chrisvoncsefalvay/vaers-outcomes huggingface dataset:
i was very sick on the first shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (i was very sick on the first shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (i was very sick on the first shot). At the time of the report, ILLNESS (i was very sick on the first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided Treatment medication was not provided
The following morning I woke up with severe migraine, fever (99.5), severe body aches, severe fatigue and slightly nauseous. I ran a fever the entire day and felt like I was in a car accident. I could not do my normal activities. I laid in bed all day and had to cancel the appointments I had. Luckily I did not have to work that day. I wouldn't been able to make it. The next day I was fine. I've run a little fever off and on since then (it's been 1 week and 4 days), but I've felt so much better.
Tinnitus got worse. I had very low level tinnitus before. The second night after the vaccine the tinnitus was quite bad, then the next day it settled down to be two or three times as noticeable as my baseline tinnitus was prior to the vaccine, at least. At this point, normally don't hear it, but when I'm going to sleep it's very noticeable. Ten weeks later, it's steady and hasn't gotten worse or better since  it steadied out on the third day.
17yr old female pt here for vaccines  Vaccines admin    After vaccine admin, pt reported severe itching.  Generalized edema noted.  No hives, no facial swelling, no tongue swelling.  Pt began to c/o dyspnea. Light insp wheezes auscultated upper airways.  No stridor. VSS (see below repeated measurements) Epi Pen admin left lateral quadricep by NP at 8:27am Medical assistant called 911 and contacted school  Writer admin Benadryl 50mg at 8:29am After a few min pt reported no dyspnea and less itching.  Less erythema noted.   VS 8:27AM  HR 74 O2 sat 99%RA 8:29AM  HR 87 BP 115/57 T98.1 8:36AM HR 92 BP 132/64 O2 sat 99%RA 8:44AM HR 87 BP 122/58 O2 sat 98%RA EMS arrived approx 20 min later IV started left AC and benadryl was admin by EMT.  Pt started to c/o dyspnea and dizziness.  EMT calmed down pt and transported to chair.   Patient transferred to Hospital at 9:12am. Sent referral letter and copy of record   Reaction presumed to be from MMR as per vaccine records this is 1st time dose.
severe lt arm pain @ site of inject; red, swollen to egg size; could not use arm; lasted 7 days; took Ibuprofen for relief; no medical care resolved;
vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concomitant products included VALACYCLOVIR [VALACICLOVIR] and PREDNISONE for Eye disorder NOS, APIXABAN (ELIQUIS), METOPROLOL, LATANOPROST, CALCIUM, COLECALCIFEROL (CALCIUM & VITAMIN D [CALCIUM;COLECALCIFEROL]), MAGNESIUM and SHARK CARTILAGE for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VOMITING (vomiting). At the time of the report, VOMITING (vomiting) had resolved.            Treatment information was not provided   This case was linked to MOD-2021-047824 (Patient Link).
Pt's wife reported patient was diagnosed with Guillan Barre syndrome on 9/20/23 two days after receiving fluarix from us at workplace clinic.  I do not have any additional info beyond her report and saying his physicians asked if we had reported incident.  His wife  as of 10/23/23 she states he is currently unable to communicate with us.
CHILLS; HEADACHEY; 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. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced chills, and headachey. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headachey and chills was not reported. This report was non-serious.
fever 101.  chills at night, uncomfortable arm pain, joint pain. headache that radiates throughout back of head to front.
Severe head pain that lasted 6 weeks. Diagnosis complex migraine.  In hospital, they gave migraine cocktail and did not relieve symptoms at all.
Per the recommendations of our local health jurisdiction, we are reporting this as an adverse event as the booster was given after unauthorized  the use of  monovalent vaccines as booster doses for individuals 12 years of age and older.
There was an opened unlabeled vial of Moderna in the VFC fridge. There had not been any mentions on the group chat of an open Moderna vial (as when we open each vial we let everyone in the chat know) . I grabbed the open vial along with an unopened vial of Moderna and proceeded to the Covid clinic. There were 7 doses of this vaccine given to patients. As of 9/27 we were off on our counts and now realize that the vial that was used on 9/24 to those 7 patients was an expired vial. The vial had originally been opened on 9/23 by  RN. These 7 patients have been located and will be contacted once recommendations from CDC are reviewed.
Acute onset weakness, fussiness, inability to stand and fever. Neuro exam revealed normal DTRs with decreased tone. CSF analysis revealed 10 WBC, normal glucose and protein and no growth. Brain MRI normal times 3. Patient empirically received doxycycline for 10 days. IVIG and prednisolone given on day of illness 4. Clinical improvement noted on day of illness 12 with increasing purposeful extremity movements and interactive gaze and smile. Patient still hospitalized and waiting placement in inpatient rehabilitation facility.
Pain/stiffness in arm, shoulder & neck. Muscle spasms in those areas.
Patient presented to the ED and was subsequently hospitalized for sepsis with a cute renal failure and septic shock within 6 weeks of receiving covid vaccination.
Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. This case is linked with 2018SA304935, 2018SA304936, 2018SA304964, 2018SA304965. This case involves a 52 years old female patient for whom accidentally gave an expired (4/4/2018) was reported, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s), and family history were not provided. No Other vaccines was reported. On 30-Oct-2018, the patient received a 0.5ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UI842AB expiry date: 04-Apr-2018 via intramuscular route in the left arm. It was a case of actual medication error due to expired vaccine used, inappropriate age at vaccine administration and overdose. It was not reported that if any adverse event occurred or not. 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. Documents held by sender: none.
sick all week with diarrhea and has a slight sore throat; sick all week with diarrhea and has a slight sore throat; 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 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (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: DIARRHOEA (non-serious), OROPHARYNGEAL PAIN (non-serious), outcome "unknown" and all described as "sick all week with diarrhea and has a slight sore throat". Additional information: The patient wanted to reschedule her appoint for the second dose on 26Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Mother of the patient reported that patient had loss of appetite and was irritable after receiving the vaccine. Fever started two (2) days after with temperature at 104 deg F (rectal). Mother administered a single dose of 1.85 ml of MOTRIN (50mg/1.25ml) and gave lukewarm baths. Fever resolved after two days but noticed a generalized rash that appears to have started in the torso. No signs and symptoms of shortness of breath nor difficulty breathing was reported. Rash resolved after a week.
Information has been received from a registered concerning a male (age not reported) with no pertinent medical history or drug reactions/allergies who on 14-AUG-2007 was vaccinated with PNEUMOVAX 23 (lot # 655289/0958f) 0.5 mL IM into the right tricep. There was no concomitant medication. The nurse reported that a patient developed an injection site reaction after vaccination with PNEUMOVAX 23. The reaction developed gradually over the next day following vaccination with PNEUMOVAX 23. Medical attention was sought. At an office visit on 17-AUG-2007, the injection site reaction was described as a mild erythema, ill defined area 10 by 7 MM with tenderness, but no duration. The patient was given a prescription for KEFLEX 500mg three times a day for 7 days. The patient recovered on 20-AUG-2007. The registered nurse asked for a lot check for PNEUMOVAX 23 vaccine lot # 655289/0958F. There was no other information to report. A standard lot check investigation was performed. All in process quality checks for the lot number in question were satisfactory. The lot met the requirements of the government and was released. Additional information has been requested.
Left shoulder required physical therapy for a few months. Severe headaches. Sore muscles. Brain fog. I still have these today.
Fainting episode, child fell in waiting room following immunizations. Hit head, was easily aroused following incidence. No bruising or redness noted on head, trunk or extremities.  Sent home with mother in 20 min.
Approximatelly 10 hours post vaccine for 2-1/2 days I experienced body aches, chills, and a desire to sleep.  Returned to normal routine by day 3 following vaccine.
Right arm red, swollen, warm, slightly firm complains of itching, no pain. Temp 98.3- dark under eyes.
Rash on stomach and chest.; Seems like hives; This is a spontaneous report received from a non-contactable consumer (patient reported for herself). A 36-Year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), as a single dose via an unspecified route of administration on left arm on 26Feb2021 at 14:00 (at the age of 36-year-old), as a single dose for COVID-19 immunisation. The patient was non- pregnant at the time of vaccination. Medical history included uveitis, had chronic urticaria a decade ago but have been asymptomatic for years. The patient reported allergy to NSAIDS. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), as a single dose via an unspecified route of administration on right arm on 26Mar2021 at 14:00 (at the age of 36-year-old), as a single dose for COVID-19 immunisation. Concomitant medications included Desogestrel, ethinylestradiol (KARIVA), netarsudil mesylate (RHOPRESSA), brimonidine tartrate; brinzolamide (SIMBRINZA), cetirizine hydrochloride (ZYRTEC) and mometasone furoate (FLONASE), all taken for an unspecified indication, start and stop dates were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. On 06Mar2021 at 10:00, the patient experienced rash on stomach and chest, does not itch, seems like hives. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome for the event rash and hives was not resolved.   No follow-up attempts are possible; information about lot number cannot be obtained.  Amendment (11Jul2021): This follow-up report is being submitted to amend previously reported information: Patient country added in patient tab. Dose 1 was ticked as primary regimen, stop date of dose 1 updated as 26-FEB-2021 14:00. Vaccine Facility Information added. Concomitant drug Zyrtec, Flonase were coded via WHODrug.
sl rash to neck & face onset approx 400 pox, hours p/vax given;to ER given DPh & APAP;mom instructed not to worry about future vaccinations;
Mother reported in office visit on 8/27/12 that child had a rash on her left leg x 1 week that was not improving. Viral exanthema vs vaccine rash.
Positive home pregnancy test on 02/24/21, followed by severe headaches starting on 2/27 and 2/28, abdominal cramping and spotting starting 2/28 at 7pm, and a negative home pregnancy test and bleeding on 3/1/21 in the AM
About a month and a half after getting the shot, I thought I was developing tendonitis in my right hand. I recently found out I have developed Dupuytrens Syndrome.
Patient returned to clinic with pain, swelling and redness covering all upper Right arm states couldn't sleep because of discomfort
My heart was racing for 30 minutes; I was very flushed for 30 minutes; received 1st dose on 4Feb2021. (8 weeks since 1st dose); This spontaneous case was reported by a non-health professional and describes the occurrence of HEART RATE INCREASED (My heart was racing for 30 minutes), FLUSHING (I was very flushed for 30 minutes) and PRODUCT DOSE OMISSION ISSUE (received 1st dose on 4Feb2021. (8 weeks since 1st dose)) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030m20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE, ANASTROZOLE (ARIMIDEX), HYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMIL (BENICAR HCT) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced HEART RATE INCREASED (My heart was racing for 30 minutes), FLUSHING (I was very flushed for 30 minutes) and PRODUCT DOSE OMISSION ISSUE (received 1st dose on 4Feb2021. (8 weeks since 1st dose)). On 04-Feb-2021, HEART RATE INCREASED (My heart was racing for 30 minutes), FLUSHING (I was very flushed for 30 minutes) and PRODUCT DOSE OMISSION ISSUE (received 1st dose on 4Feb2021. (8 weeks since 1st dose)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was received for the events.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Reporter provided email address.TCR attached.
Chest pain and back pain around heart area and shortness of breath started Saturday morning, 5/22/2021, at 11:00am. At 2:30, decided to go to ER as pain was not getting better. Had blood work, EKG, Chest X-Ray, and CT with contrast done. Advised all tests seemed ok. Diagnosed with Inflammation, possibly pleurisy. Prescribed Ibuprofen 600mg up to 4 times a day and rest. Follow up with primary care if symptoms don?t improve in 3-5 days with treatment.   To date, symptoms come and go, but seem worse when lifting anything heavy or getting stressed out. Sometimes, symptoms such as chest pain or shortness of breath happen when lying down, or getting up, or doing normal activities, like cooking and cleaning.
This case was reported by a physician and described the occurrence of seizure in a neonate subject of unspecified gender exposed to FLULAVAL trivalent or quadrivalent unspecified (GlaxoSmithKline) transmammary over an unknown period when the mother was being treated for prophylaxis. On an unspecified date the mother of the subject received a dose of FLULAVAL (transmammary, unknown) and the infant subject experienced vaccine exposure via breast milk. Within months of vaccination with FLULAVAL, the infant subject experienced seizure. Physician reported that a mother received FLULAVAL in the hospital after she delivered her baby. The mother is currently breastfeeding the infant subject who has developed seizures. At the time of the report no additional information was provided. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the seizures was unspecified.
Fifteen to 20 minutes after flu shot upper left arm got numb burning sensation and numbness went down to outer two fingers. Left eye and sinuses felt dried out with pressure. Left side of neck and upper back felt tight and painful. Left hip down to ankle had pain.
Felt sick on 6/14/2022 but tested negative that evening. Extremely ill with all the usual covid symptoms including 101.9 fever.  Next morning and did not go to work. Did another covid test on 06/16/2022 and tested positive. Symptoms continued including the fever which went over 102 until 06/17/2022.  My fever broke the next day. All other symptoms continued. The only symptom I did not experience was loss of taste and smell. Symptoms have decreased since then but none have gone away. I make still experiencing symptoms but at a much lower level. Still have fluid in my lungs as well. Started back to work this week on July 5th.
Pt recvd 3 doses of Engerix-B & titer test indicated did not respond;
Fever chills nausea from 10.30 pm 23 march 2021. Wednesday same. Wednesday evening extreme nausea vomitting fever severe trembling and chills. During the night nightmares and migraine woke me up. Tried to go to the bathroom but collapsed and knocked my head on the wall. Could not get up crawled to the bathroom and tried to pull myself up but fell headfirst and hit my nose and cheek on the toilet. Cut nose and hurt cheek bone. Felt terrible head spinning and unable to get up/ Crawled to bed; Live alone. Could not even find the telephone; Woke up and tried to get up.  Freezing cold. Finally called Ambulance Their doctor refused to send an ambulance and said " go to your GP its not an emergency". I was disgusted barely could walk but somehow drove to the GP. he was closed so went to emergency. the Dr in charge of the vaccination center was there but did not accept it was the vaccine; Finally on the verge of collapse another lady took me to the entrance of emergency. I was finally seen:; Same thing. Dr there told me its not an emergency and to go and see my GP. I was so sick and told him th eGP was not there; His reply " There are plenty of others to see"  It was the nurse who persisted and even  thought may be I had covid and did the PCR test. I started uncontrollably shivering and was freezing. I had a fever. they did blood tests lung x ray and finally a urine test, Full of blood leucocytes and protein. The same wonderful nurse said its bad. I was by then vomitting again and thought I would die; Uncontrollable shivering ;  taken to the lab or a pelvic cat scan;Couldnt even get to sip water. SEVEN hours later the  same DR who told me I was not an emergency came in and said " You will have to be hospitalised as you have a serious kidney infection. Acute pyelonephritis. I vomitted on him!  Taken to a ward 25 March until 29 March. Rocephin antibiotics. Allergy to that too with migraines and skin rash; They changed the antibiotics.  After five horrible days I finally went home on antibiotics Ofloxacine
Patient is complaining of severe pain in her right arm that is radiating into her chest. Worried that it may be having an effect on her heart.
The patient was accidentally administered the adult dose (0.5 ml) instead of the children dose (0.25 ml) of the bivalent Moderna booster vaccine. The parents were advised to monitor for increased adverse effects since the child received a higher than usual dose. So far, no adverse event has been reported by the parents.
I thought I had COVID again. I had body aches, and chills, fevers, and diarrhea. Sweating, and then freezing cold. It was not pleasant at all.
Recipient described diffuse aches and pain a few days after vaccine given, progressive to nuchal rigidity and cramps. Alleviated by care from her own provider. More = was sick with flu like symptoms along with bad symptoms of sinusitis, used nasal spray and OTC meds to manage symptoms.
sustained high blood pressure; Have 2 aneurysms; Continuous headache; some dizziness; This is a spontaneous report from a contactable 68-year-old female consumer reported for herself. A 68-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL9262), via an unspecified route of administration (right arm) on 26Jan2021, 17:15 at SINGLE DOSE for covid-19 immunisation, at 68 years old. Medical history included allergies: Penicillin from an unspecified date. Patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient is taking unspecified concomitant medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot  EH 9899, at 68 years old), on 05Jan2021, 16:30, right arm for COVID-19 immunization. The patient experienced sustained high blood pressure, have 2 aneurysms, continuous headache, and some dizziness on 26Jan2021. Therapeutic measures were taken as a result of the events which include 3 different blood pressure medications, still not under control; medications and monitoring of pressure. She mentioned she has 2 aneurysms so she needs to keep her pressure normal. Outcome of the events was not recovered. The event was considered non-serious by the reporter.
I woke up that morning and my sense of balance was terrible. For about 3 months, I had to hold on to walls and furniture to get around the house. Leaving the house was most difficult, and eventually I had to use a cane.
Atypical varicella post vaccinated vaccines given 10/21/98 #1 & again 7/9/07 #2.
Evening following vaccine administration, mom reports child developed high fever greater than or equal to 103 and became "delerious" crawling all over floor.
My left arm became extremely sore. Painful at times. Almost impossible to move. It locked up on me. I could not sleep on that side, lift my arm. No rotation. It started a few hours after receiving the vaccine. By 5pm it was at it's sorest and locked in position . Not warm to touch. Just painful.  This lasted a total of 3 days until all soreness and full normal movements without discomfort could resume.