chrisvoncsefalvay/vaers-outcomes huggingface dataset:
who received Pfizer COVID vaccine first dose on 20Jan2021 and then on 29Jan2021, He tested positive for COVID-19; This is a spontaneous report from a contactable nurse other Healthcare Professional. A 73-year-old male patient received first dose  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date: Not provided) via an unspecified route of administration, in Arm Left, on 20Jan2021, as a single dose for COVID-19 immunisation. Patient medical history was not reported. Concomitant medications included monoclonal antibody Bamlanivimab. On 29Jan2021,tested positive for COVID-19.On 31Jan2021 started treatment with monoclonal antibody Bamlanivimab. It will be 90 days (from his first dose of the vaccine) till 31Apr2021. Patient didn't get his second dose. Further stated there will be a hub in their hospital this coming Wednesday and they wanted to know the guidance/clinical considerations for this patient's case. Patient underwent lab test and procedures with Covid-19 (Positive) on 29Jan2021.The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: The association between the event COVID-19 with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
On 05/01/2018 Patient reported a local adverse reaction with a red, itchy area approximately 70 MM. in diameter at injection site of first VARIVAX injection, no systemic reaction reported. There remains a round hyper-pigmented area at the injection site about 5 mm. in diameter. Patient also noted that a scab had formed that she scratched off.
Pt had a hot swollen bump show up on her arm 7 days after the vaccine. It was itchy and redness is now moving down her arm to her elbow. I advised her to reach out to her physician as soon as possible.
fever off & on all day; mom did not have thermometer; given APAP 1030AM, 1PM, 730PM; 930PM episode convuls like body stiff-shaking-unconcious-drooling; lips blue lasted approx 5mins; called 911 taken to ER
values were elevated compared to previous lab tests; Alanine Aminotransferase; Lactate Dehydrogenase (LDH); Non fasting glucose; This case was reported by a consumer via call center representative and described the occurrence of aspartate aminotransferase increased in a 57-year-old female patient who received Herpes zoster (SHINGRIX) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   Concurrent medical conditions included cancer.   On 29th September 2020, the patient received the 1st dose of SHINGRIX. In September 2020, the patient received Influenza vaccine Quadrivalent 2020-2021 season. On 12th October 2020, 13 days after receiving SHINGRIX and less than a month after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced aspartate aminotransferase increased, alanine aminotransferase increased, lactate dehydrogenase increased and blood glucose increased. On an unknown date, the outcome of the aspartate aminotransferase increased, alanine aminotransferase increased, lactate dehydrogenase increased and blood glucose increased were unknown.   It was unknown if the reporter considered the aspartate aminotransferase increased, alanine aminotransferase increased, lactate dehydrogenase increased and blood glucose increased to be related to SHINGRIX and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The case was reported by patient's husband. The patient had a diagnosis of cancer and was taking oral chemotherapy medication (name not provided). The patient got the first dose of the SHINGRIX vaccine and had gotten a lab test done on 12th October 2020 and the Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Lactate Dehydrogenase (LDH) and non fasting glucose values were elevated compared to previous lab tests. The HCP would be repeating the lab test in two weeks. In addition the reporter stated that, the patient received a flu vaccine (unknown name) about 2 weeks before receiving the SHINGRIX vaccine. The reporter consented to follow up. The case US2020AMR208127, should be deleted from argus core and all the information was captured in the case US2020206840
Patient felt discomfort and pain in arm. Arm was red and she felt like their was a grapefruit sized lump under her skin that felt as hard as a rock. Patient stated that the area was very warm where the lump was.
Information has been received from a nurse concerning a female who on an unknown date, was vaccinated with a dose of GARDASIL. Subsequently the patient's injection site arm became very cold to touch. The patient went to the doctor's office to seek medical attention. At the time of this time, the outcome was unknown. Follow up information has been received from the registered nurse concerning the 11 year old female patient with sore throat at time of vaccination and no pre-existing allergies, birth defects and medical conditions who on 20-JAN-2010 at 12:36 was vaccinated in the deltoid with the first dose of GARDASIL (lot number 662529/1317Y). On 20-JAN-2010 at 13:30 the patient came back to office after immunization complaining of coldness in extremity. Patient's arm had darken bluish color and blood pressure was elevated. Patient also had numbness. Patient was examined by a physician and sent home and instructed to call for worsening symptoms. There was no lab diagnostic test performed. The patient recovered on 20-JAN-2010. Additional information is not expected.
No adverse reaction noted. HPV vaccine given out of ACIP recommendation to 46 year old female.
Started with tingling of fingers within 15 minutes of vaccination. Another 15 minutes patient developed tightness in throat and whole arm began to tingle. Patient seemed okay and then at 11:26 AM patient felt sick and felt like throwing up and dizzy then patient rolled eyes back into head. She was pale and clammy. Epinephrine was then given at 11:28 AM. Upon administration of epinephrine patient woke up and took a deep breath. She was then picked up by ambulance. Patient was oriented x 3. Vitals were stable (Oxygen 98 %. Heart rate was 68, BP 100/68).
The day following vaccination, pt experienced vaginal spotting which over a period of days increased to the point she sought medical care of her OB/GYN. Bleeding progressed to the point that she was saturating menstrual pads and bleeding through clothes. This continued for 12 days which then began to taper off for another 3 days. This occurred simultaneously with progressive migraines that increased in frequency, severity, and duration. Pt reports being prescribed Fioricet by Dr. to control migraine pain.
within 30 seconds my hands turned bright red as if I had dipped them in paint. Both sides of my hands were bright red. it is ok now at 3:55pm same day.
Arm was very hot to the touch at the injection site; Sporadic low grade fever; No energy.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0161), via an unspecified route of administration in the right arm on 25Apr2021 at 13:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not receive any concomitant medication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration in the right arm on 30Mar2021(at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Apr2021 at 13:00, the patient reported that her arm was very hot to touch at the injection site (vaccination site warmth) for more than four days at the time of reporting. On 26Apr2021 at 13:00, the patient also experienced sporadic low-grade fever and she reported that she had no energy. The clinical outcome of all the events arm was very hot to touch at the injection site (vaccination site warmth), sporadic low-grade fever and no energy were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Pt returned to pharmacy 3-5-12 complaining of muscle soreness in right arm still from injection of FLUVIRIN on 1-13-12.
Pt devel swelling on both sides of neck below ears; t101; pain & painful to swalllow specially tart foods;
Patch of pink skin raised directly over vaccine administration sites. The following day the rash spread as smaller papular rash over trunk adn extremities.
TDAP vaccine was given March 26, 2008, left deltoid IM.  Within one hour, site reddened, itchy, patient complaining of pain.  Symptoms subsided temporarily approximately 48 hours after.  On 4/01/2008, symptoms returned with increased severity (erythema and warmth to touch).
Information has been received from the wife of a consumer concerning her 72 year old husband with "Mild Diabetes" in approximately "May or June 2007", was vaccinated with a dose of Zostavax (Oka/Merck).  Concomitant therapy included simvastatin (MSD) and diabetes medication (therapy unspecified).  In approximately June 2007, the patient experienced "some sort of sensitivity on his back".  There was no itching, but it felt like something was affecting his "nerve endings".  She said that this "sensitivity" progressed to "horrific pain" in his back and also in his mid-frontal or lower chest area.  They are shooting pains.  She added that he has no visible marks, rashes, or blisters on the skin of these areas.  He has had a variety of tests and all of the test results were negative.  The patient's some sort of sensitivity on his back and horrific pain persisted. Follow-up information received on 24-Sep-2007, from the wife of the patient indicating that her husband is still in pain.    No further information is available.
Very sore, hot arm at point of injection (later, also red rash on bicep). Very tired, fever of 100 degrees. Went to bed at 8:30 PM after supper about 7 PM. The next morning, feverish, tingling skin, tired, weak and unsteady. Sitting in chair in kitchen and fainted. My husband said my head fell back. Eyes rolled back and I was unconscious for about a minute to 90 seconds. My husband called 911 and EMT came, checked pulse, blood pressure and blood sugar. They recommended that I be transported to the hospital by ambulance. My husband drove me to the hospital. EKG and  X-Rays and blood work at ER. There was not anything out of the ordinary according to ER MD. My bilirubin was 2.7 (higher than normal). Fever into the evening and overnight. My husband also had a fever and painful arm. We had the shots at the same time. My arm continued to swell, be hot and a rash continued until today (4-5 days). Arm is still tender and I am tired and don't feel quite right. I'm trying to make an appointment with a doctor for follow up.
Initial report received from a health professional on 03 December 2008. A 61-year-old female patient received a dose of FLUZONE (lot number U2757AA); a dose of MENOMUNE (lot number UF282AA); and a dose of TWINRIX (manufacturer GlaxoSmithKline, lot number AHABB132AC) on 25 November 2008 at 4 PM. Routes and sites of administration were not reported. Fours hours later, the patient complained of congestion, sore throat and high fever (temperature was not taken). The patient took Nyquil, Benadryl and Motrin and went to bed. She awoke at 2 AM with chills, fever and malaise. The patient was very tired the next day. At the time of the report, patient outcome was unknown. The patient had previously received a dose of TWINRIX one month ago (date not specified). Follow up information was received on 05 January 2009 from a health professional. On 09 October 2008 the patient received a first dose of TWINRIX (manufacturer GlaxoSmithKline, lot number AHABB128AA) intramuscularly in the right upper arm, a first dose of TYPHIM VI ( lot number A0347) intramuscularly in the left upper arm and a first dose of IPOL (lot number AB0342) intramuscularly in the left upper arm. The patient recovered from the events on 26 November 2008. Follow up information was received on 28 January 2009 from a health professional. The patient received an initial dose of FLUZONE intramuscularly in the left upper arm, an initial dose of MENOMUNE subcutaneuosly in the right upper arm, TWINRIX intramuscularly in the upper right arm, IPOL and TYPHIM VI both in the left upper arm. The patient reported having a reaction in the 1980's to a possible flu vaccine. No other information was provided. Follow-up information received 12 February 2009 from a health care professional in response to our request for additional information pertaining to the specific flu vaccine manufacturer, lot number and type of reaction experienced by the patient during the 1980s. According to the reporter, this information was "Unknown. Patient relocated to a foreign country, and we did not give the vaccine in 1980." No further information was provided. Documents held by sender: None.
Moderna COVID-19 Vaccine EUA Patient received vaccine around 12:00pm on 4/19/2021.  On the same day around 6:00pm he began to have severe diarrhea and vomiting that lasted until 2:00am, and he could not retain anything.  It is 4/21/21 and he said that he is still feeling ill from the effects.  Advised to contact doctor, rehydrate and possibly take and anti-diarrheal medication.
Pt received pre-exposure rabies #1 on 9-16-08 - experienced headaches with nausea/ vomiting lasting 24 hrs. Returned for #2 on 9/23/08. Complained of headache within15 minutes of receiving injection. State she had headache and N.V until she went to the ER on 09/26/08
I had migraine headaches for 4 days. Muscle aches and fatigue for 3 days
Headache, Sedation, Fever, CHILLS, ARM PAIN AND SWELLING Narrative:  Other Relevant History:
1hr p/vax pt was lethargic, staring, dec tone but fairly responsive lasted about 30-60 min (report by mom);12 hr later pt was crying vigorously & very cranky/irritable lasted 1hr-cranky for several days thereafter;
Pt developed a fever to 105 degree the evening of the vaccine.  Fever returned the next day and she had a seizure.  She was taken to the local ER.  Blood work and CXR negative.  Assumed reaction to vaccine.
Per vaccinator,  while administering vaccination the syringe separated from the needle and the vaccine sprayed out. A replacement dose was given.   Syringe/needle was Haiou brand.
Discharge Provider: MD Primary Care Provider at Discharge: DO  Admission Date: 10/30/2022 Discharge Date: 11/4/2022  PRESENTING PROBLEM: Acute respiratory failure with hypoxia (HCC) [J96.01]   HOSPITAL COURSE: Patient is a 72 year old female with history of small cell lung cancer, type 2 diabetes mellitus, hypertension and COPD who presents with shortness of breath since Sunday with productive cough. She denies chest pain, fever or chills. She lives alone and felt short of breath and called ems. She was brought to ER for evaluation. Upon arrival she was hypoxic on room air and tachypneic. Covid-19 was detected. She required 4 liters via nasal cannula. WBC  was 11. Chest CT was negative for pulmonary embolism and showed redemonstration of left hilar mass. Slight worsening of patchy opacities in the right lower lobe which could reflect pneumonia. Enlarged right hilar lymph nodes may be reactive. She received IV solumedrol and albuterol nebulizer. Agreed to admit patient for management of acute respiratory failure with hypoxia due to covid.    The patient was started on IV antibiotics, azithromycin and ceftriaxone, and remdesivir, and received a 5-day course of all,. Additionally she received daily dexamethasone and supportive care. Her oxygen was weaned down, though she continued to need 1 liter per nasal canula to maintain consistent saturations above 88% at rest and with activity.  Her work of breathing decreased and she was tolerating activity in her room. PT and OT evaluated the patient and her strength was increasing, they recommended home health care with PT and OT to continue strengthening, balance, and endurance. She was discharged home in stable condition with services, nebulizer with solution, refills of chronic inhalers, and home oxygen. She is recommended to follow up with her PCP as soon as she is out of quarantine for continued monitoring of chronic lung condition and assessment for continued need of supplemental oxygen.
Swelling from feet too both knees, swelling from elbow to hands, both eyes swelling
Headaches, migraines, and tired after vaccine for 2 weeks. 14th day after vaccine noticed some red spots on leg that looked similar to a heat rash and over the next 24 hours entire legs were covered in red dots and feet were almost solid purple. On the morning of 16th day constant nose bleed and multiple blood blisters in mouth inside cheeks and all over tongue. Blood was coming from mouth. At that point legs were covered in dark red almost purple and spreading to chest, back, and arms.
not  been feeling well; huge knot at injection site; under arm tenderness; painful to touch under arm; dizziness; loss of appetite; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 19Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced not been feeling well, huge knot at injection site, under arm tenderness, painful to touch under arm, dizziness and loss of appetite on an unspecified date. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Tachycardia; Palpitations; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Tachycardia) and PALPITATIONS (Palpitations) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TACHYCARDIA (Tachycardia) and PALPITATIONS (Palpitations). At the time of the report, TACHYCARDIA (Tachycardia) and PALPITATIONS (Palpitations) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: high (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided No treatment information was provided
Noted 5 inch by 2 inch erythema and edema to left upper arm.  Patient complained of pain rated 10/10.  Area tender and warm upon palpation.  Reflex and sensation intact.  Patient treated with ice and Benadryl per instructions given by Dr.  Upon follow up with patients mother, all symptoms resolved.
After pt received the last vaccine he fainted, lost consciousness for 10-15 seconds and had urinary incontinence. Patient fell, hitting his head on the floor and for that reason was sent to the ER for further evaluation.
On day 8 post vax red rash on arm  On day 9 post vax red rash on arm spread by about 30% No treatment
Patient received ROTARIX vaccine IM instead of PO. Per mother there has been no side effects at the time and pt. is doing fine.
Patient developed shingles outbreak on 01/20/2019. She received both doses of SHINGRIX, 1st dose 5/2018 and 2nd dose 7/2018, at a pharmacy. Patient is requesting that this be reported to CDC as an adverse reaction.
One hour after the vaccine he became light-headed and nauseated. In 5 hours after vaccine, he developed a headache and was very sleepy. 24 hours after vaccine, he developed a fever and sore throat and a rough loud cough. (symptoms were very).
Patient died 1-11-09.  Had received vaccines in our office 1-5-09.  Coroner determined cause of death as SIDS after autopsy completed. 3/16/09-autopsy report received-COS Sudden Infant Death Syndrome (SIDS). Manner of death natural. Moderate thymic and pleural petechiae. Pulmonary and visceral congestion.
This case was reported by a consumer via call center representative and described the occurrence of keratosis in a 65-year-old female patient who received SHINGRIX. The patient's past medical history included mood disorder, stress, hives (during stress) and migraine (during stress). Concurrent medical conditions included allergy. Concomitant products included lamotrigine. In January 2018, the patient received the 1st dose of SHINGRIX. In February 2018, 14 days after receiving SHINGRIX, the patient experienced keratosis, eye crusting, pain, pruritus, allergy aggravated, rash toothache and eyelid rash. The patient was treated with Cortisone Cream. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the keratosis, eye crusting, pain, pruritus, allergy aggravated, rash, toothache and eyelid rash were recovered/resolved. The reporter considered the keratosis, eye crusting, pain, pruritus, allergy aggravated, rash, toothache and eyelid rash to be possibly related to SHINGRIX. Additional details were provided as follows: In late January 2018, the patient received SHINGRIX on the right arm. Approximately 2 weeks after receiving SHINGRIX, the patient experienced a crusty rash on her eyelids, and rash on forehead and behind the ear. The patient experienced more general allergies than before SHINGRIX therapy. The patient saw a dermatologist and a diagnosis of keratosis was made and a cortisone cream helped alleviated the skin issues of rash and crustiness on the eyelid. The permission was given to send a letter requesting physician information. This case has been linked with case US2018GSK088924 (next dose), reported by same reporter.