chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fell a couple of times; wanted to sleep all day; Super sick; felt strange, terrible; felt dizzy; like throwing up; felt like throwing up; Second shot was given more than 36 days after first shot; This spontaneous case was reported by a consumer and describes the occurrence of FALL (fell a couple of times), SOMNOLENCE (wanted to sleep all day), ILLNESS (Super sick), FEELING ABNORMAL (felt strange, terrible) and DIZZINESS (felt dizzy) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0101A21A and 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (She was diagnosed with Co-vid 19 back in Mar2020) in March 2020 and Back surgery. Concomitant products included OXYCODONE for Pain, COLECALCIFEROL (VIT D3), CALCIUM and TIZANIDINE for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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. On 16-Apr-2021, the patient experienced OFF LABEL USE (Second shot was given more than 36 days after first shot). On 17-Apr-2021, the patient experienced FALL (fell a couple of times), SOMNOLENCE (wanted to sleep all day), ILLNESS (Super sick), FEELING ABNORMAL (felt strange, terrible), DIZZINESS (felt dizzy), NAUSEA (like throwing up) and VOMITING (felt like throwing up). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 16-Apr-2021, OFF LABEL USE (Second shot was given more than 36 days after first shot) had resolved. At the time of the report, FALL (fell a couple of times), SOMNOLENCE (wanted to sleep all day), ILLNESS (Super sick), FEELING ABNORMAL (felt strange, terrible), DIZZINESS (felt dizzy), NAUSEA (like throwing up) and VOMITING (felt like throwing up) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.   This case was linked to MOD21-078174 (Patient Link).
1 1/2 hours after vaccination, pt's eyes were puffy and rash developed on body and face. After Benadryl was given, symptoms subsided.
Three months after 4th dose, tested positive with a home COVID-19 test. His Dr. prescribed Paxlovid. Breakthrough case.
Weakness; Aches; Left side of mouth where top and bottom meet has been sore; This spontaneous case was reported by a consumer and describes the occurrence of ORAL PAIN (Left side of mouth where top and bottom meet has been sore), ASTHENIA (Weakness) and MYALGIA (Aches) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ORAL PAIN (Left side of mouth where top and bottom meet has been sore). On 21-Mar-2021, the patient experienced ASTHENIA (Weakness) and MYALGIA (Aches). The patient was treated with PARACETAMOL (TYLENOL) for Ache and Weakness, at an unspecified dose and frequency. At the time of the report, ORAL PAIN (Left side of mouth where top and bottom meet has been sore) outcome was unknown and ASTHENIA (Weakness) and MYALGIA (Aches) had not resolved.            No concomitant medications were provided. Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to MOD-2021-036847 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow-up information received on 03-MAY-2021 contains significant information: Added new treatment drug, new events "Aches"and "Weakness".
Pt. received 4 injections at our clinic- Alert, walked to lobby to schedule return visit when c/o feeling funny sat in chair- sucker given, cool cloth to neck; cold cool water offered.  Pale did not faint but feet weak. water offered- pale looks, did not faint but feel weak.  pc 10/29/2008 2p- still looks pale but fine.
Information has been received from a registered nurse referring to patient of unknown age.  The patient's medical history, concurrent condition and concomitant medication were unknown. On unspecified date, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (dose and route unknown, lot # M035486, expiration date: 05-JUN-2019) for prophylaxis. The vaccine was stored in -1.5 degrees Celsius for 2 hours 53 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
The morning of 03/19/2021 I woke up in the middle of the night having a stroke. I could not walk. I flapped around like a fish. When I fell, I fell onto the bed. I was able to get up to the bed. We did not call 911 because they recommended to not go to the hospital unless it was for COVID-19. I was able to get up and get back on the bed, where I stayed until we got a hold of the doctor who said come in and I will see you. He saw me that day. I was in a wheelchair because I could not walk. My husband was helping me. They did an MRI, CAT scan, Doppler on my legs that I had been scheduled for because the podiatrist could not get a reading on my left leg a week prior. We took everything one day at a time. He sent me to a neurologist, who saw me right away. He did more tests and determined I had an ischemic stroke. That was the first one. I started taking a blood thinner. I was seen by my cardiologist who determined it was not a heart event. A month and a half later, the first week in May I had another stroke. At that point I was already doing physical therapy to try and regain control of my walking and my arms. Since then, everything has intensified. I did not call 911 because I did not want to go to the hospital.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated one dose of an improperly stored one dose of PROQUAD (concentration, vaccination site and dose number were not provided) with lot # N021724, expiration date 06-FEB-2019, for prophylaxis, diluted with properly stored sterile diluent. The vaccine was exposed to a temperature excursion of -14 degrees Celsius (degree C) to -10 degree C during a time frame of 90 minutes which was detected by the data logger. There was no prior temperature excursion. No adverse events were reported.
This spontaneous report as received from a physician refers to a 15 year old patient of unknown gender. The patient concurrent condition, medical history and concomitant medication were not reported. On 07-SEP-2016, the patient was vaccinated with first dose of GARDASIL 9 for prophylaxis. On 19-JUL-2017, the patient received second dose of GARDASIL 9 for prophylaxis (Inappropriate schedule of drug administration). No adverse effects reported. No PQC reported. Additional information has been requested.
Within minutes of receiving 2 vaccines my 12 year old fainted and started jerking. She came to fairly quickly but had a very rapid heart rate and they had to keep checking her blood pressure. She had to stay lying down for quite a while. Afterwards she was very sore and lethargic the rest of the afternoon.
Just started her period today after her vaccination/ not expecting her period for another 2 months; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of MENSTRUATION IRREGULAR (Just started her period today after her vaccination/ not expecting her period for another 2 months) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ETHINYLESTRADIOL, LEVONORGESTREL (SEASONIQUE) for Birth control.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced MENSTRUATION IRREGULAR (Just started her period today after her vaccination/ not expecting her period for another 2 months). At the time of the report, MENSTRUATION IRREGULAR (Just started her period today after her vaccination/ not expecting her period for another 2 months) outcome was unknown. Not Provided      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.   The patient was on quarterly birth-control medication.  No treatment information was provided.
Patient had pain in left arm, confusion and mumbled speech. Friday night,- nonsensical speech, left sided dystonic movement- left shoulder and left leg. Multiple seizures After 30 minutes sublingual clonazepam  was given and Nayzilam nasal spray.  Started to get full motor activity on sunday and speech improved
Severe joint and muscle pain; Severe joint and muscle pain; tiredness; headache; This is a spontaneous report from a contactable consumer (patient) and other HCP. A 71-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: FN6200), via an unspecified route of administration, administered in arm left on 28Feb2021 at 09:30 AM (at the age of 71-year-old) as dose 1, single for COVID-19 immunization. The patient medical history included diabetes, hx breast cancer, arthritis and allergy to xray contrast ionic and non-ionic. The patient received concomitant medication in two weeks which included metformin taken for an unspecified indication, start and stop date were not reported. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN6199), via an unspecified route of administration, administered in arm left on 06Mar2021 as dose 2, single for COVID-19 immunization. The patient previously took valium, rocephin and experienced drug allergy. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient was diagnosed with COVID prior vaccination. No COVID tested post vaccination. On 05Mar2021, the patient experienced severe joint and muscle pain, tiredness, daily headache about 1 week after 1st injection and continued past 2nd injection up until 12Apr. No treatment was received in response to the adverse events. The outcome of all the events was recovering.  No follow-up attempts are possible. No further information is expected.
adult male early 30s. complained of stomach issues on night of 11/26-11/27 believed to due to diet earlier 11/26.Probably vaccinated, but unsure which one and when.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) 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: ABDOMINAL PAIN UPPER (non-serious) with onset Nov2021, outcome "unknown", described as "adult male early 30s. complained of stomach issues on night of 11/26-11/27 believed to due to diet earlier 11/26.Probably vaccinated, but unsure which one and when.". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After receiving the vaccine 10:20 AM on 11/11, I woke up with a mild fever and crushing headache at 1 AM on 11/12 for which I took some aspirin.  I was extremely fatigued and nauseated all day on 11/12 as well as sweating a lot and still had an intensive headache.  I continued to treat with aspirin, which did help somewhat..  on 11/13 I noticed a large red, hot circle around the area of the vaccine.  Nausea and fatigue are much improved on 11/13, but still not totally back to normal.  My arm still hurts a lot.
Mild headache and myalgia - onset began approximately 12 hours after 2nd dose of Pfizer covid vaccine. resolved within 24 hours of vaccination.
rash is raised bumps; Blister; Itches; Severe rash on both of my arms; This spontaneous case was reported by a consumer and describes the occurrence of RASH VESICULAR (rash is raised bumps), BLISTER (Blister), PRURITUS (Itches) and RASH (Severe rash on both of my arms) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history). Concomitant products included METHYLPREDNISOLONE SODIUM SUCCINATE (SOLU MEDROL), LEVOTHYROXINE, DIPHENHYDRAMINE, ESCITALOPRAM and NIACIN for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced RASH VESICULAR (rash is raised bumps), BLISTER (Blister), PRURITUS (Itches) and RASH (Severe rash on both of my arms). At the time of the report, RASH VESICULAR (rash is raised bumps), BLISTER (Blister), PRURITUS (Itches) and RASH (Severe rash on both of my arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact; Reporter'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.
Information has been received from a RN concerning a 12 month old female who over the past year was vaccinated SC with a dose of 0.5ml varicella virus vaccine live. Almost immediately after the injection, the pt experienced hives around the injection site. Unspecified medical attention was sought. The RN reported that the pt has recovered. No product quality complaint was involved. Additional information has been requested.
Patient is a 49 y/o female with ESRD on dialysis T/Th/Sat who presents to the ED with shortness of breath, generalized weakness, left upper back pain and itching x 1 week since having an infusion of immunosuppressant drug for RA. Patient reports new onset chest discomfort today. 5/17 -- admitted to the medical ICU 5/18 -- remdesivir 200mg IV x1 given then discontinued because she is a dialysis patient. dexamethasone 10mg IV daily x 7 doses While in the ICU she was hypotensive and required pressors Maximum oxygen requirement -- 15L High flow, never required mechanical ventilation 5/19 moved to COVID floor (nonICU) 5/24/21 - discharged to home
June 10th achy pain across top of head  June 22 ears and head clogged and pressure  in  Eustachion  tubes  ears and sinus  loud roar in ears , hearing muffled, tinnititus   saw primary care giver, told to take Flonaisse and Zyrtec     no relief, saw Nurse  prescribed Amoxicillin   No relief
The month after getting my vaccine my period came very early and lasted for almost  20 days ( spotting mostly)  then went away for 40 days.  My whole life I have had very regular periods ever 28 -29 days like clockwork .  They are finally seeming back to normal, but this was very disconcerting as I was not warned about this at all and it made me afraid that the vaccine could have other side effects that I was not warned about.
This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 59-year-old female patient who received SHINGRIX for prophylaxis. On 4th June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site swelling, allergy, injection site burning, pain in arm, tiredness and injection site inflammation. On an unknown date, the outcome of the injection site swelling and injection site burning were recovered/resolved and the outcome of the allergy, tiredness and injection site inflammation were unknown and the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the injection site swelling, allergy, injection site burning, pain in arm, tiredness and injection site inflammation to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX shot at the doctor's office in the left deltoid. The patient stated that, her doctor told her to call GlaxoSmithKline to see if she should get her second shot or not since she had a severe allergy. The patient experienced all-over-body tired. She said that, the injection site (left arm close to the shoulder) had swelling about the size of your palm (big surface) with burning and pain. After about 4 to 5 days, the arm swelling started to fade. One week later the arm swelling resolved. However, the patient felt that, the inflammation inside the muscle was still present because it still hurts inside the muscle when she lift her arm shoulder high. For a while she could not drive due to the arm pain but at the time of reporting she can drive again. She stated that, the arm pain was much better. The reporter gave consent to follow up.
I started out with itching all over my arms and legs. I contacted my doctor in May some time. Like 2 months after getting the vaccine. They did not do any medical tests. They suggested to do some blood work but I have not had those yet. They gave me some cream to try out and to stop using detergents. The last few weeks it started to dissipate. It was all over my body and it was driving me crazy. My symptoms are improving but I have not recovered completely.
Severe abdominal pain; cannot move; Severe abdominal pain; cannot move; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for covid-19 immunisation. Medical history included allergy to nuts and nut oils. The patient's concomitant medications were not reported. The patient experienced severe abdominal pain; cannot move on 08Jan2021. The patient had the COVID-19 vaccine yesterday (08Jan2021), the first dose of it and about 2 hours after that she started having some abdominal pain, no fever, no nausea, no throwing up, the side effects and everything that was listed on the information that she was given, she was not really been having. But she had been having really severe abdominal pain to the point she cannot hardly move, it had got to buckle over. She had got an allergy to nuts and nut oils and this was the same type of thing that she had when she had that reaction. Reporter asked if it could be an allergic reaction to the shot. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Escalated temperature in a range of 99.9 to 100.7 over a 19 hour period of time. Extreme fatigue - During  a 34 hour period beginning 6 hours after receiving vaccination, I slept approximately 30 hours Diarrhea lasting fewer than 4 hours
From initial information received on 18/Mar/2005 from a health care professional regarding an adverse event occurring in the USA, it was reported that a four year old female patient received a fifth dose of DAPTACEL, lot number C1696AA, administered in the right deltoid, a dose of IPOL, lot number X0367, administered in the left deltoid; and a dose of Measle, Mumps and Rubella Vaccination lot number 1035N, administered in the left deltoid on 02/Jan/2004. The route of administration were not reported. Two days later on 04/Jan/2004, the patient developed redness, swelling and blisters at the sight of the DAPTACEL injection. The reactions site measured approximately the size of quarter. As per the reporter, the symptoms resolved and the patient recovered from these events. From additional information received on 14/Apr/2005 from responsible physician, it was reported that the DAPTACEL vaccine was administered intra-muscularly in the right deltoid, IPOL vaccine was administered subcutaneously in the right arm and Measles, Mumps and Rubella vaccine MMR was administered subcutaneously in the left arm with no reaction. Reportedly, the patient had an area of induration greater than one and half inches at the site of injection and also had sore small vesicles in fold of her right arm. She was treated with Benadryl by mouth for two days. Additional information received from a physician on 07/Nov/2005. The patient has had no additional problems and "is fine." Further information is not expected.
Around 6pm of the day of vaccine, patient started having chills and body ache and was tired and felt weak and lasted for 3 days.
bruising and swelling at injection site, patient described it as burning pain. patient put ice on it, took benadryl, tylenol and ibuprofen.
Employee states on 09/08/2022 a few hours after receiving 1st dose of HepB Recombivax employee felt lightheaded and started to vomit. Employee states requested to leave work early, but did not report event to medical staff. Employee states from 09/09/2022- 09/10/2022 had moderate nausea /vomiting and chills. Employee states by 09/11/2022 all symptoms had resolved.
Around 10 or 11 p.m. the night of the vaccine, I started having chills and body aches. Chills mainly, but later on after I had gone to bed and taken 2 extra strength Tylenol, I got generalized body aches. That lasted about 24 hours. The next day or so, I started having more severe pain on the right side of my body (hip, shoulder, and back.) I thought it may be something related to my hip replacement. I called the guy that did my hip replacement who referred me to rheumatology because he thought I might have something systemic going on. The pain continued and I was having to take 1000MG of Tylenol 3 times a day and that wasn't really helping the pain. When I saw doctor, he gave me Cortisone injections in the shoulder and hip which helped for a while, but he pain has continued.
Patient developed mild chest pain roughly 24 hrs after receiving 2nd Moderna Vaccine injection. He initially managed this with ibuprofen, but pain intensified and he presented to the ED approximately 1.5 days after 2nd injection with severe chest pain, diffuse ST elevations on EKG and elevated Troponin I measurement of 6 ng/ml. Patient transferred to hospital for further management and remains under inpatient care at time of report. Testing initially suggested pericarditis but cardiac MRI consistent with myocarditis. Troponin I peaked @ 75 ng/ml on 4/16/21.
Started as a little itch, scratched the itch then it swoll up about the size of 6 in X 6 in. To date I still get pains in the same area.
Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash Generalized-Severe