chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PAIN; MUSCLE SENSITIVITY; CANT BEAR WEIGHT ON FOOT; LEG MUSCULAR STRAIN; TIREDNESS; RIGHT LEG NUMBNESS GOES FROM GLUTEUS TO ANKLE THAT STARTED A WEEK AFTER INNOCULATION; This spontaneous report received from a patient concerned a 50 year old male. The patient's weight was 195 pounds, and height was 180 centimeters. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced right leg numbness goes from gluteus to ankle that started a week after innoculation. On 03-APR-2021, the subject experienced tiredness. On 10-APR-2021, the subject experienced leg muscular strain. On an unspecified date, the subject experienced pain, muscle sensitivity, and cant bear weight on foot. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tiredness on 03-APR-2021, had not recovered from leg muscular strain, right leg numbness goes from gluteus to ankle that started a week after innoculation, pain, and muscle sensitivity, and the outcome of cant bear weight on foot was not reported. This report was non-serious.
Anaphylaxis; This literature-non-study case was reported in a literature article and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.   LITERATURE REFERENCE.     The patient's past medical history included SARS-CoV-2 infection. Concurrent medical conditions included Penicillin allergy.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis) (seriousness criterion medically significant). The patient was treated with EPINEPHRINE in 2021 at an unspecified dose and frequency. In 2021, ANAPHYLACTIC REACTION (Anaphylaxis) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ANAPHYLACTIC REACTION (Anaphylaxis) to be related.    Concomitant medication not provided.  Patient had swelling of tongue, flushing, tightness of the arm, poor range of motion in her head after taking vaccine which was assesses as anaphylaxis by National Institute of Allergy and Infectious Diseases /Food Allergy and Anaphylaxis Network criteria.  Company comment: This literature non-study case concerns a 30-year-old female patient, with history of penicillin allergy, who experienced the serious (medically significant) expected event of anaphylactic reaction that occurred 15 minutes after receiving the first dose of mRNA-1273 vaccine. Patient experienced swelling of tongue, flushing, tightness of the arm and poor motion in her head. She was treated with epinephrine and the event resolved within 20 minutes. Patient's history of drug allergy (penicillin) could be considered a risk factor for developing anaphylactic reaction. The benefit-risk relationship of mRNA-1273 is not affected by this report.    This case was linked to US-MODERNATX, INC.-MOD-2022-610053 (E2B Linked Report).; Sender's Comments: This literature non-study case concerns a 30-year-old female patient, with history of penicillin allergy, who experienced the serious (medically significant) expected event of anaphylactic reaction that occurred 15 minutes after receiving the first dose of mRNA-1273 vaccine. Patient experienced swelling of tongue, flushing, tightness of the arm and poor motion in her head. She was treated with epinephrine and the event resolved within 20 minutes. Patient's history of drug allergy (penicillin) could be considered a risk factor for developing anaphylactic reaction. The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2022-610053:38 year female
THE  MORNING AFTER BOOSTER SHOT PATIENT WAS RUNNING A FEVER 99.8 HE STAYEDIN BED TOO TIRED TO GET UP. BY THE EVENING OF DEC 31 HE  WAS E UNABLE TO WALK, OR TALK,VERY STIFF RIGID MUSCLES , CONFUSION , HE WAS TREMBLING AND i THOUGHT HE WOULD PASS OUT STANDING IN THE BATHROOM UNABLE TO MOVE FINALLY ABLE TO GET HIM DOWN TO FLOOR WHERE HE COULD BE SAFELY MOVED TO BED NEIGHBOR ASSISTED 911 CALLED EMT'S WORKED WITH HIM, HE WAS NOT RESPONDING TO THEM VERY LETHARGIC AND HIS BLOOD PRESSURE WAS SO LOW THEY CARRY HIM TO AMBULANCE AND WAS TAKEN TO BOULDER CITY HOSPITAL ER. BLOOD TESTS , XRAYS ,EKG DONE. INTRAVENOUS WAS GIVEN. ER DOCTOR POSSIBLE REACTION TO BOOSTER
Terrible headache, fatigue, nerve pain, nausea (threw up stomach acid) and body aches
I had a stroke on the right side of my brain; My whole left side is paralyzed; This is a spontaneous report from a contactable consumer (patient).   A 68-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 19Mar2021 at 10:30 (Lot Number: EN7539) (at the age of 68-year-old) as single dose for COVID-19 immunisation.  Medical history included diabetes from an unknown date and unknown if ongoing and pituitary tumor from 2004 to an unknown date. Concomitant medication included metformin taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 26Feb2021 at 10:30 (Lot Number: EN6205) (at the age of 68-year-old) as single dose for COVID-19 immunisation. On 19Mar2021 at 21:00, the patient reported that: "I had a stroke on the right side of my brain. My whole left side is paralyzed. I am an invalid walker. This has changed every aspect of my life". The events were serious, after emergency room visit the patient was hospitalized for 2 days, the events were also life-threatening and disabling. Therapeutic measures were taken as a result of the events and included physical therapy. On an unspecified date, the patient underwent lab tests and procedure which included electrocardiogram (ECG), chest X-rays, magnetic resonance imaging (MRI), all results were unknown. The patient outcome of the events was not recovered.
Pt felt dizzy after vaccine.   Asked pt if had history of hypertension. Pt said yes.  Asked if was compliant. Pt stated had not been adherent for 1 week.   Onsite EMS Checked bp, it was greater than 170/90.  pt was recommended to go to urgent care by family member who was going to pick him up. Pt was escorted out of building by onsite ems.
The pt experienced a red rash "hives" on face, back, chest, legs immediately following vaccinations. Rash began decreasing within 20 minutes of vax.
This spontaneous report was received from a medical assistant regarding multiple unspecified patients of unknown age and gender. Pertinent medical histories, drug reactions or allergies and concomitant therapies were not provided. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL (lot # K009482, expiration date: 06-MAR-2017; lot # M014929, expiry date 27-MAY-2017) (exact dose and frequency unknown). No adverse effects were reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
Patient started on dupixent 10/20/31. 2 weeks later on 11/3 developed biopsy proven pustular drug eruption. Also had eosinophilia. Of note, 1 week prior additionally had Moderna vaccine booster.
Approximately 29 hours after injection I began feeling fatigue, muscle aches, headache and fever of 100.6
Pt recv vax on 11/19/98; on 11/21/98 pt exp redness & swelling/ warm & itchy of vax site, fever & chills, stiff back; tx=Tylenol, Benadryl, warm compresses
arm still bruised and still sore; arm still bruised and still sore; possibly allergic to the vaccine; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 06Oct2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CONTUSION (non-serious), PAIN IN EXTREMITY (non-serious) all with onset Oct2021, outcome "not recovered" and all described as "arm still bruised and still sore"; ALLERGY TO VACCINE (non-serious) with onset Oct2021, outcome "not recovered", described as "possibly allergic to the vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
he has symptoms like Guillain-Barre; The initial case was missing the following minimum criteria: unspecified AE. Upon receipt of follow-up information on [10Nov2021], this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient's friend). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  The patient medical and concomitant medications were not reported. It was reported that the patient (friend of the reporter) that was hospitalized after receiving the first dose of the Pfizer Biontech covid 19 vaccine. As of 10Nov2021 the reporter noted that she doesnt have much information, the patient is not her son, she just knows he has symptoms like Guillain-Barre for the last 11 days after the booster shot (as reported). The outcome of the event was unknown.   Follow-up attempts completed; information about lot/batch number cannot be obtained. No further information expected.
Received vaccine at 6:30pm on 1/26. Woke up at 7:30am on 1/27 feeling nauseous and had a headache. Rested for a few hours and went to work. At work (noon), suddenly became very lightheaded, cold, sweaty,  experienced blackout vision around periphery and felt faint and nauseous. Threw up. Went home and had extreme chills and could not get warm. Nausea subsided around 6:00pm 1/27. Headache and neck soreness continues still today (1/30). Headache feels like pressure inside my head, pushing and causing dull pain at the base of my skull and top of neck.
dose given beyond 30-day expiration date; dose given beyond 30-day expiration date; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose given beyond 30-day expiration date), PRODUCT STORAGE ERROR (dose given beyond 30-day expiration date) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose given beyond 30-day expiration date), PRODUCT STORAGE ERROR (dose given beyond 30-day expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose given beyond 30-day expiration date), PRODUCT STORAGE ERROR (dose given beyond 30-day expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (dose given beyond 30-day expiration date) and PRODUCT STORAGE ERROR (dose given beyond 30-day expiration date).    Concomitant medications were not reported.  It was reported the vial was initially stored in the refrigerator on 13-Sep-2022 and was administered on 18-Oct, 25-Oct, 01-Nov, 02-Nov and 08-Nov.  The vial did not underwent any temperature excursion. It was unknown if individual vials or unbroken cartons were used. The vial size was unknown.  Treatment information was not provided.
Intracranial shingles terrible; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported this case. Age at vaccination was not reported. The patient received dose of Shingles vaccine and experienced intracranial shingles. The patient couldn't get second dose. The follow-up would not possible as no contact details were available.
23 year old male who presented with chest pain 11 days following his smallpox immunization. EKG and echo are consistent with mild myocarditis. Pt is being transferred to hospital. Per 60 day follow up: After the patient left foreign country to return to the US, I have not heard any further reports about this patient. I am unsure of where he is at this time.
Since the shot i have had cough/congestion I can not seem to get rid of.  My period was very late and was horribly painful which is NOT common at all for me and I cannot remember it being late in over a 15 years unless I was pregnant. Also after the shot I had a sore arm for a week, aches two days after the shot that lasted a couple of days and a fever less than 24 hours after the shot  that lasted for well over a day. I was extremely tired for several days following the shot as well.
Having very heavy periods after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (Having very heavy periods after the 2nd dose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (Having very heavy periods after the 2nd dose) (seriousness criterion medically significant). At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (Having very heavy periods after the 2nd dose) outcome was unknown.            No concomitant medications were reported. Treatment information was not provided.  It was reported that patient was perfectly healthy. Patient have been post menopausal for 15  years.  Company comment: Very limited information regarding this event has been provided at this time. Further information has been requested   Most recent FOLLOW-UP information incorporated above includes: On 06-Jun-2021: Upon internal review on 23-Sep-2022, non-significant correction was performed to update case received from field to blank.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Fever, body aches, fatigue, arm soreness-Onset 16 hours after vaccine, symptoms resolved within 24 hours of onset. Tylenol
I received a flu shot - AFLURIA, Lot 11149111A, NDC# 33332-0010-01- from Pharmacy Saturday 10/23 about 2:00 pm. By 8:00 pm I was running a low grade fever -99.8- and my arm was extremely painful, like I had received a tetanus shot. I have had countless flu shots in the past and never had a reaction. By 2:00 am I had severe pain in my knee joints, and could barely get around even with crutches. I spoke to my physician Sunday morning 10/24 and he thought I might be suffering from Serum Sickness. I was admitted to the Emergency room where I spent the next 4 or 5 hours. They were planning to admit me to the hospital, but decided I could return home with Rx pain medication. On Monday 10/25 I was no better so was started on a 6 day Prednisone -10mg-taper. About 12 hours after beginning the Prednisone the pain began to ease. Throughout the week the pain continued to abate and my knees are considerable better, just a few twinges and weakness with standing.
Patient received a Covid vaccine in right arm.  Patient started c/o eye swelling, tingly nose, itchy mouth. 1108: BP 146/118 RR 16 HR 105 O2 98, starting to cough, eye swelling increased. 1112: Epinephrine 0.3 mg auto injector given in left thigh, EMS called. 1115:BP 162/112, RR 28, HR 121 O2 98, Pt states feeling better. Within 3 mins Pt started to c/o itchy throat and mouth, starts dry coughing. 1120: BP 158/112 RR 28 and labored HR 142 O2 98 2nd dose of Epi given in left thigh. Started O2 and bag valve. 1122: EMS arrived assessed client, albuterol given and transported to hospital.
Large rash covering my entire torso and both upper thighs; Severe itching; Hundreds of bumps like chicken pox; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 24Apr2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included 10 Days post diagnostic laparoscopy and known allergy to wheat. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. On 25Apr2021, the patient experienced large rash covering the entire torso and both upper thighs, severe itching and hundreds of bumps like chicken pox. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with unspecified steroid gel and antihistamine. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events large rash covering the entire torso and both upper thighs, severe itching and hundreds of bumps like chicken pox were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Severe headache, t 101.9, left arm pain, decreasing ROM, abdominal pain, nausea, muscles aching
Information has been received from a certified medical assistant concerning a 15 year old female with no medical history and no drug allergies, who on 19-MAR-2008 was vaccinated IM with a 0.5mL first dose of GARDASIL (Lot# 659180/1758U).  Concomitant therapy included hormonal contraceptives (unspecified).  On 19-MAR-2008 a few seconds post vaccination the patient fainted and experienced convulsions of her arms and legs that lasted for a few seconds.  The patient had a blood pressure reading of 60/42 mmHg after she fainted.  The patient remained at the physician's office until she recovered.  The patient left with her mother.  No laboratory diagnostics were performed.  No product quality complaint was involved.  Upon internal review convulsions were considered to be an other important medical event.  Additional information has been requested.
redness, soreness, itchy, swollen glands in armpit and top of my arm, continues to be red hives on my arm and has not cleared up.  Took a Claritin to stop itching . Also had a very bad headache on sat.
At 20 minutes after the first shot, my mouth went numb.  The numbness moved across my entire face and moved down my throat.  I drove to the nearest pharmacy on my way home, and took one Benadryl.  I then drove to the ER.  It felt like my tongue  was swelling a little, but the Benadryl was controlling it.  The ER doctor said I had a good airway, and did not administer epinephrine.  He observed me for one hour and sent me home.  The left side of my face stayed numb for the rest of the night.  It was fine the next day.    I got the 2nd shot on Feb 26th.  I took 2 Benadryl right before in anticipation that this would happen again.  After the 2nd shot it took 40 minutes for my face to get partially numb.  The Benadryl seemed to keep it under control.  I got a 102 degree  fever the next day , on Feb 27th.  On Feb 28th I was severely nauseated, ached all over, had a bad headache, and was really "washed out".  This has continued (headache, nausea, and washed out feeling) most of the day  March 1, 2, and today (Mar, 3).  I am feeling a little better today, but it feels like I am recovering from the flu, where you have to sit down a lot.    I did not expect to feel this lousy for so long after the vaccine.
When I got my booster and it was two days later Friday night I was unable to breath and I went into a COPD flare up. I had to take my prednisone for about three days and after that I was able to get back to normal. I called my doctor and they had me stop the prednisone but I was normal again. On 8/10/22 I got my second booster and I had been sick beforehand for about three weeks. I slowly was getting better and using my prednisone. That same night I could not breath and had to turn my oxygen on and started taking prednisone but this also induced a second flare up of my COPD.
Right shoulder/neck/arm/finger pain and numbness.  Pain has been constant since the injection.  minor relief using acetaminophen 600 mg  and/or ibuprofen 600 mg .
Two doses of pediatric seasonal flu vaccine were given, rather than one dose of seasonal and one dose of H1N1 (0.25cc). One dose of seasonal flu vaccine lot SP U3174AA had been placed in the storage area for H1N1 0.25cc syringe vaccine.
Patient stated that she developed about a quarter sized slight redness at injection site, temperature that peaked at 101, shivering and clammy feeling, difficulty breathing and difficulty cathcing her breath
pt recv vax 9FEB96 & 21FEB96 seen w/rash over entire body positive AC & PC nodes
UrticariaPruritus Narrative: pt was given 50mg diphenhydramine orally and itching resolved within 15"; she ambulated out of clinic.
swollen, red, warm injection site same day, around 8pm. fever next day of 100.5, lasting all day.