chrisvoncsefalvay/vaers-outcomes huggingface dataset:
All over body rash - extremely itchy, burning and hot; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730), via an unspecified route of administration in the left arm on 21Mar2021 at 15:45 (at the age of 47-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took sulfamethoxazole; trimethoprim (BACTRIM) for an unspecified indication and experienced drug allergy. 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 vaccination. On 22Mar2021 the patient experienced all over body rash which was extremely itchy, burning and hot. 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 reported events. The clinical outcome of the event rash pruritic was not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
Multiple Flu/Common Cold-like symptoms beginning 1/31 and continuing through 2/8: Mild headache, sore throat, shortness of breath, chills, fever, cough, chest/sinus congestion, fatigue. Fever began on  Wednesday 02/03 and ended on  Saturday 02/06. Fever max unknown, but suspected in the 102 range. There has been no fever for the last 48 hours but there is lingering chest/sinus congestion, fatigue.
pt recv vax 23MAY for cut on lt arm; 29MAY states inj site became swollen, reddened w/induration; site feels feverish; pt came to clinic to report rxn 30MAY95; about 1105AM; pt referred to primary care MD;
+ AG 5/10 with sneezing and tested pior to travel some rhinorrhea; + AG 5/10 with sneezing and tested pior to travel some rhinorrhea; + AG 5/10 with sneezing and tested pior to travel some rhinorrhea; + AG 5/10 with sneezing and tested pior to travel some rhinorrhea; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 53-year-old male patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EL3247), on 22Mar2021 as dose 2, single (Lot number: EL3247), on 29Oct2021 as dose 3 (booster), single (Lot number: FF2589) and on 12Apr2022 as dose 4 (booster), single (Lot number: FL3197) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), RHINORRHOEA (non-serious), SNEEZING (non-serious) all with onset 11May2022, outcome "unknown" and all described as "+ AG 5/10 with sneezing and tested pior to travel some rhinorrhea". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (11May2022) +5/10; (11May2022) Positive; (11May2022) Positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, rhinorrhoea, sneezing.  Clinical Course: Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. The patient receive any other vaccines within 4 weeks prior to the COVID vaccine was unknown. Device Date 11May2022  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure (LOE) cannot be ruled out.
on first dose of the Moderna Covid19 Vaccine, her arm was sore if she touched it; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (on first dose of the Moderna Covid19 Vaccine, her arm was sore if she touched it) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.  On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (on first dose of the Moderna Covid19 Vaccine, her arm was sore if she touched it). At the time of the report, PAIN IN EXTREMITY (on first dose of the Moderna Covid19 Vaccine, her arm was sore if she touched it) outcome was unknown.      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   No concomitant medication details was reported.  It was reported that, when patient tried to move her arm, it would hurt a little more than it should have probably.  This case was linked to MOD-2021-406224, MOD-2021-406226 (Patient Link).
received the first dose/on 25-Sep-2020 and has not received dose two.; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on 25th September 2020, batch number-EG3A3).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follow: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter consented to follow up.
drowsiness mode; like he was almost high; was speaking but it made no sense at all; stutter/slow motioned type of speech/speaking to him, about 2 incidents in 1 minute/speech difficulty or impediments; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 39 year-old male patient received bnt162b2 (BNT162B2), administration date 06Apr2021 (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: SOMNOLENCE (non-serious) with onset 06Apr2021, outcome "unknown", described as "drowsiness mode"; EUPHORIC MOOD (non-serious) with onset 06Apr2021, outcome "unknown", described as "like he was almost high"; SPEECH DISORDER (non-serious) with onset 06Apr2021, outcome "unknown", described as "was speaking but it made no sense at all"; DYSPHEMIA (non-serious) with onset 06Apr2021, outcome "recovering", described as "stutter/slow motioned type of speech/speaking to him, about 2 incidents in 1 minute/speech difficulty or impediments".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
STOMACH BUBBLING; STOMACH ACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included acid reflux. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown). The batch nunmber was not reported and has been requested. On 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced stomach bubbling. On 11-MAR-2021, the subject experienced stomach ache. Treatment medications (dates unspecified) included: bismuth subsalicylate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stomach bubbling and stomach ache was not reported. This report was non-serious.
SWELLING, REDNESS, TENDERNESS AND HEAT OF LT LATERAL THIGH AREA.
Sweats, cough, fever, chest pain after 10 days, the pain travelled from my chest to the neck, to the left head by the left ear, with feeling of pressure behind the ear.
Approximately 35 minutes after the patient received the vaccine, she reported a muscle spasm and tremor in her right arm, numbness in her lower lip, nausea, jaw heaviness; numbness, tingling and weakness bilaterally in legs.
Client received 1st dose of Pfizer COVID vaccine (Lot # FK5618 exp 1/19/22) on 11/13/2021 in left deltoid at 3:00 PM. Client received Flu shot shortly after (Lot 7557A exp 06/30/22) at 3:04 PM. Right after vaccination, patient stated he is dizzy, and he appeared pale. stated that patient stated, ?I am okay,? but advised patient to stay seated and wait for anti-gravity chair. Pt was carried into anti-gravity chair at 3:05 PM. Vital signs were taken by and BP was 130/82, pulse 83, 99% Sp02, and respirations were at 22 at 3:10 PM. Patient was given juice at this time and was reclined on anti-gravity chair. At 3:20 PM, patient states that he is feeling, ?not dizzy at all.? EMT moved patient, who is in anti-gravity chair, to observation area. EMT takes another set of vital signs at 3:20 PM and BP is 128/84, pulse is at 77, and respirations are 20. At 3:25 PM, patient states to EMT that he is not feeling dizzy, but he does have a small headache. Vital signs are taken, and BP is 128/82, pulse is 78, respirations are 22 and oxygen saturation is 98%. Patient?s BP at 3:30PM is 118/84, heart rate 83, respirations 22 and oxygen saturation is 100%. Patient denies dizziness and headache. Patient?s mom stated that she will be driving him home. A last set of vitals was taken by EMT at 3:35 PM and BP was 120/86, pulse 72, respirations 20 and oxygen saturation 99%. Patient left with his mom unassisted and stable at 3:40 PM.
Chills; Soreness; This is a spontaneous report from a contactable other health professional via a Pfizer Sales representative. A male patient of an unspecified age received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced chills and soreness both on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from a nurse practitioner referring to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date, the patient was vaccinated with ZOSTAVAX subcutaneously, for vaccination (strength, dose, lot # and expiration date were not reported). On an unspecified date, the patient was diagnosed with a mild case of shingles (herpes zoster). The patient sought medical attention but it was unknown if any treatment was given for the adverse experience or if any laboratory study was performed. At the reporting time, the outcome of herpes zoster was unknown. The causality assessment between herpes zoster and ZOSTAVAX was not provided.
BOOSTER #1 Pfizer 6FS6317 Received injection 10/30/21 in the morning at local grocery store pharmacy. Normal ADLs. Normal bedtime. Got up in middle of night to use bathroom (10/31/21). Legs collapsed in bathroom. Experienced muscle weakness. Could not get up independently or with assistance. Husband pulled her on a sheet into bedroom. Was still unable to get off floor. Called 911-ambulance. Transported to Hospital, and admitted for three days. Felt better about 24-hours after admission. At discharge, she was prescribed antibiotic and told probable cause of collapse was urinary tract infection.  BOOSTER #2 Pfizer FK9895 Received injection (04/11/22) in the morning at local grocery store pharmacy. Normal ADLs. Normal bedtime. Got up in the middle of the night to use the bathroom (04/12/22). Legs collapsed in hallway. Experienced muscle weakness. Could not get up independently or with assistance. Neuromuscular weakness more severe. Husband provided pillow, blanket, and diaper (not used prior to event)? Patient stayed on floor until the next day when she was able to roll to hands and knees and crawl to bedroom. Did not go to hospital/seek medical attention due to cost/expense of prior hospitalization. Bed rested the following day. Was able to walk downstairs/eat dinner that evening.  Patient has not experienced this type of event outside of the two episodes after booster vaccinations. Both events occurred within 24-hours after booster vaccinations. Both episode symptoms improved about 12-24 hours after collapse. Patient was able to return to ADLs 24 to 36 hours after event onset. Return to baseline about 48-72 days after episode.  - Patient is concerned about receiving additional COVID vaccinations.  - Patient is concerned about increased severity of second event.  - Patient is concerned about cost of medical treatment with event.    - Patient discussed events with primary care physician at annual checkup. Patient felt physician disregarded her concerns. She was told to get the next booster. She is afraid to do so.  - Patient does not believe either event was reported to VAERS by hospital or primary care physician. - Continued mild neuromuscular deficit (strength and balance)  and neuropathy in feet and toes. Unknown if related to episodes or other ongoing health conditions (type 2 diabetes mellitus, age?)
3 weeks after injection was given, pain in hip started. Pain was later confirmed to be bilateral avascular necrosis of the hip caused by blood clots.
10AUG92 in the PM recvd 1st dose of Engerix-B that same day (?) devel inject site swelling; treated w/warm compresses & APAP as of 12AUG92 swelling persists;
Severe diarrhea; so acidic that it burnt his skin to the point of blisters from hind end all the way past and including the penis and scrotum, to just below the belly.
WEAKENED MUSCLES, AND JOINTS, DROWSINESS, LOSS OF APPETITE, NAUSEA
COVID-19; A spontaneous report was received from a  Consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the patient wanted to know if false positive test is possible after being tested COVID-19.    The patient's medical history was not provided. The patient's concomitant therapy is not given.    On 19/01/2021, the patient tested positive for COVID-19 after, the patient received their first of two planned doses of mRNA-1273.  On 19/01/2021, The patient was tested positive for covid-19 .  Laboratory detail are not provided.   No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events are not reported.
Patient received vaccine the morning of 4/24/2021. A hard knot and rash about 2-3 inches was noticed the night of 4/24/2021. The rash progressively enlarged to included the injection site and up towards the shoulder and neck area. The arm is sore and warm to the touch. The patient has been taking OTC pain medication. The patient was advised to contact his primary care physician.
developed a dull headache; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient (pregnant: No) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in left arm on 04Feb2021 (lot number: EL9264) at 14:15 at single dose for COVID-19 immunisation. The relevant medical history was reported as none. Concomitant medications included l-methylfolate, venlafaxine, cyanocobalamin (VIT B12), ascorbic acid (VIT C) and ergocalciferol (VIT D). For the first 24 hours the patient felt fine. Around 24 hours later she developed a dull headache on 05Feb2021 at 3:30 PM. This lasted from 05Feb2021 to 06Feb2021. She medicated with one dose of Advil on 06Feb2021. It was alleviated totally by 07Feb2021 at 7:00 AM. No covid prior vaccination. The patient underwent lab test included Nasal Swab and PCR on 05Feb2021, which were both pending. The outcome of the event was recovered on 07Feb2021.
Chicken pox; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 28Jul2021 at 13:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient did not take any concomitant medications. On 01Aug2021 at 14:00, the patient had chicken pox. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of reported event which included treatment with unspecified medications. The clinical outcome of event chicken pox was not resolved at the time of this report.
it is aching into her shoulder, shoulder blade and in the front; my arm started hurting/aching at injection site,; arm sore; headache; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 71-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 15Mar2021 13:15 (Batch/Lot number was not reported: Expiry date: unknown) as dose 1, single for covid-19 immunisation (at the age 71-years-old). The patient medical history and concomitant medications were not reported. The patient doesn't have family history. No relevant tests were conducted. The patient did not receive any other vaccines within 4 weeks prior to the covid 19 vaccine. On 15Mar2021, the patient experienced headache for a day then it was gone. On 22Mar2021, the patient experienced arm sore then last night it was really painful; and today it is aching into her shoulder, shoulder blade and in the front and she also reported yesterday on 23Mar2021, her arm started hurting/aching at injection site, going up into her shoulder. Reporter said and enquired for information about this and some information says a delayed onset can happen. The outcome of the event headache was recovered; arm sore was not recovered and for the remaining events it was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt husband called reporting pt has swollen lip, I urged to take pt to emergency room and informed that this is a a severe reaction
severe kidney pain; feeling like he was literally dying; vomitting; body pain; This spontaneous case was reported by a consumer and describes the occurrence of RENAL PAIN (severe kidney pain), FEELING ABNORMAL (feeling like he was literally dying), VOMITING (vomitting) and MYALGIA (body pain) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In October 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, the patient experienced RENAL PAIN (severe kidney pain), FEELING ABNORMAL (feeling like he was literally dying), VOMITING (vomitting) and MYALGIA (body pain). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, RENAL PAIN (severe kidney pain), FEELING ABNORMAL (feeling like he was literally dying), VOMITING (vomitting) and MYALGIA (body pain) outcome was unknown.            No concomitant medications were reported. Other treatment medications include Gatorade.   This case was linked to MOD-2021-390804 (Patient Link).   Reporter did not allow further contact
At 2PM, I began to feel a little nauseated and extremely tired. I lied down and began to get the chills. By 5pm my temperature was at 99 degrees F and by 7pm, my temperature was 100 degrees F. My muscles on my back, neck and legs were painful. I had no problems drinking liquids. I refrained from Tylenol until about 7pm, I had 1000mg. I slept for 8 hours and woke up with no fever but the muscle aches have reduced by about 50%.
This case was reported by a consumer and described the occurrence of ringing in ears in a 40 year old male subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. The reporter is this subject. A physician or other health care professional has not verified this report. The subject reported that he had previously received immunization with influenza virus vaccine (unknown manufacturer) with no subsequent adverse events. On an unspecified date in November 2005 at 10:00 am, the subject received a dose of Fluarix in the left arm (dose number and lot number not provided). "Two days later," on an unspecified date in November 2005, the subject experienced ringing in ears, a rash on the upper part of the body and red faced. "Three weeks after receiving" Fluarix the subject was seen by dermatologist. The subject was prescribed antihistamines. The rash and facial redness resolved on an unspecified date on or before 19 January 2006, the ringing in the ear was ongoing.
A nurse reported that a 36 year old female received an injection of Tetanus Diphtheria Toxoids Adsorbed, Purogenated on 05/27/00. On 05/29/00, the patient developed a "severe"  injection site reaction characterized by pain, warmth, and swelling. The patient was seen by a physician and treated with Prednisone and a methylprednisolone pack. This is 1 of 3 patients from this facility who had an adverse experience following receipt of Tetanus Diphtheria Toxoids Adsorbed, Purogenated lot # 470-536.
Unfortunately, I did react to the shot and was seen in the ER for monitoring.  I had shortness of breath (felt like a mild asthma attack which I do have asthma), high blood pressure and my face/lips turned red.  After about an hour I had returned to my office and took 2 Benadryl.  Came back a couple of hours at the end of my day to check.  Breathing was better yet face and lips remained red.  Had Dr. walk over to my office from the ER to check.  Per his recommendation, I had checked in to the ER to be monitored and reactions documented
6x7 in area of erythema edema, & warmth interior to injection site in left thigh.
Situation: patient was administered 1st dose of COVID-19 (Pfizer) by certified tech. Post-administration, patient was instructed to sit for observation. Technician stated that approximately 2 min or so after patient sat down, he came up to her at the window to state that he was feeling lightheaded and weak. Consequently, while in conversation with her, patient gently collapsed onto the floor. He was alert and conscious the entire time; temp was 97; patient was noted to be pale and sweating profusely. Patient was provided water, ice pack and orange juice. Ambulance was offered and he was taken by paramedic for further evaluation.
Shortly after receiving vaccine the patient developed lip swelling, throat swelling. EMS evaluated patient and found tonsils were swollen. Vital signs BP 152/100 RR 20 HR 104 Oxygen sat-98% on room air. Patient received IV benadryl and was transported to local hospital ED for further evaluation and treatment.
Received MMR 09/01/2005 States on 09/05/2005 at approx 10pm, she started feeling bad on 09/06/2005 complained of headache, nausea, joint pain, numbness, tingling to left side. Bilateral leg cramps, hoarseness, glands in neck swollen. Dr informed her she had an adverse reaction to the MMR injection and was given Vicodin for pain. She is call him today for a follow up appt in 3 weeks. At this time 09/12/2005 9:30am patient states she feels better each day, however she is still weak, light headed and continues to have leg cramps. It was recommended that she refuse future MMR injections.