chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Changes to menstrual cycle; This is a spontaneous report received from a non-contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 28-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 01Nov2021 (Lot number: 32030BD) at the age of 28 years 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: MENSTRUAL DISORDER (non-serious) with onset 02Nov2021, outcome "unknown", described as "Changes to menstrual cycle". Therapeutic measures were not taken as a result of menstrual disorder.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19.   No follow-up attempts are possible. No further information is expected.
This case was reported by a pharmacist via call center representative and described the occurrence of erythematous rash in a 77-year-old female patient who received SHINGRIX (batch number C523T, expiry date 4th July 2020). Concurrent medical conditions included allergy to vaccine (allergy to ZOSTAVAX, unsure of which component). On 13th April 2018, the patient received the 1st dose of SHINGRIX. On 14th April 2018, 1 days after receiving SHINGRIX, the patient experienced erythematous rash. On an unknown date, the outcome of the erythematous rash was recovering/resolving. It was unknown if the reporter considered the erythematous rash to be related to SHINGRIX. Additional details were provided as follows: The patient experienced rash described as a flat, red, patchy rash all over her body except her face. The patient might had been seen by her physician but the health care professional was unsure.
Patient stated day of the vaccine (1/13/22) she had normal flu-like symptoms (nausea, vomiting, aches), following day upon awakening her face was swollen (more on right side), lips were numb, warmth in legs, and felt like she was "swallowing glass". The day following that, her eyes were extremely swollen and said they were darker/brown in color. Came in today (1/22/22) and eyes still have darkening and dryness to them.
Patient came back about 15 minutes after immunization (appx. 10:45am) and said she felt fine but that her arm itched. The injection site was warm to touch, red, and had mild swelling about one inch in diameter. one teaspoon of diphenhydramine 12.5mg/5ml was administered at that time. Patient did not want to wait in pharmacy for further monitoring, but retuned again at 11:30. She reported that the itching had subsided but upon examination of injectio site, it was found that the local smptoms were about the same. Another 12.5mg dose of diphenhydramine was administered at that time for a total dose of 25mg diphenhydramine.
Immediately after injection pt got metallic taste in mouth, burning in back of throat, dizziness. Blood sugar at 220. Pt dizziness increased went to ER 1 hr later, blood sugar remained high. Her B/P low x2, able to increase with laying flat. Pt with Hx of hypotension. Pt began to get HA about 2 hrs after IM. Pt released from ER & at home had temperature high for three days. Highest 102.4 degrees. Headache x 3 days, cough x 1 week. 12/4/2009 ED records for 10/29/2009, patient with c/o's lightheadedness, scratchy throat, fever, chills and a metallic taste in the mouth, Tx IVF, IV Ativan DC DX allergic reaction to vaccine 12/7/2009 PCP visit for 11/3/2009 for c/o's cough, tx: rest and fluids
Information has been received from a registered nurse concerning an adult female patient with history not known who was vaccinated IM with a dose of pneumococcal 23v polysaccharide vaccine 0.5ml (lot # 645255/1212M). It was noted that the patient called the office on 9/24/03 to schedule an appointment because she had a fever and her left arm was red, swollen, and hard. It was noted that everyone in the office was very concerned, the reporter expressed concern about the particular lot of vaccine and she commented that she has never seen a reaction like this in 31 years. The reporter also mentioned another patient who experienced a similar reaction with pneumococcal 23v polysaccharide vaccine (lot # 643249/0358M) and was hospitalized. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested.
Numbness in hands and feet, also felt numbness in neck and lower part of back of the head. Difficulty breathing, heart palpatations, feeling of needing to pass out multiple times. Nausous for a wee straight, with gastro symptoms. I have lost 10 pounds in the week since I have had the shot. Still having tingling sensations in hands and feet.
Resident was found pulseless and without respirations, was pronounced dead at  0445 after unsuccessful CPR.
Systemic: Pt complained of mild neck swelling and mild itchiness on side of neck. Visible irritation and pt believes it was due to vaccine.-Mild, Systemic: Lymph Node Swelling-Mild
On May 17th got an ekg test on his heart was having extra beats and stated he never had that problem until the vaccination.
The next day I had very swollen elbows and knees. I was unable to move without extreme pain. I had extreme fatigue and was not able to do much with feeling very drowsy and short of breath. I still continue to have these symptoms intermittently.
I was initially injected into my left arm and 4 weeks later injected into my right arm.  On May 28, 2021 six weeks after my second injection, I had a reaction to what I thought was a bug bite. Within several days, I began to get similar, extremely itchy spots on the right side of my abdomen. I saw my doctor on the fifth day after the initial "bite".  We concurred that it was likely a flea bite as I had recently treated my dog for fleas but failed to treat my cat until May 29, 2021.  He prescribed a topical steroid. It did not help and I continued to have more outbreaks of extremely itchy spots.  Subsequently, I have seen a primary care provider 4 times, a dermatology physician 4 times, an allergist 4 times while this condition has  migrated to random parts of my body--from my neck and ears  to my ankles. Although the itching has abated somewhat, this condition is still active. NONE of the professionals have a clue about why this is happening
Pain and soreness to Left Arm; Pain and soreness to her left arm, left chest, left armpit and collarbone; Pain and soreness to left armpit; Pain and soreness to collarbone; Swelling to her left arm, left chest, left armpit and collarbone; Swelling to her left arm, left chest, left armpit and collarbone; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2018-2019 season) for prophylaxis.   Concurrent medical conditions included multiple allergies.   On an unknown date, the patient received Fluarix Quadrivalent 2018-2019 season (intramuscular). On an unknown date, unknown after receiving Fluarix Quadrivalent 2018-2019 season, the patient experienced pain in arm, chest pain with radiation to left arm, axillary pain, bone pain, swelling arm and swelling. On an unknown date, the outcome of the pain in arm, chest pain with radiation to left arm, bone pain, swelling arm and swelling were recovered/resolved and the outcome of the axillary pain was unknown.   It was unknown if the reporter considered the pain in arm, chest pain with radiation to left arm, axillary pain, bone pain, swelling arm and swelling to be related to Fluarix Quadrivalent 2018-2019 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Quadrivalent 2018-2019 season on left arm intramuscularly. The caller wanted to know what ingredients were in the Fluarix vaccine from 2018 and 2019. The patient had pain, swelling, and soreness to her left arm, left chest, left armpit and collarbone.  The reporter did not consent to follow-up.
Damaged the nerves; Tingling in his arm; Arm went out; couldn't use his left arm; relapse in his arm; Arm went out; couldn't use his left arm; relapse in his arm; Muscle was gone in the back of the left arm; This is a spontaneous report received from a contactable consumer (patient's spouse) from medical information team.  A male patient received BNT162b2 (BNT162B2), on 13Mar2021 as dose 2, single (Lot number: EN6207; 59267-1000 or 1080-1) for COVID-19 immunisation. The patient's relevant medical history included: "Couldn't use his left arm" (unspecified if ongoing); "Surgeries on his neck", start date: 1998 (unspecified if ongoing), notes: 25 years ago; two titanium plates in his neck from C3-C7; "Stint" (unspecified if ongoing); "BBB" (unspecified if ongoing). Concomitant medication(s) included: IVERMECTIN. Vaccination history included: BNT162b2 (DOSE 1; Lot Number: EN6200 (59267-1000-1)), administration date: 02Feb2021, for COVID-19 immunization, reaction(s): "Never had a reaction to the shot at all and he never did have any problems". The following information was reported: NERVE INJURY (medically significant), outcome "unknown", described as "Damaged the nerves"; PARAESTHESIA (medically significant), outcome "unknown", described as "Tingling in his arm"; MUSCULOSKELETAL DISORDER (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "Arm went out; couldn't use his left arm; relapse in his arm"; MUSCLE DISORDER (medically significant), outcome "unknown", described as "Muscle was gone in the back of the left arm". The patient was in the early part of the clinical trial and was taking ivermectin at this time. The patient's spouse asked could the relapse in his arm be related to getting the vaccines. The patient had two surgeries on his neck within 3 days of each other, which was repeat of a surgery he had 25 years ago. It damaged the nerves and all of a sudden there was a tingling in his arm and his arm went out. His arm went bad again and he couldn't use his left arm. His muscle was gone in the back of the left arm. He had to start steroid shots. He has two titanium plates in his neck from C3-C7. Therapeutic measures were taken as a result of nerve injury, paraesthesia, musculoskeletal disorder, disease recurrence, muscle disorder which included two surgeries in Feb2023. The patient's spouse assessed the case as non-serious.
diagnosed with COVID-19 three weeks after first dose; had sinuses like situations; Second dose greater than day 36; nausea; stopped up ears; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (diagnosed with COVID-19 three weeks after first dose), SINUSITIS (had sinuses like situations), PRODUCT DOSE OMISSION ISSUE (Second dose greater than day 36), EAR DISCOMFORT (stopped up ears) and NAUSEA (nausea) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthmatic.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (diagnosed with COVID-19 three weeks after first dose), SINUSITIS (had sinuses like situations), PRODUCT DOSE OMISSION ISSUE (Second dose greater than day 36), EAR DISCOMFORT (stopped up ears) and NAUSEA (nausea). At the time of the report, SARS-COV-2 TEST POSITIVE (diagnosed with COVID-19 three weeks after first dose), SINUSITIS (had sinuses like situations) and NAUSEA (nausea) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Second dose greater than day 36) and EAR DISCOMFORT (stopped up ears) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was provided by the reporter as Asthma Medications. Treatment information was provided Steroid and Antibiotic.   This case was linked to MOD-2021-265840 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jul-2021: Follow-up received and contains significant information updated new events (stopped up ears and nausea). On 25-Jul-2021: Follow-up received and contains no new information.
Patient was to recieve Moderna Bivalent.  Patient recieved Moderna Monovalent.
Pt broke out on stomach and back with hives on 1-3-15. 1-4-15, broke out with hives on entire body. Mom gave BENADRYL and on 1-7-15 was still broke out with hives.
Scratchy throat with possible swelling. Red splotches on tongue and swelling.} 4:30 pm Later developed breathing difficulties. Treated and observed at hospital for 2 hours before returning home.
15 minutes after the injection, I had lightheadedness, and felt like a mild pressure headache was starting.  This is not change or worsen over the next 24 hours.  5 hours after the injection, I had chills without fever for about 2-3 hours. I also began to feel tired, and overall malaise, which continued through the initial 36 hour period.  Moderate headache developed close to the 24 hour mark, and was relieved with Tylenol. Intermittent, mild headaches continued through the second day.
Was 33weeks and 6 days pregnant on 9/23/21 that morning I had a non stress test done to monitor my baby as I got them done twice weekly and she was perfectly fine. I got my second covid vaccine that afternoon. Sometime after that and sunday morning my babies heart stopped beating and I had to deliver her stillborn. The autopsy and placenta pathology came back normal. Vaccine is only cause.
Within the first 15 minutes of injection, patient complained of dizziness. BP taken 150/70; HR 64. No nausea noted. Pt. transferred from chair to portable bed. After 20 minutes on portable bed, patient no longer felt dizzy. BP 140/70, HR 64 Oxygen saturation 97% on room air. No fever noted. Pt left without further incident.
On the Friday after my vaccine, exactly one week later my arm started to get itchy, by the next morning it was red and had a welt the size of a baseball. As far are the circumference, it wasn't too raised though. It was warm too touch. I thought it was a spider bite but I did call my DR and my DR said to monitor the vaccination site. He had me mark the outside perimeter of the welt and make sure it was not spreading. Within two days it went away and it did not spread.
On april 1st I started to feel a numbing sensation on my left side only in my upper lip, then went to my upper jaw, my nose, to my cheek, my side of my face all the way back to my ear. this all started around 7pm on the 1st. I put off going to the ER to have it checked out until April 2nd around 9am. There they did a cat scan, blood work. They sent me to  Hospital to get further checked out, by ambulance.
Within 2 to 3 minutes after the shot, I experienced swelling in my throat. My glands were sore. I was monitored for 30 minutes by the nurse and as the symptoms were not getting worse she suggested I drive home and take Benadryl. It was a 45 minute drive. Halfway home (about one hour after my shot) I started experiencing itching, swollen tongue, swollen lips. I took 62.5 mg of Children?s Benadryl and met up with my husband and he drove me to the ER, arriving at about 10;15.  After being there about 15 minutes some of my symptoms started going away. At about 11 a rash appeared on my chest. The ER doctors gave me Pepcid 10 mg around 1130 or so. They just charge me and recommended I follow up with my allergy doctor.
more fatigue after 3rd dose than the others; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (more fatigue after 3rd dose than the others) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (more fatigue after 3rd dose than the others). At the time of the report, FATIGUE (more fatigue after 3rd dose than the others) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-353605, MOD-2021-353900 (Patient Link).
Patient developed a rash about 3 inches from injection site. The rash was about 1-2 inches in diameter. She asked what I thought. I said it looks like dry skin/eczema or psoriasis. She said she had psoriasis but this looked different.
Client stated she felt "dizzy, lightheadedness, and nauseous" ~10 minutes after receiving vaccination. Vital signs (HR 76, RR 16, BP 100/50, O2 sat 96%). Client became lethargic, drowsy, unable to open eyes and barely able to respond to verbal stimuli. EMS activated, but client refused to be transported to the hospital despite encouragement and education. AMA form filled and client left site accompanied by her 2 sons. Client stated she was still dizzy and with unstable gait.
There is a pinching sensation in the right arm about 2-3 inches below the shoulder.  She can not reach all the way up and extending the arm out can cause stiffness and pain.  She reports having a sore muscle the first day and then the pinching pain since then.  She has not sought the care of a physician but has tried ibuprofen, aspirin, cream, heat patches and a brace.
anxiety, tachycardia, flushing, diaphoresis, HTN, SOB
had a swollen, red reaction at injection site; had a swollen, red reaction at injection site; This is a spontaneous report from a contactable physician via Pfizer Sales Representative. This physician reported same events for 3 patients. This is 3rd of 3 reports. A patient of an unknown age and gender received meningococcal group b rlp2086 (TRUMENBA) at single dose via an unknown route for immunisation. Medical history and concomitant drug were not provided.  The 3 patients had a swollen, red reaction at injection site. The events took place after use of product. Outcome of the events was unknown.   No follow-up attempts needed, information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020307303 Same reporter/drug, different patient;US-PFIZER INC-2020307227 Same reporter/drug, different patient
11:55 Felt light-headed and weak on way home. 12 - Arrived home. Still light-headed and weak. needed to sit down. Read info on side effects.  12:30 - called pharmacy and talked to pharmacist.  12:45 - some itching in mouth and a little bit of difficulty swallowing noticed for ~ 15 minutes. 1:00 - laid down. 2:00 - felt better.
Patient reported injection site swelling and rash, body aches, chills, abdominal distress, dehydration. These adverse events resolved in 2-3 days.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot#J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share with Merck.  Follow up information has been received from the registered nurse who provided patients details. This report refers to a 10 weeks old infant patient of unknown gender. On 24-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot#J015437, expiration date 09-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Left axilla pain; Left axilla pain and swelling; This is a spontaneous report from a contactable healthcare professional. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177) via intramuscular route of administration in the left arm on 17May2021 at 10:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none known. The patient had mild shellfish allergy. Concomitant medications included escitalopram oxalate (LEXAPRO), colecalciferol (VITAMIN D) and oral contraceptive (MANUFACTURER UNKNOWN), all taken for unspecified indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via intramuscular route of administration in the left arm on 25Apr2021 at 13:45 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. 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 18May2021 at 06:00, the following morning of vaccination, the patient woke with left axilla pain and swelling that progressed throughout the day, the pain and swelling persisted 34 hours after the vaccine. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included treatment with tylenol, ice and heat. The clinical outcome of the event left axilla pain and swelling was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
I need to talk with someone re: effects getting shots  Before getting the shots I was walking 3-5 miles a day, going to the gym 5-7 times a week, playing tennis 5 nights a week and getting up before 7 am  Now, I don't want together out of bed. every joint in my body aches, I have no energy, my hands are swollen and i have no stamina when I tr to go to the gym or play tennis I hurt so bas the I do not want to play  I have gone from being active and strong to being totally depressed because of the constant pain that I am in
Moderna. The above reaction times do not make sense when giving month year only of vaccination.  After  each vaccination two weeks after I had what felt like pulled muscle or tendon not caused by me doing anything strenuous of out of the norm.  After first one was in right upper chest (solar plexus) after sevond was left back neck muscle.
Blistering irregular rash on upper L arm - erythematous swollen area with mild tenderness.
Patient came to pharmacy on 2-10-12 says her left shoulder still hurts from flu shot. She claims she has loss of mobility in that arm and she can not raise it. Pt. has been to family physician for this and has had MRI done on shoulder, but did not discuss details.