chrisvoncsefalvay/vaers-outcomes huggingface dataset:
first major MS exacerbation; legs went weak; I knew something else did not feel right; showed so many lesions that it is sad. I only had 2 lesions 15 years ago; This is a spontaneous report from a contactable consumer (patient herself). This is one of the two report from same reporter. A 45-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: unknown, via an unspecified route of administration approximately in 2021 as a single dose for COVID-19 immunization. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown, via an unspecified route of administration in left arm on 27Jan2021 at 12:00 pm. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient's 2 weeks prior vaccination was none. Patient's medical history included Multiple Sclerosis and codeine allergy. The patient's concomitant medication was not reported. On 03Feb2021, at 12:45 pm (One week after the first shot), the patient stated that her legs went weak and gave out. The patient also stated that she fell while she was walking at work and got a concussion because I hit my head. The patient also stated that 3-4 weeks after the second shot, she had the first major MS exacerbation in 15 years. The patient stated that it was the worst she ever had. The patient also stated that her legs went weak when she stood up at home and her teenage son caught her so she would not fall and hit her head again. The patient stated that her son took her to the Emergency room 2 days later because she felt something was not right. The neurologist at the hospital took a 2-hour MRI scan which showed so many lesions. The patient lab test and investigation results included Magnetic resonance imaging (MRI) scan which showed so many lesions and Blood test on 02Apr2021 with (Covid negative) result. The patient felt horrible and sad as she had only 2 lesions 15 years ago. The patient did not take any treatment medication for the events. The outcome of the events was not resolved.  No follow-up attempts possible. No further information expected.
Syncope, vomiting - dry to mucous (all approximately within 1/2 hr to 45 minutes). Treatment: rehydration.
Nausea; Extreme fatigue; Light headedness; Headache; Pain at injection site; Bleeding at injection site more than normal; This is a spontaneous report from a contactable consumer (parent). A 17-year-old female patient received meningococcal group b rlp2086 (TRUMENBA, lot number: CH2637, expiration date: 28Feb2022, NDC number: 0005010005) on 21Aug2020 11:30 first dose at single dose for recommended vaccine. Medical history and concomitant medications were not reported. Patient experienced Nausea after injection, extreme fatigue, light headedness, and headache, definitely pain at injection site, she said it is bleeding at injection site more than normal, all on 21Aug2020. She is taking ibuprofen and Tylenol for treatment. She got vaccine at 11:30 and they had side effects like 3' O clock. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Syncope; passed out; This is a spontaneous report from a contactable pharmacist reported that a 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), intramuscular on the left arm on 25Jan2021 15:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received flu vaccine on an unspecified date for immunization and experienced fever. On 25Jan2021, the patient was experienced syncope and passed out. She woke up within the next couple of minutes and was monitored. The patient eaten food. The outcome of the events was unknown.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported events, syncope and passed out, and the administration of COVID-19 vaccine, BNT162B2, based on the reasonable temporal association, and lacking alternative explanations.   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 RA, IEC, as appropriate.
Headache, NauseaVomiting, fatigue; headache; arm pain; hot and cold flashes; nausea Narrative:  Other Relevant History:
Dose #1 about 4 hours later bilateral conjunctivae with burning sensation and along floor of nose, oro and nasopharynx and trachea and esophageal and epigastrium with sunburned sensation.  Overall felt crummy with malaise, mild injection site tenderness.  But the burned mucus membrane sensation lasted about 2.5 weeks.  Dose #2 1-9-2021 about 10 hours after felt super strong, clarity of mental focus, and everything was funny, about 2 hours later felt cold to the bone and could not get warm.  Severe chills by Midnight, Temp 103.0.  Chills with such severe muscle contractions I felt I would fracture my teeth from them clattering together or even my lower mandible.  Tachycardic about 130, Hit self in the face after finally crawling to the medicine cabinet to swallow some tylenol- lost most of the water in the cup due to rigors and hit my face a few times when raising the cup to my lips.  Nausea.  Left submandibular gland visibly enlarged and palpable by physician.  OU with gritty sensation, left much worse.  Urine felt hot exiting the body.  Bad gas pains generalized abdomen and diarrhea x 2.  Nose with worse burning sensation with inhalation.  Left nare did bleed the next day.  By 1-11-21 I was too sick to work so I called off.  Left eye with worse gritty sensation, heartburn sensation in epigastrium but more like a burnt sensation.  Left face pain, left,scalp,left  forehead and tip of nose, (not ear) very painful skin to light touch and electrical nerve prickles and hot pains.  T down to 99.6. 1.12.21 went to doctor, dx herpes zoster of the left face.  My work tested me as negative for Covid via PCR test.  It took me over 4 days after dose #2 to start to feel normal and resume normal activities.  Ophthalmologist found no zoster in eyes but did comment my eyes were extremely, and very very dry.
28OCT recvd flu vax; 2NOV dizzy spells; 4NOV h/a; 5NOV seen by MD; 9NOV had pressure taken 160/180; 25NOV sick all day; 26NOV rapid heart beat & TIA:
Patient was vaccinated on 8/10/10 and on 8/13/10 presented with swelling and redness measuring 10cm x 10cm.
Varicella - Information has been received from a physician concerning a 10 year old white female who on 18 apr 2000 was vaccinated with the first dose of varicella virus vaccine vaccine live sc in the left deltoid lot 631065/0445J.  the reporter stated that on 19 apr 2000.  the patient was exposed to the wild type varicella by her brother who had developed wild type chicken pox and chicken pox is going through the local school right now.  On 30 apr 2000 the patient developed chicken pox with a total of 15-20 lesions.  the patient sought unspecified medical attention and recovered on 08 may 2000.  also reported was the patient's sister who was vaccinated and experienced similar events (waes 0005029).  No further information is expected.
Had H1N1 at approx 10:30 am 11/13/09 - Sx of SVT started at 1:30 PM - taken to hospital by amb. Converted and hydrated. 12/11/09 ED and hospital records received for DOS 11/13/09-11/16/09.  Pt. presented with SOB, vague chest pressure,SVT,treated with adenosyn in field.  Admitted for stabilization; IV fluids, BP management. Cardiology consult obtained.  Transferred to Morristown Memorial  for cardiac catheterization. DX: acute SVT; acute myocardial infarction 12/21/09 Cardiac catheterization results received  for DOS 11/16/09.
Breakthrough case admission after 2 vaccines Pfizer 3/12/21 Lot# EN6207;  Pfizer 4/2/21 Lot# ER8730
Technician  provided the vaccination, Pfizer, to the patient and informed the patient he had to wait 15 minutes before going anywhere.  stated, the patient did not express any signs of feeling unwell during or after the shot. Once the patient got up and walked a few steps, the patient stated he blacked out, his mom helped him, then told us that his son is deathly afraid of needles, a bystander patient saw what happened and called 911. Patient was provided water, stated he hasn't eaten all day yet so maybe that's why he felt faint. He said he didn't feel weak and could walk. We gave him a wheelchair and the paramedics came to take his vitals. He did not leave with the paramedics. No medications were provided either. He sat in the wheelchair by the waiting are about 30 minutes then left the store feeling fine.
Seizure.  He felt dizzy, tired, weak, had a headache and his stomach hurt within 5 min of shot.  After that he had a seizure.  He went stiff, fell over, began shaking, his lips went blue and he was unconscious for about 45 seconds.  He was then awake, but confused and not talking, for another minute.  I called 911 and drove him to the ER.  ER doc said they don't think it would be the shot as they expect it to happen days later.  The information sheet, however, says it would happen within minutes and up to hour.  He's never had a seizure before or more than a fever/fatigue after a flu shot and I am reporting out of an abundance of caution.  He has follow-up appt. on 10/22/13.
I'm fully vaccinated for the shingles/suspected vaccination failure; I'm fully vaccinated for the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (the patient had them 2 years ago from the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In November 2021, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient was fully vaccinated for the shingles and 3 weeks ago from the date of reporting had the start of shingles. It was much worse than the first time the patient had them 2 years ago from the date of reporting. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as time to onset and laboratory confirmation for shingles were unknown at the time of reporting.
Patient reported that during the night post vaccine, he developed hives and shortness of breath. He used home oxygen and felt better. Symptoms resolved on own without additional treatment. He went to his PCP approximately one week later.
PETECHIAL RASH OFF/ON ON TORSO, BUT MOSTLY ON LEFT ARM.
The patient was also very cold; sore injection site arm; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of NASOPHARYNGITIS (The patient was also very cold), INJECTION SITE PAIN (sore injection site arm) and FATIGUE (Fatigue) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A, 012L20A and 939905) for COVID-19 prophylaxis.     No Medical History information was reported.   On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced NASOPHARYNGITIS (The patient was also very cold), INJECTION SITE PAIN (sore injection site arm) and FATIGUE (Fatigue). At the time of the report, NASOPHARYNGITIS (The patient was also very cold), INJECTION SITE PAIN (sore injection site arm) and FATIGUE (Fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was reported.   This case was linked to MOD-2023-746386 (Patient Link).
Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. Concurrent or historical condition was not provided. On unknown dates the patients received improperly stored doses of PEDVAXHIB (lot # L051123 with expired date of 13-OCT-2018, lot # M001813 with expired date of 14-OCT-2018, lot # L042258 with expired date of 18-AUG-2018, dose and route unknown). Concomitant therapy was not provided. The vaccines were stored under 33F for 1 hour (6 cycles, 10 minutes each cycle). Storage temperature had been back in range. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. This is one of 2 reports receiving from the same reporter. Additional information has been requested.
Received the flu shot for the first time ever on 11/1/2001.  Night of 11/2/2001, woke up from sleeping feeling ascending numbness and tingling in my feet and legs.  Felt my arms randomly falling "completely" asleep".  went to the emergency room at around 2 am after symptoms did not resolve, for evaluation.
Patient experienced shortly after receiving vaccine itching and redness on injection site . By day 3 the area appeared to be a blister like rash  and grew in size from day 1.  Patient reported these reactions to his Doctor who told him not to proceed with getting dose 2.
Headache  New loss of taste or smell  Nausea or vomiting  Diarrhea
This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a male patient of unknown age.  Medical history and concomitant medications were not provided.  On or about 21-FEB-2014, the patient was vaccinated with ZOSTAVAX at a hospital as recommended for routine health maintenance for the prevention of shingles (route and lot # not provided).  The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster.  On or about 04-JUN-2015, the patient was treated for an itchy rash that was diagnosed as shingles.  He was prescribed lidocaine 5% ointment to manage his symptoms.  As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.  The outcome was unknown. Additional information has been requested.
1 day after receiving Tdap injection, patient experienced a fever up to 101 F and swelling surrounding the injection site with redness and heat up to 5 inches in diameter. Today on 10/18/17, the fever is gone and the swelling remains. He is not in pain.
Heart racing/pounding  Loss of feeling in hands Bone pain/muscle pain Memory issues/confusion Repetitive movements/ticks in feet   Nausea  Exhaustion Fever/chills
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Apr2022 at 15:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 52 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. No known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19: Paxlovid from 04Aug2022 to 08Aug2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events Covid 19 and Drug ineffective cannot be completely excluded.
Persistent cough was reported to pediatrician on 11/01/2021. Pediatrician saw no issue with the cough. Flu shot was administered this day.  Day of 11/18/2021 patient complained of sore throat. Persistent cough is assumed to be the reason. Patient also had a runny nose. Night of 11/18/2021 patient developed a slight fever (100.6) and had a poor night's rest.  Day of 11/19/2021 child complains of a sore throat and begins to wheeze while simultaneously breathing faster. Patient has a loss of appetite and is fatigued. An at-home COVID-19 rapid test (BinaxNOW) come back with a negative result but due to the problem being a respiratory issue, the patient is taken to the ER at Medical Center in the area.  Nasal swab shows the patient has a rhinovirus and chest x-rays show signs of bronchiolitis.  Oxygen is given to the patient. 3 doses of a respiratory treatment and 1 steroid treatment. Patient is discharged with a prescription for ALBUTEROL 90 mcg/puff inhaler + spacer (monaghan, medium-sized mask spacer) and DEXAMETHASONE (DECADRON) 1mg/mL solution.  Day of 11/20/2021, patient is breathing much easier but still has some wheezing. Coughing has brought up clear phlegm. Pediatrician is called for consultation and no additional notes given. Throat is still sore.
No further adverse events; Doses administered during temperature excursion; This spontaneous report was received from a office manager  (who was a clinical manager and also a medical assistant) and refers to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.  On 22-DEC-2021, improperly stored pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) syringe (lot#U018309 and expiration date:08-JAN-2023) (dose, route of administration and anatomical location were not provided) was administered to the patient for prophylaxis (product storage error). No additional adverse event was reported.  This is one of three reports received from the same reporter. ; Sender's Comments:  US-009507513-2203USA007589: US-009507513-2204USA004696:
Redness, swelling, and soreness on the areas of injection site.  It happened a week after the injection.   The areas are my hand size and still red with inflammation.
Had covid 1 month ago; genital herpes; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Had covid 1 month ago) and GENITAL HERPES (genital herpes) in a 66-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: COVID-19 VACCINE and Influenza. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE and Influenza. Concomitant products included ACICLOVIR SODIUM (ACYCLOVIR JPI) for an unknown indication.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Had covid 1 month ago) and GENITAL HERPES (genital herpes). At the time of the report, COVID-19 (Had covid 1 month ago) and GENITAL HERPES (genital herpes) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Negative.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No treatment medication details was reported. It was reported that patient had 5 or 6 shots. Most recent one was probably 7 months ago. Given 3 tablets by patient doctor for 5 days, starting 2 days after first experiencing symptoms. patient forget what they were called but it reduced the symptoms quickly. Starting the second day of symptoms patient got congested. Symptoms improved quickly after this medication started. Currently taste is a little off. patient had home test on 6th day after taking the pills which was negative for COVID-19. Most recent vaccine was probably pfizer, but contact is unsure. Contact has genital herpes and had not an outbreak of these since receiving the Moderna vaccines. There was one exception to this where patient had an outbreak on the back of his leg where patient took acyclovir and it went away within one day. This abnormal to his usual experience with his herpes.
Calling for her daughter who took 1st dose of Covid vaccine a few weeks ago and developed an intermittent, fine, itchy rash and still had it as of last weekend; This is a spontaneous report from a contactable consumer. A contactable mother reported for her daughter (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. After receiving 1st dose of Covid vaccine patient developed an intermittent, fine, itchy rash and still had it as of last weekend. The outcome of the event was unknown.    No follow-up attempts are possible: information about lot/batch number cannot be obtained.
This spontaneous report as received from a medical assistant refers to multiple (unspecified how many) unidentified patients of unknown ages and genders. No information about the patients' medical history, concomitant medications, concurrent conditions or drug reactions and allergies was provided. On an unknown dates, the patients were vaccinated with incorrectly stored doses of RECOMBIVAX HB (lot number: M020926, expiry date: 11-AUG-2018, dose and route of administration were not reported). No adverse effects were reported. Digital Data Logger was involved, the storage temperature was reported as 48.52 degrees Fahrenheit in a 20-minute timeframe. On an unknown date. No previous temperature excursion was reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1612USA008794: US-009507513-1612USA008795:
Massive headache, night sweating, body aches, shortness of breath, odd taste in mouth, body weakness. Malaise and fever.
Severe and debilitating pain in back of left shoulder, left shoulder, left arm, left wrist, left hand lasting from 04/24/2021 onset through 06/16/2021. As pain leven subsided began to lose functionality of left hand, fingers and left wrist. Diagnosed by Dr with Parsonage Turner Syndrome on 08/23/2021.