chrisvoncsefalvay/vaers-outcomes huggingface dataset:
paralyzed diaphragm; labored breathing; This case was reported by a pharmacist via call center representative and described the occurrence of diaphragmatic paralysis in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced diaphragmatic paralysis (serious criteria GSK medically significant) and labored breathing. On an unknown date, the outcome of the diaphragmatic paralysis and labored breathing were unknown.   It was unknown if the reporter considered the diaphragmatic paralysis and labored breathing to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that he heard from a patient's wife that the patient has experienced a paralyzed diaphragm and labored breathing ever since receiving Shingrix about a year before the date of reporting. The patient was administered Shingrix at a different facility, so additional information about the patient and vaccine dose was unknown. The patient experienced a paralyzed diaphragm and labored breathing receiving Shingrix. The patient has reportedly received medical attention for the events,but what treatment the patient received was unknown. The reporter consented to follow up.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 58-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. 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 "Treatment of COVID-19". 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, bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccines BNT162B2, BNT162B2 OMI BA.4-5, BNT162b2 cannot be completely excluded.
Right arm was swollen by injection site. Hemangioma on right shoulder became swollen. 3 days later rash broke out all over body. Fever and crying after vaccines also.
Pt developed rubella looking rash 12 days after MMR-face, neck, chest-4 days high fever 103.
Left bicep swollen and red at injection site. Sick in bed with chills, sweating, headache. 10/6 redness clear to wrist. Saw MD, started PCN 500mg for 10 days.
Loss of voice occurred 48 hours after 2nd covid injection followed by aspiration pneumonia resulting in hospital admittance for over 3 weeks. ENT doctor confirmed paralyzed left vocal fold and right vocal fold not moving normally. Doctor injected hyaluronic acid gel into paralyzed left vocal fold to help the paralyzed vocal cord close the glottis.
Swollen arm; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm) and PAIN IN EXTREMITY (Sore arm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In July 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced PERIPHERAL SWELLING (Swollen arm) and PAIN IN EXTREMITY (Sore arm). At the time of the report, PERIPHERAL SWELLING (Swollen arm) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication was not provided by the reporter.  Treatment information was not reported.  Reporter states that Patient had her second shot on Aug 2021.
Covid arm. Large red rash, heat at site, pain and tenderness of effected area, welt formed underneath skin.
Extreme leg, hip foot pain; Extreme leg, hip foot pain; Extreme leg, hip foot pain; Muscle aches that moved uno and down; Tingling; Burning sensation in foot, toes; Now have several bumps appear near a tick bite from last summer; Tennis ball size swelling in arm; Headache; Extreme, deep body ache; Chills; Lethargy; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 06Apr2021 at 10:45 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included suspected COVID-19 on Jan2020. The patient did not have any known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included ascorbic acid (VITAMIN C), vitamin b complex (VITAMIN B), tocopherol (VITAMIN E), vitamin D nos (VITAMIN D), magnesium glycinate (MANUFACTURER UNKNOWN) and collagen (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknown if ongoing. On 06Apr2021 at 22:00, the patient experienced tennis ball size swelling in arm, headache, extreme, deep body ache, chills, lethargy first 3 days then was slowly subsiding, had muscle aches that moved up and down, tingling, burning sensation in foot, toes that lasted about a week then subsiding and also had several bumps appear near a tick bite from last summer. On 16Apr2021, 10 days later, the patient had extreme leg, hip foot pain. It was reported that the patient walks about 5 miles a day, eat a vegetarian diet, take vitamins & know body well, the patient rarely caught colds/ flu but the patient believe that she had COVID-19 in Jan 2020. It was reported that the patient was concerned about taking a second dose of vaccination after the pronounced reaction to 1st dose of COVID vaccine injection. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swelling in the arm, headache, extreme, deep body ache, chills, lethargy and extreme leg, hip foot pain, had muscle aches that moved up and down, tingling, burning sensation in foot, toes and now have several bumps were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient informed his PCP that he has had ongoing shingles and is requesting the vaccine. Patient is currently homeless and is not receiving the care that he needs. PCP felt that even though patient is only 36 years of age he needed to be vaccinated against shingles before leaving the building, even though the CDC does not recommend it. Patient was given vaccine before leaving the building.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL 9 lot # M040412 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL 9. Additional information has been requested.
Client received the Booster COVID vaccine (Moderna, Lot #070H21A, exp 4/7/2022) at approximately 1220.  At 1259,  re-entered the observation room after leaving notifying Observation RN,  and Co-Lead that when she left the building she started feeling dizzy and having some blurry vision.  At 1300 Client was seated in the anti-gravity chair and vitals assessed (BP 122/67, P 60, color wnl).   Client  reports she had not eaten breakfast or lunch today.  Client  was provided water and snacks.  Client  has hypothyroidism and takes 44 mg synthroid daily.  Client  denies any allergies.  At 1309 Client  states she's feeling shaky/chills and lightheaded but no longer experiencing blurry vision.  Client provided juice and tolerating.  At 1317 vitals assessed (BP 114/77, P 62, color wnl).  Client feels cold but no other symptoms at this time. At 1327 Client reports feeling better and ready to leave.  Vitals assessed (BP116/69, P 63, color wnl).  Client educated on signs/symptoms when to seek medical care and to follow-up with primary care provider.  Client  left with steady gait and with mother present.
Information has been received as part of a pregnancy registry from a physician concerning a female who was vaccinated with Gardasil. As of 26-NOV-2007, the patient "recently" miscarried. Upon interval review, spontaneous abortion was determined to be an other important medical event. Additional information has been requested.
My son had his well child check up on September 30th 2015. He passed with flying colors and before his shots he was his happy healthy self. After the appointment, he fell asleep on the way home. We only live 5 minutes away. I laid him down in his crib and he slept for about 4 hours. When he woke up I went to get him and he wasn't acting normal. He usually stands up and yells for me. This time he was just sitting there whining. I picked him up and brought him downstairs. He saw his brother and tried to walk to him. He took a step forward and fell down. He laid on his stomach until I picked him up. After that he refused to walk. He couldn't bare weight on his legs. His left leg and foot were swollen and his right leg had a red bump where his shot was given. He laid on the couch for awhile. His breathing became labored and had limp arms and legs. He kept his eyes squinted and wouldn't move off of the couch for about 2-3 hours. I gave him juice and tried to get him to eat but his food and drink would just roll out of his mouth like he couldn't chew. At this time he didn't have a fever yet. I called the ER around 8:30/9 pm. When his breathing began to concern me. I counted 45 breaths per minute. They told me to bring him in so I did immediately. When we got there a fever set in. It went from 97 to 99, up to 101. They gave him Motrin and basically told me I was over reacting even tho they saw him laying in my arms basically limp and screaming a terrible high pitched scream. I finally told the nurse I wanted him hooked up to an O2 monitor and sure enough I was right. We stayed there until they cleared us to leave. The next day I had a bad feeling because he still refused to walk. He was showing the exact symptoms as the day before. A 15 month old doesn't wake up and forget how to walk. He's been walking perfectly since he was 9 months old. I brought him in to pediatrics and he saw doctor. Doctor looked at him. Tried to get him to walk. And he decided that patient needed to be seen by another hospital. He called them and we rushed there ASAP. When we got there his temp was at about 102. He still was not bearing weight on his legs. He was in and out of it and not really responsive. The ER then sent us to have an MRI and spinal tap. They admitted us and we ended up staying there from October 1st to 3rd. They ruled out all life threatening diseases but did tell me that he had cerebritis. Which is inflammation of the brain and spine. But it was only acute or minor. Making them think it was a virus. But online - it shows that the shots he got show adverse side effects 4 hours after injection. Just like my child. One doctor told me it probably was from the vaccines. More agreed. We had so many tests and my baby was so miserable. Fevers reaching 103. He began walking again on his own again shortly after but his fever is still here. This has been the scariest time of our lives.
For 6 consecutive months after moderna covid 19 vaccine dose 2, my period was significantly heavy. It caused me to Saturday an Ultra Tampon every 45-90 minutes. Completely abnormal to my usual light to moderate flow. It resolved on month 7.
Arm was extremely sore, swollen and red for the first 3 days. On the 12th day, it was still a bit tender and very itchy with a large red circle (about the size of an apple) around the injection site. A day later 2 smaller spots appeared underneath the circle that are very red and tender to the touch.
her right lung has pulmonary fibrosis,and her left lung has 80% pulmonary fibrosis; feeling very lethargic; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY FIBROSIS (her right lung has pulmonary fibrosis,and her left lung has 80% pulmonary fibrosis) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced PULMONARY FIBROSIS (her right lung has pulmonary fibrosis,and her left lung has 80% pulmonary fibrosis) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced LETHARGY (feeling very lethargic). At the time of the report, PULMONARY FIBROSIS (her right lung has pulmonary fibrosis,and her left lung has 80% pulmonary fibrosis) and LETHARGY (feeling very lethargic) outcome was unknown.            Patient was put on ventilator and in hospice care.  No concomitant medication was reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
The day after receiving my second dose of the Covid-19 vaccine I experienced bright red vaginal bleeding. I currently have an IUD in place and have no had a period ever since this device was placed (and also replaced twice). This is completely abnormal for me! I am still experiencing bleeding. No cramping or any other of the known side effects were experienced.
Fever, chills, body aches, exhaustion. Swelling, redness, heat and itching in entire upper arm (from shoulder to elbow). Treated with Ibuprofen.
I felt severe arm pain after the injection.  About 12 hours later I had a fever of 100.1 and went to bed.  At 1 am I went to the restroom and passed a good deal of blood as I am on my period.  I got up and then fell to the floor.  Then I went to my parents bedroom and fell again.  I drank two bottles of water and took Tylenol at that point and after about two hours I felt better and went to sleep.  I also twisted my ankle when I fell the first time.  I have never fainted nor have I had such severe cramps or passed so much blood associated with a period.
Pt had an onset of facial rash & rash @ sites of vaccines within minutes post VARIVAX @ 1205- refractions was noticed.  1/1000 EPI 0.1 ml given in pt left arm.  EMS was called
Doctor administered vaccine to a patient that didn't meet age requirement. Pt under the age of 18 years old. Pt has reported no adverse reactions. Doctor spoke with patients mother as well and she has reported no adverse side effects.
Two days after receiving the vaccine I started breaking out in a rash just on my right arm where I received the shot.  The rash continued down my arm to the wrist.  It only itches and continues to be uncomfortable to this day.  No other adverse effects.
she is past 42 day mark for 2nd dose; aching; sweating; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aching), HYPERHIDROSIS (sweating) and PRODUCT DOSE OMISSION ISSUE (she is past 42 day mark for 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (aching), HYPERHIDROSIS (sweating) and PRODUCT DOSE OMISSION ISSUE (she is past 42 day mark for 2nd dose). At the time of the report, PAIN (aching) and HYPERHIDROSIS (sweating) had not resolved and PRODUCT DOSE OMISSION ISSUE (she is past 42 day mark for 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  The patient reported that she missed the second dose of the vaccine that she was scheduled to receive on 20-Apr-2021 and requested guidance on whether she should receive the second dose or not.  The patient disconnected the call before Customer Care could transfer her over to Medical Information.  No treatment information was provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 11-Jul-2021: Patient declined consent for further follow up.
other zoster-related conditions; shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions or concomitant medications was provided. On 20-DEC-2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) as prescribed and/or administered by a pharmacist at a pharmacy for the long-term prevention of shingles and zoster-related conditions. On unknown dates, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by healthcare providers, including but not limited to a physician assistant at a clinic, for shingles, and other zoster-related conditions. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the events was considered to be not recovered/not resolved. The reporter considered the events of shingles, and other zoster-related conditions to be related to zoster vaccine live (ZOSTAVAX).
Flu shot was provided by my employer and given at the Sheriff's Department.  A couple hours after getting flu shot, my upper arm hurt and felt warm in the area of the shot. My upper arm was extremely sore and achy for almost 2 weeks.  My upper arm still hurts and feels warm but to a much lesser degree. I have never had a reaction with previous flu shots.
Rash on right elbow; Rash on left elbow; Rash on right foot; Rash on left foot; Rash on palm of right hand; Rash on palm of left hand; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (Rash on right elbow), RASH (Rash on left elbow), RASH (Rash on right foot), RASH (Rash on left foot) and RASH (Rash on palm of right hand) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced RASH (Rash on right elbow), RASH (Rash on left elbow), RASH (Rash on right foot), RASH (Rash on left foot), RASH (Rash on palm of right hand) and RASH (Rash on palm of left hand). At the time of the report, RASH (Rash on right elbow), RASH (Rash on left elbow), RASH (Rash on right foot), RASH (Rash on left foot), RASH (Rash on palm of right hand) and RASH (Rash on palm of left hand) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Patient was prescribed steroid medication for the rashes.
pt recvd vax & following vax pt devel joint pain & hives; No further details were provided;
Painful left arm for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful left arm for 24 hours) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     Concurrent medical conditions included Herpes simplex type I. Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALTREX) for Herpes simplex type I.    On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2021, the patient experienced PAIN IN EXTREMITY (Painful left arm for 24 hours). On 27-Aug-2021, PAIN IN EXTREMITY (Painful left arm for 24 hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.    This case was linked to MOD-2021-344229 (Patient Link).
RECEIVED H1N1 VACCINE WHILE SEATED IN A CHAIR. SHE FAINTED, BUT DID NOT FALL.
Patient received the second dose Pfizer and the first dose was Moderna; 1st dose of Moderna vaccine 8 Jan 2021. 124 days since first dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient received the second dose Pfizer and the first dose was Moderna) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of Moderna vaccine 8 Jan 2021. 124 days since first dose.) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of Moderna vaccine 8 Jan 2021. 124 days since first dose.). On 12-May-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient received the second dose Pfizer and the first dose was Moderna). On 08-Jan-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of Moderna vaccine 8 Jan 2021. 124 days since first dose.) had resolved. On 12-May-2021, INTERCHANGE OF VACCINE PRODUCTS (Patient received the second dose Pfizer and the first dose was Moderna) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.