chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe cramping; Nauseous; Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 36-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 36 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious) with onset Sep2022, outcome "unknown", described as "Diarrhea"; NAUSEA (non-serious) with onset Sep2022, outcome "unknown", described as "Nauseous"; MUSCLE SPASMS (non-serious) with onset Sep2022, outcome "unknown", described as "Severe cramping".  Additional information: Reporter stated, "My daughter who is 36 and hardly 6 months old received the Pfizer Vaccine (Clarified as Pfizer COVID-19 Vaccine Bivalent) this morning and just about an hour ago started to eventually I don't know prior during the mid-day and then about an hour ago started to have severe cramping, nauseous and diarrhea."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient is a 75 y.o. female patient of, MD with history of dementia, hyperlipidemia, hypertension presented to Hospital with altered mental status over past few days and less responsive.  Per patient's caretaker patient has been choking while eating and drinking.  While in the ER patient found to have sepsis with elevated WBC count, fever, chest x-ray concerning for pneumonia.  Patient is admitted for further evaluation and management.   CT chest showing dense consolidation throughout the left lower lobe as well as within the superior segment of posterior basilar segment of right lower lobe compatible with bibasilar pneumonias.  Retained secretions almost completely occluding the proximal lower lobe bronchi with a small amount of retained secretion also noted in the bronchus intermedius and central left mainstem bronchus.   Acute metabolic encephalopathy likely in the setting of sepsis from pneumonia Dementia CT head with no acute intracranial process. Patient listed as DNR CC. Per husband patient is now back to baseline have a private aide at home would like to be discharged home.   Aspiration pneumonia  Acute hypoxemic respiratory failure 2/2 above Sepsis 2/2 above Status post ceftriaxone azithromycin.  Finished 7 days of antibiotics. Seen by speech therapy and modified barium swallow. Puréed diet with thin liquids. Continue similar diet at discharge. No more antibiotics at discharge per   Covid-19 Virus Infection Date of onset of symptoms: 4/4/2023 Symptoms present on admission: Confusion Date of covid positive test: 4/5/2023 Vaccination status: vaccinated Imaging: CT chest showing bibasilar pneumonia Oxygen requirements on admission: 5 L Current oxygen requirements: 1 L Medical therapy: remdesivir, steroids, rocephin, and zithromax Consultants following: ID Anticipated special isolation end date: 4/16 Conservative fluid management, out of bed when possible
Began itching at injection site after vaccine was given; redness, swelling, & pain with hard lump at injection site.  Continued x 1 week; now has a small lump at site at this time.
Information has been received from a physician concerning a female (age not reported) with pertinent medical history and drug reactions/allergies unspecified who on approximately 18-JAN-2007 was vaccinated with HPV rL1 6 11 18 VLP vaccine (yeast) (lot# not reported) 0.5 ml injection.  On approximately 18-JAN-2007, the patient experienced a rash on her wrist and forearm.  The patient sought medical attention.  At the time of reporting, the patient had recovered. Additional information has been requested.
Tremendous body aches. Skin sensitivity. Sound created body pain waves. Fatigue. Mild nausea. 9 pm Tuesday through 5 pm Wednesday.
I started having like allergic reaction on my injection arm and that leg. It started general then it was very red and started itching. It looked like a skin rash very red a raised in the surface. I have to take allergy medication like CLARITIN/losartan/ZYRTEC. This kept going for about 4 weeks and then I saw a doctor and he told me to continue taking this medication. I then went for a physical and he told me to just keep taking the medication and to contact the CDC.
This case was reported by a physician via call center representative and described the occurrence of torticollis in a adult male patient who received Flu unspecified (Influenza vaccine) for prophylaxis. On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced torticollis. On an unknown date, the outcome of the torticollis was unknown. It was unknown if the reporter considered the torticollis to be related to Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. After receiving unknown Flu vaccine, the patient experienced torticollis. The physician consented to follow up.
Skin above injection site appeared like it had been sunburned and it flaked off exposing a large scab that was slightly indented. The doctor I saw said that the injection was most likely not into the deltoid muscle, but put into soft tissue causing a large bruise.
tested positive; This is a spontaneous report from a Pfizer-sponsored program. A ontactable male consumer of 59-years-old patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 15Apr2021 as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 23Apr2021, the patient experienced covid-19 tested positive. They're currently in quarantine and will be out for quarantine on Wednesday 05May2021. His 2nd dose is scheduled on 06May2021, the day after he will be out for quarantine. He would like to confirm if he can still take the 2nd dose since he got tested positive with the Covid19. The patient underwent lab tests and procedures which included sars-cov-2 test positive: positive on 23Apr2021. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Administered dose past the manufacture expiry date; Full 3rd dose of 0.5 mL was administered on accident instead of 0.25mL; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered dose past the manufacture expiry date) and ACCIDENTAL OVERDOSE (Full 3rd dose of 0.5 mL was administered on accident instead of 0.25mL) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered dose past the manufacture expiry date) and ACCIDENTAL OVERDOSE (Full 3rd dose of 0.5 mL was administered on accident instead of 0.25mL). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered dose past the manufacture expiry date) and ACCIDENTAL OVERDOSE (Full 3rd dose of 0.5 mL was administered on accident instead of 0.25mL) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.
Vaccine given at 12:30 PM. Ten minutes following vaccine administration, patient complained of dizziness, sweating, and headache. On examination, pulse was regular, blood pressure 90/60 and patient was alert. Extremities were cold. Patient was then observed for 30 minutes and clinically felt better, BP returned to normal range at 100/80. Following this, patient was observed another half an hour and discharged with instructions to follow up in the ER if adverse reactions occur. Follow up appointment was given and patient returned within 48 hours with no complaints.
Nausea, vomiting, itchy throat, redness and swelling around site measure 4 cm in diameter
I started having abdominal pain consistent with diarrhea. Have had several loose stools and pain.
Seizures, anemia, low red and white blood cells NO FEVER...seizure disorder, anemia neutropenia .. checked for childhood disease and disorders... Transient Erythroblastosis of Childhood, Diamond - Blactfan Anemia, Parvo or Fifth Disease...found no other cause  //Shots - 03/13/2009...ER - 03/23/2009- Would not turn head toward right, would not focus, lethargic, no use of the right arm, nonverbal... 03/24/2009- 4AM Ambulance to Medical Center ...03/27/2009 - 2 Blood Transfusions, MRI showed Seizures with no abnormalities // Medications Diastat 2.5 mg for seizures lasting > 5 minutes AS NEEDED, Phenobarbital 6.25 2X a day, Levetiracetam (Kappra) 100 mg/ml 1.5ml 3X a day Fosphenytoin (Injections were only given while in hospital 03/27 - 03/29) Medical Center Stay was 03/24 thru 03/30/2009 ... weekly blood tests with Pediatrician...follow up appointments with Hemotologist and Neurologist June 3 & 4.  Plan to drop one seizure med then.  4/23/09 Vax rec and OV received from PCP.  Infant in for 12 mon. WCC on 3/13/09 with normal exam. DX:  Well child. Vax given. 5/18/09 MR received for DOS 3/24-30/2009 with D/C DX:  Seizure disorder.  Anemia.  Neutropenia. Pt transfered from local facility for eval of transient  R-sided paralysis. Initially presented with episode of altered mental status and not moving the R side. Pt had been fussy given Tylenol and put down to nap, but awoke with above sx. Sepsis w/u done and (-) at local hospital. In status epilepticus of complex partial seizure on arrival but back to baseline prior to admission PE which was normal. Neuro consult. Heme consult for anemia. Impression:  Normocytic anemia. Transfused. Anemia and thrombocytopenia noted.  Developed worsening neutropenia during admission. to be followed by neuro and heme as outpt.
A nurse reported the occurrence of a 52 year old female who did not seroconvert after receiving three injections of hep B vaccine recombinant (Engerix B). The subject's medical history, concurrent medical conditions, and concurrent medications were not provided. On 7/13/01, 8/13/01, and 1/13/02, the subject received injections of Engerix B. Two months following the third injection, the subject's "titer" was less than two indicating that the subject did not seroconvert. The reporting nurse stated that she has investigated the "Lab" to see if there was a problem. Results of the inquiry were not provided. Treatment and outcome of the events were not provided. Comment: This report has been linked to reports A0376434A and A0395494A due to the same reporter.
Status epilepticus for 30 minutes. Ativan, Phenytine, intubated, 39C temperature. Continued seizures trilepta. Information from discharge summary states eye disorder, rash, somnolance, confusion, paralysis, apnea. msv Medical records states fever. msv
Severe shaking started 14 hours after injection, along with chills.  About 20 hours after injection, low-grade fever, severe headache started.   General feeling of tiredness, sore arm and achy accompanied.  Lasted all together about 24 hours from onset of adverse effects.
I woke up the morning of 04/22 around 09:00am and my stomach was itching and I continued to itch real bad. I lifted my nightgown and realized that I had a rash all of my stomach, as I took my night gown off I realized that the rash was all over my body but worse on the opposite arm that I got my vaccine on, also on my back and my hands. I had several auto immune diseases so I get rashes sometimes and I thought maybe this will go away but it just kept getting worse, so I was then concerned to get my second shot so I went to see my doctor because it did not look like any rash I had ever seen before it was really severe, I went to urgent care, I went to allergist who gave me an epi pen and neither could not tell me if I should get the next shots, I also saw my rheumatologist, and then I went to se my dermatologist and she  said it was the CSVV right away, she said the best thing to do was to take steroids but it would suppress the working of the vaccine or oral steroids so she just said use topical cream and take over the counter allergy medicine. It took a good six weeks before it was gone. It really itched really bad and burned really bad as well, but my doctor said it was more important to have the vaccine than to have COVID with all my health conditions.
Patient was asked pre-screening questions and answered "no" to receiving another vaccine in the last 14 days.  Her sister was in the treatment station next to her and they both had received the tetanus vaccine on 2/25/21.  When she went to make sure her sister answered "yes" to that question, the vaccine was already given. It was then found out patient is confused and would not have remembered receiving the tetanus vaccine.
Bilateral progressive lower extremity weakness, spinal fluid testing showing an elevated protein possibly consistent with Guillain-Barre syndrome. Receiving IVIG currently
Injection site arm was sore; greater than 35 days between Moderna Covid-19 vaccinations; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site arm was sore) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 35 days between Moderna Covid-19 vaccinations) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 35 days between Moderna Covid-19 vaccinations). On an unknown date, the patient experienced VACCINATION SITE PAIN (Injection site arm was sore). At the time of the report, VACCINATION SITE PAIN (Injection site arm was sore) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 35 days between Moderna Covid-19 vaccinations) outcome was unknown.  No concomitant medication was provided by reporter. No treatment information was provided by reporter.
I had same side effects with series 1 from January 2019: swelling under arm ping pong/golfball size - extremely painful with flu like symptom for 1-3 days - lack of energy, aching all over. The swelling lump is most painful - Received series 1 on upper right arm and series 2 upper left arm - same side effects - arm that was vaccinated has swelling in armpit area.
The pt presented to ER with hives. Arrived at 22:58 on 05/15/2002. Mother stated that the child received vaccination at approximately 11:00 on 05/15/2002 and developed urticaria to trunk and back at approximately 12:00. Child was treated with Benadryl and Prelone syrup.
Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. The patient's concomitant medication, medical history and drug reactions/allergies were not reported. On unknown dates, might between 07-SEP-2016 and 22-SEP-2016, the patients were vaccinated with doses of frozen VARIVAX (lot #, expiration date, dose and route were not reported). It was reported that the vaccine was reconstituted with improperly stored sterile diluent (lot # K024556 with expiration date 01-OCT-2017; lot # M019199 with expiration date 16-OCT-2018; lot K019030 with expiration date 21-AUG-2017; lot # L044085 with expiration date 29-MAY-2018). The sterile diluent was improperly stored at -0.1 Celsius (C) for cumulative 131 hours. There was previous temperature excursion: 15 C for 15 hours. Data logger was involved. VARIVAX was properly stored. No adverse event was  reported. This is one of several reports received from the same reporter. Additional information has been requested.
strange side effect 8 days later; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (strange side effect 8 days later) in a female patient of an unknown age 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 VACCINATION COMPLICATION (strange side effect 8 days later). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (strange side effect 8 days later) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-092609, US-MODERNATX, INC.-MOD-2021-091728 (E2B Linked Report). Sender's Comments:  US-MODERNATX, INC.-MOD-2021-091728: Phone number is matching in this case with mothers case US-MODERNATX, INC.-MOD-2021-092609: Phone number is same in mother case and this case
On 3/23/12 visit pat. reports itching on his back and stomach. Lasted 2 weeks.
Patient recieved Flumist (lot 500570P) intranasal 13Nov08 as part of his vaccination program.  He developed vague lower back pain approx 10Dec08, sought care 16Dec08, and over next several days had progressive neurologic deficits.  This lead to evaluations on 23 and 24Dec08, with admission to hospital, rapid deterioration, and ICU admission-intubation due to respiratory compromise due to neurologic impairment 26Dec08.  The patient is currently in the ICU with a diagnosis of multilevel (C-2 to T-10) transverse myelitis of unclear etiology.  He is on the ventilator for respiratory support, and has severe neurologic deficits corresponding to the levels of his myelitis.  Due to the proximity of his Flumist vaccine a VAERS report is being filed.  The treatment team recognizes that this vaccine is unlikely to be the causal agent and continues to actively pursue other causes and treatments.
1 hour after receiving the injection I had black spots in my left eye, I got lightheaded, my vision was affected while watching TV.   I took 2 Tylnenol and layed down on the couch.  I also had a tingling sensation in my left armpit lymph nodes and down into my left arm.  The black spots & lightheadedness went away in about an hour.  Generally so did the left arm sensations.  The injection site was mildly sore for about a week.
Pt recv vax on 11/10/98; on 11/19/98 pt exp LA shaking, pain, limited movement
pt recv vax 1APR97 & 3APR97 & devel a h/a, fever  99.5 & lethargy;
No additional adverse effect reported.; M-M-R II, VAQTA and GARDASIL 9 that underwent a temperature excursion (case 01907249) were administered.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were not reported.  On 22-JAN-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #: S022599, expiration date: 25-FEB-2022, dose, strength and route were not reported) for prophylaxis.   The vaccine underwent temperature excursions and was stored at 9 degree Celsius (C) to 25 C (8.7 C) for 30 minutes, 2 C to 8 C (8.2 C) for 30 minutes and 9 C to 25 C (9.43 C) for 45 minutes. There was no previous temperature excursion. The digital data logger was involved. No additional adverse effect reported.   This is one of 20 reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022599; expirationdate: 25-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002944: US-009507513-2104USA002963: US-009507513-2104USA002970: US-009507513-2104USA002971: US-009507513-2104USA002972: US-009507513-2104USA002980: US-009507513-2104USA002976: US-009507513-2104USA002975: US-009507513-2104USA002974: US-009507513-2104USA002973: US-009507513-2104USA002978: US-009507513-2104USA002982: US-009507513-2104USA002983: US-009507513-2104USA002984: US-009507513-2104USA002985: US-009507513-2104USA002986: US-009507513-2104USA002987: US-009507513-2104USA002988: US-009507513-2104USA002989:
05/17/2022, I had a sore throat. On 5/18/2022, I had a scratching voice, sneezing and nose was running.. I took a COVID test at home and it tested positive. On 5/19/2022, I had a headache, a lot of coughing and chest congestion. I laid around all day and wasn't feeling particularly tired or aching but was coughing a lot with a lot of mucous. I had a tele health on 5/19/2022 and was prescribed Paxlovid. I started the Paxlovid that day and by the next day it was almost all gone.
Parent called to report a swollen bump at the back of the child's head. It was painful to touch. She took him for evaluation. It was recommended he get an ultrasound.
Hives on upper lip, forehead temple, ears and neck. Denied temp denied SOB. Broke out 4-14-07. Gone 4-16-07.
Got vx 2 weeks ago. Now shingles in eye; Now I have shingles in my face; So painful; This case was reported by a consumer via interactive digital media and described the occurrence of ophthalmic herpes zoster in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 3 weeks after receiving Shingles vaccine, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the ophthalmic herpes zoster, shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the ophthalmic herpes zoster, shingles and pain to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient got vaccinated 2 weeks before the date of reporting and at the time of reporting the patient had shingles in eye and face and stated it was so painful.
Two months after vaccine, tested positive with a home test for COVID-19. Went to a local clinic and was prescribed PAXLOVID. The clinic didn't test for COVID.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's relevant medical history, concomitant medications and concurrent conditions were not known. On 26-FEB-2019 the patient was vaccinated with an improperly stored dose of VARIVAX lot # R002509 and expiration date 25-JAN-2020, for prophylaxis (strength, dose, frequency and route of administration were unknown). Sterile diluent used was properly stored. The patient experienced no adverse events. It was reported that the vaccine used had been at 6°F to 14°F (12.9 F) for 30 minutes. No previous excursions were reported. Data logger was involved. This is one of three reports from the same reporter. Sender's Comments: US-009507513-1903USA009466: US-009507513-1903USA009465.