chrisvoncsefalvay/vaers-outcomes huggingface dataset:
With pharmacist approval I took 1 benadryl Diphenhydramine HCI 25 mg right before pharmacist gave me the vaccines.   I sat in front of the pharmacist window.   Within a few min of sitting I began to feel light-headed , then dizzy.   The pharmacist asked me how I was feeling, I said "light headed".   I was getting very dizzy and the pharmacist was very busy on the phone / computer / customers so I texted my partner to bring me a nut bar bc I was not feeling well.   After my partner arrived and I ate the nut bar, I began to feel more dizzy.  I told him I could not drive myself home, I could barely walk out of the pharmacy (which I did after waiting 30 min).    I began to feel nauseous.    When my partner got me home I am feeling like I am "drugged".   I call a friend who is a RN, saying I was concerned about how I was feeling.   She noted I was slurring my words and sounded tired.     I had taken Benadryl multiple times before and did not have this reaction.     I was unable to sleep much that night, felt like day 2 of the flu; I had chills, sweats, nauseous,  very achy.   So cold but unable to move out of bed bc I was so sick.   When I was able to get out of bed the next day I tried to sip some apple cider.  I immediately got very nauseous and threw up.   I did not move most of the day,  continuing to feel light headed, dizzy, achy.    It took until Saturday (vax given on Thursday) before I started to feel better.
Pt's arm started just red around injection site (2 days after injection), then came into pharmacy on 3-31-19 and redness spread over her entire upper arm and was slightly warm to the touch. She went to see her PCP on Monday 4-1-19, and was given rxs for KEFLEX and a MEDROL dose pack.
Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details: keeps breaking out in hives
Flushing/sweating, dizziness. BP 113/57 (pulse 66).
Patient is a 85 y.o. male who presents with headache.  Patient received his Covid vaccination proxy 72 hours prior to ER arrival this morning.  Patient states that been having complaints with increasing weakness plus mild headache.  Patient also complained about some mild increasing shortness of breath.  Patient denies any chest pain nausea vomiting.  Patient has had no dysuria or frequency.  Patient states he has had a headache for at least a month but in route to the headache is probably just been within the last 72 hours.  Patient had increasing weakness and because this is brought to the emergency room by patient's wife for further evaluation.  Covid vaccine was not at our facility and is not documented in Database.  Looks like he Doctors at the Facility as well.
For several days after the injection, experienced pain, swelling , redness and a linear blue bruise at the injection site.  These symptoms improved .  Then on February 3rd, noted itchy red bumps measuring about  2.5 by 1.5 inches and a deep sharp pain at injection site.  Today, the red bumps have been replaced by a confluent  red itchy area.
Pt telephoned the office on 11/9/06 one day after receiving the vaccine, stating that she was having joint pain in her legs markly both knees. States that it hurt to straighten her legs. Pt stated that her arm was not sore, red, or swollen. Advised her to come in to the office or at least see her physician for check up and she refused. Instructed pt that this is probably not a reaction to flu vaccine.
Severe autism with a C.A.R.S. rating of 39.  Headbanging, tantrums, speech disorder. Son received a total of 75 micrograms of mercury from 3 DTAP vaccines within first 6 months.
Three of them has it Luer lock unsecured so it popped off; Some of the vaccines got wasted and leaked; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 23Oct2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group, Program ID. A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HH1819, Expiration Date: Feb2025) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE LEAKAGE (non-serious), outcome "unknown", described as "Three of them has it Luer lock unsecured so it popped off; Some of the vaccines got wasted and leaked".  The reporter considered "three of them has it luer lock unsecured so it popped off; some of the vaccines got wasted and leaked" associated to device constituent of rsv vaccine prot.subunit pref 2v. Causality for "three of them has it luer lock unsecured so it popped off; some of the vaccines got wasted and leaked" was determined associated to device constituent of rsv vaccine prot. subunit pref 2v.  A brief summary of noted that this is a medical device related. Reportability Determination: This complaint for a Pharmacist on the other line and he mentioned that he was dispensing bunch of Abrysvo and three of them has it Luer lock unsecured so it popped off and we sent some of the vaccine. So, he did not try or he did not administer this vaccines to patient but he is requesting if this can be replaced. That is right. So, it popped off, and some of the vaccines got wasted and leaked" for ABRYSVO INJECTABLE (VACCINE) is a reportable malfunction. If it were to recur, could likely cause or contribute to death or serious injury. This event is NOT a reportable malfunction for ROW since the deficiency of the device was found prior to use on the patient and the deficiency would always be detected. Product used for treatment. This is 30-day reportable. Forward to Clinician Peer Reviewer 25Oct2023.   The information on the batch/lot number for rsv vaccine prot.subunit pref 2v has been requested and will be submitted if and when received.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment medications were reported.  Patient received vaccine which was more than 30 days in the refrigerator (30 days were on 03-JUL-2021). For this patient, the number of days that have passed were 5.
Presented to hospital with AMS with possible seizure activity. Daughter at bedside to assist with HPI, given patient's AMS.  Daughter reports that she went over to see her mom at approximately 930 this morning and found her alert and oriented x3 with complaints of nausea, congestion and cough s/p her second COVID-19 vaccination, which she received yesterday.  Daughter reports that at approximately noon, her mom had an episode of emesis, with her arms clenching up and shaking for approximately a minute, for which she called EMS. Daughter reports that her mom has been lethargic with AMS s/p episode. Daughter reports her mother has never had seizure activity before, but she has had several previous TIAs.  She denies any recent injury, fall or medication changes.  Patient lethargic with AMS noted, unable to follow simple commands, does tell me her first name with several prompts.  PATIENT REMAINS HOSPITALIZED AT THE TIME OF THIS REPORT.
App 20-30 minutes after receiving vaccine pt stated her tongue felt big and heavy- no obvious swelling, speaking clear and in full sentences- tolerating secretions, O sat 95% r/a- no itching or rash observed, although brisk cap refil, pt color has darkish hue- pt states tongue felt as it was getting bigger and bigger- lungs clear and no stridor- alert oriented, 911 to local hospital.
fever; chills; body aches; joint pain overall; muscle pain overall; This case was reported by a consumer via call center representative and described the occurrence of fever in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th May 2019, the patient received the 2nd dose of Shingrix. On 11th May 2019, 5 days after receiving Shingrix, the patient experienced fever, chills, general body pain, joint pain and muscle pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever was not recovered/not resolved and the outcome of the chills, general body pain, joint pain and muscle pain were unknown.   It was unknown if the reporter considered the fever, chills, general body pain, joint pain and muscle pain to be related to Shingrix.  Additional details were provided as follows: The reporter reported that he received Shingrix last Monday, and on Saturday and Sunday he began to experience, fever and body temperature was recorded as 101 degree F, chills that required him to stay under the covers, body aches and overall joint and muscle soreness.  The patient took Tylenol for the fever, which resolved but it was back again at the time of reporting. The patient referred to his physician.
Felt as if I almost died. Lower back pain, The very lower part the pain is extreme. I have had back pain before but nothing like this. I have been going to physical therapy for the last three months. I also have an have a MRI to see why this is happening. I have to say the mucus problems. I have started drooling when speaking. I have never done that in my life. I have swollen legs, initially it was very painful, now the pain is constant. I have a MRI scheduled to see if these events were indeed caused by the vaccine.
Breakthrough case admission after 3 vaccines Moderna 2/12/21 Lot# 038K20A;  Moderna 3/12/21 Lot# 030A21A;  PFizer 11/11/21 LotA# Fh8030
Severe whole arm pain (injection arm couldn't use); Severe dizziness; Severe tiredness; Bad metallic taste in mouth; Moderate body pain; Mild nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0138) via an unspecified route of administration in the left arm on 16Apr2021 at 10:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, upper respiratory allergies and known allergy to soy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metronidazole (MANUFACTURER UNKNOWN), glycopyrronium bromide, formoterol fumarate, budesonide (BREZTRI AEROSPHERE) and levocetirizine (MANUFACTURER UNKNOWN); all taken for an unknown indication, from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took acetylsalicylic acid (ASPIRIN) and experienced drug allergy. On 16Apr2021 at 13:00, 2.5 hours after injection, the patient experienced severe whole arm pain (injection arm couldnt use), severe dizziness, severe tiredness, bad metallic taste in mouth, moderate body pain and mild nausea which lasted for 48 hours. After 48 hours the symptoms started to wane and resolved after 72 hours. 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. Therapeutic measures were not taken as a result of the events.  The clinical outcome of the events experienced severe whole arm pain (injection arm couldnt use), severe dizziness, severe tiredness, bad metallic taste in mouth, moderate body pain and mild nausea was recovered on 19Apr2021 at 13:00.  No follow-up attempts are possible. No further information is expected.
Dizzy 15 minutes into the vaccine. No Benadryl was given due to patient driving alone. Shallow respiration to deep breaths.
Hep A given (R) deltoid, MCV4 given (L) deltoid - 5/9/11. Pt reports (L) deltoid -> elbow swelling 5/10/11 seen 5/11/11. Application of ice reduced swelling & blotchiness distal to inj site. No fever or systemic symptoms.
Patient reported swelling, redness, tenderness next morning after shot, that seemed to grow worse.
1st Vac HA within 10 minuet that continued fro 1 week, later in the evening mild temp with chills, sever aches/pain of muscles and joints spending 2.5 day in bed.  2nd Vac occurrence of the previous symptoms including spending 2.5 days in bed and this time mild closing of throat taking benydral 24 hours, vertigo, trigeminal neuralga, sever aches of muscles and joints. Returned to Dr because of symptoms ~ 2 weeks later because they did not subside At this time Dr feels the Vac triggered a Fibromylagia flareup.  It is now 7 week later symptoms have subsided somewhat but continued vertigo, trigeminal neuralga, constant HA, intermittent body aches/pains  requiring to take pain med 24/7.
Administered second dose of Pfizer Covid 19 vaccine. After 5 minutes, patient stated that he was feeling hot, having a scratchy throat and wanting water. Prepared Epipen for possible anaphalaxis reaction. Patient stated that he was not having difficulty breathing therefore the decision was made just to monitor patient. No medications administered. Patient then stated that he was feeling a bit dizzy. Tested patients blood pressure with no issue. Patient was asked to wait for 30 minutes to be monitored for any changes. Atter 30 minutes patient stated that he was doing well with no issues. Asked patient to wait for a bit longer just to make sure, patient agreed. No other issues present and patient was able to leave. Followed up with patient later in the day and he stated that he was doing well with no issues.
INITIAL DOSE OF MODERNA VACCINE (LOT 016C21A) GIVEN AT HEALTH DEPARTMENT ON 04/30/2021 TO PATIENT AGE OF 17. SECOND DOSE GIVEN ON 07/27/2021 PER COVID GUIDLINES AS OFF-LABEL USE.
Pt has swelling and redness in arm that patient received HPV vacc. Patient reports pain with movement. (R Deltoid) Treated with 60 mg Benadryl BID for 2 days.
Pt recvd 1st dose of Engerix-B 12JUN91, 02JUL91 exp a rash; 04JUL91 rash spread to neck, arms & chest & became large blister-like welts w/no fluid;
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received SHINGRIX for prophylaxis. In February 2019, the patient received SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced pain in arm, erythema of extremities, swelling arm and skin warm. The patient was treated with Cold Compresses and TYLENOL. On an unknown date, the outcome of the pain in arm, erythema of extremities, swelling arm and skin warm were unknown. It was unknown if the reporter considered the pain in arm, erythema of extremities, swelling arm and skin warm to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX on Tuesday. The patient's arm at the time of reporting was sore, red, and a little swollen also warm to the touch and seemed to be traveling down her arm. The patient tried calling her physician's office but they were closed. The patient would try cold compresses and TYLENOL.
Information has been received from a physician concerning a 60 day old patient who on 28-JUL-2010 was orally vaccinated with a dose of ROTATEQ. Concomitant therapy included PENTACEL, "PCV-13" and hepatitis B vaccine, recomb (manufacturer unknown). On 04-AUG-2010, the patient's mother called in to report that on 28-JUL-2010 the patient had had a low grade fever and watery pee colored stool. The physician recommended that the patient drank PEDIALYTE SOLUTION and ate yogurt. At the time of the report, the child was still recovering. Additional information has been requested.
This spontaneous report was received from a 61 years old male consumer who refers to himself. It was reported that on 05-DEC-2012 the patient was vaccinated in upper left arm with a dose of live ZOSTAVAX (dose, route and lot# not reported). Concomitant medication included unspecified blood pressure drugs. The patient stated that his arm was painful at the injection site from the moment of insertion to 4-5days later before the pain subsided. To date the pain has completely stopped (recovery date was not reported). The patient did not seek medical attention and he did not get any treatment. Additional information is not expected.
How was the vial stored post puncture? RT/fridge? RT the whole time.; Booster dose administered 27 hours and 8 minutes post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster dose administered 27 hours and 8 minutes post puncture) and PRODUCT STORAGE ERROR (How was the vial stored post puncture? RT/fridge? RT the whole time.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2022 at 2:16 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2022 at 2:16 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster dose administered 27 hours and 8 minutes post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (How was the vial stored post puncture? RT/fridge? RT the whole time.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Booster dose administered 27 hours and 8 minutes post puncture) and PRODUCT STORAGE ERROR (How was the vial stored post puncture? RT/fridge? RT the whole time.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  Number of doses/vials: 1 booster dose. On 28-Mar-2022 at 11:24 AM, the vial was initially stored in the refrigerator The vial was first punctured minutes after taking it out of the refrigerator. The vial was stored at room temperature (RT)  (8° to 25°C= 46° to 77°F) the whole time post puncture. Dose was administered >12hours post puncture. The vial did not undergo any temperature excursions.  No treatment medication was provided.
EMPLOYEE COMPLAINED OF HEADACHE, CHILLS, SINUS CONGESTION AND GENERALIZED SKIN RASH THE DAY AFTER RECEIVING THE COVID VACCINE WITH SYMPTOMS STILL PRESENT ON 4/4/2022
no adverse effects; Improperly stored administered doses; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.  On 09-MAY-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R034394, expiration date 27-NOV-2020; dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion from -14 to 10 degrees Celsius (C) for 15 hours. Data logger involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-1906USA001826: US-009507513-1906USA001827: US-009507513-1906USA001828: US-009507513-1906USA001829: US-009507513-1906USA001830: US-009507513-1906USA001831: US-009507513-1906USA001832: US-009507513-1906USA001833: US-009507513-1906USA001834: US-009507513-1906USA001835: US-009507513-1906USA001836: US-009507513-1906USA001837: US-009507513-1906USA001838: US-009507513-1906USA001839: US-009507513-1906USA001840: US-009507513-1906USA001841: US-009507513-1906USA001842: US-009507513-1906USA001843: US-009507513-1906USA001844: US-009507513-1906USA001845: US-009507513-1906USA001846: US-009507513-1906USA001847: US-009507513-1906USA001848: US-009507513-1906USA001849:
ANA Abnormalities-After the 2 Pfizer vaccines listed here on Feb.11, 2021 and March 4, 2021, I had routine blood work done on June 29,2021 and the result was Positive Abnormal. It was the first time in my life that this showed up as abnormal. On 10/06/2021, my ANA was negative.  On 10/11/21, I had my 1st Pfizer Booster LOT FH8027 in left arm, and on 6/07/22, LOT FM5773 in left arm.  on 6/23/22, I had blood work done and the ANA was Positive Abnormal, but this time it showed the Centromere Pattern as >1:1280 Abnormal, Very High.  On 9/12/22, this same numerical result appeared again plus it showed tests EBV Ab VCA, IgG >600.0 High and EVB Nuclear Antigen Ab, IgG >600 High.  Also in the past months I have developed asthma and now use an inhaler 2x's a day and nasal rinse. Persistent cough as well, with strong possibility of Crest Syndrome, though symptoms not yet present. Presently, Dr. is calling it Auto Immune Syndrome.  Blood work on 12/29/22 shows my ANA #'s remain at the same high rartio as in the begiining of all of this.  My Hemptologist, continues to check my Kappa Lt. Chains and my Lamda Lt. Chains and ratios since they, too, have been fluctuating during this same vaccination period.
Severe joint pain; consistent dual aches in all joints. Hard to sleep due to getting stiff quickly and can't move because they are sore and stiff. I can't relax my muscles. Started after first shot, and got worse after second shot. I started seeing a chiropractor and it is getting a little better with that treatment but so have to go three times a week to get a small relief. Tylenol helps but doesn't stop the pain. (I can not take NSAID because I have a stomach ulcer)
On 9/7/00, the pt developed maculopapular vesicular rash on trunk spreading to pelvic area and legs.
2/3/2021 I felt very bad headache and myalgia 8/10,Chilly ,tired,.Took two doses 650mg Tylenol doesn?t help.7:30pm took 650mg Tylenol 10mg hydroxyzine by mouth ,about 10pm felt to sleep.2/4/21 around 5:30am wake up and fell better.