chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen lips; Itchy throat; Fever; This is a spontaneous report from a contactable healthcare professional, the patient. A 45-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191) via an unspecified route of administration in the left arm on 10Aug2021 (at the age of 45-years-old) as a single dose and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 03Sep2021 at 15:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to shell fish. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included paroxetine hydrochloride (PAXIL) and THRIVE vitamins; both for unknown indication from unknown date and unknown if ongoing. The patient previously received acetylsalicylic acid (ASPRIN) for unknown indication on unknown date and experienced drug allergy. On an unknown date in 2021, the patient experienced swollen lips, itchy throat and fever. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events swollen lips, itchy throat, fever was resolved on an unknown date in Sep2021.
grandmother reports pt was playing & suddenly @ 450PM was noted to have swollen neck, turned white, then black & became limp; seen by MD was cyanotic, not breathing, convul, t104; tx w/APAP; started breathing & convul stopped;
Pharmacist stated that a patient received their first dose of Shingrix three years ago.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 3 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Pharmacist stated that a patient received their first dose of Shingrix three years ago.). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date:10-NOV-2023 Caller declined to provide more information. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Patient presented with acute onset of SOA, CP, ab pain, N/V sepsis 2/2 probable prostatitis. Treated for prostatitis. COVID PCR positive on 11/4. Discharge Disposition/Condition. Disposition: Home. Condition: Stable (s/sx potential problems absent or manageable)
Hot; itch; hive; Swollen; red; soreness; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness), VACCINATION SITE WARMTH (Hot), VACCINATION SITE PRURITUS (itch), VACCINATION SITE URTICARIA (hive) and VACCINATION SITE SWELLING (Swollen) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no historical condition was reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN (soreness) and VACCINATION SITE PAIN (Sore arm). On 21-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot), VACCINATION SITE PRURITUS (itch), VACCINATION SITE URTICARIA (hive), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE ERYTHEMA (red). At the time of the report, PAIN (soreness), VACCINATION SITE WARMTH (Hot), VACCINATION SITE PRURITUS (itch), VACCINATION SITE URTICARIA (hive), VACCINATION SITE SWELLING (Swollen), VACCINATION SITE PAIN (Sore arm) and VACCINATION SITE ERYTHEMA (red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  An elderly male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in right arm for COVID-19 immunization. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "crohns" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective received Paxlovid .  Clinical course: Patient had not known allergies. Patient anti-viral medication included Paxlovid (oral) for COVID-19 Treatment. Treatment started on 08Aug2022 and stopped on 13Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) cannot be ruled out.
Subsequently post vax, the pt experienced isolated left flank muscle pain. A doctor visit was required. He was treated with an anti-inflammatory, which did not improve his symptoms.
Expired Havrix administered; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 18-month-old female patient who received HAV (Havrix) (batch number T57F3, expiry date 15th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th February 2023, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 20th February 2023, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-FEB-2023 Reporter's Comment: The reporter was a physician. The reporter reported that the 18 months old patient received an expired dose of Havrix vaccine. The reporter did consent to follow up. Additional supportive information: The patient received a Havrix which was already expired, which led to expired vaccine used.
20AUg98 was OK when getting vax;hypertonic sz;pt stated was sl dizzy;eyes rolled back, arms curled up;incontinence;Bp 120/80;
chills and fever started around 2:30am, shivering occurred for an hour and a half
Upon administration of vaccine (1252pm) patient stated she felt dizzy. Patient moved to high observation area. Vs 118/73 hr 60 sat 99%.Lead nurse made aware and medical director on call advised patient clear to go. Left with no acute distress.
Lightheaded during the day, dizzy spells upon laying down and getting up, foggy headed. Started about 24 hours after shot.
This case was received from a health professional in the United States on 08 June 2007. An 18-year-old male patient with a medical history of ADHD had received an intramuscular injection of Adacel (lot number C2730AA) and Menactra (lot number U2181AA) on 17 May 2007 and 14 days later he developed cervical and thoracic myelitis. The patient, who had developed a viral illness on 30 May 2007, developed symptoms of ascending motor neuropathy on 31 May 2007. On 01 June 2007 he was hospitalized and underwent and underwent a brain scan, spinal cord MRI, and lumbar puncture, in addition to laboratory testing including CBC and electrolytes (results were not provided). He was diagnosed with cervical and thoracic myelitis, and was discharged on 06 June 2007. According to the reporter, the patient was recovering at home but continued having symptoms of sensory neuropathy and motor neuropathy in the legs. The patient was not ill at the time of vaccination, and had no known allergies; concomitant medication included dexamphetamine.  07/02/2007 MR received for hospital admission on 6/6/07 for an ascending motor neuropathy.  Pt had URI symptoms x 1 week and then developed increasing weakness of the lower extremities with difficulty walking 2 days prior to admission. He also described sensory symptoms which felt like sunburn or chaffing on the chest, and altered temp sensation. Pt seen in ER and discharged for c/o vomiting 2 days prior to admission.   PE significant for difficulty walking and inability to walk on balls of feet or stand on heels. Unable to squat and stand. LE DTRs 4+/3 with sustained clonus in L ankle. Neurology consult with DX of viral myelitis. Pt remained stable during hospitalization. D/C DX: Myelitis, probable post-viral. ADHD. Pansinusitis. 07/16/2007 F/U offive visit 6/18/07 with significant improvement noted.  Walking improved.  Patellar DTRs 4+/3 L>R. Assessment:  Probable post-viral myelitis
I had a fever 101 degrees Fahrenheit when i woke up.; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (I had a fever 101 degrees Fahrenheit when i woke up.) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PYREXIA (I had a fever 101 degrees Fahrenheit when i woke up.). At the time of the report, PYREXIA (I had a fever 101 degrees Fahrenheit when i woke up.) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jan-2021, Body temperature (Unknown-101): 101 degrees (High) 101 degrees.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Injection site left upper arm. Area warm to touch swollen site 16cmX15cm. Also had generalized body aches sore neck and upper back.
Bilateral shoulder pain after first shot After second shot developed significant joint swelling in fingers, hands, wrists. Continued with significant pain in shoulders. Approx 1 month later developed significant pain and stiffness in knees. This pain and stiffness has continued, as well as swelling in hands and fingers.
swelling right under the arm (mentioned axilla); This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on unspecified date at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced swelling right under the arm (mentioned axilla) on an unspecified date. The outcome was unknown.    Information about batch/lot number has been requested.
this was my third dose; this was my third dose; I can''t walk; something happens at top of my right foot there''s a big fluid sac on top of my right foot and it''s very painful; I can't walk; something happens at top of my right foot there's a big fluid sac on top of my right foot; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received third dose of bnt162b2 (BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number EW0191, Expiry date were not reported) via an unspecified route of administration, administered in left arm on 13Sep2021 (at the age of 65-year-old) as dose 3 (booster), single for COVID-19 immunization (Clinic). The patient medical history included Crohn's disease, high blood pressure, low potassium, and high cholesterol. The patient concomitant medications included ustekinumab (STELARA) taken for Crohn's disease, Potassium taken for low Potassium, Atenolol for high blood pressure, losartan potassium (COZAAR) taken for heart and atorvastatin calcium (LIPITOR) for high cholesterol. The patient previously received first dose and second dose of bnt162b2 (BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiry date were not reported) via an unspecified route of administration on an unspecified date (at the age of 65-year-old) for COVID-19 immunization. On an unspecified date in Sep2021, the patient experienced I can't walk, something happens at top of my right foot there's a big fluid sac on top of my right foot and it's very painful. Patient had reported that no treatment was taken for the events. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
immed p/vax pt became apneic w/peri-oral cyanosis;pt recovered w/tactile stimulation;
1/23/14 Vaccine given. 1/20/14 Consult for headache and H. pylori - started clarithromycin and NEXIUM 1/23 - started Amoxicillin 1/20/14. 1/25/14 Started diarrhea and twitching of muscles. 1/27/14 To emergency low potassium (3.0 mEq/L).
Patient received one dose of Pfizer after receiving one dose of Janssen in March 2021. The patient intentionally misled the pharmacy to receive this vaccine based on a study the patient read in order to boost his immunity,
Abdominal pain, epigastric and periumbilical. Worse over 24 hrs. Took over 48 hrs to resolve
Puffy/swelling in her face; she has blotchy rashes on her face/Red blotches/hives to her face; it is itchy/ itchiness to face; This is a spontaneous report from a contactable consumer (patient). A 51-years-old female patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EM9810) via an unspecified route of administration, administered in Arm Left on 08Feb2021 16:45 (at the age of 51-years-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date not reported), via an unspecified route of administration in an unspecified anatomical location on 18Jan2021 as single dose for COVID-19 immunization. On 09Feb2021 18:30 the patient experienced she has blotchy rashes on her face/red blotches/hives to her face, it is itchy/ itchiness to face, On 10Feb2021 05:30 the patient experienced puffy/swelling in her face. Therapeutic measures were taken as a result of she has blotchy rashes on her face/red blotches/hives to her face, it is itchy/ itchiness to face, puffy/swelling in her face. Patient stated she has blotchy rashes on her face and has taken Benadryl because it is itchy and put some itch cream on it and asked if this is a common symptom. The outcome of event was not Recovered.  Follow-up attempts completed. No further information expected.
Mild body aches and fatigue started at 10:00 pm, approximately 11 hours after injection. Next morning body aches and fatigue increased, generalized ill-feeling, also with joint achiness.   Surface swelling, redness and warmth with approx 4 inch circumference at site of injection.  Painful to move arm that had injection; raising arm above shoulder level (over head) extremely painful, almost impossible. All symptoms fading after 48 hours.  All symptoms resolved within 72 hours except warmth and tenderness at injection site.  Injection site back to normal without symptoms 7 days after injection.
Normal labor and delivery on 12/27/2021. Hospital admission within 6 weeks of receiving the COVID vaccine.
This spontaneous case, received from a pharmacist on 15-Oct-2018, (initial and follow-up 1 combinedly processed) concerns a 33-Year-old, adult female patient. On an unspecified date, FLUCELVAX QIVc was stored at a maximum temperature of 56 F for 8 hours following a power outage (explicitly coded as incorrect product storage). On 13-Oct-2018, the patient was administered FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252668 and expiry date: 30-Jun-2019) which was stored inappropriately (explicitly coded as drug administration error). At the time of this report, no adverse event was reported. The reporter assessed the case as non-serious. This case 201804538 was cross-linked to source case: 201804533 due to same reporter.
Pt. developed large inflamed, red area around injection site approx. 4" in diameter - "cellulitis" - which required pt. to seek medical attention and go through a course of Azithromycin 250 mg. Condition resolved after tx.
Patient became pale, sweaty, nauseous and was not wanting to talk with staff.  Patient was slumped over so it was difficult to get an accurate BP reading. At approximately 5:30 pm, the patient took a few sips of water.  See the following timeline: 5:08 pm--cold pack applied to back of neck 5:13 pm--BP65/38 5:16 pm--BP 82/48 5:18 pm--BP 78/55 5:23 pm--BP errored 5:25 pm--BP 85/55 5:30 pm--BP 87/62 5:40 pm--BP 81/58 5:48 pm--BP 91/54 5:54 pm--BP 100/75  Patient left with brother and father.  Tried to call patient at 7:30 pm, but left a voicemail.
11/22/04: approximate time 18:00 pm Fluzone 0.5IM given deltoid; employee reported 12 hours later, she developed rash and itching starting with her feet. She also reported this incident 12/2/04. Self medicated Benadryl and Medral dose
104.5 fever that was difficult to control even with medication. 10-28-09, anal/vulva pain in evening.  10-30-09, anal fissures, anal/vaginal inflammation documented.  11-07-09, high 104.5 fever (muscle aches, headache previous day) 11-09-09, ulcers became more pronounced and numerous, small blisters and a raised nickel-sized area. (9 ¼ month interval from presentation of first ulcers) 9-16-10, She was seen for pain at the introitus; she was referred to facility with a diagnosis of vulvodynia which I was told progresses to vaginismus.  OBGYN also wanted her tested for leukemia.  However, paperwork was not forwarded by OBGYN and the appointment became focused on her history of vulva ulcers.  An internal exam was performed at a follow-up appointment at U of M.  Her pain had diminished to a 1-2 pain at the introtitus.  She felt level 10 pain with tears as the cervix was viewed via a small speculum.  Cervix and wall tissues were described as normal.   (almost an 8 month interval) 5-1-11, ulcers on the vulva following a high fever with vomiting.   Before ulcers were fully erupted, she was seen at facility.  Blood was tested for Syphillis, Chlamydia, Gonorrhea, HSV, HIV, Hepatitis B, EBV, and CMV; all were negative.   The ulcers coalesced and were the worst she has experienced; they were large, deep, and oozed white-yellow pus. Healing took almost three weeks and some tissue did not fill-in completely. (8 month interval) 12-29-11, muscle aches and pains 12-30-11, vomiting, 103.5 fever 12-31-11, ulcers, multiple small and medium ulcers on the vulva presented with green edges and black centers before fully erupting, followed by smaller blisters at the introtitus.
Large Local reaction to injection site.  Warm to the touch.  Swelling was 11 x 9 cm.
Information has been received from a physician concerning a female patient (age and demographics not reported) who on 01-Dec-2006 was vaccinated with the first dose of HPV  vaccine (yeast) (Lot# not reported). On 01-Dec-2006 immediately after being vaccinated the patient developed widespread hives. No respiratory difficulty was noted. The patient was transported to the emergency room for evaluation and was not admitted to the hospital. At the time of this report the patient had not recovered from the hives. Additional information has been requested.
Approx. 4 1/2 hours after vaccine noted "Something wrong in throat". 7 hrs after vaccine "lips tripled, tongue felt as if recovering from Novocain". Following morning, lips still a little tirply and felt loopy". Went to ER -Rx with Nebulizer IM  steroid
Information has been received from a registered nurse concerning a 2 month old patient who on 09-OCT-2007 and 10-OCT-2007 was vaccinated PO with 2.0 ml doses of ROTATEQ vaccine live (human-bovine). No adverse experience was related to this event. It was unknown whether medical attention was sought. There was no product quality complaint. Additional information has been requested.
Worse asthma than usual for several hours, but not so bad that I had to use my rescue inhaler. At noon I had severe pain the entire length of my right arm, and I felt drowsy so I fell asleep for several hours and the pain in my arm was moderate and restricted to injection sight when I woke up. I went to bed at 10 pm and woke up at 1 am with diarrhea. I spent the the next hour having a few diarrhea bowel movements. On 3/20 my right arm was still in moderate pain and injection site was swollen and red. At 8 am I woke up with a headache and so I went back to bed. By afternoon I had the chills and went to bed for another nap and when I woke up the chills were gone. On 3/21 my right arm still had moderate pain. On 3/22 I had another bout of diarrhea for one bowel movement, and my arm pain was still moderate. On 3/23 the swelling and redness at the injection site went away but the area is still slightly tender to the touch on 3/25. On 3/25 at 1 am I was in bed trying to sleep, but I kept having intense dizzy spells that lasted 3-4 hours.
This case was reported by a physician via a medical assistant and described the occurrence of blood in stools in a 2-month-old male subject who was vaccinated with live attenuated ROTARIX, (GlaxoSmithKline).  Concurrent vaccination included HIB, (Sanofi), PEDIARIX, (GlaxoSmithKline) and PREVNAR, (Wyeth Labs) all given on 8 February 2010.  There were no concurrent medications.  On 8 February 2010 at 11:00 the subject received 1st dose of ROTARIX (oral).  On 9 February 2010, 1 day after vaccination with ROTARIX, the subject experienced diarrhea around 12:00 with blood in stools.  At the time of reporting the events were unresolved.
I felt tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (I felt tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heart valve replacement (artificial heart valve).   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced FATIGUE (I felt tired). At the time of the report, FATIGUE (I felt tired) outcome was unknown.            It was reported that, the patient did not have her vaccination card with her and it was at home. She also stated , she had an artificial heart valve and her cardiologist wants her to have the booster dose.  No concomitant medications were reported.  No treatment information was reported.   This case was linked to MOD-2021-378196 (Patient Link).