chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I noticed right away that when she administered the shot it was much higher on my left shoulder than the first shot. The next couple of days I felt lousy so I didn't work out. When I started to work out again on Friday, Feb. 26th, I noticed I couldn't lift my arm across my body or directly above without severe pain. My range of motion was immediately impacted. It's been six weeks and I cannot put on a shirt or take it off without pain. I've had to modify my typical workout routine. The pain wakes me up at night when I shift positions.
This spontaneous report was received from a physician refers to a 6 year old female patient. The medical history, concurrent medications and concomitant medications were not reported. On 20-MAR-2014, the patient was vaccinated with PROQUAD (Merck), lot# was not reported. On 08-MAR-2011, the patient was vaccinated with VARIVAX (Merck) lot# was not reported. Approximately on 06-MAR-2016, (reported as 5 days ago) the patient developed 8 painful varicella like lesions on the back of her back. The outcome of was reported as not recovered/not resolved. The patient sought medical attention. Additional information has been requested.
Muscle fatigue; Stiffness; Chills; Fever; Aching joints; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE FATIGUE (Muscle fatigue), MUSCULOSKELETAL STIFFNESS (Stiffness), CHILLS (Chills), PYREXIA (Fever) and ARTHRALGIA (Aching joints) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease and Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced MUSCLE FATIGUE (Muscle fatigue), MUSCULOSKELETAL STIFFNESS (Stiffness), CHILLS (Chills), PYREXIA (Fever) and ARTHRALGIA (Aching joints). At the time of the report, MUSCLE FATIGUE (Muscle fatigue), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown and MUSCULOSKELETAL STIFFNESS (Stiffness) and ARTHRALGIA (Aching joints) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication were provided The reporter's causality for the event(s) of Lab work showed too many antibodies following Covid  vaccination with HUMIRA(ADALIMUMAB) was a reasonable possibility This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna
This is in follow-up to report (s) previoulsy submitted on 2/13/2007. Information has been received from a registered nurse (RN) concerning a 6-month-old patient who was vaccinated with the 2nd dose of rotavirus vaccine after receiving the first dose at 2 months of age.  It was unknown if medical attention was sought.  Additional information has been requested. Follow information was received from the RN who indicated that the 6-month-old was never vaccinated with the second dose. There was no adverse event. Therefore WAES #0701USA04098 will be deleted from our files for ROTATEQ. Additional information has been requested.
Information has been received from a pharmacist concerning a patient who was vaccinated with a dose of PNEUMOVAX 23 IM in the shoulder bursa. The patient experienced "high fever and pain at injection site". The patient received unspecified medical attention. At the time of the reporting, the patient had not recovered. No further information is available.
Tinnitus may have started (low-level) after first shot (1/15/21), but was much more noticeable and steady/non-stop following second shot (2/1/21).  It has grown somewhat louder over past few weeks.
Headaches; Body aches; Chills; Ringing in the ear; Unable to sleep; This case was reported by a consumer via patient support programs and described the occurrence of headache in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd October 2022, the patient received the 1st dose of Shingrix. On 3rd October 2022, less than a day after receiving Shingrix, the patient experienced headache, general body pain, chills, ringing in ears and sleeplessness. On an unknown date, the outcome of the headache, general body pain, chills, ringing in ears and sleeplessness were resolved with sequelae.   It was unknown if the reporter considered the headache, general body pain, chills, ringing in ears and sleeplessness to be related to Shingrix.     Additional Information: GSK Receipt Date: 05-OCT-2022 Reporter's Comments:  The patient  stated that she received the 1st vaccine on Monday and she had headaches, body aches and chills, ringing in the ear, and unable to sleep been up since 4am from 3rd October 2022. The reporter seriousness for patient stated events were unspecified The reporter stated verbatim event relatedness were unknown. The reporter had given consent to contact.
5 days after treatment, arm swelled, felt very hot, it got worse after 5 days. Patient had to go to md to get steroids and allergy pill because it is severely itchy and hot.
Everyone was very sore in their arm; everyone felt off; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 03 patients. This is 1st of 03 reports. This consumer (Girlfriend) reported for a (Boyfriend). A 72-years-old male patient received  the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: unknown), via an unspecified route of administration on 18Jan2021 as a single dose, for COVID-19 vaccination. The patient medical history and  concomitant medications were not reported. On an unspecified date, the patient experienced everyone was very sore in their arm and everyone felt off. The clinical outcome of very sore in their arm and everyone felt off was unknown.    Information on the lot number has been requested.; Sender's Comments: Linked Report(s) : Same reporter/products/events, different patients; Same reporter/products/events, different patients
Pt received DT and developed local reaction consisting of 8x6CM erythema, induration & edema w/pain after injection.
about 2:45 pm on 12/29/2020 I because extremely fatigue to the point I couldn't concentrate. I couldn't figure out why as I got proper sleep the night before so powered through until leaving work at 4 pm. When I got home I ate a small amount, I wasn't hungry and went to bed at 5 pm and slept through until 6 am. during the night I noticed my arm bothering me, itchy but didn't get up to check on it. When I woke this a.m. my arm had a big red bump, warm to the touch and itchy so now I'm convinced the fatigue was related to the COVID vaccine. I feel fine, I am not tired today but I am aware of my arm and it is itchy. I am surprised this happen a week later.
5 days post vax pt started running a temp of 104.8;when mom contact hlth dept 17AUG98 T105;17AUG98 mom took child to MD;MD dx ear infect;child placed on ATB
This spontaneous report as received from a physician regarding a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 25-JUN-2015, the patient received improperly stored PROQUAD (lot# L002419, expiry date: 23-JUL-2016, dosing details were not specified) which was stored at 23 Fahrenheit for 27:00 hours. There was no concomitant medication reported. No adverse effects was reported and no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 66 year old female patient with drug reactions/allergies to codeine. The patient did not  have pertient medical history. On 13-OCT-2014 the patient was vaccinated with ZOSTAVAX 0.65 ml, subcutaneous (lot#K009198 and expiry date: 27-SEP-2014). There was no concomtiant medication. On 15-OCT-2014 the patient developed swelling and redness at the injection site, which spread to ther "upper arm". The patient was seen by physician and was prescribed  sulfamethoxazole, BACTRIM DS to treat a diagnosis of cellulitis (on 15-OCT-2014). The was no lab diagnostics stuides perforomed. The patient did not recover from cellulitis and swelling and redness at the injection site. Relatedness between the events and ZOSTAVAX was not specified. Additional information has been requested.
Infant death.  Infant discovered in crib by parents on 7/16/07 expired. No conclusive findings on post.  8/24/07 Received autopsy report which reveals COD as undetermined & manner of death as undetermined.
Fatigue , headache , some joint pain, chills and fever starting the day after vaccination . Treated with Tylenol .
Ten days after vaccination, bruise, redness, tenderness at injection site.  None before that day.
blood clots; expelled hemorrhagically; abdominal pain/cramping; resembled menstruation, but 2 weeks ahead of my cycle; skipped menstrual period following the hemorrhage event; irregular menstrual periods; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Aug2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown, Location of injection: Arm Left), administration date: Jul2021, when the patient was 46 years old, for Covid-19 Immunization. The following information was reported: THROMBOSIS (medically significant) with onset 01Aug2021, outcome "not recovered", described as "blood clots"; HAEMORRHAGE (medically significant) with onset 01Aug2021, outcome "not recovered", described as "expelled hemorrhagically"; ABDOMINAL PAIN (non-serious) with onset 01Aug2021, outcome "not recovered", described as "abdominal pain/cramping"; MENSTRUATION IRREGULAR (non-serious) with onset 01Aug2021, outcome "not recovered", described as "resembled menstruation, but 2 weeks ahead of my cycle; skipped menstrual period following the hemorrhage event; irregular menstrual periods". The events "blood clots", "expelled hemorrhagically", "abdominal pain/cramping" and "resembled menstruation, but 2 weeks ahead of my cycle; skipped menstrual period following the hemorrhage event; irregular menstrual periods" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of thrombosis, haemorrhage, abdominal pain, menstruation irregular.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Received moderna vaccine on 3/17/21 and 4/14/21. COVID positive on 1/29/22. Presented to ER on 1/30/22. admitted on 1/30/2022 for presented with unresponsive state.               Found to have comatose, severe metabolic acidosis.  Hyperkalemic with EKG changes. Dialysis was done.             Acute hypoxia episode, SpO2 87-90%, did not require oxygen. comatose patient. Intubation was not done because of no CPR status. COVID-19 pneumonia, was vaccinated. CXR-bilateral consolidative changes consistent with atypical pneumonia related to COVID-19.              CT head -Extensive changes from prior left cortical stroke centered at the parietal lobe level with additional small area of involvement now visible at the posteromedial periphery of the right occipital lobe having CT characteristics of evolution of changes related to extensive cortical laminar necrosis since the prior examination.          Discussion with family.  Opted for comfort care 1/31/22. Patient is stable to be discharge to Hospice
Have been dealing with significant nosebleeds since the day of the 2nd vaccination and the accompanied fever - reported via VSAFE and to PCP nursing team but no follow up opportunities given yet. Seems to occur 1-2x a day without any ostensible trigger.
I went to my doctor on July 9 appointment time was around 10:15 am She said it was time for my neumoccal shot I told her I had one in January & the flue shot She said I needed this pneumococcal polysaccharide vaccine so she gave it to me. I was ok when I left her office around about 10:30 AM that day around about twenty minnuts later I started not feeling right I was starting not to see to good and could not talk to good I went to pay my phone bill & my electric bill. The girl at the window could unstand what I was saying I told here that I would pray to God so he wold help me get home So when I got home I was shaking all over plus I was fezzing and buring up at same time. I felt like Ice water was running all over me. I thought that I was dieing. So I manged to call 911. They could not unstand what I was saying our could not make out while I lived. I cant harley rember all of what happen to me You can see from my writting and spelling is not very good now. I am still very weak and cant see to good, and I am hurting real bad. I cant harley tell you everthing right now. All I know this shot really did a number on me. Dont wont it every again. I cant harley think right now I am sorry for taking so long to finish all of the questions I am tring to remember everthing I have had other adverse event to other shots Dont know if I am spelling them right
Patient stated the day after the vaccine  he began feeling pain in his muscles along his back and the upper part of his back. Although not indicated on his vaccination form questionnaire he injected with Repatha 10 days prior.  The site of the flucelvax vaccination appeared normal with no redness/swelling/ or pain.  The patient also stated it has not affected his breathing.
pt admitted to hosp with respiratory failure; positive for COVID; COVID PNA; required intubation and eventually tracheostomy; MSOF with shock, renal failure and encephalopathy; pt transitioned to comfort care and he passed away in the hospital
I received the 2nd dose of Covid vaccine at 12:40 pm on Tuesday 1/12/2021, around 6:30 pm I started with cough and the need to keep clearing my throat.  By 9 pm, I felt like my lymph nodes in my neck were swollen, my throat was getting sore, and my head was starting to throb.  I took 2 tylenol and went to bed.  I woke up at 3 am with a 101.6 temp and body aches.  By 8 am on 1/13/2021, I could not lift my own body out of bed or roll over.  The fever and body aches continued around the clock for 55 hrs.  The headaches are debilitating and continue. I have tried Tylenol, Ibuprofen, Excedrin, and Imitrex and none of these have helped.  I missed 3 days of work and 2 weekend days trying to recover and i am still not back to normal.  Headaches are still happening everyday.  At one point in the middle of this, i felt like I should go to the hospital, but I was too sick to get out of bed and shower and make myself go.
Dizzy and started falling back, pale, BP 90/48 at 17:45. BP 104/60 at 18:00. At 18:05, color is returning to client, he states he is feeling fine. Client left bldg at 18:05 with parents. Advised to call if further problems.
I had sparkles in my vision 5 min. after getting my shot. They went away quickly, so I wasn't concerned. I had a little bit of hotness up my neck and a little itchy, but both also were quick to go away. I went home and went to bed without issue. I woke up at 4am crying and in a lot of pain all over my body. I had a crushing headache, my back, arms and legs ached down to the bone. I had a fever of 100.7, and had to call in sick from work. I took 3 ibuprofen and it didn't help stop the pain or fever. I cried myself back to sleep after wreathing in pain for 3 hours. Woke up again crying again and the pain and fever continued on. I drank 2 beers to see if that would help relax my muscles and back around 3pm and by 4pm I finally felt somewhat better, but still couldn't get up out of bed. I had to call my brother over to help me and considered asking him to take me to the hospital several times because the pain was so intense. The spot where I got my shot wasn't inflamed, or if it was I didn't notice. It did seem a little stiff. I managed to fall back asleep and by the time I woke up again the next day around 5am, I felt completely fine. Fever disappeared and the body pain was gone. It was like nothing had ever happened.
Scattered mac/pap rash over face, trunk and all extremities. Afebrile.  MMR given 14 days prior to rash.
This spontaneous report was received from a physician concerning to a patient of unknown age and gender. On 12-MAR-2013 the patient was vaccinated with a dose of M-M-R II (lot number H013041, expiration date 17-JUL-2014) (dose and route not reported). The vaccine administered was improperly stored, was exposed to 66F since 21-JAN-2013. No adverse effect reported. This case is linked to the following MARRS cases: 1304USA007561, 1304USA008124, 1304USA008125, 1304USA008126, 1304USA008127. Additional information has been requested.
Writhing pain in midsection. Hot like fever then cold sweat, dizziness. Later in the night vomiting then vomiting early morning hours next day.
pt recv vax 3APR98 & 4APR98 pt devel mouth ulcers;
Information has been received from a registered nurse concerning a male who on an unspecified date was vaccinated subcutaneously with a 0.5 ml dose of ZOSTAVAX (Merck) (lot # not provided). About 2 weeks after receiving ZOSTAVAX (Merck), the patient developed a rash above his eyebrow. Patient sought unspecified medical attention. The adverse event improved after stopping vaccination. Follow-up information received from the registered nurse stated the patient was not their patient, just a friend of their patient. No further information is available.
arm swelling; Aches; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm swelling) and PAIN (Aches) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No medical history reported by the reporter.     On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PERIPHERAL SWELLING (arm swelling) and PAIN (Aches). The patient was treated with PARACETAMOL (TYLENOL) on 24-Mar-2021 at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (arm swelling) and PAIN (Aches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow-up information received on 12-May-2021 contains non-significant information
Presented to ED today with complaint of emesis onset this morning. Pt received her second dose of her Covid vaccine on 5/3. Endorses hx of DKA. Denies hitting head, fever, cough, dysuria, nausea, dizziness. She is initially called a sepsis alert secondary to SIRS criteria although I do not think she likely is septic as she has no other illness symptoms but rather either DKA or dehydration from vomiting from viral illness or her history of gastroparesis.  Patient was treated with Benadryl Reglan fluid bolus Rocephin as part of the sepsis protocol and has had improvement in condition. The patient is given IV fluids along with antibiotics for what appears to be a UTI.  She will be admitted to the CDU for ongoing observation and management of her blood sugar as well as her mental status. She has Reglan and Zofran at home but was given refills. She has follow-up with gastro.
Dtap series were given at 6 months, 2 and 3rd in three years of age and fourth dose after he turned 4 years old (4 months apart of third dose) /No AE; Initial information was received on 10-Sep-2020 regarding an unsolicited valid non-serious case from an other health professional.  This case involves a 4-year-old male patient who received four doses of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (inappropriate schedule of product administration).  Medical history, past medical treatment, vaccination and family history were not provided. Concomitant medication if any, not reported.  The patient received, first, second and third dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE at the age of 6 month, 3 year and later but still at 3 year respectively via an unknown route at an unknown administration site for prophylactic vaccination.  In 2015, on an unknown date (4 months apart of third dose), the patient received a fourth dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [lot C4751AA, expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to inappropriate schedule of vaccine administered. Reporter he asked if the 4th dose would be considered valid because the school is concerned and iIf it is not valid, she asked if ADACEL would be ok to use even though the patient is below age 10.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Received the Moderna Monovalent Booster instead of the bivalent vaccine; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received the Moderna Monovalent Booster instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 prophylaxis.     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 WRONG PRODUCT ADMINISTERED (Received the Moderna Monovalent Booster instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received the Moderna Monovalent Booster instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Received the Moderna Monovalent Booster instead of the bivalent vaccine). No concomitant products reported. It was reported that during a Moderna Covid-19 clinic patient received Moderna Covid-19 vaccine monovalent instead of the bivalent dose for the booster dose. The nurse stated that happened because the monovalent vaccine with the purple border was labelled as booster dose.  No treatment products reported.
Patient developed rash on 6/28/13 that spread to entire body. Pimple fluid filled itchy lesions. Advised ER for assessment diagnosed by ER on 7/1/13. Family called to inform us. Note: All Varivax vaccines given at prior pediatricians offices.