chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Muscle spasms in right leg; Leg cramps; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Muscle spasms in right leg) and MUSCLE SPASMS (Leg cramps) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 11-Jan-2021, the patient experienced MUSCLE SPASMS (Muscle spasms in right leg) and MUSCLE SPASMS (Leg cramps). At the time of the report, MUSCLE SPASMS (Muscle spasms in right leg) and MUSCLE SPASMS (Leg cramps) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information provided. No treatment information provided.
Expired Shingrix was mistakenly administered to patient; This non-serious case was reported by a physician via sales rep and described the occurrence of expired vaccine used in a female patient who received Herpes zoster (Shingrix) (expiry date 18-SEP-2023) for prophylaxis.   On 01-NOV-2023, the patient received Shingrix. On 01-NOV-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: Expired Shingrix was mistakenly administered to patient). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 02-NOV-2023 It was reported that expired Shingrix was mistakenly administered to patient which led to expired vaccine used. Office realized it after administration had occurred. Advised office to document administration and let the patient know what happened.
Felt horrible after the booster dose; Slept for hours after the booster dose; Recieved booster dose was grey in colour and contained particles which was different from primary series; Booster dose had particles in it that are different from the Primary series; Booster dose was grey in colour; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Felt horrible after the booster dose), SOMNOLENCE (Slept for hours after the booster dose), POOR QUALITY PRODUCT ADMINISTERED (Recieved booster dose was grey in colour and contained particles which was different from primary series), LIQUID PRODUCT PHYSICAL ISSUE (Booster dose had particles in it that are different from the Primary series) and PRODUCT COLOUR ISSUE (Booster dose was grey in colour) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Epilepsy (had a long history). Concurrent medical conditions included Brain damage (had a long history, started when he was a child well before he took the Moderna Covid-19 vaccine) and Short-term memory loss (had a long history, started when he was a child well before he took the Moderna Covid-19 vaccine). Concomitant products included CARIPRAZINE HYDROCHLORIDE (VRAYLAR) for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Recieved booster dose was grey in colour and contained particles which was different from primary series), LIQUID PRODUCT PHYSICAL ISSUE (Booster dose had particles in it that are different from the Primary series) and PRODUCT COLOUR ISSUE (Booster dose was grey in colour). On an unknown date, the patient experienced FEELING ABNORMAL (Felt horrible after the booster dose) and SOMNOLENCE (Slept for hours after the booster dose). At the time of the report, FEELING ABNORMAL (Felt horrible after the booster dose), SOMNOLENCE (Slept for hours after the booster dose), POOR QUALITY PRODUCT ADMINISTERED (Recieved booster dose was grey in colour and contained particles which was different from primary series), LIQUID PRODUCT PHYSICAL ISSUE (Booster dose had particles in it that are different from the Primary series) and PRODUCT COLOUR ISSUE (Booster dose was grey in colour) outcome was unknown.            Patient had no reaction to first and second dose. Patient might not be taking Vraylar anymore. Patient lost focus during conversation. No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2022: Follow-up was received and included no significant information.
the second dose I am still having some side effects keeping me out of work; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Jan2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single, ), for Covid-19 immunisation. The following information was reported: IMPAIRED WORK ABILITY (non-serious), outcome "unknown", described as "the second dose I am still having some side effects keeping me out of work".  Additional information: consumer had received the vaccine in January and the second dose and still having some side effects keeping the patient out of work.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax & 2 days later pt devel intense pain in lt scapula, radiating down lt arm to elbow;4th & 5th digits of lt hand were numb & weak;
After I received the second shot, in my left arm, it felt sore for a few weeks. But after that the pain worsened, which aggravates the muscle and joint pain from the fibromyalgia and MS I have been afflicted with the past several years. It's so painful that I'm unable to dress/undress, ,extend my left arm forward and outward, brush my hair upward into a ponytail, which all causes extreme pain in my left arm that extends up into my neck and down to my hand. This is chronic, daily pain that has occurred since the second COVID shot in my left arm.
After first dose on March 22, I was fine.  However on March 31,  I woke up very nauseous, headache,  head felt foggy and cloudy, dizzy.  Went to work. At 9am, i got so dizzy when I turned head that I blacked out, hit cheek on chair as I fell to floor. Saw Dr. at the Family Health Clinic, who did EKG, Epply test, blood pressure and recommended going to ER for further evaluation.  Cat scan with contrast was done to check for anything unusual.   On April 1, was prescribed Meclizine by Dr. to take for dizziness.  On April 20- received 2nd dose of vaccine- started to feel headache, slight dizzy by 11:30 that evening.  Next morning, felt slight nausea, light headed and dizzy.  Started taking  meclizine again for dizziness at recommendation of Dr.   Spoke with Dr. from Family Health Center again on 4/22/21 to advise of stronger  symptoms.
Muscle weakness resulting in the inability to walk or control speech or bladder. Guillain-Barre syndrome.
Tingling lips; Swollen lips; myalgia; joint pain; tachypnic; headache; Weakness generalized; Nausea; she said she was really pale, so much so, that her husband was scared for her; This is a spontaneous report from a contactable other HCP. A 50-year-old female patient  received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular in left deltoid on 22Dec2020 07:00 at a single dose for covid-19 immunization. Vaccination was done in a hospital. There were no relevant medical history and concomitant medications. On  to 22Dec2020, she said she feels like she has had a severe reaction to the COVID-19 Vaccine, saying she was not doing so great.  Reported she received her first COVID-19 Vaccine dose on 22Dec2020 at 7:00AM in her left Deltoid. She said she had a reaction after receiving the first dose of the COVID- 19 Vaccine. She said her lips were tingling slightly, clarifying her lips were swollen too. She said she took some Benadryl (she clarified she did not have the Benadryl NDC/UPC, Lot or Expiration Date), and the Benadryl took away the lip tingling and swelling. She said she was tachypneic, and developed muscle pains (clarified as myalgia), joint pain, severe headache, weakness, and nausea. She said she also was really pale, so much so, that her husband was scared for her. She said the symptoms lasted for about 3 days, but the weakness lasted longer. Reported she took some Zofran disintegrating tablets for her nausea. Clarified she did have a PCR COVID-19 Virus test after she developed symptoms from receiving the first COVID-19 Vaccine dose. She said she had the PCR COVID-19 Virus test about 3 weeks ago, Dec2020 and the test was negative. She said she thought she had the COVID-19 Virus after receiving the first COVID- 19 Vaccine dose because no one else she knew who had the COVID-19 Vaccine had any issues. The outcome of the events joint pain,. myalgia, tachypnic, headache, pale and nausea was recovered on an unknown date in Dec2020; the outcome of the event tingling lips and swollen lips was recovered on 22Dec2020; while the outcome of weakness was unknown. The events were assessed as medically significant and causality was reported as related.; Sender's Comments: Based on the close compatible temporal association, there was a reasonable possibility that the events were related to the vaccination with BNT162B2. 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
side effects after the booster shot; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (side effects after the booster shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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 IMMUNISATION REACTION (side effects after the booster shot). At the time of the report, IMMUNISATION REACTION (side effects after the booster shot) outcome was unknown.            No concomitant information was reported. It was mentioned that the reporter knew someone else who had side effects after the booster shot.   No treatment information was reported.
Pt. received their first dose of Moderna Covid 19 vaccine on 2/11/21 and was asked to come to the 2nd dose clinic on 3/8/21 as the two doses have to be given 28 days apart. Pt. came to clinic on earlier than asked date of 2/24/21 and was given 2nd dose by accident.  Pt. was called to inform him that his 2nd dose was given too soon and next steps for resolution. Pt. was called on 2/24/21, 3/1/21 and 3/2/21 with no answer or call back. We will continue to call the patient and offer next steps.
Client presented to Clinic on 11/1/2022 for COVID-19 Moderna 12+ Bivalent Booster (0.5mL dose). Client inadvertently received COVID-19 Moderna 12+ Monovalent (0.5mL dose). Following CDC guidance, the recommendation is that providers may administer 1 bivalent booster dose as a repeat dose based on clinical judgement and patient preference. If a repeat dose is given it must be adminstered at least 2 months after the dose given in error. This nurse called the client on 11/1/2022. Client understood the events that occurred. Nurse addressed client's concerns, ensured client that dose was not harmful, and provided education on what to expect. Client prefers to still receive the COVID-19 Moderna 12+ Bivalent Booster, 2 months from today.
I had redness and swelling at the injection site or 2-3 days, and then everything was back to normal.  But then on the 8th day I had slight itching and a rashy redness at the injection site about 2.5 inches long and wide.
little bit swollen on her face and neck; allergic reaction; This is a spontaneous report from a contactable consumer or other non-Health Care Professional via Pfizer-sponsored program.A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 1 via an unspecified route of administration on 24Feb2021 as DOSE 1, SINGLE for Covid-19 immunization.The patient medical history was not reported.The patient's concomitant medications were not reported.On an unspecified date the patient experienced little bit swollen on her face and neck. On 11Mar2021 the patient experienced allergic reaction. Therapeutic measures were taken as a result of allergic reaction. She will need to take 3 medicines for Tuesday, Prednisone for Wednesday Benedril and Pepcid. The outcome of event was unknown.  No follow-up attempts are possible: information about lot/batch number cannot be obtained.
Tightness in the chest; Sinus congestion; Headache; tongue felt tender; Metal taste; felt disoriented; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (felt disoriented), GLOSSODYNIA (tongue felt tender), DYSGEUSIA (Metal taste), CHEST DISCOMFORT (Tightness in the chest) and SINUS CONGESTION (Sinus congestion) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (Allergic to amoxicillin).    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced DISORIENTATION (felt disoriented). On 10-Mar-2021, the patient experienced GLOSSODYNIA (tongue felt tender), DYSGEUSIA (Metal taste) and HEADACHE (Headache). 10-Mar-2021, the patient experienced SINUS CONGESTION (Sinus congestion). On 12-Mar-2021, the patient experienced CHEST DISCOMFORT (Tightness in the chest). At the time of the report, DISORIENTATION (felt disoriented), GLOSSODYNIA (tongue felt tender), DYSGEUSIA (Metal taste), CHEST DISCOMFORT (Tightness in the chest), SINUS CONGESTION (Sinus congestion) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  It was reported that no medical attention was pursued and did not self medicate with any over-the-counter medications.  No concomitant medications were  reported.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.
Extreme sore throat, achy feeling over entire body.  Took two aspirin and went to bed by 8:30 p.m. Sore throat lasted for three more days. Back to normal by following Tuesday (Oct. 11)
COVID-19 monitoring documentation. Patient admitted 10/21/2021 documented positive for COVID-19. She received Pfizer (dose 1) on 2/13/2021 batch/lot# EL9267, and Pfizer (dose 2) on 3/6/2021 batch/lot# EN6205.
Headache; Nauseous; Diarrhoea; Throwing up; Sweating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2), administration date 12Mar2021 (Lot number: EN6204) at the age of 78 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: HEADACHE (non-serious) with onset 13Mar2021, outcome "unknown", described as "Headache"; NAUSEA (non-serious) with onset 13Mar2021, outcome "unknown", described as "Nauseous"; DIARRHOEA (non-serious) with onset 13Mar2021, outcome "unknown", described as "Diarrhoea"; VOMITING (non-serious) with onset 13Mar2021, outcome "unknown", described as "Throwing up"; HYPERHIDROSIS (non-serious) with onset 13Mar2021, outcome "unknown", described as "Sweating". Therapeutic measures were not taken as a result of headache, nausea, diarrhoea, vomiting, hyperhidrosis.  Additional information: The patient reported that when she got the shot on Friday, she was fine and until the next morning and when she get up she had severe headache, she was nauseous and she had the diarrhoea. she was throwing up, she was sweating and she just wondered if that is normal and if she got that bad through the first shot what she going to do with the second shot. She was getting next vaccine on 01Apr.  No follow-up attempts are possible. No further information is expected.
Headache, Myalgia, Arthralgia, Fatigue, Chills Narrative: No further details given
Pt recvd 2 doses of Engerix-B 15JUN91 & 15JUL91; 01AUG pt exp jaundice & reporter indicated "Hep A serology is negative"; In addition, Hep B surface was positive & anti-Hepa B surface was undetectable; Pt is probably in acute hepatitis;
I just finished my bout with Shingles; blisters; my body was in so much pain; I mostly slept; I only had one shot because they run out of the 2nd shot; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and did not receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles, blister, general body pain, sleep excessive and product availability issue. On an unknown date, the outcome of the shingles, blister, general body pain and sleep excessive were recovered/resolved and the outcome of the product availability issue was unknown.   It was unknown if the reporter considered the shingles, blister, general body pain and sleep excessive to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 01-NOV-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The reporter mentioned as he/she just finished his/her bout with Shingles.  The blisters were not the worst. The rest of his/her body was in so much pain. The patient mostly slept.  He/she only had one shot because the pharmacy had run out of the second shot. Get the vaccines. Additional supportive information:  Follow up would not possible, as no contact details were available.
A consumer posted the information on a website, that reported by a mother concerning her 18 year old daughter who on unspecified dates was vaccinated with GARDASIL shots. On approximately 11-NOV-2008 (reported as 11 months ago) her daughter had her first episode that's when the whole nightmare began and had never stopped. Her daughter can not live a normal life. Her daughter was diagnosed with: vagal vasal syncope, bradycardia and heart arrythmias. She hardly made it through her senior year, she did not get to attend her high school ceremony because she was passed out on bathroom floor and was taken by ambulance to the hospital. She was missing out on so much, because of her condition. One week she passed out twelve times. The doctors didn't know when this would go away, they had been told it could be years. She was on a lot of different medications, but nothing seemed to work. No matter how much they increased the dosage, it did not work. She was constantly tired, headaches, aching joints, and sometimes vomits. They had been to many cardiologists. Some recommend a pacemaker, some didn't. They didn't know what suddenly caused this. They said she was a difficult but interesting case. The mother had mentioned the vaccination shot to all the doctors, only one said it could be connected to the shot. The others said there was no proof that her daughter's condition was connected to the shot. Upon internal review, bradycardia, arrhythmia and vasovagal syncope were considered to be disabling. No further information is available.
Stroke on the morning of 2/9/21. First stroke at 6 am at home second at work at 9 am. Admitted to hospital for several days with lots of test and labs. An underlying PFO was found in my heart but no reason was found as to why I had a clot that caused me to have a stroke.
We were in line for dinner and my son just did not look right, I asked him if he was feeling alright and he said he was okay just did not look right to me. We are driving home and right before we got home, he just started throwing up. He threw up for about 12 hours and complained of a headache during this. I finally took him to the ER after the 12 hours of him throwing up. When we were at the ER they did give him nausea medication and got him to keep fluids down and then finally sent us home. The headache did last for a few more days as well.
The caller had some slight ringing in ears prior to receiving the second dose Pfizer Covid 19 Vaccine, nothing alarming; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: EP7533) at the age of 46 years, in arm for COVID-19 immunization. The patient's relevant medical history included: "Vertigo", start date: 26Nov2020 (ongoing), notes: Vertigo. There were no concomitant medications. The following information was reported: TINNITUS (non-serious) with onset 2021, outcome "not recovered", described as "The caller had some slight ringing in ears prior to receiving the second dose Pfizer COVID 19 Vaccine, nothing alarming". The event "the caller had some slight ringing in ears prior to receiving the second dose pfizer COVID 19 vaccine, nothing alarming" required physician office visit.  Additional information: Reporter stated she started getting ringing in her ear and then she went to her doctor office (ENT specialists) and have not been able to treat the ringing in ears. She was advised it may last up to 90 days, it has been a year since then and it is getting worse and has not stopped. She had three shots, it was the First shot which is when it is all started. Sometimes there were days the ringing got so loud, it was nerve racking. The ringing in ears was initially mild and it had a domino effect for caller. Having some trouble sleeping because of the ringing. Indication, to reduce the spread of COVID, reduce caller from getting infected of dying. Time the Vaccination Was Given: First dose: somewhere in middle of day. Anatomical Location of Administration of Pfizer vaccine considered as suspect: Arm, caller does not recall if left or right arm. Vaccine was not Administered at Military Facility. List of other vaccinations within four weeks prior to the first administration date of the suspect vaccine was reported to be none. Relevant Tests: none
It started with an itchy scalp followed by sudden hair loss (I would say significant loss) I also was having  hot flashes with a flushed face. The hair loss is my concern, I did see my dermatologist and primary care provider. Both were undetermined of what was causing the hair loss.
just in the arm that shingrix was administered, patient reported soreness and redness approximately 5 to 7 days after initial administration. also felt feverish.