chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2014US025104 is an initial spontaneous report received from a nurse on 09 Dec 2014. This report refers to a 69 year old female patient. Medical history and concomitant medication were not reported. She was vaccinate with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 19 Nov 2014. Nurse reported that patient received FLUVIRIN that was at 49 degree F 12 times over a period of 34 days. The temperature excursions began around 16 Oct 14. 12 separate temperature excursions lasting 30 minutes each in which the temperature was 46-49 degree F during each of those excursions. No adverse event was reported following this maladministration. No further information was provided.
Tested positive for COVID-19; Tested positive for COVID-19; This is a report based on the information received from a non-contactable female consumer (patient) (No. 21K-163-4037026-00).   A 69-year-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular in Feb2021 (Batch/Lot number was not reported, at age of 69 years old) as single dose, dose 1 intramuscular on Jan2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. HUMIRA subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date for psoriatic arthritis and moderate to severe rheumatoid arthritis. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced tested positive for COVID-19 in May2021. The patient underwent lab tests and procedures which included COVID-19 virus test positive in May2021. The action taken in response to the events for Humira was unknown. The outcome of events was recovered in 2021. The reporter's causality for the event(s) of Tested positive for COVID-19 with HUMIRA was no reasonable possibility.  The reporter's assessment of the causal relationship of the event with the suspect product bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up. Sender's Comments: The causal association between the suspect product BNT162B2 and the reported events Covid-19 and Drug ineffective was assessed as unrelated. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and drug ineffective is as expected. Vaccination per does not contribute to the infection of this disease, so it is difficult to attribute covid-19 infection to vaccination, so the causal relationship between covid-19, drug ineffective and BNT162B2 is considered as unlikely.
Fever 100°F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 100°F) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 014M20A) for COVID-19 vaccination.     The patient's past medical history included Palpitations and BP. Concurrent medical conditions included Drug allergy (allergy to statin) and Arthritis. Concomitant products included AZELASTINE HYDROCHLORIDE, FLUTICASONE PROPIONATE (DYMISTA), CORTISONE, LATANOPROST (XALATAN), METOPROLOL SUCCINATE (TOPROL), FEXOFENADINE HYDROCHLORIDE (ALLEGRA), ROSUVASTATIN CALCIUM (CRESTOR), METOPROLOL and DILTIAZEM HYDROCHLORIDE (CARDIZEM CD) for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced PYREXIA (Fever 100°F). On 03-Feb-2021, PYREXIA (Fever 100°F) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) High. On an unknown date, SARS-CoV-2 test: negative (Negative) Covid-19 test Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment for the event included Tylenol.   Most recent FOLLOW-UP information incorporated above includes: On 22-Mar-2021: follow-up received addition of concomitant medications, relevant history and addition of second dose; Reporter's Comments: This case concerns a 78-year-old male who experienced NS expected events of PYREXIA.  COVID-19 test negative. The event occurred 7 days after the first dose of mRNA-1273. Treatment included Tylenol. Event outcome resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Pt. c/o tremors and shaking uncontrollably, and was monitored by adverse effects  monitoring coordinator, and EMTs. Paramedics arrived, and pt. was transport to ER.
Patient had fever the morning after the vaccine also developed left axillary swelling on the ipsilateral side of he injection. Mildly tender, but improved by the time he was seen in the office the next day.
He was supposed to receive Bivalent COVID booster but received Comirnaty accidently.
rashes on arm; itchiness on arm; This is a spontaneous report from a non-contactable consumer. A 42-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730) via an unspecified route of administration in the arm on 20Mar2021 (at the age of 42-years-old), as asingle dose for COVID-19 immunisation. Medical history of the patient included diabetes. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Mar2021, after 9 days of vaccination, the patient developed rashes and itchiness on arm where vaccine was administered. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown if the patient had received any treatment for the events. The clinical outcome of the events rashes and itchiness on arm were unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Vaccination Facility Country  added, Narrative "This is a spontaneous report from a contactable consumer" updated to "This is a spontaneous report from a non-contactable consumer"; Final sentence updated to " No follow-up attempts are possible. No further information is expected".
February 16, 2022, I woke up with left facial weakness. I sent a text to my Doctor and they told me to go to the ER. I didn't feel bad, but my mouth and eyelid were drooping and she was afraid I was having stroke. I went to Medical Plaza ER and was the attending Doctor that day and so they put me through a stroke protocol. They wanted to admit me but there was no room available and I stayed overnight in the ER and the next morning they did a MRI of brain without contrast. All results were unremarkable. I had a visit via video with 2 neurologists and was diagnosed with bells palsy. I had the droop, numbness, and tingling on the left side and symptoms lasted 2 weeks. I had a mild case of it. They sent me home on Valtrex 1000 mg and I took those 3 times a day for 7 days, and prednisone 20 mg 3 tablets in morning for 7 days.
The first vaccine shot July 8th I had a little hives but after my second I had a lot of hives breaking out mainly in the crease areas breast armpits thighs and down my arms as the times gone on its now covering my arms trunk and top part of legs  it's super itchy comes and goes in different places raised bumps
Approx 20 mins post immunization, pt scratching at whelts on upper back and left deltoid area Given zyretec, Adreilun and prarmasone cream applied. Pt improved in 10 mins and rash resolved.
Left arm (deltoid region) swelling, redness, warmth 8cm area. Tender to touch.
scheduling error, patient received second dose Moderna Covid-19 vaccine 12 days earlier than was supposed to. no adverse reaction occurred.
This spontaneous report as received from a physician, via company representative, refers to a female patient (11-12 years old). In 2014 the patient was vaccinated with GARDASIL (dose, strength, site and route of administration not reported). After receiving the GARDASIL the patient fainted and fell forward after the observation period. It was not confirmed during if the patient was given any medical treatment for this adverse event. The outcome of the events was not provided. The relatedness between events and GARDASIL was not reported. Additional information has been requested.
Vaccine was administered with 5/8 inch needle, resulting in sub-q administration versus desired IM administration with 1 inch needle.
Sore and tender right deltoid, slight frontal headache and myalgia in the evening.  Slight frontal headache the next morning.
Vitilgo spots noticeable around eyes starting in May 2007, in between the second and third administration of the Hep B Vaccines.
Redness pain, and increased warmth at injection site after 24 hours-fever 102 day after infection.
Fever, joint and muscular pain, headache, chills. Receive shot at 3o?clock in the afternoon and symptoms didn?t start the show until 10 o?clock that evening.
Patient given HPV, Hepatitis B-Child, and PPD during office visit at 07:49. Patient sat down while receiving all vaccines and reported no complaints. Patient proceeded to stand up with no difficulty and walked out of clinic. Patient arrived at another clinic 10 minutes later at 07:59 and had a vasovagal syncope. Patient immediately regained consciousness and was seen by family health provider and cleared of all concerns. Patient reported history of vasovagal episodes but not with receiving immunizations.
This spontaneous report as received from a health worker about herself, refers to a female patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX23 (dosing information and route were not provided). She was vaccinated at the physician's office where she works. No other co-suspects were reported. No concomitant medications were reported. The patient experienced that the injection site was warm and sore to the touch and the nickel size area was red. No treatment information was reported. The outcome of the events is unknown. The relatedness for the events for PNEUMOVAX23 was not provided. No contact details available. Additional information is not expected.
This spontaneous report as received from a Registered Nurse refers to a 4 year old male patient. He had no pertinent medical history and no drug reactions or allergies. On 21-APR-2015, the patient was vaccinated with (Oka-Merck) PROQUAD subcutaneous (lot # reported as: K007157, dose not provided). There was no concomitant medication. On 26-APR-2015, the patient developed a rash and swelling at the injection site. Therefore the patient was seen at the unspecified physician's office on 28-APR-2015. No treatment was given and no lab diagnostic studies were performed. By the time of the report, the patient did not recovered from the events. Relatedness between the events and suspect product was not specified. Additional information has been requested.
This is a prospective pregnancy case. This 33-year-old female subject was enrolled in a study. On 8th October 2014, the subject received the 1st dose of Flu Seasonal QIV Dresden (injection). Concomitant products included no therapy (None) and Vitamins. the subject's last menstrual period was on 22nd July 2014 and estimated date of delivery was 30th April 2015. The subject received Flu Seasonal QIV Dresden at week 11 of the pregnancy and during the first trimester of pregnancy. On 8th October 2014, an unknown time after received Flu Seasonal QIV Dresden the subject developed exposure during pregnancy (Non-serious). The outcome of exposure during pregnancy was unknown. The pregnancy was ongoing. It was unknown if the investigator considered the exposure during pregnancy to be related to Flu Seasonal QIV Dresden. Additional details: Caller stated she received the FLUARIX QUADRIVALENT vaccine last week at her job, it was administered by the Employee Health Department at her job. She doesn't know the dose that was given or the lot and expiration date of the product.
she had another headache 'on a scale of 1-10 its like a 12'; she has a rash.; This is a spontaneous report from a Pfizer sponsored program support via a contactable consumer (patient). A 56-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE, for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Mar2021 for covid-19 immunisation and experienced headache and migraine-like.  After the 2nd dose the patient had another headache 'on a scale of 1-10 its like a 12'. And now, on her upper torso, she had a rash. She had taken Benadryl. The outcome was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Temporary loss of eyesight left eye.; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration, in the left arm on 26Feb2021 10:15 at a single dose (at the age of 68-years-old) for COVID-19 immunisation. Medical history included atrial fibrillation (A-fib) and gout. The patient has no known allergies. Concomitant medication included allopurinol and acetylsalicylic acid (ASPIRIN (E.C.). The patient received the first dose of BNT162B2 (lot number was not reported) in the left arm on 29Jan2021 10:15 (at the age of 68-years-old) for COVID-19 immunisation. No other vaccines were administered within four weeks. No COIVD prior vaccination. On 27Feb2021 at 11:00, the patient experienced temporary loss of eyesight left eye. The patient did not receive treatment for the event. No COVID tested post vaccination. The patient recovered from the event in Feb2021.  Information on the lot/batch number has been requested.
severe headache, fasciculations in both arms. Induration and erythema at site of injection.
On four separate occaisions, for as long as 15 minutes, my left hand became paralyzed.  This is the same arm as my shot.  The first time I called my PCP and we discussed it and she said if it happens again to let her know.  A week later, my hand became paralyzed again.   I called my HCP and they told me to go to the nearest emergency room.  I explained the relationship between the shot and the paralyzation to the health care company, my PCP, the er attendant, and the nurse practitioner.  When I was released after an hour in the ER, they hospital said they had no idea what was happening.  I asked if they would report it to the CDC.  They said anything flagged as covid related was to be sent to you.  I was not reassured that they cared about Covid or vaccine related causes.  I have the feeling that they checked me for a stroke and sent me on my merry way.  When I arrived at my ultimate trip destination, one of my clients told me she had her non-shot arm paralyze two years ago from the flu vaccine.
Information has been received from a physician concerning a 4 year old male with a history of sinus infection who in approximately 2004 was vaccinated with varicella virus live (Oka/Merck) at approximately 1 year of age. On 14-FEB-2007, the patient developed shingles in the mandibular area with 3 separate crops of vesicles on inflamed bases. Unspecified medical attention was sought. The patient was treated with acyclovir (Zovirax). No lab tests were performed. At the time of the report the patient had not recovered. Additional information has been requested.
Toothache starting with pain, then severe pain swollen sore glands red irritated gums all on right side of mouth and base of tongue  a few small blisters that broke
have been very dizzy; had significant muscle pain; swelling in the arm in which it was given; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd September 2020, the patient received the 1st dose of Shingrix. On 3rd September 2020, 1 days after receiving Shingrix, the patient experienced dizziness. In September 2020, the patient experienced muscle pain and swelling arm. On an unknown date, the outcome of the dizziness, muscle pain and swelling arm were unknown.   It was unknown if the reporter considered the dizziness, muscle pain and swelling arm to be related to Shingrix.  Additional details were reported as follows: The patient received vaccine in unknown arm. The patient experienced dizziness, significant muscle pain and swelling in the arm in which vaccine was given after vaccination. The reporter asked whether these were possible side effects of vaccine.
Patient reported to medical on 04Nov19 with complaint of dysesthesia, numbness, and tingling of extremities. Patient evaluated and instructed to RTC if Sx worsen or do not improve. Patient RTC 07Nov19 with complaint of worsening Sx, sent to Neuro for urgent consult. Seen by Neuro 11Nov19 and referred to hospital for possible Dx of GBS. Patient treated with IVIG and extensive physical therapy while hospitalized. Transferred to Rehab Facility to finish physical therapy.
On 11/07/2021, patient was feeling heart palpitations and drove himself to the hospital.  They kept him from that Sun. until Tues. doing further testing.  Hx. of anxiety, and they found elevated B/P.  They ordered an event monitor to be worn x30 days after he receives it.   Is not on any meds.  Dr. mentioned his heart inflammation could be from the vaccine.  Hx. smoking off and on.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients in her facility received doses of RECOMBIVAX HB (strength, dose, route and lot number were not provided) that may have been exposed to 9C for approximately 8 days. Concomitant medications were not provided. At the time of the report medical assistant did not have access to the vaccination records, or the lot numbers of the doses there were administered. This case is linked to cases1311USA012344 and 1309USA005768 via sane reporter link. Additional information has been requested.
Mom brought child into clinic today 3/20/08 for PPD reading and stated since 3/18/08 has not been walking. No redness or swelling at injection site (L) thigh. Seen, by provider diag with viral syndrome. Rxd ice to area, a MRI
Vaccination adverse reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was provided.
Deltoid muscle pain at injection site began D1; involvement extended to all upper arm musculature and elbow on around D3 and to distal arm around D5. Presently (D10) muscle involvement and severity is unchanged. Muscle pain is dull ache whereas injection site pain is sharp.  No swelling or redness is noted.  No fever, chills or other signs of infection, just myalgia and questionable arthralgia of joints.
Patient presented to ED on 10/11 for upper and lower extremity weakness associated with significant 2- lb weight loss. Patient reports on 10/11 that some weakness started "a few months ago", acutely worsening in the past few weeks. Patient discharged on 10/18 and symptoms were thought to be secondary to a nutritional deficiency. Patient was readmitted on 12/1 from rehab for AMS and bacteremia per rehab staff. Due to time course of symptoms sounding very acute and occurring 2 days after COVID booster, concern for possible autoimmune reaction, (AIDP, now technically SIDP). Patient received empiric IVIG x 5 days. Seen by neurology outpatient on 1/12/2023 for Guillain-Barre Syndrome follow up.
12 hours after injection experienced fever chills/ flu symptoms/ lasted 1 day.   Shortly after that some intermitent cough ( am avid runner) fatigue. On 5/2/22 tested neg for covid just curious as I had some mild symptoms. On 5/3/22 A ripid onset sore throat and dry cough that progressessed over several days. Shortness of breathe. Unable to find relief especially at night. Bronchial cough. 3 virtual visits and z pak prednizone cough pills minimal affect. Chesht xray neg. Inhaller new antibiotic. Slow progress. Urgent care on 5/14/22 Confirmed bronchial congestion O2 100percent. Difficulty clearing airway. Advised to stop antibiotic after 1 day Inhaler. Very Unusual for me. I feel like something else is occurring here. Possibly adverse reaction long haul vaccine. Still hoping to improve.
This case was reported by a other health professional via call center representative and described the occurrence of injection site reaction in a 54-year-old female patient who received SHINGRIX (batch number 424A7, expiry date 28th April 2021) for prophylaxis. On an unknown date, the patient received SHINGRIX (subcutaneous). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site reaction and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site reaction and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site reaction to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX subcutaneously, which led to intramuscular formulation administered by other route. The patient had experienced an injection site reaction (unspecified).
Syncope immediately after second vaccine was delivered. After regaining consciousness, he was unable to move for about another 5 seconds and was blanched, cold, and nauseous for several hours after. Tingling in extremities on the drive home, and nearly fainted again. Tingling in extremities still occurring during driving 19 hours later.