chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administering the first dose of Moderna COVID-19 vaccine to a patient under 18 years of age; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administering the first dose of Moderna COVID-19 vaccine to a patient under 18 years of age) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administering the first dose of Moderna COVID-19 vaccine to a patient under 18 years of age). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administering the first dose of Moderna COVID-19 vaccine to a patient under 18 years of age) 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.
FULL ON FLU FEELING; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced full on flu feeling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of full on flu feeling was not reported. This report was non-serious. This case, from the same reporter is linked to 20210744087 and 20210744116.
Swollen bruised injection site.  Facial rash 3 days post vaccine,, chills headache at 24 hours post injection.  Rash at injection site
Patient called our onsite registered nurse on 18MAR21 to report injection site pain, swelling and redness (left deltoid).
Pt was given Influenza vaccine with preservative in it. Box stated vaccine for 6 mos - 18 yrs.
Beginning around midnight the evening after getting the 2nd COVID vaccine, I started having severe body aches and chills/signs of fever. After taking Tylenol around 3am, I was able to sleep until about 8am, when I woke up covered in sweat and shivering. I checked my temperature at that time, with a reading of 100.5°F. I was too sore to get out of bed (body aches, headache) and was extremely light headed when I tried to sit up, so I had no choice but to call off my scheduled work shift for the day. Throughout the morning, my fever continued to increase despite taking Tylenol regularly (2-3 tablets every 4 hours), up to 101.8°F. I was too nauseous to eat, or really to even drink much, despite several spells of feverish sweating followed by chills/uncontrollable shivering. I stayed in bed nearly all day miserable and all but completely incapacitated. I took Xyrem at night (as normal, I take this every night) so was able to sleep most of the night, but woke once again drenched in sweat and shivering, with painful bodyaches and a headache. I took more Tylenol, but was once again forced to call off work in the morning due to my temperature still being high, 101.5°F, and not feeling well enough to stand or work. The body aches, headache, and nausea have continued throughout today as well (two full days after receiving the 2nd vaccine... No adverse reaction to the 1st vaccine)
I started to get hives on the face, I begin to have pneumonia like symptoms; runny nose, difficulty breathing, watery eyes. I began to have swelling of the throat and redness all over my face, hand and body. I ened up in the burn unit with Stevens Johnson syndrome also known as TENS.
Patient presents for weakness, fatigue, generalized muscle ache and upset stomach following flu and pneumonia vaccination yesterday. Also c/o significant tenderness, swelling in area where he received the pneumonia shot. When he received his pneumonia shot he felt a shooting that went down into his 2nd and 3rd digits of the right hand. Has not been monitoring his SMBGs since he has been worried that they will be high. States in currently working with Dr to better controls his BGs which have not been well controlled recently. Const; reports body aches, chills and fatigue. Denies cardiovascular symptoms. Reports productive cough. Assessment: pain in limb, malaise and fatigue hypertension unspec. Sounds like a localized reaction to pneumonia shot and generalized reaction to flu shot. Advised heating pad for localized reaction and will also try lidoderm patches for pain. Discussed with patient that if this is a nerve issue that it may take a while to completely resolve.  Prior to patient leaving his Blood glucose was checked. shortly after that patient began complaining of being very dizzy and became anxious. Became very pale and diaphoretic. Bp was 50/60 with very weak radial pulse. He was lowered to the floor and 911 was immediately activated. EKG done showed no onset of RBBB no other changes. Patient was transferred to the care of the OFD and transported to OH.
Patient complained of radiating arm pain to her wrist. It was "intense" for 2 days and then diminished. Patient said it was not red and it was not swollen.
Hospitalized (9.29.21);  COVID-19 positive (9.28.21);  fully vaccinated Admission Date: 9/29/2021 Discharge Date: 10/02/2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Dehydration AKI (acute kidney injury) COVID-19 HOSPITAL COURSE: Patient is a 74 year old male with h/o CAD and ischemic cardiomyopathy, prior DVT on chronic Xarelto, HTN, HLD, NIDDM and BPH who presented to the ER with complaints of increasing fatigue.  Patient reported increasing myalgias and had not been eating or drinking well for the past several days.  Wife reported he was answering questions sore than normal and incorrectly.  She also had transient loose stools and was sometimes to her to reduce her bathroom in time.  In the ER, patient was mildly hypotensive in the ER which responded to IVF. COVID testing was positive. CXR revealed subtle bilateral patchy airspace disease, consistent with early COVID pneumonia. He was admitted under observation for AKI in setting of COVID 19 infection.  Renal function improved with gentle IV fluids with baseline creatinine 1.4-1.5. AKI likely prerenal in setting of nephrotoxic medications. Lisinopril and hydrochlorothiazide were held during his stay and resumed after discharge.  Patient had no evidence of hypoxia during his hospitalization less not qualify for Decadron or Remdesivir.  As he was under observation status, patient received monoclonal antibody infusion on 09/30.  PT/OT recommended home with assistance in no identified needs.  Patient felt much improved on 10/02.  Renal function had returned to baseline (Cr 1.45), and patient was discharged to home in improved condition.  We discussed signs and symptoms to monitor for any worsening of COVID infection.
Temp 102.4, nausea, achiness, pressure in chest, congested in nose,
The patient had waited for 15 minutes after vaccination and then walked around store for 5-10 minutes and came back and said that her tongue felt tingly, roof of her mouth, tongue and throat all felt weird. I asked her if she was short of breath and she denied. I asked her if she wanted  benadryl or epi and she declined but agreed to me calling 911. I  told patient that if she started to feel short of breath then I was going to give her epi. No medication was given to patient EMS arrived within 5 minutes and checked her out. They said she was not having an allergic reaction and asked if she wanted to go to ER but she declined. They advised that is she started to feel short of breath or tightness in the chest to immediately go to ER. The patient ended up leaving the store and was fine.
SHORTNESS OF BREATH; BAD COLD/HEADACHE/SORE THROAT; RAISED RED BUMP ON ARM; WEAK; TIGHTNESS IN THE CHEST; This spontaneous report received from a patient concerned a 48 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced tightness in the chest. On APR-2021, the subject experienced raised red bump on arm. On APR-2021, the subject experienced weak. On 10-APR-2021, the subject experienced bad cold/headache/sore throat. On an unspecified date, the subject experienced shortness of breath. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the weak, shortness of breath, tightness in the chest, raised red bump on arm and bad cold/headache/sore throat was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Dizziness, gradually got worse over the month. Severe dizziness. Nausea. Vomitting. Couldn't walk. Double vison.  Went to ER on 11/02/21. Hospitalized 8 days.  Sent to rehab. Released 11/10/21.  Original diagnosis was vertigo. Pain in check, mouth started to drop, Left eye wouldn't close. Having symptoms of Bell's Palsy. Formally diagnosed on 11/11/21.
I had a headache for the following 3 weeks, abdominal weak for the next weeks and I'm still having cramps but it started after the vaccine, Pain on my lower right side. I called my doctor last month due to my symptoms and I want to know what is going on. I saw the NP 12/29/2021 she advised to take a few things to calm it down, I was referred to a GI because the cramping wasn't clear. My primary care had me take Bentyl. I'm still trying to figure out what is going on with me.
I started feeling a bit off balance in the morning. Buy 9 pm I was exhausted and went to bed. Next am I had fever (100.6). I was too weak to function and went back to bed. Slept on and off with fever (never more than101.8) and muscle pain for next 24 hours. Fever broke and am feeling increasingly normal. Have slight cough and runny nose.
Painful arm; Hot to touch arm; Red arm; Flu like symptoms; Received 2 shots 3 months apart; Some site reaction; This case was reported by a other health professional via call center representative and described the occurrence of injection site reaction in a 57-year-old male patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2021-2022 season) (batch number 579C9, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis and PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   Concomitant products included Flu Seasonal QIV (FluLaval Quadrivalent 2021-2022 season).   On 21st February 2022, the patient received FluLaval Quadrivalent 2021-2022 season, Flulaval Tetra Pre-Filled Syringe Device and PNEUMONIA VACCINE. On 21st February 2022, less than a day after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced injection site reaction, influenza-like symptoms and extra dose administered. On 23rd February 2022, the patient experienced injection site pain, injection site warmth and injection site erythema. On an unknown date, the outcome of the injection site reaction and influenza-like symptoms were recovered/resolved and the outcome of the injection site pain, injection site warmth, injection site erythema and extra dose administered were unknown.   It was unknown if the reporter considered the injection site reaction, injection site pain, injection site warmth, injection site erythema and influenza-like symptoms to be related to FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received FluLaval Quadrivalent 2021-2022 season and Pneumonia vaccine on an unknown same arm. The patient received 2nd dose of FluLaval Quadrivalent 2021-2022 season, which led to extra dose administered. After receiving FluLaval Quadrivalent 2021-2022 season, the patient developed some site reaction and flu like symptoms at the end of day which was resolved in 24 hrs. The patient was also complained of painful hot to touch and red arm. The reporter consented to follow up. The Vaccine Administration Facility is the same as Primary Reporter. It was unknown if the reporter considered the injection site reaction, injection site pain, injection site warmth, injection site erythema and influenza-like symptoms to be related to Pneumonia vaccine.
completed the Hep B series as a child, however had low titers; This case was reported by a other health professional and described the occurrence of therapy non-responder in a 20-year-old female patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis and Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received the 1st dose of Hepatitis B vaccine, the 2nd dose of Hepatitis B vaccine and the 3rd dose of Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.  Additional details were provided as follows:  The age at vaccination was not reported. The patient was completed the Hepatitis B series and had low titers, which leads to therapy non responder. it was determined the patient would need to be re-vaccinated.  No further details provided. For tolerance of dose to hepatitis B refer case, US2020187913.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020187913:same reporter
Information has been received from a mother concerning her 12 year old daughter who sometime in October 2007, was vaccinated with the first dose, in DEC 2007 with her second dose of Gardasil (lot numbers not provided). In October 2007, the patient experienced terrible consistent headaches. The headaches went away for a while but came back after she had the second dose in December 2007. The patient states the headaches have remained constant and she said on a scale of 1-10 they remain a 7 and they last all day and all night. Patient has missed 2 weeks of school because of it. The patient's mother states that her daughter has been to the physician 13 times regarding her daughter's headaches. Patient has been to several neurologists and they could not find anything wrong. Patient has been give Tylenol with codeine, Aleve, hydrocodone, Motrin, Advil and Immatrex (manufacturers unknown) and this past week she was given Depakote intravenously. Patient's mother states that none of the medications have helped but have only made her feel worse. The patient's terrible consistent headaches persisted. No further information is available. 07/08/08 Follow up was received on 31-MAR-2008. There was not further AE information and the practice does not want to receive any further letters.
1 inch diameter swelling from PNEUMOVAX IM, received swelling began to decrease after approximately 5 min diphenhydramine 50 mg once.
After receiving the second dose, I was sick as a dog, couldn't get out of bed for 2 days. Then it was gone and there was nothing what so ever. The fasciculations that I have had on going have gotten worse since the 2nd dose. They are in the opposite arm that I had my vaccine in. I started to notice them a few months ago.
I ended up giving birth early after my second vaccine dose (first dose of Pfizer was on 3/13/21, second dose was on 4/3/21). My expected due date was 9/1/2021. My baby was 23 weeks 6 days when he was born.  He weighed 720 grams. My OB diagnosed that I have placental abruption. I ended up having C section. For the first dose of Pfizer vaccine,  I have red eye (blood in one of my eyes) and my arm hurt. I only feel my arm hurts after the second dose but then ended up giving birth early.
After 1st Booster (Moderna) I began having numbness of tongue and sporatic muscle spasms, facilations for approx. 6 mo.. It had gone away prior to getting this 2nd booster (Pfizer), approx 48 hours after the Pfizer booster I began feeling numbness in my tongue again, which is present at this time.
knee has given out completely; haven't been able to walk; sharp pain in  left knee; fatigue; This spontaneous case was reported by a nurse and describes the occurrence of JOINT LOCK (knee has given out completely), GAIT INABILITY (haven't been able to walk), ARTHRALGIA (sharp pain in  left knee) and FATIGUE (fatigue) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 022M20A) for COVID-19 vaccination.     The patient's past medical history included Rheumatoid arthritis. Concurrent medical conditions included Hypertension in 2000 and Drug allergy (Codeine). Concomitant products included AMLODIPINE BESILATE (NORVASC) for Hypertension.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced JOINT LOCK (knee has given out completely), GAIT INABILITY (haven't been able to walk), ARTHRALGIA (sharp pain in  left knee) and FATIGUE (fatigue). At the time of the report, JOINT LOCK (knee has given out completely), GAIT INABILITY (haven't been able to walk), ARTHRALGIA (sharp pain in  left knee) and FATIGUE (fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2021: Follow up was received on 16 may 2021 included patient details,height,weight,race and historical condition, and event are added. On 22-Jul-2021: NNI Followup received
Cellulitis (red, hard firm swelling, hot tissue along the left upper extremity into the axilla.
hurt at the site of the shot; bad headache; can't breath in when I have to blow my nose; This is a spontaneous report from a contactable consumer. A 60-years-old female non-pregnant patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number EP7533, Expiry date: unknown) via an unspecified route of administration on 04May2021 11:00 (at the age of 60-year-old) as dose 1, single for COVID-19 immunization. Medical history includes high blood pressure ongoing, water retention, acid reflux, pain from accidents, thyroid, allergies, attention deficit caused by accident. Patient had known allergies: Don't known about medication but nose run after patient eat/when they mow the lawn. Concomitant medications included diphenhydramine hydrochloride (BENADRYL), gabapentin (GABAPENTIN), ibuprofen (IBUPROFEN), pantoprazole (PANTOPRAZOLE) all taken for an unspecified indication, start and stop date were not reported and received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 10May2021 the patient art hurt at the site of the shot on second or forth day, it lasted for about a week. After about week I caught and had drink honey for it. Patient had to drink coffee or caffeine dabs for bad headache. Patient also have lisinopril and triamterene. Normal day patient have vitamin A,B,E and mineral zinc. Patient eat one egg in morning for vitamin Bs. Headache was really bad on the top of patient head and cant breath when she blow nose or get sinuses head ache from the things they clean paper nose tissue or tree product might give allergic sinus condition, but headache was really bad for about 1 or 2 weeks it comes back if patient don't drink caffeine. Still happens my arm stop hurting few days ago, but don't remember when they hurt yesterday or day before again. The clinical outcome of the event was recovering.   Follow-up (23Jun2021): Follow-up attempts completed. No further information expected.
Sore throat, muscle aches and pain more than usual tired. Started the next day and lasted 2 days.
Ear felt plugged like I had gotten water in it. It did not subside, so I went to my PCP after a week. My balance was off, eyes seemed to have a control issue with movement and brain to follow, My hearing has been impaired, so I was fast tracked ENT for examination. No liquid in ear, given an audiology consult with hearing being significantly diminished. Prescribed Prednisone 20MG for 10 days for possible inflammation of the ear gland with a follow up on October25th and another audiol ogy test.
Patient received 4th dose of Moderna @  a pharmacy.  She began to feel extreme dizziness in the middle of the night/early Thursday morning.  She was not even able to get out of bed, she was so dizzy.   Her MD advised her not to take her Ofev doses on Thursday morning and not until the dizziness improved. She did vomit x1  later Thursday but was only bile. By Friday her dizziness had progressed and she was unable to walk about her house with out assistance and she vomited a bowl of cereal.  She began to improve some on Sunday but still has light headedness at this time. She has restarted her Ofev as she does not think that is the cause of the dizziness now.
Swelling at the injection site. Swelled more, red & itchy the next day (today). Not sure what treatment to use. Will call pharmacy to see what they suggest.
Marked left axillary lymph node swelling and pain began 10 hours after vaccine administrstion. Pain significant enough to interfere with sleep. Ibuprofen has no effect on the swelling or pain.
Red macular rash approx. 14 by 5 cm diameter on (L) thigh.
tired/ tiredness; Body aches/ achey; Arm pain at the site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 15Jan2021 16:40 (Lot number: EL3247) as dose 1, single and administered in arm left, administration date 08Feb2021 08:30 (Lot number: EM9810) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "recovered", described as "tired/ tiredness"; PAIN (non-serious), outcome "recovered", described as "Body aches/ achey"; VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "Arm pain at the site". Therapeutic measures were not taken as a result of fatigue, pain, vaccination site pain.  Additional information: The patient reported that the first two vaccines left patient very tired, body aches and arm pain at the site for a few days - 4.5.   No follow-up attempts are possible. No further information is expected.