chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It doesn't feel comfortable, and it wakes me up; It doesn't feel comfortable, and it wakes me up; severe muscle and joint pain; severe muscle and joint pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Oct2023 as dose 1, single (Lot number: HG4432) for covid-19 immunisation. The patient's relevant medical history included: "She had covid", start date: Jul2023 (unspecified if ongoing), notes: Caller states she had covid earlier this year in July and it wasn't as bad as what she is experiencing with the shot. The patient's concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 Immunisation, reaction(s): "severe muscle and joint pain", "severe muscle and joint pain". The following information was reported: MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 01Oct2023, outcome "recovering" and all described as "severe muscle and joint pain"; DISCOMFORT (non-serious), SLEEP DISORDER (non-serious) all with onset 02Oct2023, outcome "unknown" and all described as "It doesn't feel comfortable, and it wakes me up". Therapeutic measures were taken as a result of myalgia, arthralgia.  Additional information: The reporter stated that, "I had severe muscle and joint pain that night I received the vaccine. Monday morning, I started having this and at 4 o'clock in the morning it woke me up it was so bad." The reporter stated, "I had similar reactions to Moderna as well, but this is more severe. I do not know if it is an allergic reaction or if it is an immune response." It was stated, reporter is wondering what could be causing it, and wondering if it is something that is similar in both of these products. The reporter stated she had covid earlier this year in July and it was not as bad as what she is experiencing with the shot. Covid was longer lasting than the vaccine symptoms. Reporter further stated, the side effect of the vaccine, "It is very mild now, I am keeping taking Tylenol to keep it under control, it is a lot less than it was yesterday". "It does not feel comfortable, and it wakes me up".   The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.
I had a Bell?s palsy episode Thats lasted at least 3 days and is still healing. Corner month on the top of my right lip was frozen and my eye brow was drooped. I initally had weakness and stiffness al over the right side of my face and ear pain in and around the ear and radiating down my neck. Muscles for swallowing on that side were weak as well. It?s slowing resolving but I?m still suffering tightness, weakness and pain.
bilateral blood clots in lungs; This is a spontaneous report from a contactable consumer or other non hcp. A 40-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, (Batch/Lot number was not reported), dose 1 via an unspecified route of administration in Jan2021 as DOSE 1, SINGLE, via an unspecified route of administration on an Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for an COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced bilateral blood clots in lungs after receiving COVID vaccine in January And Feb2021. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency and PROBIOTICS NOS at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment includes: BRAT Diet No concomitant medications were reported.
This nurse was notified by  Pharmacy at 12:15pm 7/29/21 that this was elder's 3rd vaccine when they were entering in . On admission, elder notified staff she was not vaccinated. No adverse effects noted at this time.  APRN/PCP were notified
Systemic: None- Excursion-Mild, Additional Details: Fridge excursion 10/29/22 a few degrees too cold overnight for a few hours not detected until 1/9/2023
I had a fever that ranged from 99.3 to 100.8. I also had muscle aches, including pain at the injection site. I also  was very fatigued. The side effects started approximately 12 hours after receiving the vaccine and were done approximately 24 hours after starting. The exception is the pain at the injection side which continued for an additional 12 hours.
This spontaneous report was received from a medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M024261 with expiry date: 30-JUL-2018, lot # M031557with expiry date 07-APR-2019, lot# M041990 with expiry date 28-JUN-2019) for prophylaxis (dosing details unspecified). No adverse effects were reported. The vaccines were exposed to a temperature 32 F to 35 F for a time period of 8 hours, 47 F to 77 F for 9 hours. Previous temperature excursions were reported as 32 F to 35 F for a time period of 9 hours. Digital data logger was involved. No additional information was provided. Product quality complaint (PQC) was not reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA001307: US-009507513-1706USA011420: US-009507513-1707USA001304: US-009507513-1707USA001305.
pt recvd vax & devel a wheal & flare @ the inject site which was described as white welts in a flat red area which persisted for 10 mins;
injection site reaction/ itchy and red round area on arm at injection site; vaccination site hardness with small bumps; Very itchy/ itch and red round area on arm at injection site; red circle/ red round area on arm at injection site; This spontaneous case was reported by a medical assistant (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE REACTION (injection site reaction/ itchy and red round area on arm at injection site), VACCINATION SITE INDURATION (vaccination site hardness with small bumps), VACCINATION SITE PRURITUS (Very itchy/ itch and red round area on arm at injection site) and INJECTION SITE ERYTHEMA (red circle/ red round area on arm at injection site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety. Concomitant products included CLONAZEPAM for Anxiety, MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 07-Jan-2021 at 11:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE REACTION (injection site reaction/ itchy and red round area on arm at injection site), VACCINATION SITE INDURATION (vaccination site hardness with small bumps) and VACCINATION SITE PRURITUS (Very itchy/ itch and red round area on arm at injection site). 21-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (red circle/ red round area on arm at injection site). The patient was treated with KETOTIFEN FUMARATE (ZYRTEC ITCHY) ongoing since an unknown date at an unspecified dose and frequency. On 26-Jan-2021, VACCINATION SITE REACTION (injection site reaction/ itchy and red round area on arm at injection site), VACCINATION SITE INDURATION (vaccination site hardness with small bumps), VACCINATION SITE PRURITUS (Very itchy/ itch and red round area on arm at injection site) and INJECTION SITE ERYTHEMA (red circle/ red round area on arm at injection site) had resolved.        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.   On 15JAN2021 the patient called her HCP who prescribed cephalexin, but the patient did not believe it was bacterial so she did not take.  Treatment also included ice.   This case was linked to US-MODERNATX, INC.-MOD-2021-102067 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow-up contains updates to: patient demographics, event and event outcome, and treatment chronology; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-102067:second dose
Patient was given both FLUZONE and PNEUMOVAX 23 in the same arm, 1 inch apart. Patient reported that evening, she felt feverish the night of the injection. Her arm was red and inflamed in the injection site, forming a band around the arm the next day. She did not go to the doctor's or emergency. Patient stated she took TYLENOL as self treatment and redness subsided but she is still feeling redness/ inflamed.
Gradually worsening local swelling Right deltoid and biceps, erythema, pain.
I have the shingles now and I was vaccinated; I have the shingles now; painful; 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient had shingles and started medication in the evening before the day of reporting. The patient stated that it was painful and prayed for some relief soon.  This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
I felt fine immediately after the shot and had no physical pain or discomfort other than mild soreness at the injection site.  The next morning I woke up and noticed a loud ringing in both ears.  That ringing has not diminished or gone away since then.  When surrounded by loud ambient noise I don't notice it unless I concentrate on doing so.  Otherwise, it is quite loud and constant.
Dull arm pain, similar to carpal tunnel feeling, pain when lifting arm Redness at injection site, spread in uneven pattern, warm to the touch, itchy, no visible bumps on top of skin but red area raised slightly. Red area spread over 3 days
Pt received vaccine felt fine right after , then got over come with a warming sensation then later with a burning in her throat.  Pt was given IM benadryl 50mg and continues to be monitored she is feeling better but still having an all over warm sensation.
Lower back pain approximately 2 days after injection. Intense on the first day of onset, which gradually dulled over time. On day 7, the pain is still there. Headache on one side of head on day 7. Worried about cerebral venous thrombosis.
I did not have an adverse reaction to the vaccine but I did contract Covid 19.  I test positive 05/24/2022. I had fever, diarrhea, bad headache, sore throat, brain fog and slept a lot. I took Tylenol and cough drops to help with discomfort. At the time of this report, I'm feeling a little better.  I continue to have brain fog, weird stuff with my vision and lingering cough.  I had telehealth visit with my doctor who prescribed the anti viral drug but I did not take it. By the time I got my hands on the prescription, I felt like I took a turn for the better and did not take it.
Lip and tongue swelling and itching.  given diphenhydramine 50mg oral solution and famotidine oral.
Mild fever; Pain at the injection site; General malaise; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 15 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Dose: 1, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 2, Manufacturer unknown), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "Mild fever"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Pain at the injection site"; MALAISE (non-serious), outcome "unknown", described as "General malaise". Therapeutic measures were taken as a result of pyrexia, vaccination site pain, malaise.  Additional information: Reporter son developed the expected side effects of mild fever, pain at the injection site, and general malaise after receiving his 3rd shot. treated with Advil and fever resolved. withheld is a healthy 15-year-old with no underlying conditions. Takes a daily multivitamin. Reporter wasn't sure how long or what other side effects/adverse events my kids might develop, so  wasn't sure of the best time to report.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Within 1 hour of vaccination, chest broke out in hives, severe migraine started along with trouble breathing.
A spontaneous report was received on 12-JUL-2016 via a phone message left from a company representative who was informed by a registered nurse that an unspecified patient received a pediatric dose of VAQTA (0.5ml) "2 years ago" at the age of "18 years old." The patient received a second dose of VAQTA (0.5ml) which was a "pediatric dose" on 12-JUL-2016 at the age of "20 years old," which is outside the recommendations in the VAQTA prescribing information. No adverse effect was reported. No further details were provided. Additional information has been requested.
patient reported left eye swelling and headache in upper left lobe of brain for two days after getting vaccine
A report was received from a healthcare professional, via another manufacturer (Ref E2006-06328) on 15/Dec/2006, concerning a 4-year-old male vaccinee. No details were provided regarding the vaccinee's concomitant medications. At the time of vaccination the vaccinee had rhinitis and increased immunoglobulin E levels. The vaccinee has a history of immunology problems and fever following vaccination. On 18/Oct/2006, the vaccinee received an influenza vaccine (brand unspecified) in his right leg and Pneumovax 23 in his left leg, exact routes and locations unknown. On 18/Oct/2006, 12 hours after vaccination, the vaccinee developed left leg pain and fever. After 24 hours the pain increased and the vaccinee refused to walk. After 48 hours, the vaccinee was seen by the physician with leg redness, fever, generalized aches and pains and  tachycardia. The vaccinee was admitted to hospital for vaccine reaction, fever, possible bacteremia and diagnosed and was treated with antibiotics. It was reported that the  tachycardia may have been due to the fever. The vaccinee recovered from the generalized aches and pains in 1- 1 1/2 weeks and made a full recovery. The physician thought that maybe the reaction was an immune reaction to the vaccine as the vaccinee has had fever in the past following vaccinations. The reporter considers left leg pain, tachycardia and fever to be an important medical event (OMIC). No further information is expected.
Can I take the second dose now; Pretty sick for 4 days; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Pretty sick for 4 days) and PRODUCT DOSE OMISSION ISSUE (Can I take the second dose now) 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 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Can I take the second dose now). On an unknown date, the patient experienced ILLNESS (Pretty sick for 4 days). On 23-Jul-2021, PRODUCT DOSE OMISSION ISSUE (Can I take the second dose now) had resolved. At the time of the report, ILLNESS (Pretty sick for 4 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.   Reporter did not allow further contact
Arm swelled and red circle around injection site was larger than a tennis ball - probably close to size of grapefruit - red and very hot to the touch
Started feeling shoulder pain one month after vaccine. Had a hard time raising my arm. Went to my doctor and was given and told to use ice packs to help with the pain and increase my Tylenol dosage.
pt says she had pain in the left side of her jaw under her ear.  she went to her PCP on 3/3/21.  She was told she had in fluid in both ears.  she was given some medicine but the pain never went away.  she went to a friends house and a doctor there told her she had Bells Palsy and told to go back and see her PCP.   She went back to her PCP on 3/6 and she was diagnosed w/ Bells Palsy.  She was prescribed Valtrex and prednisone.  After completing her meds she had a another severe episode on 3/17/21.  Her face was messed up more and to wear she cant close her left eye.  She went back to PCP and was prescribed more Valtrex and prednisone and scheduled her to see a Neurologist.  She went to a Neurology Center.  They did blood work and ordered an MRI. She was prescribed her more Valtrex and more prednisone for 21 days.  She went back to see neuro doctor after completing this medicine and then prescribed her 120 mg of prednisone and to taper down dose each day.   She has trouble eating and drinking because of her mouth drooping and damaging the nerve in her face.
dose of Twinrix expired on 9/22/2023 and was administered to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 58-year-old male patient who received HAB (Twinrix adult) (batch number 2KE55, expiry date 22-SEP-2023) for prophylaxis.   On 04-OCT-2023, the patient received Twinrix adult. On 04-OCT-2023, an unknown time after receiving Twinrix adult, the patient experienced expired vaccine used (Verbatim: dose of Twinrix expired on 9/22/2023 and was administered to a patient).  The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 4-Oct-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via mail. The patient received an expired dose of Twinrx, which led to expired vaccine used.
Patient became diaphoretic and faintness, assisted to floor with semi-responsive EMS activated. Lower extremities raised on chair, B/P 115/70, pulse 68.. 1052 ambulance arrived b/p 108/71 pulse 76, 02 sat 100 % Blood glucose 84. Patient refused further treatment , released from ambulance. 1108 left with spouse, no further treatment requested, encouraged follow up with primary MD if symptoms persist.
Chills, shaking - possible fever first symptoms that night. Next day examined at clinic red hot area over majority of upper arm. Continued to spread and have should joint pain area. Antibiotics and prednisone ordered.
10 hour following - chills, fever, shortness of breath 24 hours following - hives on trunk, fever, shortness of breath 36 hours following - hives from scalp to thighs, fever, shortness of breath  60 hours following - hives mostly cleared, low grade fever remaining, breathing returning to normal
miserable; slight fever today; headache was much worse; got sick from the vaccine; Kind of tired/very tired; feeling weak/very very weak; not feeling well a few hours later/did not feel well/not feeling 100%; reaction to the vaccination; red mark on his right arm; red rash where the needle went in his arm; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (feeling weak/very very weak), MALAISE (not feeling well a few hours later/did not feel well/not feeling 100%), VACCINATION COMPLICATION (reaction to the vaccination), FEELING ABNORMAL (miserable) and ERYTHEMA (red mark on his right arm) in a 69-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 Headache (Before we went to get the vaccine, he had a headache.) and Stomachache. Concomitant products included WARFARIN for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced VACCINATION COMPLICATION (reaction to the vaccination), ERYTHEMA (red mark on his right arm) and VACCINATION SITE ERYTHEMA (red rash where the needle went in his arm). On 21-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ASTHENIA (feeling weak/very very weak), MALAISE (not feeling well a few hours later/did not feel well/not feeling 100%), ILLNESS (got sick from the vaccine), FATIGUE (Kind of tired/very tired) and HEADACHE (headache was much worse). On 22-Nov-2021, the patient experienced FEELING ABNORMAL (miserable) and PYREXIA (slight fever today). At the time of the report, ASTHENIA (feeling weak/very very weak), MALAISE (not feeling well a few hours later/did not feel well/not feeling 100%), VACCINATION COMPLICATION (reaction to the vaccination), FEELING ABNORMAL (miserable), ERYTHEMA (red mark on his right arm), ILLNESS (got sick from the vaccine), FATIGUE (Kind of tired/very tired), PYREXIA (slight fever today), HEADACHE (headache was much worse) and VACCINATION SITE ERYTHEMA (red rash where the needle went in his arm) outcome was unknown.            No treatment medications provided by the reporter.   Reportedly, Patient daughter was thinking that patient already had COVID, and the vaccine just came at the time when patient had it.  Patient was not coughing and was not showing any respiratory signs. Patient had headache and stomachache, before went to get the vaccine,  but he got the Moderna booster anyway.
1. exhaustion - slept almost 20 hours after vaccination 2. 48 hours after vaccination mild ear infection 3. 96 hours after vaccination fever, intense ear infection, fever continued for 3 days. Infection required antibiotics and MILD INFECTION PERSISTS. WAITING AND WATCHING. 4. 9 days after vaccination a new headache with stiffness and pain in knees, mild fever (below 100). Could not bend knees without pain. Knee pain and stiffness lasted 48 hours, with a peak at about 24 hours. Headache lasted approximately 48 hours.