chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Generally feelings of unwellness, headache, body aches, sharp shooting pain in joints, shaking, swollen lymph nodes in neck, nausea, significant pain and warmth at injection site
Information has been received from a CMA concerning an 11 year old "healthy" white female with an allergy to Zithromax who on 07/13/98 was vaccinated in the left arm with a first dose of varicella virus vaccine. Concomitant vaccine therapy included a first dose given in the right arm of MMRII (Lot # 638359/0163L). There were "no routine medications". There was no illness at the time of vaccination. On 12/05/03 the pt developed a moderate to mild case of chickenpox with vesicles/lesions that were widespread. The pt had no fever. The pt was told to watch for other symptoms but none occurred. There were no diagnostic lab tests performed. Unspecified medical attention was sought and no treatment was required. On 12/16/03 the pt recovered. There was no product quality complaint involved.  No further information is expected.
Whole face felt numb like it was asleep; Her left arm felt like it had fallen asleep; Felt tired; Felt strange; Numbness in left arm (from injection site to hand); Pressure on left side of head; Cold sensation in left arm; Panic attack; Anxiety; This spontaneous case was reported by a patient and describes the occurrence of HYPOAESTHESIA (Numbness in left arm (from injection site to hand)), HEAD DISCOMFORT (Pressure on left side of head), FEELING COLD (Cold sensation in left arm), PANIC ATTACK (Panic attack) and ANXIETY (Anxiety) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 12-May-2021, the patient experienced HYPOAESTHESIA (Numbness in left arm (from injection site to hand)), HEAD DISCOMFORT (Pressure on left side of head), FEELING COLD (Cold sensation in left arm), PANIC ATTACK (Panic attack) and ANXIETY (Anxiety). On 13-May-2021, the patient experienced FEELING ABNORMAL (Felt strange) and FATIGUE (Felt tired). On an unknown date, the patient experienced HYPOAESTHESIA (Whole face felt numb like it was asleep) and LIMB DISCOMFORT (Her left arm felt like it had fallen asleep). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, HYPOAESTHESIA (Numbness in left arm (from injection site to hand)), HEAD DISCOMFORT (Pressure on left side of head), FEELING COLD (Cold sensation in left arm), PANIC ATTACK (Panic attack), ANXIETY (Anxiety), FEELING ABNORMAL (Felt strange), HYPOAESTHESIA (Whole face felt numb like it was asleep), LIMB DISCOMFORT (Her left arm felt like it had fallen asleep) and FATIGUE (Felt tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Day of injection  4/15/2021 4:30pm I got the shot waited in the lobby to see if I had sensitive symptoms and if not I was free to leave.   After getting home I started getting chills and fever.   4/16  Chills, fever, muscle aches the whole day and dizzy when standing. But it was all manageable.   4/17  Chills, fever, muscle aches the whole day and dizzy when standing, nauseas, head ache. Not manageable   I did no physical activities that day as well, my fitness watched  showed my heart rate was up +10 beats. This lasted for about a week as well as my stress levels and body energy depleting faster then usual.  My period cycle happened earlier  then what is what I consider normal. That was worrying to me. I am a very active person I bike a lot and hike a lot. After taking an Tylenol to try and get my self together. Biking was very difficult for the same amount of miles I usually have no problem biking.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6203), on 25Mar2021 as dose 2, single (Lot number: EL3248) and on 15Dec2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLUOXETIN, start date: Aug2021. Past drug history included: Doxycycline, reaction(s): "Drug allergy: Doxycycline". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Paxlovid treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical Course: Patient took other medications in 2 weeks. Paxlovid was taken as Covid-19 treatment from 06Oct2022 and to 31Oct2022. Patient administered pantoprazole from Sep2022.
Client received 1st dose of COVID-19 vaccine (Moderna).  She walked to the observation area and sat down.  She started to feel weak and complained of ear blockage.  Patient stood up and fell slowly to her knees with assist from the nurse.  She did not hit her head or any other body parts.  She was assisted to the cot.  Heart rate within normal limits, no shortness of breath.  Patient reported that her symptoms only lasted 15 minutes and then she felt normal.  She was observed for 30 more minutes without any further complaints  Patient was escorted to her vehicle and transported home by her husband.  She notified her her primary care physician and has a telehealth visit on 3/10/2021
C/o nausea, vomiting, fever, cough, and sore throat x 2 days. Rx for TAMIFLU and PHENERGAN.
2-17-10 awhile at school arm became red, swollen, and warm to touch. Other students were bumping into arm. Went home early (at school for 1 1/2 hrs). No elevated temperature, mother stats it looked like "bullseye". He complained of it itching. Ice applied. Stayed home from school on 2/18. 2-22-10 -Mother states his arm is better and back to school.
COVID-19; COVID-19; This is a literature report for the following literature source.  This study involved individuals  hospitalized for laboratory-confirmed COVID-19 and a control group of adolescents hospitalized for other causes between June and September 2021. Six vaccinated patients were hospitalized for COVID-19, and none were admitted to the intensive care unit (ICU) or died. It excluded partially vaccinated individuals. A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single and administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 2021, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: laboratory-confirmed COVID-19: (2021) positive.; Sender's Comments: Based on the information currently available, a lack of efficacy with bnt162b2 vaccine in this patient cannot be completely excluded, Linked Report(s) : US-PFIZER INC-202101695462 Same article/ drug/event and different patient.
Approximately 45 hours after the COVID Bivalent injection I felt poorly and started to shiver. Was not cold and did not have a fever; just needed to shiver. This continued even as I got into bed about 11:30pm. About 3:15am I was awake attempting to satisfy a perceived need for a bowel movement without success; at that time the shivering had stopped. At 3:45am I went back to bed and slept until 9:15am when I got up and the event had apparently ended.
Headache, ringing loss of hearing in one eat, chest pain tightness, breathing inhibited, fatigue
No period! I received dose 2 of the Pfizer vaccine, and I have not had a period since. My doctors are baffled as to how this could happen as my periods are normally clockwork, and all levels are normal.
Information was received from a nurse concerning a patient of unknown age and gender. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On 24-FEB-2017, the patient was inadvertently vaccinated with an expired dose of M-M-R II lot # L004658, expiration date 11-FEB-2017 (dose number, dosage and route of administration not provided). No adverse effect reported. No further information was provided. Additional information has been requested. Sender's Comments: US-009507513-1703USA001778.
The evening of the vaccine I laid down to watch Masterpiece Theater at 9pm. I could not put my arm down, I had a tennis ball size lump under my arm that was very uncomfortable and solid. I had to put a pillow between my body and arm to try and be as comfortable as possible to sleep. On March 10, 2022 I had a Crohn's Flare that lasted until June, 2022
Bright red, swollen, itchy on the inside, looks like there is water ( for lack of another word) still in my left arm.  This arm is now larger than my right.  Seems to have settled near my elbow joint.
This case was reported by a physician, via a GSK representative, and described the occurrence of decreased therapeutic response in a 19-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On unspecified dates the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (details unknown). The 3rd dose was administered 3 to 4 years prior to the time of the report. At an unspecified time later, the subject was found to have a low antibody titer. No further details were provided.
Had a fall after booster; If he tried to stand up he would fall, after booster; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Had a fall after booster) and ASTHENIA (If he tried to stand up he would fall, after booster) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F210, 002B21A and 013A71A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, the patient experienced FALL (Had a fall after booster). 23-Oct-2021, the patient experienced ASTHENIA (If he tried to stand up he would fall, after booster). On 24-Oct-2021, FALL (Had a fall after booster) and ASTHENIA (If he tried to stand up he would fall, after booster) had resolved.            No concomitant medications were reported. No treatment medications were reported.
Induration, pain, warmth at site of injection x3 days.  Followed by 3 weeks of tenderness/soreness at the site.
pt recv vax 13AUG96 & 22AUG97 pt exp atypical shingles on lt forearm 7 hand & significant swelling of the lt hand;
pt recv vax & 2.5 wk later pt exp neurological sx, weakness, & poss multiple sclerosis-like signs & sx;sx lasted a couple days & then resolved;
Hives all over body, itch and patient became warm. Patient was given Diphenhydramine 50mg tablets orally at 10:32am. Patient was observed from 10:32am until 11:56 am upon which the patients side effects had subsided and patient wanted to leave.
Fever at max 39.7, body aches, chills, headache, nausea Severe lymph node swelling armpit on the side of injection ( size of a ping pong ball)
pain; swelling; aching at injection site; This is a spontaneous report from a non-contactable consumer. An 86-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration at the age of 86 years old on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced pain, swelling and aching at injection site. The outcome of the events was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Onset of Juvenile Idiopathic Arthritis Pain in multiple joints, with associated swelling and redness, rash
Information has been received from a physician for concerning a 16 year old female patient who on 24-AUG-2010 was intramuscularly vaccinated with a dose of GARDASIL. Concomitant vaccine included MENACTRA and meningococcal vaccine (unspecified) (manufacturer unknown). On 24-AUG-2010, the patient and experienced headaches, fatigue, loss of appetite and fever. Field employee said the patient received a MENACTRA and a meningitis vaccine (manufacturer unknown). The patient sought unspecified medical attention. At the time of reporting, the outcome was unknown. Additional information has been requested.
Body aches, fatigue, fever for first 48 hours. Severe heartburn, nausea, stomach cramps.  Vomiting. Headache on and off. These symptoms also lasted 48 hours. Still feeling slight body aches and fatigue 96 hours later, nausea comes and goes.
Soreness in left arm immediately following vaccine; 5 hours later developed a headache; went to bed; a couple hours later woke up with a severe headache, chills, severe body aches, nausea, dizziness, loss of appetite that lasted approximately 24 hours from onset;  felt fatigued with headache for 10 days after that;
From 10 PM first night through the following 48 hours: body aches, headache, low grade fever, general fatigue.  After 72 hours: excessive sweating, especially at night - along with random hot flashes.
Pt received 0.5ml instead of 0.25ml Moderna 6m- 11yrs covid vaccine.
INJECTION SITE BRUISE; CHILLS; GRADUALLY INCREASING HEADACHE; This spontaneous report received from a patient via a company representative 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 (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 30-MAY-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On 30-MAY-2021, the subject experienced injection site bruise. On 30-MAY-2021, the subject experienced chills. On 30-MAY-2021, the subject experienced gradually increasing headache. Laboratory data included: Body temperature (NR: not provided) 104 F. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from injection site bruise, and the outcome of gradually increasing headache and chills was not reported. This report was non-serious.
Initial SAE report received on 13 May 2005. Additional information received on 06 June 2005. This subject is 16 month old male, who died from the congential anomaly static encephalopathy while enrolled in a study of DAPTACEL administered with other recommended vaccine according to the standard of care at 2, 4, and 6 months of age in infants and as a booster to toddlers. The subject received four dose of study vaccine. The last dose prior to the event was given on 03 November 2004. On that same date, the subject concomitantly received a dose of ActHib, lot number UE237AA (lot number 200672); a dose MMR/Measles, Mumps and Rubella Vaccine lot number 0181N and a dose of Prevenar lot number A74399C. The subject suffered from static encephalopathy and had a past medical history of central hypoventilation syndrome. The subject died on 28/Nov/2004, 25 days post-vaccination. Autopsy information is pending. The event of static encephalopathy was reported by the investigator as not related to the study vaccine. From additional information received on 06 June 2006 it was reported that pathological studies determined that the patient had Rett Syndrome. During internal review on 17 June 2005 it was noted that congenital anomaly was ticked in error for serious criteria. A corrective version was created to amend this. List of additional information available in source documents. Death certificate received which revealed COD: cardiopulmonary failure, arrhythmia-V-tach, encephalopathy and seizure disorder/ss
no Event  or symptoms reported by patient.  Went to 10/5/21 and saw she received Pfizer in feb/march 2021.   Per patient no adverse events experienced.
Contacted COVID-19 and currently with Cory a symptoms; Contacted COVID-19, tested positive; This is a spontaneous report from a contactable physician reporting for himself.   A 68-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot number=EL3246, via an unspecified route of administration on 12Jan2021 14:00 (at the age of 68 years old) as a SINGLE DOSE in the left arm for Covid-19 immunization.  Medical history included Sulfa allergy from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Historical information included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number EK5730, first dose in the left arm on 22Dec2020 (at the age of 68 Years old) at 02:00 PM for COVID-19 immunization. The most recent COVID-19 vaccine was administered at a hospital.  The patient contacted COVID-19, tested positive on 22Jan2021 and currently with "Cory a symptoms". The events were non-serious. No treatment was received for the adverse events.The patient underwent lab tests and procedures which included post vaccination=Nasal Swab: COVID test result positive on 22Jan2021.   Outcome of the events was unknown. Prior to vaccination, the patient was not patient diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 virus test positive and suspected LOE. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given. There is limited information provided in this report.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Vaccine administered beyond Expiration date. However, per Moderna- all vaccines met viability requirements.  Completing VAERS per town's requirements.
Patient developed hives on the face and neck and arms the night of the vaccine. Felt otherwise well. Hives subsided with prednisone oral taper. She developed the same reaction after her second dose.
About 45 minutes after vaccine received patient developed rash and hives spreading to both arms, entire chest, torso, neck, face, and upper thighs. 4/3 started vomiting. Started Benadryl 4/2 around 5:30 which helped resolve some of the rash. Had general reaction of muscle aches, fatigue, low grade fever, migraine, and sore arm.
she took her first dose 01/05/2015 and the second dose 07/30/2015. She had not received the 3rd dose. Physician davised her to ask if she could receive the 3rd dose years later; This spontaneous report was received from a 25 year old female patient who was reporting on herself. Patient had not any pertinent medical history, concurrent conditions, drug reactions/allergies and was not taking any concomitant medication.  On 05-JAN-2015, patient took her first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and on 30-JUL-2015, she received the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) both given as a shot in the arm.   Patient explained she had not received the 3rd dose and the doctor in charge of her first two doses was now retired. She currently was seeing a new physician who advised her to call to the company and ask if she could receive the 3rd dose years later or had to start a new dosing schedule. No treatment was given, no laboratory studies were performed and no medical attention was sought. Therapy with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was discontinued in 2015.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA012541:
The pt got shot at 8:30-9AM and reported sxs at 10:30am. She was dizzy, nausea, itching on the back of her neck & hands. She was taking IBU on an empty stomach & had not eaten all day. She was shaking. Oral BENADRYL & eating & H2O relieved symptoms.
hives 30 minutes after the shot; This is a spontaneous report from a non-contactable consumer, the patient. A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Apr2021 at 12:15 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Patient had no allergies to food, medications or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 08Apr2021 at 12:45, the patient experienced hives 30 minutes after the shot. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event hives was recovered on unknown date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old male patient who received HAVRIX (batch number XD72G, expiry date 5th November 2016). On an unknown date, the patient received HAVRIX. On an unknown date, an unknown time after receiving HAVRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional information received: HAVRIX given to a 2years old.
Symptoms started directly after painful  injection,  then worsened, continued over weeks/months. Resulted in extreme shoulder pain, limited shoulder arm rotation.  Injection site still painful if pressed. Constant sharp shoulder pain, exacerbated by any exercise activity, lifting or moderate alcohol consumption. Sleep deprivation incurred, hard to get dressed. Going on 5 months now. Never had this reaction after other Flu injections...but this was my first high dose injection recommended at 65. Not allergic to eggs, however, prepared a Quiche Lorraine meal few weeks later and had a severe side-effect/pain throughout. Could not put wait on limbs for several days.
Mild swelling of the tongue, flushing/sweating, tingling in the mouth. BPs 117/81 (pulse 84), 98/68. Patient felt anxious. O2 sat 98%.