chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Allergy to vaccine/ Allergic reaction to COVID  vaccine shot that had Polyethylene Glycol; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Allergy to vaccine/ Allergic reaction to COVID  vaccine shot that had Polyethylene Glycol) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    No relevant medical history was reported.  Previously administered products included for Product used for unknown indication: Polyethylene Glycol. Past adverse reactions to the above products included No adverse event with Polyethylene Glycol. Concurrent medical conditions included Polyethylene glycol allergy.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On 01-Jan-2022, the patient experienced ALLERGY TO VACCINE (Allergy to vaccine/ Allergic reaction to COVID  vaccine shot that had Polyethylene Glycol). On 03-May-2022, ALLERGY TO VACCINE (Allergy to vaccine/ Allergic reaction to COVID  vaccine shot that had Polyethylene Glycol) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked in.  No concomitant medication reported. No treatment medication reported.  The reporter causality for the Co-suspect Humira for the Event Allergic reaction to COVID  vaccine shot that had Polyethylene Glycol was not provided.  Primary reporter contact for lot number information was unsuccessful.
This is an 81-year-old male with a history of dementia also a history non traumatic SAH over the right cerebral convexity in 7/17 thought due to  amyloid angiopathy , stroke and TIA who is brought by his wife for evaluation of changes that she noted last night around 9:00.  She stated around 9 when she was getting ready for bed she thought his speech was a little bit thick but thought she had worn about since they were outside doing a lot of walking and had been to a picnic.  The morning of the admission he has been more tired his tongue has been thick his speech is been a little bit slurred and his gait was slow with a shuffling gait.  In the afternoon when visiting her son he recommended she bring him in immediately for evaluation.head CT showed small amount of bilateral subarachnoid hemorrhage Neurosurgery at Medical Center was consulted and no surgical intervention was recommended. He was transferred to Hospital for further evaluation treatment . repeat ct head was stable.  He was discharged on  5/20/2021 and his aspirin was stopped.   He also tested positive for covid 19 despite being fully vaccinated. ddimer was 1787- venous doppler was not done. he did not require oxygen. He was placed on quarantine on dc. Called wife on 5/22 and she reports he is complaining of fatigue but no cough or sob.  He also has a history of covid 19 on 12/20 and was hospitalized and discharged on 1/6/21 and tested negative on 1/7/21. during that admission he was treated with remdesivir and decadron. He did not require oxygen. His hospital stay was protracted due to deconditioning and confusion but he was ultimately discharged home .  the baby aspirin was added on dc. mri during that admission was normal with no acute abnl seen.
three smallest toes on both feet (left/right) feel swollen; discomfort in wearing shoes and sleeping at night; balance is affected; nerve damage; discoloration; blood clots; This is a spontaneous report from a contactable consumer (patient). A 57-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration, administered in Arm Left on 06Mar2021 11:00 as single dose for COVID-19 immunization. The patient had no medical history and known allergies. Patient did not have COVID prior vaccination. Patient was not tested for COVID post vaccination. Concomitant medications were not reported. It was reported that patient had three smallest toes on both feet (left/right) feel swollen. He had discomfort in wearing shoes and sleeping at night. He had movement of the toes but balance is affected. Just really troubling as nothing like this was affecting him before. He had been told it was COVID toe. He first thought it is was nerve damage. Could be blood clots small based on reading information. He never got sick. He was attempting to set a doctors appointment. There is a small amount of discoloration. He was hopeful with time this will get better. Events started on 09Mar2021 14:00 with outcome of not recovered. No treatment received. Events resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Events were reported as serious due to disability. Patient had second dose of bnt162b2 (lot no.: ER2613) on 27Mar2021 on Left Arm.  Information on the lot/batch number has been requested.
pt says that on day 8 when she woke up that her right arm was hot to touch.  She had about a 1x1 red spot around the injection site that became worse during the day.  Within 2 days it turned into a painful 6' red rash that went down to the elbow.   She did not have an itching but had alot of pain. She had joint pain in her left arm. Pt has only taken Advil for her arm pain. Symptoms started getting better after the second day and lasted for about a week.  On the nights of 4/5/2021 and 4/6/2021 she would wake up with her heart racing.  These episodes would last a couple of minutes before heart race would get back to normal.  She contacted her PCP and he thought she may have had an allergic reaction to the vaccine due to her allergy to shellfish.
This spontaneous report as received from a licensed practical nurse refers to a 12 year old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was reported. On 14-SEP-2015, the patient was vaccinated with a dose of GARDASIL 9 lot # L007560 (dose, route of administration and expiration date were not reported) that had experienced temperature excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
About 12 hours after the immunizations patient was left with grandma who was      patient. She was sleeping and woke up and couldn't breathe. Then she started crying. She had turned purple. Paramedics were called.
Pt reported legs/feet were numb, unable to wiggle toes or move feet, was able to stand but c/o dizziness. Deny pain/injury. Pt seemed confused to mother. Taken to ER by parents. Medical records state allergic reaction, foot pain. msv
skin hot, pt chilled, trouble walking, stomach cramps, stated had trouble breathing-no obvious signs & sx;
Moderate pain from elbow to collarbone that is getting better with time. Still hurting today (03/07/21)
patient went to sit down, and after a few minutes felt nauseous, then started dry heaving; symptoms resolved within a few minutes; patient stated she had been really nervous and anxious about getting the vaccine and believes it may have been a psychosomatic reaction
This spontaneous report as received from a healthcare worker refers to an unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history was not reported. On an unspecified dates, an unspecified number of patients received an improperly stored dose of GARDASIL with lot # K004205 and expiration date 12-JAN-2017; lot# K005881 and expiration date 14-JAN-2017; lot# K008931 and expiration date 04-MAR-2017; (strength, dose number, dosage and route unspecified). No adverse effect reported. No product quality complaint (PQC) was involved. No further details provided. This  is one of two reports received from the same reporter. Additional information has been requested.
Migraine  Numbness in face  Tingling in feet Eye twitching Eyes hurt
Shortly after receiving the vaccine, patient began coughing & had tongue swelling. She complained of being dizzy, shaky & SOB. Epi 0.3mg given, Solumedrol 125mg and Benadryl 150mg IV rash noted on chest & upper back.
12 hours after the vaccination I started to have tachycardia, fever and diarrea. I started taking panadol every 4 hours and the symptoms lasted for two days. Drink a lot of water for tachycardia.
Information has been received from a health professional concerning a 7 year old female who was vaccinated with a dose of Variavax. In March 2006, the patient experienced breakthrough. At the time of the report the patient was recovering. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. The patient's sister experienced breakthrough following vaccination with Variavax (WAES#0604USA00311). Additional information has been requested.
Client states she received her second Moderna vaccine on 4-8-2021. Client states exactly one month later on 5-8-2021, her injection site began "feeling like a sore pulled muscle/like it was trying to cramp" and has felt this way up to now (2.5 weeks later). She states she has taken tylenol to relieve the dull pain as well as numbing spray. She states these help, but the soreness persists. Client was asked if she had tried heat/cold compresses; states no. Client was asked if she had done any yard work/strenuous work/exercise a day or two before 5-8-2021 (when the muscle soreness began), and again client states no. Advised to follow up with her primary physician for further evaluation of injection site/muscle.
SEVERE FLU; THYROID NUMBERS OFF; EYE INFECTION; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to genetically modified organism (gmo), no corn, no soy, and thyroid autoimmune disease. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 2021, the subject experienced thyroid numbers off. On 2021, the subject experienced eye infection. Laboratory data included: TSH (NR: not provided) 34. On 09-APR-2021, the subject experienced severe flu. Treatment medications (dates unspecified) included: ciprofloxacin. The action taken with covid-19 vaccine  was not applicable. The patient recovered from severe flu on 10-APR-2021, had not recovered from thyroid numbers off, and the outcome of eye infection was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Patient should have gotten the Pfizer Bivalent vaccine.  Instead she was given the Pfizer purple 12+ yrs  primary series vaccine. Patient did not have any reaction.
This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. The patient's relevant medical history was not reported. On 10-NOV-2014, the patient was vaccinated with a dose of MMR II (therapy type, route, dose, frequency and lot # were not reported) which underwent an excursion. This is one of several reports received from the same source. Additional information has been requested.
Patient was vaccinated with Pfizer #1 on 3/09/2021 (lot EN6205). She received a second invitation for vaccine in error, signed up, and was vaccinated a second time with Moderna  on 4/2/2021.  No adverse outcomes or symptoms reported;  counseled by RN that this is not preferred but is acceptable and he will not need additional vaccine. Troubleshooting: This was missed in screening and the vaccinator did not ask for shot card.
COVID like symptoms; COVID like symptoms; This is a spontaneous report received from non-contactable reporter(s) (Physician) from a sales representative.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID like symptoms".  Clinical course: It was reported that young female patient experienced COVID like symptoms after the Covid vaccine. Event experienced after the use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events.
itching all over body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching all over body) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 032M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced PRURITUS (itching all over body). On 15-Mar-2021, PRURITUS (itching all over body) had resolved.            No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.
multiple sores/lesions on her labia minora, red/purple in color; Fever; Aches; Chills; Headache; Fatigue; Nausea; This is a spontaneous report from a contactable nurse (patient). A 24-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK4176 and expiry date: unknown), intramuscular on the right arm, on 11Jan2021 18:00 at a single dose for COVID-19 immunization. The first dose was received on 21Dec2020 16:00 in which the patient experienced a small sore on the vagina. Medical history included birth control. Patient was not pregnant at the time of vaccination. Concomitant medication included ethinylestradiol, norgestimate (SPRINTEC).  After the 2nd vaccine a few days later, on 12Jan2021 18:00, patient had multiple sores/lesions on her labia minora, red/purple in color. She also had fever, aches, chills, headache, fatigue, and nausea. Patient went to gyno and she tested her, and swabbed the sores for everything you could think of and everything came back negative. Treatment was received for the event and antiviral (ValAcyclovir) in case HSV1/HSV2 swab came back positive - but they did not. Outcome of the events was not recovered. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
Muscle aches, fatigue, loss of appetite, "bubbling in stomach." Patient reported not feeling well enough to report to work.
Patient came in on 6/24/2022 at 2:00 p.m. to receive her 2nd booster vaccine which would've been a partial dose of 0.25 mg instead patient received 0.5 mg the full dose. As soon as discovered, I called the patient to make them aware and signs and symptoms to monitor for. Patient stated at the time had no side effects at 4:31 p.m. Called again on monday to see how she was doing and patient stated other than a sore arm she had no side effects.
Swollen arm, bumps around site.  Ringing in ear, sever headache and body pain, chills.  Fatigue.  Headache and ringing in the ears lasted about a week.  Fever, chills, body pain lasted about 12 hours
Hospitalized 10/2/2021; COVID-19 positive 10/2/2021; fully vaccinated  ED note: 10/2/2021 Assessment/Plan  DIAGNOSIS at time of disposition: 1. COVID-19   New Prescriptions  No new medications prescribed this visit.  ED Disposition   ED Disposition  Hospitalized MEDICAL DECISION MAKING Supervising Physician: Patient is a 72-year-old female with a history of multiple sclerosis presenting to the emergency department with shortness of breath, weakness.  She was saturating in the high 80s at her living facility and placed on 2 L oxygen transported to the emergency department.  On arrival, she was satting in the high 90s on 2 L of oxygen.  She had coarse breath sounds bilaterally.  She has chronic left-sided deficits due to her multiple sclerosis.  She is minimally communicative due to her multiple sclerosis.  I did obtain a complete blood count, CMP, chest x-ray, and COVID-19 test.  COVID-19 test was positive.  Labs were notable for white count 2.64.  Labs are otherwise unremarkable.  Chest x-ray showed no acute cardiopulmonary processes.  She is given Decadron and remdesivir.  I spoke with the on-call hospitalist was agreeable to admit the patient.  Patient is admitted to the hospitalist service in stable condition with all questions answered. 10/4/2021 note: ASSESSMENT / PLAN: No new Assessment & Plan notes have been filed under this hospital service since the last note was generated. Service: General Medicine  COVID-19 infection - Symptoms include reported fever, fatigue and anorexia - Saturating normally on room air despite reported history of desaturation at assisted living facility - Symptom onset: 10/2/21 - COVID-19 positive: 10/02/2021 - Vaccination status: 2 doses of Moderna in January and February of this year - CXR:  Cardiomegaly without pulmonary vascular congestion.  No consolidative pneumonia. - Patient is not a candidate for remdesivir or Decadron due to lack of hypoxia - Pt received monoclonal antibody infusion on 10/2 - Encourage incentive spirometry hourly - Supportive measures with antipyretics, analgesics, antiemetics and antitussives - Monitor continuous pulse oximetry - Trend BMP, complete blood count, CRP and D-dimer daily for 3 days - DC IVF.  - PT/OT/SLP 10/6/2021 note: CHIEF COMPLAINT: COVID-19 virus infection Assessment/Plan  ASSESSMENT / PLAN: COVID-19 infection - Symptoms include reported fever, fatigue and anorexia. Saturating normally on room air despite reported history of desaturation at longterm care facility. Symptom onset: 10/2/21. COVID-19 positive: 10/02/2021. Vaccination status: 2 doses of Moderna in January and February of this year - Patient is not a candidate for remdesivir or Decadron due to lack of hypoxia - Pt received monoclonal antibody infusion on 10/2 - Encourage incentive spirometry hourly - Supportive measures with antipyretics, analgesics, antiemetics and antitussives - Monitor continuous pulse oximetry Dispo: Placement back to home facility once out of isolation F/u  tomorrow
Pt volunteer fireman, called out on evening of 12/1/00, was photographer. Wasn't feeling well. Vomited at the scene. Refused treatment by EMT's. Returned home, collapsed and EMT's were unable to resuscitate.
After Pfizer COVID vaccine, patient was monitored for 15 minutes.  Upon standing up, patient complained of headache and flushing and was transported to the ER.  He  proceeded to complain of jaw pain that radiated into chest.  EKG performed was significant for STEMI.  Patient was transported immediately to cath lab and received 3 drug eluting stents to L main/ramus, LAD, and L Cx.  Other past medical history significant for hyperlipidemia, hypothyroidism, and remote history of obstructive sleep apnea.
PATIENT RECEIVED MODERNA VACCINE INSTEAD OF PFIZER VACCINE FOR APPROPRIATE AGE
light headed, nausea, a this went on for awhile and then on the 23rd of November 2010 he started having numbness and tingling in the bottom of his feet and it started moving up his legs and then he could not walk he and was in a wheelchair due to paralysis
30Jun95 Pt recv vax. Prior to vax, Pt exposed to varicella. 03Feb98 Pt devel chickenpox approx 30-40 lesions.
injection site pani; muscle pain; chills; joint pain; This is a spontaneous report from a contactable consumer. A 67-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: El9265), dose 1 via an unspecified route of administration, administered in Arm Left on 06Feb2021 (age at the time of vaccination was 67-year-old) as dose 1, single for COVID-19 immunization. Medical history included diabetes mellitus from an unknown date and unknown if ongoing, spinal stenosis from an unknown date and unknown if ongoing, hypersensitivity pneumonitis from an unknown date and unknown if ongoing, drug hypersensitivity (Penicillin) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccine prior to COVID-19 Vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. It was reported that the patient experienced injection site pain, muscle pain, chills, joint pain on 06Feb2021. It lasted for about 26 hours. No treatment was received for the events. Outcome of the events injection site pain, muscle pain, chills, joint pain was reported as recovered on an unspecified date at this time of the report.  Follow-up attempts completed. No further information expected.
Side effects were mild for all three shots; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Side effects were mild for all three shots) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) for COVID-19 vaccination.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. and third dose of TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Side effects were mild for all three shots). At the time of the report, IMMUNISATION REACTION (Side effects were mild for all three shots) outcome was unknown.            No concomitant medications were reported. It was reported that the patient took the first two Moderna shots and third booster shot with Pfizer and the patient was wondering which shot the patient should take when the patient would be eligible. No treatment medications were reported.   This case was linked to MOD-2022-570187 (Patient Link).
tested positive on binax rapid antigen test 8/26/22- asymptomatic, was tested as part of routine follow up due to known exposure from another positive resident
Itching rash with raised bump on back; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL3302), via an unspecified route of administration on 28Jan2021 12:30 at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included hypertension, seasonal allergies, arthritis, allergic to avocado, cantaloupe, water mellon. Concomitant medication included lisinopril, atorvastatin, allopurinol, loratadine. The patient experienced itching rash with raised bump on back on 28Jan2021 16:00 with outcome of not recovered. Patient didn't receive treatment for the adverse event.