chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Immediate flushing and redness on face and neck; Immediate flushing and redness on face and neck; Itching; pins and needles feeling on my face mostly but and all over intermittently. Very intense and aggravating; This is a spontaneous report from a contactable consumer (patient). A 45-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 28Mar2021 12:45 (Lot Number: ER8730) as single dose (at 45 years old) for COVID-19 immunisation. Medical history included anxiety, known allergies: cats, seasonal allergies and dairy. Concomitant medications included unspecified drugs. On 28Mar2021 12:45, the patient experienced immediate flushing and redness on face and neck, itching, pins and needles feeling on my face mostly but and all over intermittently, very intense and aggravating. The events required a visit to the emergency room/department or urgent care. Therapeutic measures were taken as a result of the events included steroid shot and 72 hours of antihistamines.  The outcome of the events was not recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 18Mar2021.
I started having a sore throat on Thursday February 23, 2023, but I thought I just tired from vacation. On the 24th, I knew I was coming down with a cold, so I took a COVID-19 test and it was negative. On the morning of the 25th my symptoms started to peak. I had a fever, fatigue, sore throat, and congestion. I took a COVID-19 test that day and it came back positive. When the test came back positive, I called my doctor. They couldn't see me in the clinic, so they scheduled me a telehealth clinic with their urgent care. I called because I had a heard of Paxlovid and wanted to get on it. I was then prescribed Paxlovid. I started taking it that evening and was incredibly fatigued the Saturday and Sunday. My fever went down quickly. The remainder of the symptoms I experienced during my quarantine was congestion and fatigue.
exposure via skin contact; patient only received half or less than half of her dose/more than half of the dose leaked out; Administered pfizer instead of moderna; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPOSURE VIA SKIN CONTACT (exposure via skin contact), INCORRECT DOSE ADMINISTERED (patient only received half or less than half of her dose/more than half of the dose leaked out) and WRONG PRODUCT ADMINISTERED (Administered pfizer instead of moderna) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, the patient experienced EXPOSURE VIA SKIN CONTACT (exposure via skin contact), INCORRECT DOSE ADMINISTERED (patient only received half or less than half of her dose/more than half of the dose leaked out) and WRONG PRODUCT ADMINISTERED (Administered pfizer instead of moderna). On 08-May-2021, EXPOSURE VIA SKIN CONTACT (exposure via skin contact), INCORRECT DOSE ADMINISTERED (patient only received half or less than half of her dose/more than half of the dose leaked out) and WRONG PRODUCT ADMINISTERED (Administered pfizer instead of moderna) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant information was provided.  Treatment information was not provided.  The Clinical Manager could not provide the name of the facility where the dose was administered nor any other details. The Clinical Manager asked if the patient should have her second dose repeated and if repeated, did it matter that several days had already passed since the patient received her second dose. Consent received to be contacted by Safety. Consent to receive the information in writing.  Company comment: This report refers to a case of an underdose, syringe leak and exposure via skin contact for mRNA-1273 (lot # unknown) with no associated AEs reported.  The follow up had received and reporter said that the patient took the Pfizer vaccine but not the moderna.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  This report refers to a case of an underdose, syringe leak and exposure via skin contact for mRNA-1273 (lot no unknown) with no associated AEs reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: The follow up document received.Pt. said they took Pfizer vaccine, not moderna.; Sender's Comments: This report refers to a case of an underdose, syringe leak and exposure via skin contact for mRNA-1273 (lot # unknown) with no associated AEs reported.
Rash on back; This case was reported by a consumer via call center representative and described the occurrence of rash in a 93-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th March 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.     Additional Information: GSK receipt date: 11-MAY-2022 Reporter's comment: The patient had her first dose of Shingrix and she was now experiencing a rash on her back.  Gave medical disclaimer.  Referred to health care professional (HCP).  Spoke per package insert (PI) and content.  Provided phone number for HCP reference.  Offered after call survey. Did not consent to follow-up.
9 days after receiving first dose of Moderna Vaccine, area around injection site became itchy and soon after (within the same day) a red rash appeared. Rash is approximately   3.5"  x  2"  wide on upper right arm. Using Hydrocortisone topical cream to reduce symptoms. Rash is still apparent and very itchy 2 days after it has appeared. Hydrocortisone and gentle non-scented cleanser will continue to be used until rash disappears or for 2 additional days, whichever is sooner, and if it does not heal on its on I will be contacting my doctor for medical advice.
COVID vaccine breakthrough event. Pfizer 2/1/21 EL9265, 2/26/21 EL9267, 11/24/21 FH8030.
This spontaneous report as received from a physician via a company representative refers to a male patient in his 70's, No pertinent medical history or drug reactions/allergies were provided. On an unspecified date in 2006, the patient was vaccinated with ZOSTAVAX (dose, route and lot number not provided. No co-suspect or concomitant therapies were provided. Shortly after receiving ZOSTAVAX, approximately in 2006, the patient developed a rash on his buttocks. The physician prescribed LYRICA and VALTREX for treatment. At the time of the report, the outcome of the event was unknown. Additional information has been requested.
After shot one ( left arm) on 01/08/2021 I had severe joint and muscle pain, fevers, chills, exhaustion, nausea and shooting pain down my left arm and up to my neck and back of skull from afternoon of injection on Friday to Sunday night. I slept all weekend.  After shot two (right arm) on 02/05/21 I had all of those same reactions by early Friday afternoon. I woke up at 10:00 pm with the need to vomit. While sitting on the edge of my bath tub waiting to vomit, I fainted and fell backwards into the bathtub, hitting me head and wrenching my neck as I was wedged into the tub sideways. My son found me and roused me. I then urinated all over myself, had extreme diarrhea and vomiting x 2 rounds. I fainted a second time while sitting on the toilet with diarrhea and vomited 2x more into my bathtub.
Noticed arm was very sore.  When I checked, it was very red, swollen, heated.  The hard knot in it was the size of my hand.  Pharmacist said it was the worse he had seen and for me to take Benadryl and Advil.   As of today, 12/15/2010 it is still very red but only the size of a 50 cent coin.  That area is still very hard and some heat in it.  Will continue medication prescribed unless you notify me to do something different.
Headache (non migraine) duration 48 hours. Impaired cognition duration 36 hours.
On October 6 I experienced severe chest and back pain tht radiated into my neck and ear.  I emailed my family practice physician describing symptoms and he suggested maybe pleurisy. By the time they could see me, 2 days later, my symptoms went away.  Then again on October 18 the same symptoms reappeared and were much worse this time.  I ended up and went to the ER and was transerred to another hospital because they CT Scans and were not sure if Pericarditis or Aortic dissection.  Upon further testing it was determined Pericarditis.  The NP suggested that I report this as a possible adverse reaction because when I got my booster shot (3rd) vaccination, my left arm was extremely painful up into my next, chest and scapula area and since the vaccination was only 7 days prior to my first ill event they said we shouldn't assume anything and just send information for your evaluation.
Immunocompromised; A spontaneous report was received from a consumer, concerning a male patient of unspecified age, who received Moderna's COVID-19 vaccine and experienced an immunocompromised event.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 23-Jan-2021, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) via unknown route for COVID-19 infection prophylaxis.  On an unspecified date, after first dose of vaccine, the patient was immunocompromised. No treatment medication was reported.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event, immunocompromised was considered unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
This spontaneous report was received from a nurse practitioner via physician via Pfizer refers to a currently 70 years old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, anatomical location, route, lot# and expiry date were not reported) for prophylaxis. On an unknown date, the patient experienced allergy while on therapy with PNEUMOVAX 23. The outcome of the event was unknown. The causal relationship between the event of drug hypersensitivity and the therapy with PNEUMOVAX was related.  This case is related to case# 1902USA003392 (Same patient link).
This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 51-year-old female patient who received FLULAVAL quadrivalent (batch number H33J2, expiry date May 2016). On 13th October 2015, the patient received FLULAVAL quadrivalent. On 13th October 2015, less than a day after receiving FLULAVAL quadrivalent, the patient experienced injection site pain. On an unknown date, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site pain and injection site swelling were unknown. It was unknown if the reporter considered the injection site pain and injection site swelling to be related to FLULAVAL quadrivalent. Additional details were provided as follows: This case was reported by a other healthcare professional, who herself was the patient. On 13th October 2015, less than a day after receiving the vaccine, the patient experienced injection site burning (injection site pain). In October 2015, less than a month after receiving the vaccine, the patient subsequently experienced swelling at the injection site (left deltoid). The pain was keeping the patient awake at night and some soreness remained. This case has been linked to 3 other cases US2015150874, US2015150886 and US2015150888, reported by the same reporter. All the patients were concerned about there being an issue with FLULAVAL quadrivalent  vaccine and or lot number of the vaccine.
Patient was at Clinic 11/22/2022 with mom for injection/s. Noticed after patient left while documenting that Pfizer BioNTech Bivalent was given instead of recommended Pfizer BioNTech Monovalent. Discussed with stated appropriate forms need to be completed AND patients parent/s needs to be notified of situation and that no harm done. Notified. Interpreter for patient.  Tried to call patient's mom x 2 tries today, but interpreter stated person "can't receive call at this time".   RN, if she can try to get a hold of mom tomorrow since I am out of Clinic. RN agreed  to try mom tomorrow and message sent to team.
a loss of smell; some minor pain in the arm in the injection; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on arm on 06Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient received the first injection of Pfizer COVID-19 vaccine on 06Jan2021. He experienced some minor pain in the arm in the injection on unspecified date in Jan2021. About two days after the injection on 08Jan2021, he experienced a loss of smell. He reported that the loss of smell has gradually come back and is not as bad now. The outcome of the event a loss of smell was recovering while unknown for the other event.  Information on the Lot/Batch number has been requested.
pt recvd vax & later monitor alarmed for apnea; which mom was required to do 4 rescue breaths to revive pt; MD observed pt in hosp 24 hrs w/no more apnea;
Patient was given the vaccine on Monday 1/21/087.  Upon waking on 1/22/08, we noticed welt over 2 inches in diameter at the site of the shot- his left thigh.  I called the Dr. office and was assured that a side effect can be redness and swelling.  There was little discomfort.  Upon waking on Wed 1/23, patient was in a lot of pain and there was another red mark surrounding the original welt.  The new mark was almost 5 inches in diameter.  I brought him to the Dr.s office immediately and he was seen by Dr.  I had given patient children's Motrin, but it did nothing to mask his pain.  The welt was HOT to the touch.  I was told to wait and see if it continued to get worse or if it hardened.   I called the Dr.'s office that afternoon to see if I could give patient an adult form of ibuprofen as he is 97lbs and was extremely uncomfortable.  The Dr.s office decided to prescribe codeine and to start an antibiotic as codeine can mask signs of infection.
This case was reported by a consumer via call center representative and described the occurrence of burning sensation in a 67-year-old female patient who received SHINGRIX for prophylaxis. On 29th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a week after receiving SHINGRIX, the patient experienced burning sensation, weakness, sickness, headache, increased skin sensitivity, feeling cold and fever. On an unknown date, the outcome of the burning sensation, weakness, headache, increased skin sensitivity, feeling cold and fever were unknown and the outcome of the sickness was recovered/resolved. It was unknown if the reporter considered the burning sensation, weakness, sickness, headache, increased skin sensitivity, feeling cold and fever to be related to SHINGRIX. Additional details were provided as follows: The patient developed a fever and headache initially. The patient at the time of reporting described that she got a burning sensation in her hands that comes and goes. She had cold sensations and nerve sensations in her legs. She felt weak and she no longer had the harmonious hum in her brain that she had prior to the vaccination. The patient said that she had been sick for six days. The patient had denied permission to contact their physician. The reporter was unable to obtain additional information.
sore arm, fatigue, chills Narrative: Patient self reported sore arm, fatigue, chills post vaccine (2nd dose). Pt did not treat with any medication. Symptoms resolved.
60 year old female experienced increasednheart rate and SOB 8 minute after receiving vaccine, Patient is on 4 liters of 02. History of COPD & pulmonary hypertension, on list for lung transplant. EMS called
This spontaneous report has been received from a Licensed Practical Nurse refers to an unknown amount of patients of unknown age. Medical history and current condition of the patients were not reported. The nurse stated that the unknown amount of patients were vaccinated with improperly stored GARDASIL (lot # K006117, expiry date 14-JAN-2017), (dose, route unspecified) from September 2014 till January 2015. No adverse effects reported. No product quality complaint (PQC) reported. Additional information has been requested.
Joint pain (left leg); Fever up to 38.9 Centigrade; Chills; Myalgia; This is a spontaneous report from a contactable physician (patient). A 38-year old male patient received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. el3302) intramuscularly, in the right arm, at single dose, on 10Jan2021, at 09:45 AM, for COVID-19 immunisation. Relevant medical history included asthma and known allergies to penicillin, and diphtheria vaccine. Concomitant medications were unknown. The patient had not received any other vaccines within 2 and 4 weeks prior to the BNT162B2 vaccine. The patient previously, on 20Dec2020 at 10:00, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. el3302) intramuscularly, in the right arm, at single dose, for COVID-19 immunisation. On 10Jan2021, 09:00 PM, the patient experienced fever up to 38.9 Centigrade, chills, myalgia and joint pain (left leg). The patient was treated with Tylenol. COVID was not tested prior and post vaccination. The patient recovered from the events on an unspecified date, in Jan2021.  No follow-up attempts are possible. No further information is expected.
Sudden onset of lightheadedness, vomiting, chills. Followed by 101 temperature and severe whole body ache. Medicated in ER with Zofran, Tylenol and Toradol. Symptoms subsided except for fatique and headache for the next 18 hours.
The pt experienced knee pains, weakness of legs, muscle soreness in legs, falling, limping, and a back ache. Diagnosed with Guillain Barre Syndrome.
sweaty, faint BP 86/50 P 60 hydration and snacks BP 96/68
sore arm; This is a spontaneous report received from a contactable consumer (patient). This consumer reported that a patient of unspecified age and gender received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included rheumatoid arthritis, chronic fatigue, and hasimotoes disease. There were no concomitant medications. The patient stated that received both covid-19 vaccinations with minimal side effects, sore arm.  Outcome of event was unknown.   No follow-up attempts are needed. No further information is expected.
We have some Moderna Covid-019 vaccine that was given after the expiration date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.). On 03-Nov-2021, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medication was reported. Treatment information were not provided.
Severe yawning with quaking/shivering in chest, likeness to shivers from waking from anesthetic. Chills, severe headache. Felt like brain lining was swelled. Fever with goosebumps. Lasted approximately 10 hours.
she had issues with the monovalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (she had issues with the monovalent vaccine) in a 52-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (she had issues with the monovalent vaccine). At the time of the report, IMMUNISATION REACTION (she had issues with the monovalent vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  No treatment medications were provided by the reporter.   This case was linked to MOD-2022-674372 (Patient Link).
Person was given multiple vaccines from varies vaccine sites according to Vax Information.  Received 3 J&J vaccines -- 6/1, 6/19, 8/6.  Two Moderna vaccines -- 6/26/21 & 7/9/21.  Also received two Pfizer doses: 05/24/21 & 06/11/2021.  No contact made with the person vaccinated at this time.
No additional AE details.; Physician assistant calling to report PROQUAD administered to patient too early. First dose given 2/22/2022. Second dose given 4/6/2022.; This spontaneous report as received from a physician assistant refers to a patient of unknown age and gender. Patient's concomitant medications, pertinent medical history, concurrent conditions and drug reactions/allergies were not reported.  On 22-FEB-2022, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, strength, route of administration, expiration date and lot number were not reported) for prophylaxis.  On 06-APR-2022, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, strength, route of administration, expiration date and lot number were not reported) for prophylaxis (inappropriate schedule of product administration). The vaccine was reconstituted with sterile diluent (STERILE DILUENT) (dose, route of administration, lot number and expiration date were not provided). The physician assistant also had follow-up question in regards to whether the patient was considered fully vaccinated. No additional adverse event (AE) details (no adverse event). No product quality complaint (PQC).
Pt received Tdap administred 4/18/16, IM L deltoid. She called on 4/21/16 at 11:32 am to report 2x2 circle redness at site, warm to touch, slight swelling and achy.
pt woke up 430AM w/swollen rt jaw, cheeks, neck, behind ears, glands; hard to touch, pinkish color; today it feels mushy to touch; can't see ear; seen by MD;