chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client reported erythema approximately 3in x 3in at site of injection 9 days after dose #1. Client went to urgent care and was told they did not know enough about reactions with COVID vaccine so they sent her to the ER. Per the client the ER diagnosed her with cellulitis and gave her antibiotics. Client states reaction was local, denies any other symptoms.
Patient received PNEUMOVAX on 9/11/09 developed swollen lymphnodes on her right arm (injection site), arm severely hurt, fever of 100.7 degrees F, and chills.
Patient was given Covid-19 Pfizer 12+ state vaccine but should have received Covid-19 Pfizer 5-11 state vaccine.
pt recvd vax 19SEP94 & 21SEP irritable;23SEP fever;25SEP MD visit-viral infect suspected;rx Advil/APAP;lethargic;28SEP head shaking uncontrollably;29SEP hosp;dx acute disseminated encephalomyelitis or anterior horn disease;fever,rhinorrhea
This spontaneous report as received from a Nurse Practitioner refers to a male patient of unknown age. The patient had received first dose of VARIVAX (merck) (0.5 ml dose/1 or 2 times, lot # not reported) from another office in 2002. No other co-suspects were reported. No concomitant medications were reported. In 2011 the patient got a bad case of chicken pox. No treatment information was reported. The outcome of chicken pox is unknown. The patient did not seek medical attention. Additional information is not expected.
This spontaneous report as received from a nurse refers to a 23 year old patient of unknown gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 29-NOV-2016, this adult patient was vaccinated with PROQUAD (inappropriate age at vaccine administration) lot # M031566, expiry date: 24-DEC-2017, 0.5 ml once subcutaneously for prophylaxis. No adverse effects were reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
Patient recieved flu shot on 10/21/06 and started having flu symptoms (myalgias and night sweats) shortly afterward on 10/28/06. The patient also developed severe itching all over his body (which was not relieved by Benadryl) shortly after recieving the vaccine. By 10/30/06, the flu symptoms had gone away, but he still had itching all over his body. He was seen by his primary care physician on 10/30/06 and had jaundice of the skin and eyes.
Patient noted fever, chills and local arm swelling at injection site approximately 48 hr after given the PNEUMOVAX in the office. Admitted to hosp for IV fluids.
Patient came to ED with abdominal pain, nausea, and vomiting and some shortness of breath.  Patient tested Covid positive and was admitted to the hospital and treated with remdesivir.
Started about 6 to 7 hours after shot and lasted to around 12 next day. Had headache, ear ache,nausea, congestion,legs and feet ached, a slight fever of 101.2, and a sore arm.
mom states rest of family ill w/flu; pt fine until day of admission 4FEB93; fever 100.2, pale & breathing funny; thought pt had flu-no sz activity @ any time; hosp stay progresses well on ATB & fluids;
pt to hospital after a fall - hip fx; found to be positive for COVID; during course of hospitalization, pt treated for pneumonia, A Fib with RVR and worsening renal failure; started HD and went asystole; life support guidelines with ROSC; transferred to ICU; pt non-responsive; transitioned to DNR without aggressive measures; eventually transitioned to comfort measures with GIP hospice; pt passed away in the hospital
Vaccine was stored at -20 Degrees F so outside of the Temperature range; A spontaneous report  was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) that was stored at -20 degrees F, so outside of the temperature range.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. The reporter stated the COVID-19 vaccine was stored at -20 degrees Fahrenheit; outside of the recommended temperature range. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, vaccine that was stored at -20 degrees F so outside of the temperature range, was considered resolved.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product storage error without any associated adverse events.
AE: Treatment/Outcome:  Patient Active Hospital Problem List:  CORONAVIRUS COVID-19 DISEASE (9/25/2021)/ACUTE HYPOX RESP FAILURE - admit for COVID pna, positive on 9/13/21.  On decadron, completed remdesivir, also s/p 1x dose tocilizumab on 9/27 when on significant HF NC settings.  Since has improved, now down to ~ 35L, 40% FiO2 on HF NC.  Suspect will be able to transition to oxymizer in next few days.  Notably, patient states he is a mouth breather, could consider simple mask instead, though this will be harder to accommodate long term after discharge as he will likely require home O2.  - Trend LFT's, LDH, d-dimer, CRP, ferritin, CK per COVID order-set  - Cont awake proning - S/p Remdesivir IV 9/24-9/28 - Decadron 6 mg daily 9/24-9/26, 10 mg daily 9/27 to present - will plan for total 10 day course.  - S/p tocilizumab x1 on 9/27/21 - Cont pepcid for GI ppx - DVT prophylaxis w lovenox 40 mg SQ q 24 hrs  - Will need 20 day total isolation
Hives occurred 12 hours after shot mom gave Benadryl x 2 doses.
This case was reported by a consumer and described the occurrence of unable to walk in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced unable to walk, crying, lancinating pain and mental disorder. On an unknown date, the outcome of the unable to walk, crying, lancinating pain and mental disorder were unknown. It was unknown if the reporter considered the unable to walk, crying, lancinating pain and mental disorder to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the GlaxoSmithKline's employee. The patient was 50-something years old at the time of reporting. The reporter's sister told to the reporter that, the patient (her friend) called her the day before after her second shot and was crying, doubled over in pain on the floor and she could not walk. The reporter had been trying to get her contact information as well as permission to be contacted as the patient suffered from severe mental illness. The reporter was asking an advice as to how she should proceed further. This case has been linked to the US2018GSK141418, reported by the same reporter.
85 year old vaccinated female was admitted for Covid-19 pneumonia and associated respiratory failure. She received Remdesivir therapy. Her condition did not improve initially. D dimer remains severely elevated and she required anticoagulation. Work up for thrombosis have been repeatedly consistently (-). She also became encephalopathic and required Lactulose therapy due to rise in ammonia level. She developed GI bleed from the anticoagulation and it was stopped. Hgb remains stable at 10.6 today. Plt still low at 69,000. She also suffered from AKI but it resolved. Pancytopenia is from the combination of recent Covid-19 infection and underlying fatty liver causing cirrhosis. She will finally be able to discharge to hospital today on O2.
Depression; extremely tired and sad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) at the age of 40 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DEPRESSION (non-serious) with onset 06May2021 06:30, outcome "recovered" (May2021), described as "Depression"; FATIGUE (non-serious) with onset 06May2021 06:30, outcome "recovered" (May2021), described as "extremely tired and sad". The events "depression" and "extremely tired and sad" were evaluated at the physician office visit. Therapeutic measures were taken as a result of depression, fatigue.  Additional info: The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any medication within two weeks of the COVID-19 vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Therapeutic measures were taken as a result of the event which included mental health counselling.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Child reported to mom, area was itchy, red, and swollen.  Mom gave Benadryl Medication, and applied ice to area. Symptoms lasted for 2 days.
Cerebellum stroke, flocculus modular area; This is a spontaneous report from a contactable consumer (patient). A 53-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm left on 14May2021 09:00 (Batch/Lot Number: EW0172) (at age 53-year-old) as dose 2, single for covid-19 immunisation. The first dose was received on 23Apr2021 13:00 on the left arm. There were no medical history. Concomitant medication included CBD for sleep and occasional calcium supplement. The patient experienced cerebellum stroke, flocculus modular area on 04Jun2021 05:30. The patient was hospitalized for cerebellum stroke, flocculus modular area (cerebellar infarction) for 3 days. Event resulted in: emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 11Jul2021. Medication, testing/monitoring, physical therapy was given as treatment. Outcome of the event was recovered with sequel.  Patient was not diagnosed with COVID-19 prior to vaccination and has been tested on 11Jul2021 (nasal swab: negative).
-Child received KINRIX vaccine 6/28/10 in RD region. Mom states today she noticed it was slightly swollen, warm and slightly pink. No decreased ROM or significant tenderness. Advised cool compress, ADVIL and rtn prn no improvement or increased S/S.
After the first dose on 2-23, I experienced a tickle in my throat within minutes. It was difficult to swallow but I did not have trouble breathing. My tongue and throat felt swollen. The nurse suggested I stay longer. I drank a bottle of water, which helped. I stayed 45 minutes until the symptoms seemed to start to go away. The nurse directed me to take Benadryl before the second shot. I took Benadryl and still experienced the symptoms above, but to a lesser extent. I looked at my throat and tongue in the mirror and saw what looks like a rash/pustules on the back of my throat and top of my tongue way in the back of my mouth. The symptoms are slowing going away (I received the second dose 7.5 hours ago), but I thought reporting them may help in some way. Thank you for making this vaccine available and thank you for all you?re doing to help keep others safe.
diarrhea; soreness in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) and VACCINATION SITE PAIN (soreness in the injection site) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 013A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced DIARRHOEA (diarrhea) and VACCINATION SITE PAIN (soreness in the injection site). At the time of the report, DIARRHOEA (diarrhea) and VACCINATION SITE PAIN (soreness in the injection site) outcome was unknown.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.
they gave it to me 'in my leg'; This is a spontaneous report from a contactable consumer reported for self. This 76-year-old patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in Leg  on 18Feb2021 at age of 76-year-old as DOSE 1, SINGLE (Lot # EL9265) for covid-19 immunisation. Medical history included Rheumatoid arthritis, Osteoarthritis, Hypertension, breast cancer issues, knee replacement. Concomitant drugs included hydroxychloroquine sulfate (PLAQUENIL S), Gabapentin, Levothyroxine for thyroid problem, and diazepam (VALIUM) at 5 mg. No vaccination prior to the COVID 19 Vaccine. The patient got the first shot in January, they gave it to the patient 'in my leg' because of breast cancer issues. They got permission to give it to in my 'leg', two weeks 'of debate they wanted to give it in my legs'.  Outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
pt received vaccine and went to waiting area. 5 minutes after in the waiting area, pt had a self reported panic attack/fainting spell.  pt did not fully lose consciousness. pt has a history of panic attacks/fainting spells, especially with needle sticks.  Paramedics assisted on scene but pt was not transported to hospital. pt left under his own power
Vomiting with every bottle starting on 11-15-08, within 24 hours of getting vaccine.
Had complex febrile seizure < 24 hrs after vaccination-required intubation in ER due to status epileptices. He was hospitalized for three days.
Patient developed fever of 102.6, multiple episodes of vomiting, diarrhea, malaise, fatigue;  she had a large raised circular swelling about 5 inches in diameter over injection site with significant pain.
Pfizer booster was given before the pre- screen paperwork was filled out. The vaccine was going to expire in 4 minutes. After the vaccine was given it was then realized the patient received Re gen-COV on 08/28/2021.
Got Shingles - Mild case #1 - 4-22-14     #6 - 12 -2016     #11 - 5 - 2018 #2 - 6 - 2015    #7 - 1 - 2017      #12 - 10 - 2018 #3 - 8 - 2015    #8 - 3 - 2017      #13 - 1 - 2019 #4 - 1 - 2016    #9 - 9 - 2017     Shingrix Vac-3-28-19 #5 - 8 - 2016    #10 - 12 - 2017   #14 - 5-2019
Vaccine was not diluted with 1.3 diluent before administration on 1/11/23. Family was informed and patient was observed for 30 minutes. No side effects present during the observation time in clinic.
VERY swollen tender arm at injection site. Swelling and pain started about 24 hours after injection.
Malaise; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (PFIZER-BIONTECH COVID-9 VACCINE) (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunisation. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "Malaise". Therapeutic measures were taken as a result of malaise.  Additional Information: The report received from a Pfizer-sponsored program. The onset of event was about 15-16 days after the 2nd dose of vaccine. The patient was treated with steroids.     No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received vaccine and was monitored for the 15 minutes. Showed no s/s of a reactions and okay to leave.  1/5/21 received notice that patient reported fever of 103.0 and chills woke up in the morning and temperature was 100.0.
Swollen tongue. Swollen neck glands. Headache, Racing heart. Blood pressure went to 190/95 Occurred after I arrived home.  Called Fire Department.  I was still able to talk and breath  so they did not use Epi pen.  Stayed with me because of BP concern.  Offered to bring me to Hospital.  Said to take Benydryl if symtoms began anew and to call them back and they would take me ER but as day progressed, symptoms subsided somewhat.  Higher BP readings continue and my PCP prescribed mild BP RX..
Today, on the 28th, I woke up with redness and heat at the injection site; Today, on the 28th, I woke up with redness and heat at the injection site; redness; my arm was sore; This is a spontaneous report from a contactable Other HCP (patient)  A 31-year-old non-pregnant female patient received dose 1 of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection; lot number EL1283), via an unspecified route of administration at Left arm on 13Jan2021 11:00 AM at single dose for Covid-19 immunization. Medical history included to ceclor allergy. The patient was not diagnosed with Covid-19 prior to vaccination and the patient has not been tested for Covid-19 after the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included gabapentin. On 14Jan2021 next day of vaccination, the patient had a mild reaction of redness and arm was sore but that went away within 24 hours. She did not have any problems until 28Jan2021 05.00am. On 28Jan2021, the patient woke up with redness and heat at the injection site. She further stated that her event did not get any worse however she was concerned about the delayed reaction. She was due to receive second dose on 03Feb2021. No treatment was received for the adverse events. The Outcome of redness and arm was sore was recovered and outcome of the patient woke up with redness and heat at the injection site was unknown.   Follow-up attempts are completed. No further information is expected.
Large red and swelling at injection site. About 1 inch diameter around injection has blisters and outside this area (about 2 inch diameter) is red and swelling. No fever.
menstruating; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 02Apr2021 14:15 (Lot number: ER8734) at the age of 40 years as dose 1, single and administered in arm right, administration date 23Apr2021 14:15 (Lot number: EW0164) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Idiopathic Thrombocytopenia Purpura" (unspecified if ongoing), notes: Idiopathic; "acid reflux" (unspecified if ongoing); "osteopenia" (unspecified if ongoing). Concomitant medication(s) included: TRI-SPRINTEC; MOMETASONE FUROATE; FLORAJEN. Past drug history included: Neomycin, reaction(s): "Allergy:Neomycin", notes: known allergies: Neomyacin; Tetracain, reaction(s): "Allergy:tetracain", notes: known allergies: tetracain. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 2021, outcome "unknown", described as "menstruating". Therapeutic measures were not taken as a result of menstrual disorder.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination included vitamin. She experienced heavy menstruation for 3 weeks after the booster shot. Since she was already menstruating for several days prior to getting the shot, the menstruation ended up lasting for 4 weeks straight. Below she answered unknown to the question regarding if she have recovered because she don't know if next month's period will be affected, but bleeding has stopped as of earlier this week. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Device Date: 22Dec2021.  No follow-up attempts are possible. No further information is expected.
12/27/2020 joint pain, body aches,  sinus congestion,  chest and throat soreness; . l cheek numb, sluggish.; left eyelid more raised and sluggish than other 12/28/2020; l armpit swollen armpit.
pt recv 1 dose of varivax & 1 wk p/ the vax pt devel macular rash followed by pox, fever & swollen glands.
Client began to notice redness and rash at site of injection.  Localized symptoms did not progress after further observation over 30 minutes.  Fire Rescue at scene to evaluate patient.  Per Fire Rescue, no further evaluation needed, patient released at 4:05pm.
On my way home from getting the vaccine I started having facial tingling, cheeks flushed, then facial numbness, weird taste in mouth that then turned to numbness especially in gums of front top teeth, and numbness in throat.  I can still breathe and eat and drink and control all of my facial muscles.  Feels like when the drugs they give you for numbing during dental work are wearing off.   Today (one day after first dose vaccination) I continue to have numbness, but it?s not worse, but I?m noticing that other parts of my skin including my forearms and scalp, left shoulder and neck are also feeling slightly numb and tingly.
This study case was received from the investigator in a trial on 27 September 2012. A 35 year-old female subject (medical history was not available) was found to have other causes of encephalitis three days after the subject had received an injection of ACAM2000 (lot number, route and site of administration not reported), Yellow Fever vaccine (lot number, route and site of administration not reported), Anthrax 1 (manufacturer, lot number, route and site of administration not reported) and Hep B -Adult 1 (manufacturer, lot number, route and site of administration not reported) on 08 January 2012. Relevant laboratory data included: a normal MRI (brain) on 08 February 2012. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Patient is under 50 years old and received second booster dose  without being immunocompromised
rash on trunk, face, legs to clinic 31AUG98;gen varicella like rash secondary to varicella vax;pt fussy, not sleeping well 2SEP98;dx viral synd probably secondary to post vax; inc fussiness, dec appetite, acting more ill;T102;
Developed severe body aches, chest pain and shortness of breath. High fever, reaching 103.3. Fever and symptoms lasted 72 hours with little relief with Tylenol or Ibuprofen. I called into PCP and he stated that because I recently had COVID, my immune response to the vaccine was exaggerated.
Pinkish Injection Site; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE DISCOLOURATION (Pinkish Injection Site) 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 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced INJECTION SITE DISCOLOURATION (Pinkish Injection Site). At the time of the report, INJECTION SITE DISCOLOURATION (Pinkish Injection Site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were provided.  No treatment medications provided by the reporter.