chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My body had started itching  and I didn't know why.  I had not eaten anything new or changed any shampoo or soap. Finally on Thursday night I realized maybe it is the shot that is giving me all the itching. My whole body was flushed I kept scratching my arms and legs, especially  around my ankle, knee, under arm and goin area.  I took an allergy pill  and called Kaiser and spoke with an advice nurse. she   mentioned that taking an allergy pill will relief some of the itching.   I fell asleep around after midnight normally I go to bed around 9:30.  I also called pfizer and explained and the person took all my information and symptoms.
I experienced extreme body aches that were so bad I was unable to perform daily tasks. I also had fever, chills and fatigue as well as nausea.
Woke up with total body weakness, muscle aches and pain, dizziness, headache and excruciating pain in my left elbow, left forearm and left hand. Unable to hold my head up and get out of bed. I called my doctor and he told me that I may be developing antibodies to the flu vaccine and that I'm experiencing a immune response to the vaccine and that I will get better in time.
injection site is swollen, warm to the touch, sore to the touch, and itches.  Entire area is red.
Sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Linked case(s) involving the same patient: US2022112326   Additional Information: GSK Receipt Date: 28-JUL-2022 Reporter's Comments: The case was self reported by the patient. The patient received first dose of Shingrix vaccine and experienced a sore arm. Patient gave consent to follow up with HCP (pharmacy). Additional supportive information: For tolerance of 2nd dose, refer case US2022112326.; Sender's Comments:  US-GSK-US2022112326:Same reporter, same case
product use in unapproved population; She would like to find out if the vaccines involved in the previous excursion would need to be readministered. 31.5 degrees FAHRENHEIT. Vaxelis administered.; This spontaneous safety report, with reference number 2023SA240457(Inquiry # 01716117, Parent Inquiry # 01715866) was received by the partner on 03-AUG-2023 and forwarded on 07-AUG-2023, from a health professional.  Due to the nature of the event, the causality between the event "She would like to find out if the vaccines involved in the previous excursion would need to be readministered. 31.5 degrees FAHRENHEIT. Vaxelis administered." and Vaxelis was not applicable.   Companion Case: MCM-005127  Further information is expected.  Non-Significant Follow-up information was received by the partner on 03-AUG-2023 and forwarded on 08-AUG-2023, from a health professional. The case is maintained as non-serious.  Due to the nature of the event, the causality between the event "She would like to find out if the vaccines involved in the previous excursion would need to be readministered. 31.5 degrees FAHRENHEIT. Vaxelis administered." and Vaxelis was not applicable.  Further information is expected.  Non-Significant Follow-up information was received by the partner on 03-AUG-2023 and forwarded on 08-AUG-2023, from a health professional. The case is maintained as non-serious.  Due to the nature of the event, the causality between the event "She would like to find out if the vaccines involved in the previous excursion would need to be readministered. 31.5 degrees FAHRENHEIT. Vaxelis administered." and Vaxelis was not applicable.  Further information is expected.  Non-Significant Follow-up information was received by the partner on 04-AUG-2023 and forwarded on 08-AUG-2023, from a health professional. The case is maintained as non-serious.  Due to the nature of the event, the causality between the event "She would like to find out if the vaccines involved in the previous excursion would need to be readministered. 31.5 degrees FAHRENHEIT. Vaxelis administered." and Vaxelis was not applicable.  Further information is expected.
On 1/22/00, pt experienced burning sensation. Arm became inflamed for about 10 days.  On 2/5/00, the pt has a knot with a rash.
Itchy throat and ears. 138/92, HR 72, 97% RA O2Sat.
VACCINE ADMINISTERED TO A PATIENT 30 MINUTES PAST THE 6 HOUR MARK OF INITIAL PUNCTURE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191, expiry: 11-APR-2022) dose was not reported (Dose number in series:1), administered on 28-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-DEC-2021, the patient experienced vaccine administered to a patient 30 minutes past the 6 hour mark of initial puncture.(Dose number in series:1) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine administered to a patient 30 minutes past the 6 hour mark of initial puncture was not reported. This report was non-serious.
This spontaneous report as received from a licensed practical nurse refers to an university student patient of unknown age and gender. On 23-DEC-2013 the patient received a dose of M-M-R II (dose, route, and lot number not provided) and on 09-JAN-2013 was inadvertently given a second dose of M-M-R II (dose, route, and lot number not provided). No adverse effects were reported. Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching Injection Site), VACCINATION SITE WARMTH (Hot to the touch Injection Site), VACCINATION SITE ERYTHEMA (Red Injection Site 4"X3.5") and VACCINATION SITE SWELLING (Swollen Injection Site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching Injection Site), VACCINATION SITE WARMTH (Hot to the touch Injection Site), VACCINATION SITE ERYTHEMA (Red Injection Site 4"X3.5") and VACCINATION SITE SWELLING (Swollen Injection Site). At the time of the report, VACCINATION SITE PRURITUS (Itching Injection Site), VACCINATION SITE WARMTH (Hot to the touch Injection Site), VACCINATION SITE ERYTHEMA (Red Injection Site 4"X3.5") and VACCINATION SITE SWELLING (Swollen Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported  No treatment information was provided.
This spontaneous report as received from a health professional refers to a 12 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Admitted for COVID pna. Fully vaccinated in April. Placed on vit-c, vit-D, zinc, steroids. Did not require O2. Improved and discharged home.
A WEEK AGO STARTED FEELING TIRED, BODY ACHES, WEAKNES
Within 9 hours extreme joint, muscle, nerve pain, chills, some arm pain lasted approx. 24-36 hours.  Since the booster my arm pain has progressively gotten worse - feel pain when I lift my are above a 90 degree angle.  I know get intermittent heart racing (sometimes feels like it take my breath away) and a overall feeling of body uneasiness. I continue to get "nerve pain" especially in my lower back (seems to exacerbated my baseline pain). I now have significant constipation.
Pt given APAP @ home; napped until 2PM started crying would not stop; tc to nurse approx 3PM; appeared to have no fever; inject site OK; 4PM spoke w/nurse again-crying less; now has hard, red lump on leg; rt thigh sl swollen-sl tender;
Moderna Monovalent given instead of Bivalent. No adverse effects or symptoms reported by caregiver.
Area/leg around DTaP injection swollen and hot to touch. Given antibiotics by mouth.
I received Moderna Covid vaccines on 3/22/21, 4/20/21, and 12/10/21. I then received the Pfizer bivalent vaccine on 9/14/22. Approximately 7-8 weeks later I noticed a constant ringing in my ears. It came on suddenly and has persisted.
Client came in for vaccine for immigration. Stated he had a reaction to the Tdap given on Sept 27,10. Reported was feeling achy and short of breath 2 day later on Sept 30 had to go to emergency room. Client was given steroid and he still feeling better.
The patient was given MMRV in stead of MMR and Varicella separately. The patient was 13 years old and should have gotten them separately.
1st dose at birth: November 3th 2020 / 3rd dose: March 12th 2021; 1st dose at birth: November 3th 2020 / 2nd dose: January 5th 2021; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 9-week-old male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HBV (Engerix B).   On 5th January 2021, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 12th March 2021, the patient received the 3rd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 5th January 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, not applicable after receiving Engerix B and Engerix B Pre-Filled Syringe Device and an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long. On 12th March 2021, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the 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 reporter was Licensed Practical Nurse and mother of the patient. The patient received 1st dose of Engerix B at birth. The patient received 2nd dose of Engerix B, later than recommended interval of 1 month after 1st dose, which led to lengthening of vaccination schedule. The patient received 3rd dose of Engerix B, earlier than the recommended interval of 6 months after 1st dose, which led to shortening of vaccination schedule. The reporter did not administered the vaccine to the patient. She did not know the facility where the vaccines were administered and no lot number nor expiration date provided. The reporter did not consent to follow up.
This is a spontaneous case, initially received from other health professional (nurse) on 19-Oct-2018, concerning a 45-year-old, adult, female patient. The patient had no relevant medical history and concomitant medications. On 09-Oct-2018, the patient was administered with FLUCELVAX QIV (dose: 1.5 ml, route of administration: not reported, anatomical location: left deltoid, batch number: 252235, expiry date: 30-Jun-2019) also the patient received 1.5 ml instead of 0.5 ml. On 10-Oct-2018, 1 day after vaccination, it was stated that, the patient was not feeling well, and she had a feeling that, she was going to get sick. The patient also stated that, her arm was about 1 inch swollen, warm and was a bit sore. It was also stated by the patient that, on 15-Oct-2018 her arm was still a bit warm and was swollen. At the time of this report, the patient had not recovered from the events. The reporter assessed this case as non-serious. This case was linked to case 201804657 due to same reporter. Significant case amendment (19-Oct-2018): The description to be coded for the verbatim 'Received 1.5 ml dose instead of 0.5 ml' was changed from 'Extra dose administered' to 'Overdose'. The narrative and case comment were amended accordingly.
Muscle aches progressing to fever and chills to hard chills. Swelling and redness at Rt Upper arm site 4 inches By 6 inches raised and warm to touch.
5 months since first dose; Made my heart race and flutter for 3 weeks on and off; Made my heart race and flutter for 3 weeks on and off; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (Made my heart race and flutter for 3 weeks on and off) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CARDIAC FLUTTER (Made my heart race and flutter for 3 weeks on and off) (seriousness criterion medically significant), PALPITATIONS (Made my heart race and flutter for 3 weeks on and off) and PRODUCT DOSE OMISSION ISSUE (5 months since first dose). At the time of the report, CARDIAC FLUTTER (Made my heart race and flutter for 3 weeks on and off), PALPITATIONS (Made my heart race and flutter for 3 weeks on and off) and PRODUCT DOSE OMISSION ISSUE (5 months since first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. No treatment information was provided. The patient did not get the second dose because of the adverse events.  Company Comment:  Very limited information regarding the events has been provided at this time insufficient for causality assessment.; Sender's Comments: Very limited information regarding the events has been provided at this time insufficient for causality assessment.
Cellulitis? Dermatitis? I noticed white material coming out of every single pore on my skin so I attempted to extract the material out of a certain spot but it almost seemed as if it was refilling. After that mild extraction attempt (which I do without any adverse reactions frequently) I started to have rapid onset (four hours) of facial swelling, blurry vision, and muscle spasms in my calves (I don't know if this was related to the vaccine but I've never had that problem before). Cephalexin and sulfamethoxazole-trimethoprim given. During the antibiotic course, the other side of my face swelled rapidly and I returned to the ER. What they believe is a connective tissue disorder (I'll have more information after a few more appointments) resulted from the reaction. I've had ongoing swelling, boils, hair loss, skin issues, intermittent weakness and constant fatigue. A host of eye problems as well (please contact me for further medical records).
A physician reported that a female received an injection of Tetanus Toxoid Adsorbed, Ultrafined on 4/18/00. On 4/24/00, she developed an injection site reaction characterized by right shoulder hives with pruritus. The pt was treated with Benadryl and cool compresses. She recovered.
Minor bleeding at the site of injection after taking the shot; This spontaneous case was received on 16-Sep-2020 from a pharmacist via Agency (reference number: SEQW20-01746) and concerned a female patient of an unknown age.   The patient's medical history and concomitant medications were not reported.  On 19-Aug-2020, the patient was vaccinated with Fluad Quadrivalent [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid] influenza prophylaxis. The batch number was not reported.  On the same day, after receiving Fluad Quadrivalent, the patient had minor bleeding at the site of injection. There was no major bleeding, just the patient bled a little after taking the shot and put a band aid on.   On the same day, the patient recovered from the event.  The reporter did not provide a causality assessment.  The reporter assessed the case as non-serious.  This case is linked with the case 202004506 (the same reporter).  Company comment:The patient developed vaccination site haemorrhage on the same day after receiving the suspect product, Fluad Quadrivalent. Chronology is suggestive. No information about concomitant medications was provided. Based on provided information, causal relationship between the suspect product and the event is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed vaccination site haemorrhage on the same day after receiving the suspect product, Fluad Quadrivalent. Chronology is suggestive. No information about concomitant medications was provided. Based on provided information, causal relationship between the suspect product and the event is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).
Developed fatigue and soreness at injection site one day following immunization.  2 days following immunization developed chest pain, and shortness of breath. which  progressively worsened over next two days.  Evaluated in ER then admitted to Hospital with elevated troponin.  Developed need for supplemental O2 and eventually place on High-Flow O2 @ 40 lpm over night with resolution of chest pain and oxygen need on hospital day 2.  Discharged on third hospital day on Colchicine.  Follow-up to include cardiac MRI and cardiac clinic follow up in 1 week
This spontaneous report has been received from a pharmacist referring to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with ZOSTAVAX (strength, dose, route, lot #, expiration date or anatomical location were not reported) for prophylaxis. The reporter stated that she had seen on facebook and online that other reporter was discussing the dangers of shingles outbreaks after the vaccination of unspecified patients with ZOSTAVAX. The pharmacist stated that she began seeing posts on facebook about this between March and April 2017 (reported as the last couple of weeks). There was no further information to report. The outcome of the shingles and the unspecified adverse event (reported as dangers) was unknown.  The causal relationship between the events and the suspect therapy was not provided. Additional information has been requested.
30SEP94 immun administered-7OCT94 to clinic dx'd w/bronchitis, tx'd Amoxicillin; 12OCT-14OCT mom notes improved congestion but dec appetite; 17OCT pt to MD w/lethargy, poor fluid intake (3-4oz in past 18 hrs), poor skin turgor-adm to hosp;
Dizziness none stop 24/7; High blood pressure; High cholesterol; This is a spontaneous report from a contactable consumer. A 58-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 31Mar2021 at 11:00 (Batch/Lot Number: ER8737) at 58-years-old as a single dose for COVID-19 immunization. The patient did not receive any other vaccine within four weeks of the suspect vaccine. The patient did not have COVID prior to the vaccination. The patient's medical history included migraine, vertigo, and psoriasis; all from an unknown date and unknown if ongoing. Concomitant medications were not reported.  The patient previously received bnt162b2 for COVID-19 immunisation on 10Mar2021 (lot number: EN6207, administration time: 11:00, vaccine location: Right arm, dose number: 1); and morphine and ciprofloxacin and experienced allergy on an unspecified date. On 18Apr2021 at 04:00, the patient experienced: dizziness none stop 24/7, high blood pressure, and high cholesterol, and resulted in an emergency room/department or urgent care visit.  The patient was hospitalized for the events from 18Apr2021 to 21Apr2021. The patient underwent lab tests and procedures which included blood pressure measurement: 197/133 in Apr2021, blood pressure measurement: high on 18Apr2021. Therapeutic measures were taken as a result of dizziness none stop 24/7, high blood pressure, and high cholesterol, which included losartan 50 mg and metoprolol 25 mg. It was reported that the patient was not stable on the medications. The clinical outcome of the events was not recovered. Since the vaccination, it was unknown if the patient had been tested for COVID-19.
CT developed fever of 102 with chills, joint stiffness, body aches within 8 hrs of receiving the Tdap and Hep. B vaccines.
I unknowingly was about 4 weeks pregnant at time of vaccination. About a week later I started cramping badly for about a week before miscarrying.
p/vax 1hr later pt exp itching around the area the pnu shot was given lt deltoid;pt stated that condition progressively worsened & lt deltoid area became edematous, erythematous & warm to touch;
12 hours after the vaccination the patient developed a fever she measured at 102 F. The fever lasted over 24 hours with little respite after taking OTC ibuprofen and acetaminophen. While she had the fever she also had a severe migraine headache. After the headache and the migraine abated the patient developed a rash on her neck that is burning.
Pt. received 2nd Moderna shot at 3:23 pm on 5/31/21. At about 3:45 pm pt. brought to our attention that she was having difficulty breathing. She said it started as soon as she got the shot but she waited thinking it would be going away. She was anxious, upset, eyes teary, looked afraid, and was raising her shoulders as she breathed. 911 was called. Pt. agreed to receive epi-pen. Time given was 3:47 pm. Pt. reported that breathing felt a little easier. BP taken at 3:51 pm was 182/121 pulse 93. Ambulance personnel arrived at about 3:52 pm. Pt told emt that the difficulty breathing was not like when she needs to use her inhaler. Ambulance personnel assessed and left with pt.
Beginning my first meal (dinner) after the vaccine, certain foods began to often smell and taste rancid, potatoes and broccoli in particular.
Itchy tongue, a little hard to swallow for about 30 minutes, progressed to being itchy on entire body. Took loratadine 10 mg at 9:45pm. No more difficulty with swallowing around 10:45pm. Parent assessed possible hives and or swelling of tongue and found none. No itchiness the following morning.
Patient was diagnosed COVID-19 vaccine-induced urticarial vasculitis on his day 8 post vaccination of his third Moderna dose. He got his third Moderna on 12/12/2021. On 12/20/21,  he started developing severe skin hives all over his torso, neck, arms, palms of hands, face, scalp, and legs. After biopsy, he was diagnosed urticarial vasculitis post covid19 vaccination. There are similar case reports available about urticarial vasculitis / skin immune reactions after getting the vaccine.    Patient is still recovering and may take a month or two to recover. He is on prednisone taper dose, Medrol, Pepcid, triamcinolone 0.1% cream.