chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HIVES MAINLY BACK, ARM, AND LEGS; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (HIVES MAINLY BACK, ARM, AND LEGS) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hives.   On 12-Apr-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 12-Apr-2021, the patient experienced URTICARIA (HIVES MAINLY BACK, ARM, AND LEGS). At the time of the report, URTICARIA (HIVES MAINLY BACK, ARM, AND LEGS) outcome was unknown. Not Provided          No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Apr-2021 and was forwarded to Moderna on 14-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (HIVES MAINLY BACK, ARM, AND LEGS) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hives.   On 12-Apr-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 12-Apr-2021, the patient experienced URTICARIA (HIVES MAINLY BACK, ARM, AND LEGS). At the time of the report, URTICARIA (HIVES MAINLY BACK, ARM, AND LEGS) outcome was unknown. Not Provided          No relevant Concomitant medications were reported.   No Treatment information for the event was provided.
This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 67-year-old (non-pregnant) female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), at age 67, via an unspecified route of administration, on Mar 7, 2021, at 11:15, single dose, for COVID-19 immunization. Medical history included drug hypersensitivity from an unknown date. Concomitant medication included Synthroid for an unspecified indication; start and stop date not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not test COVID-19 positive prior to vaccination. No COVID-19 prior vaccination. The patient has not  tested for COVID-19 post the vaccination. On Mar 7, 2021, at 11:15, patient experienced numbness of lower left-side of lip and left-side of face. The patient did not receive treatment for the events. The outcome of the events: recovered on an unspecified date in Mar 2021. No follow-up attempts possible. Information about batch/lot number cannot be obtained.
I was hurting a lot. 8 out of 10 - the pain. My arm was so but my chest was in pain. I couldn't breathe. I was so light headed I thought I would pass out if I stood up. I went to ER - Dr thought it was  from my wearing personal protection equipment - mask and goggles for work after receiving the vaccine. He told me I was fine but I was so much in  pain that I was too out of it to ask for tests. I was in pain for two week. Chest was in pain.  I had to use my inhaler once a day at least - sometimes more.
Side effects: migraine, upset stomach, nausea, tiredness which lasted 3-4 days. Took Excedrin for migraine. Other than that I let it run its course (based on previous symptoms from last shot).
Fever up to 103.8, rash, vomiting diarrhea, sudden onset, all voiced by mother of child. ER record shows fever 99.5ax no resp distress.
Mother reports small knot noticed left deltoid several hours after getting vaccine 10/03/18. When got child up 10/04/18 AM noticed swollen area and splotches on left deltoid, no fever, c/o slight pain discomfort. Gave TYLENOL and put cool compress on left deltoid. Brought child in Health Dept 10/05/18 2 cm x 2 1/2 cm swollen area left deltoid. No fever or pain to touch deltoid area. Disc with mother cool compress, give TYLENOL prn fever, s/s reaction to monitor, report, and seek ER attention. Followed up with mother 10/08/18 no additional problems, no swelling or fever.
6 x 6 mm - reddened, erythema, slty warm to touch, no fever, no systemic complaints.
pt recv vax in lt arm immed p/needle removed from arm pt became weak & lost consciousness;pt was assisted to floor;BP 146/86, P 64, R16;EMS called pt was unresponsive for 30seconds;
This spontaneous report was received from a pharmacist via Company representative regarding an unknown age female patient. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 intramuscular route, for prevention of Human Papillomavirus Infection (HPV) (strength, frequency, lot# and expiration date were not provided). On an unknown date, after vaccination, the patient developed seizures and was taken to an unknown hospital. In addition, it was unknown if the patient was admitted to the hospital. It was unknown if the patient received treatment for the event. The patient's present status was unknown. The causal relationship between GARDASIL 9 and the event was not reported. Upon internal review, the event of seizure was considered to be medically significant.
Fever of 101 degrees F > Broke out in Hives > Pt. called into H. Dept 9/23 c/o of these symptoms did not seek medical care- Never returned phone calls from many messages left by doctors office- Eventually phone disconnected
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Additional Details: Patient called pharmacy on 9-16-22 saying that she thought her flu shot was given too high in her arm yesterday 9-15-22. She is experiencing a lot of pain. Additionally, she is pregnant. She came in 9-16-22 for us to look at her arm. The injection site was too high and showed some redness. She demonstrated the mobility/pain she was experiencing at different spots when moving/rotating her arm. She stated that the immunizer was standing during the injection. Advised that she seek medical attention
Extra dose of Rotavirus given to pt, pt is to recieved 2 doses and pt recieved 3.
Patient received a dose of vaccine that may be less than completely effective due to storage conditions.  No adverse effect noted
57 Y male  with multiple medical issues significant for HTN, CAD s/p on pump CABG x 4v (LIMA to LAD, SVG to OM, ramus, PDA) in 7/2018, DM, ESRD on PD, HLD, HFpEF EF 50%, anemia, COVID+ on 11/2, who initially presented with hypoglycemia and poor PO intake.    Date of initial sx: 11/2. Had 2 doses of Pfizer vaccine, no booster. Presented with elevated T: 102.3 and elevated RR. He also had an elevated troponin which peaked, likely from demand ischemia. His glucose was 45 on admission, likely from poor PO intake and improved after he received dextrose 50% in the ED and received  dexamethasone 10 mg IV x1.  He was started on decadron 6 mg PO and remdesivir.  Nephrology was consulted for ongoing PD requirements and the patient has been receiving daily PD. On 11/11 the patient had BGs in the 500s and an elevated AG to 18. He was given IVFs and started on lantus, and high ISS. There was thought that the patient could be in DKA, however after discussing with endocrine and nephrology, more likely that anion gap was related to his uremia. Urine ketones and beta hydroxybutyrate negative.   His sugars continued to remain elevated during his hospital course, and the patient was switched from lantus 16 units to NPH 5 units BID) on 11/12. The patient takes PTA glipizide 7.5 mg BID, has never used insulin.  Remdesivir stopped on 11/12 and decadron stopped on 11/13.  Adjustments in his NPH were made based on his blood glucose levels: his NPH was increased to 8 units BID on 11/13 and again increased to 14 units BID on 11/14. His anion gap closed on 11/14. The patient received a insulin kit and has received diabetes/insulin teaching via nursing staff.    Throughout the course the patient's vent settings have been stable. He has been on minimal oxygen settings 3 L NC-> 2 L NC, and social work has already set up home O2. The rest of his PTA medications have been continued with the exception of his PTA torsemide which has been held since his admission. He does not appear volume overloaded on exam, but can consider restarting torsemide on discharge if blood pressures can tolerate it.      Primary Procedures:  None   Secondary Procedures: None   Reason for Hospital Admission (Admitting Diagnosis):  Covid Pneumonia
About 30 minutes after shot,  I got a warm sensation.  I started to break out is cold sweats, I felt extremely nauseous.  Had slight tunnel vision.  Lasted about 30 minutes then I was fine.  Just felt very cold the rest of the evening.
Next say extreme shivers(almost seizing) temp over 101° extreme fatigue which lasted 4 days
A pharmacist at reporter's store administered 2 doses of the product to the patient on the same day; A pharmacist at reporter's store administered 2 doses of the product to the patient on the same day; nonstop headache; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  A 45-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose number unknown (booster), single (Lot number: GJ6665, Expiration Date: May2023) at the age of 45 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), OVERDOSE (non-serious) all with onset Oct2022, outcome "unknown" and all described as "A pharmacist at reporter's store administered 2 doses of the product to the patient on the same day"; HEADACHE (non-serious) with onset Oct2022, outcome "not recovered", described as "nonstop headache".  Additional information: NDC number of Pfizer COVID Booster was 59267-0304-02. The caller had no reference as the staff on duty at time of reporting was not there. This Pharmacist called regarding Pfizer COVID Booster, adult gray cap bivalent multidose vial formulation. A pharmacist at reporter's store administered 2 doses of the product to the patient on the same day. The patient was reporting nonstop headache for the last 48 hours. The patient did not want to take any over the counter products for the nonstop headache like Tylenol or Ibuprofen. She called to ask how long they should expect the nonstop headache to last; how long to wait to go to the doctor; and what the patient could take for the nonstop headache. She was reading any studies to see if it was known how long headaches should last and kind of got the idea it was about a week, a person could have on and off headaches.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On 16-AUG-2016, the patient was inadvertently vaccinated with an improperly stored dose of ZOSTAVAX (dose and route were not reported, lot # M018593, expiration date 28-JUN-2017). The vaccine was exposed to a temperature of 20 Fahrenheit degrees for 11 hours. Data logger was not used. There was no previous temperature excursion. No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
SWELLING IN THROAT AND DIFFICULTY SWALLOWING,THROAT ITCHING, TINGLING IN THROAT, HEART PALPITATION EXTREME WEAKNESS IN MUSCLES, ARMS AND LEGS.  ADMITTED TO HOSPITAL AND WAS MEDICATED WITH SOLU-CORTEF 100MG, BENADRYL 50MG AND PEPCID 20MG INTRAVENOUSLY EVERY 4-6 HOURS
04/05/2021 11 days after had myoclonic jerking left leg and body1 1/2 days. 04/21/2021 5 days after 2nd vaccination had myoclonic jerking 1 day lessen the next morning
I was completely fine until the next morning. When I got home after work the next day, I went to the restroom and there was blood every time I wiped. It was bright red. Around midnight, there was dark red blood when I wiped. It continued off and on until Monday (1/11) morning. I contacted my doctor (telehealth) on 1/12 and he ordered blood and urine testing. I'll follow up with my OB/GYN when I go for my yearly.
Syncope due to unknown cause. Loss of consciousness events transpired on 5/15/2015, 6/18/2015, 7/23/2015, 8/19/2015 and 1/10/2016. Incidents are <1 minute in duration. Upon regaining consciousness, patient experiences shortness of breath, watery eyes.  Nausea and headache follow episodes. Patient has NO prior history of fainting (syncope), is athletic, has no other known conditions and is otherwise considered in excellent health.
Patient Previously received a booster vaccine in October 2021. Patient again received a second booster on March 23rd, 2022 before the CDC approval of a 2nd booster on March 30th, 2022. No treatment and no adverse outcome from this VARES incident.
I got a hive like rash on my right arm, hand, abdomen, back and my left side of my back. I went to the doctor, and she said it could be because of the COVID-19 vaccine. She prescribed me prednisone and my rash was almost completely gone in 3 days. I contacted my primary doctor, and she said not to get a COVID-19 vaccine again.
First day weak and kept forgetting what he was doing. Next day doesn't remember the day real hazy and slept. Following day fever, body aches, chills, shaky. Today fever, bones aching dizzy very tired. Body still weak and dizzy.
Raynaud's disease, currently trying to treat with calcium-channel blocker, frequent cold hands and feet with color changes to toes and hands.
Chills from fever-like  Heart muscle tighten (excessive caffeine effects) , difficult breathing
The patient reports NVD, headache and dizziness several hours after given the vaccine lasting atleast 2-3 days
Patient c/o itching, redness noted on neck / reported that throat felt tight. 11:47 a.m. 25 mg Benadryl taken (patient's own medication)  11:50 a.m.  EMS requested by on site police officer B/P 150/90 P 80  / Dr reported that patient had bilateral wheezing. 11:56 a.m. B/P 150/90  12:00 p.m. B/P 154/94 P 80 12:03 p.m. Transfer care to EMS
Severe chills by third day after vaccine. Body severely cold and unable to warm, eventually the chills moved to the right limbs and (fingers and feet) and numbness. Better the next day, but same effects returned the following week. Now experiencing weakness on the right side.
This spontaneous report as received from a pharmacy technician refers to a patient of unknown age. Information on medical history, past drugs, concurrent conditions and concomitant medications were not provided. On an unknown date, the patient was vaccinated with ZOSTAVAX vial dose 1, 1 DF, (lot# N025704, Exp date: 16-DEC-2018, route, frequency were not provided) for prophylaxis which was stored at a temperature of 6.6 degree Fahrenheit at a time frame of 40 minutes and there was no previous temperature excursion and call was because of digital data logger and no adverse symptoms were reported. No product quality compliant (PQC) was present. Lot# N025704 has been verified to be a valid lot number for zoster vaccine live.
Weakness LE progressing over 2 week. 1/20 LP increased protein 126-/no cells. Dx: neuropathy myositis. Weakness started early in January
States he got severe headache 2 hrs after receiving shot that lasted the rest of the night and all of the next day. Nothing he took helped it. Also had extreme muscle soreness - all over body. Felt like he was getting the flu lasted a whole day.
Pt recv vax on 11/27/98; within 24 hr pt exp hot rx at vax site
Large 20cm x 16 1/2 cm, erythematous confluent area on left thigh. No warmth, no vesicles
Vaccine was administer at incorrect site of posterior arm in shoulder and I developed extreme arm heaviness, pain that night. Numbness/tingling of complete left arm developed and lasting several months after administration. Still have tenderness to site 5 months after.
had swelling right below the injection site; rash which was contiguous and extended to the hand and wrist of the injected arm; feeling tired; feeling fuzzy; could not concentrate; always felt like taking a nap; she was diagnosed with mononucleosis; This case was reported by a consumer via call center representative and described the occurrence of local swelling in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose in August 2019).   In November 2019, the patient received the 2nd dose of Shingrix. In February 2020, between 2 and 4 months after receiving Shingrix, the patient experienced mononucleosis. On an unknown date, the patient experienced local swelling, rash, tiredness, fuzzy, concentration impaired and sleepiness. On an unknown date, the outcome of the local swelling, rash, tiredness, fuzzy, concentration impaired and sleepiness were recovered/resolved and the outcome of the mononucleosis was recovering/resolving.   It was unknown if the reporter considered the local swelling, rash, tiredness, fuzzy, concentration impaired, sleepiness and mononucleosis to be related to Shingrix.  Additional details were reported as follows: The patient received 2nd dose of the vaccine,on the left arm in November 2019 and had swelling right below the injection site 1 week after receiving the injection with rash which was contiguous and extended to the hand and wrist of the injected arm. The patient stated that for about a month she was feeling tired, feeling fuzzy, could not concentrate and always felt like taking a nap. About 2 weeks ago, she was diagnosed with mononucleosis. All her lab values were normal, except for the early antigen level which was slightly elevated at 9. The reporter consented to follow up.      Lab Comments: On an unknown dates lab test were performed
Allergic reaction on face: right side  throat swelling, left cheek swelling, upper nose , left eyes  and forehead . Urgent Care put epipen and two injections of benedrill Around 4:30 sent to hospital then 9:30 I feel a little reaction again  like in my eyes , cheek and lost my voiCe
Fever, body aches, joint paint, headache, all over muscle pain/aches, chills, shaking, nausea, vomiting, diarrhea, and a rash on my neck.  Symptoms started 36 hours after vaccine was administered. The rash on my neck started 4 days after the vaccine.
Pt reported bloating that kept her up the night of the vaccination.  The bloating had not resolved 9 days post vaccination.  She has experienced this type of bloating in the past but not to this extent.  She is seeking further information from the hospital to determine if they believe the polysorbate  from the vaccination is the cause or an alternate cause.
accidentally administered an extra dose  (Extra Dose); per record, the patient received the first dose /on 08/20/2003, / and third dose on 01/2004. The schedule between 1st and 3rd dose was one month early. (Inappropriate schedule of vaccine).; per record, the patient received the first dose / on 08/20/2003, second dose on 10/08/2003; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 1-month-old male patient who received HBV (Engerix B) (batch number N4GA4, expiry date unknown) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, Hepatitis B vaccine for prophylaxis and Hepatitis B vaccine for prophylaxis.   Previously administered products included Hepatitis b vaccine (1st dose received on 20th August 2003).   On 7th June 2021, the patient received the 4th dose of Engerix B (intramuscular) .5 ml and Engerix B Pre-Filled Syringe Device. In January 2004, the patient received the 3rd dose of Hepatitis B vaccine. On 8th October 2003, the patient received the 2nd dose of Hepatitis B vaccine. On 8th October 2003, not applicable after receiving Engerix B, Engerix B Pre-Filled Syringe Device and Hepatitis B vaccine and unknown after receiving Hepatitis B vaccine, the patient experienced drug dose administration interval too long. In January 2004, the patient experienced drug dose administration interval too short. On 7th June 2021, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered, drug dose administration interval too long and drug dose administration interval too short were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient accidentally received dose of Engerix B which led extra dose administered.  The patient received 2nd dose of Hepatitis B vaccine, more than recommended interval which led lengthening of vaccinaton schedule. The patient received  3rd dose of Hepatitis B vaccine, less than the recommended interval which led to shortening of vaccination. The reporter consented to follow up via email. This case was linked with case US2021122659 reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021122659:Same Reporter
pt recv vax 28OCT95&exp numbness,tingling&heaviness in the same area where flu vax given;sx gradually lessened throughout the day;pt has recovered;
patient reports vaccine being given high on arm toward shoulder. Soon after the injection she experienced shoulder pain that did not resolve. Patient has since received one cortisone injection in shoulder and has been referred to physical therapy
Starting immediately after receiving the vaccine, I was sick for 3 days. I became aware of the eye issue 3 days later and it felt very irritated. It became more irritated and red, and on 06/01/2022 and 06/09/2022 I saw the eye doctor. They told me I had a recurrent viral infection (which I had originally had in my 20s). I had lesions and graying on the surface of my eye. After a few days of run around due to the cost of the prescriptions, I finally got substitutes and samples for the medications and started them. Since starting them, it has gotten better and they have noticed my eye pressure in both eyes is elevated (unsure if related to this or not). I saw them on Monday 06/13/22 and they said its about 75% better.
Severe back ache in mid + lower back muscles which woke me from sleep.  Restlessness + achey that night.  Gradually decreased over next 3 days.
Next day: small Red rash warm to the touch at injection site, soreness, small swelling. Two days after:  extreme swelling golf ball size, rash spread around arm, intense itching. Took 1 benedryl at night. Three days after: swelling went down a lot, redness less intense but still present, still warm and itchy, new symptom arm pains shooting down from elbow. Sometimes cramp like of sharp pain moving arm. Feeling itchy all over and possible light rash on chest but not severe.  Not sure too seek medical attention or not? I feel perfectly fine otherwise.
4-23-09 Child had respiratory arrest @ home. He was life flighted to hospital where he is currently brain dead. Infant was given vaccines 4-21-09.  5/11/09-records received for DOS 4/24/09-presented to outside in ED in cardiac arrest transferrred to facility with PICU. Found in bed unresponsive and blue.  Parent initiated CPR, intubated and placed on mechanical ventilator. Down time approximated at one hour or more before spontaneous return of circulation.   6/25/09 Autopsy report received DOS 4/25/09.
was called over by staff to eval client approx 5 mins post injection.  Client has c/o "throat feeling different and slightly itchy"
PT states that she got the Shingrix vaccine on 07-18-2023 and she had chills, joint pain, headache, pain in ears, pain at injection site