporting the outcome of injection site swelling, injection site pain and injection site erythema was unknown. There was not a product quality complaint (PQC) involved. The causality assessment between injection site swelling, injection site pain and injection site erythema and PNEUMOVAX 23 was unknown. Additional information has been requested.
I had a sore arm after the vaccine.  I started to not feel well sometime in March 2022.  I tested positive for Covid 19  at a unknown date.  My parents gave me the Covid 19 home test and it was positive.  I was= kept home and isolated. I gargled with salt water for the sore throat and maybe Tylenol.  Sore throat, severe fatigue, muscle aches (flu like symptoms). I slept a lot during this time.
Pt reports hard, red, swollen area around site where vaccine given on 4/18/2011.  Woke up with these symptoms on the morning following the injection.
01/07/2021 Pt stated:"after getting the vaccine I felt dizzy, and woozie, and nauseous.  I felt fine after the monitoring period of 15 minutes" 11:07AM When I got home :"I felt my my throat constricting" 03:00PM Her PCP by Tele - health told her to take Benadryl 11:39PM Pt had trouble breathing. Pt took the Benadryl and Albuterol (inhalor) 01/12/2021 Pt asymptomatic and she took based with her PCP,  on 01/09/2021 "do not recommend to have the second dose of the vaccine." Her PCP advised
Severe nausea and vomiting, fever, fatigue, chills, body aches, headache lasting beyond three days post injection.
About 14 hrs after the shot, Headache like a migraine, dizziness, cold sweat, chills, fever, severe body aches, fatigue, lasted until the Monday after shot administered
Woke up 1/31/03 with R arm cellulitis. Entire upper arm red and swollen 18cm long.
itching; Rash that goes from the top that extends down little below the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching) and VACCINATION SITE RASH (Rash that goes from the top that extends down little below the injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itching) and VACCINATION SITE RASH (Rash that goes from the top that extends down little below the injection site). At the time of the report, VACCINATION SITE PRURITUS (itching) and VACCINATION SITE RASH (Rash that goes from the top that extends down little below the injection site) had not resolved. Possible      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
The next day I realized the lymph nodes under my arms were swollen, in the arm of the vaccine was worse, today it is less swollen in the arm of the vaccine, in the other it has disappeared, I only took Tylenol.
Patient became hypotensive, cold and clammy, had syncopal response. Symptom started less than 5 minutes after administration. Patient was sent to the emergency department.
The patient called and reported swelling in the left cheek. She took BENADRYL and the swelling went down.
Injection site pain, swelling.  Significant Soreness in entire arm (joint pain and neuropathy type feeling).  Joint pain throughout body
This case was reported by a nurse via call center representative and described the occurrence of lymphadenopathy inguinal in a 16-year-old male patient who received BEXSERO (batch number 166801, expiry date May 2018). On 3rd July 2017, the patient received BEXSERO. In July 2017, several days after receiving BEXSERO, the patient experienced lymphadenopathy inguinal. On an unknown date, the outcome of the lymphadenopathy inguinal was recovering/resolving. It was unknown if the reporter considered the lymphadenopathy inguinal to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. The nurse reported that the patient complained of lymph nodes in the groin area after receiving the BEXSERO vaccine in Hip Area. It was not painful. The patient came to physician's office on 8th July 2017. No additional information was provided. The safety could follow up with health care professional. The patient visited emergency room.
Left upper arm has a large red raised area. Area measures 4.5 inches X 3 inches . Area is not painful and patient is not running a temperature. Patient is 12 days out from receiving her vaccine.