chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Large red spot (3 inches wide and circular/oval) at site of vaccine injection. Showed up 1 day after the vaccine and then, also, 1 week and 1 day after injection following a workout that included shoulder muscle training.
Nausea; fast heart rate; low grade temp (99.4-100); headache; body aches; soreness at site; This is a spontaneous report from a contactable Nurse (patient herself). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 13:00 (Lot number: EK5730) at SINGLE DOSE (first dose, left arm); and via an unspecified route of administration on 07Jan2021 13:00 (Lot number: EK9231) at SINGLE DOSE (second dose, left arm) for COVID-19 immunization. Medical history included hypertension, high cholesterol, Graves disease, and Known allergies: Sulfa from an unknown date and unknown if ongoing.  The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 since vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received the vaccine at hospital. Concomitant medication included hydrochlorothiazide, atorvastatin, amlodipine from unspecified dates for unspecified indications. The patient experienced nausea, fast heart rate, low grade temp (99.4-100), headache, body aches, soreness at site on 08Jan2021 06:00. The patient underwent lab tests and procedures which included temp 99.4-100 and heart rate fast on 08Jan2021. Treatment was not received for adverse events. Event outcome was recovering. The reporter assessed the events as non-serious.
The Pfizer vaccine diluted with sterile water instead of normal saline and administered to the patient.
caught covid 10 days after booster dose; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (caught covid 10 days after booster dose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061F22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 1, Lot Number:EM9810) on 05-Feb-2021, PFIZER BIONTECH COVID-19 VACCINE (Dose 3, Lot Number: FF2588), PFIZER BIONTECH COVID-19 VACCINE (Dose 2 and Lot Number:EN6205). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    In April 2022, the patient received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2022, the patient experienced COVID-19 (caught covid 10 days after booster dose). At the time of the report, COVID-19 (caught covid 10 days after booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received the additional booster around 15-Apr-2022 and had COVID-19 vaccine, 10 days after the booster dose. The patient received the last booster as Moderna bivalent on 22-Oct-2022.  The concomitant medication was not reported.  The patient received the fourth dose of Moderna vaccine with batch number as 005M21A.  The treatment medication was not reported.
12/9/2022 Informed that resident that they received a second Bivalent Modern vaccine today.  First Modern Bivalent vaccine was administer on 9/23/22 at another location.  Vaccine card presented during clinic did not indicate that the vaccine administered  on 9/23/2022 was a Bivalent Modern vaccine.    Patient received a second dose of Moderna Bivalent during our clinic.  Patient was called when error was discovered approximately two hours later and informed of medication error.  Pt stated he had no reactions and felt well.     12/12/2022    Pt called once again today to check for vaccine reaction. No reaction reported, patient feeling well.
Vaccine administered on Wed. 10/20/10. When I had occasion to raise arm (L) to shoulder height it felt like it was sprained. Lasted at least 7 days.
Extremely enlarged axillary and mammary glands with postmenopausal bleeding on days 2,3 and 4 following vaccine. Returned to normal by day 6.     Follow up pelvic ultrasound to be done- not yet completed.
This case was reported by a nurse via call center representative and described the occurrence of redness of legs in a patient who received FLULAVAL Quadrivalent. On an unknown date, the patient received FLULAVAL Quadrivalent at an unknown dose. On an unknown date, unknown after receiving FLULAVAL Quadrivalent, the patient experienced redness of legs and swelling of legs. On an unknown date, the outcome of the redness of legs and swelling of legs to be related to FLULAVAL Quadrivalent. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported that a pediatric patient had an adverse reaction included redness and swelling from knee to thigh. The reporter did not currently have the patient demographics or vaccine information, but would be available to get the information. The healthcare professional would be submitting follow up with more details. This was one of 4 cases, reported by same reporter for same events.
patient alleges she developed a rash on her neck within 1 hour of COVID (Pfizer) vaccination
itchiness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 026L20A) for COVID-19 vaccination.     The patient's past medical history included Guillain Barre syndrome since an unknown date.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced PRURITUS (itchiness). At the time of the report, PRURITUS (itchiness) outcome was unknown.            No relevant Concomitant medications were reported.   No Treatment information for the event was provided.    This case was linked to MOD-2021-030578 (Patient Link). This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Mar-2021 and was forwarded to Moderna on 01-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 026L20A) for COVID-19 vaccination.     The patient's past medical history included Guillain Barre syndrome since an unknown date.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced PRURITUS (itchiness). At the time of the report, PRURITUS (itchiness) outcome was unknown.            No relevant Concomitant medications were reported.   No Treatment information for the event was provided.    This case was linked to MOD-2021-030578 (Patient Link).
Itchy rash appeared on underside of both forearms continues n itchy rash on upper chest, itchy spots on top of feet, on top of toes, on top of hands and fingers, a few spots on face, a few spots on upper arms.; Tiny spot near two moles on underside of left forearm.; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the arm left on 11Mar2021 at 14:15 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, allergy and poison ivy rash. Concomitant medications included fluticasone propionate (MANUFACTURER UNKNOWN), fluticasone propionate, salmeterol (MANUFACTURER UNKNOWN) and loratadine (MANUFACTURER UNKNOWN), all from an unknown date for an unknown indication. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the arm left on 18Feb2021 at 14:15 as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10May2021, the patient experienced itchy rash appeared on underside of both forearms. About four days earlier it started with a tiny spot near two moles on underside of left forearm on 06May2021. Itchy rash continues on forearms till 17May2021, but includes an itchy rash on upper chest, itchy spots on top of feet, on top of toes, on top of hands and fingers, a few spots on face, a few spots on upper arms. It was not poison Ivy but she had poison Ivy before and it reminds her of it, except the itchy rash and bumps just stay as was, no evolving into crusty/painful areas. So this was not poison Ivy, but the itch was similar. She had not gone out of her house at all prior to this rash starting so that's why she thought it could be related to the COVID vaccine. It was worth noting this was right at high allergy season there, and in the past she had allergy shots for 5 years. She stopped the shots a few years ago, but continued to take: fluticasone propionate nasal spray, fluticasone propionate & salmeterol, loratadine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of these events. The clinical outcome of the events itchy rash and spot like rash was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient presented to the ED and was subsequently hospitalized for 3 days on 1/9/2021. On 1/21/2021 he presented to the ED with rash and hypertension. On 1/23/2021 patient presented to the ED and was subsequently hospitalized for 6 days for SIRS.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. Information on patient's pertinent medical history, drug reactions/ allergies and concomitant medications were not provided. On 23-NOV-2015, the patient was inadvertently vaccinated with PROQUAD (Merck) (lot # L033698, expiration date 28-FEB-2016) (route, strength, dosage and frequency were unreported) and a dose of VARIVAX (Merck) lot #K010439 and expiration date 28-FEB-2017 (route, strength, dosage and frequency were unreported). No adverse effect reported. No product quality complaints were reported. Additional information has been requested.
red mark at injection site; a massive swelling at the injection site/Patient described it as a "bump; red welt reaction from the vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 73-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included pneumonitis and ground glass opacity on chest x-ray (Grown Glass Opacity in the right lung).   On 07-SEP-2023 14:30, the patient received Arexvy (intramuscular, left arm). On 08-SEP-2023, 1 days after receiving Arexvy, the patient experienced erythema urticarial (Verbatim: red welt reaction from the vaccine). On an unknown date, the patient experienced injection site erythema (Verbatim: red mark at injection site) and injection site swelling (Verbatim: a massive swelling at the injection site/Patient described it as a "bump). The outcome of the injection site erythema was not resolved and the outcome of the injection site swelling was resolved and the outcome of the erythema urticarial was not reported.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Arexvy. The reporter considered the erythema urticarial to be related to Arexvy.     It was unknown if the company considered the injection site erythema and injection site swelling to be related to Arexvy. The company considered the erythema urticarial to be related to Arexvy.   Additional Information: GSK Receipt Date: 18-OCT-2023 The reporter was a patient. The patient reported that she received Arexvy vaccine 6 weeks ago from reporting day, and the next morning she had a big red welt reaction from the vaccine. Patient described the size of the redness of about 4 inches in circumference. Patient reported a massive swelling at the injection site which described as bump. Patient reported that the swelling and the bump had decreased but and the redness was now a pink color that had not disappeared. The reporter consented to follow up with the pharmacist at the vaccination facility.
Pt recvd vax & 2 days later exp stomach pains, tiredness, cold-lke sx, burning eyes, coughing, pimple on lt arm, pink mucous, felt cold & yellow phlegm; dx sinus infect;
Initial report received from a consumer via the marketing program TOBI care on 14 Feb 2011: This patient started to receive TOBI at 300 mg on an unknown date for CF (cystic fibrosis) and seasonal influenza vaccine (manufacturer and batch number unknown) at an unknown dose on an unknown date for an unspecified indication. It was reported that, the patient had flu shot this season but feels he might have flu now. The outcome of the event was not reported.
Developed low grade fever on 07/01 and 07/02, then became very irritable for entire week. Not sleeping well, clingy, cranky, not acting like herself, not smiling. Developed rash on face on 07/07 and on back on 07/08. Was given Tylenol but vomited meds. Examined on 07/09/02-fully, hard nodules on thighs, less interactive. Rest of exam-nl.
Pt. sated "I started feeling a metallic taste 20 minutes after getting vaccinated."  Vital signs done.  BP 136/84, O2 Sat 98%, HR 62, R 16, glucose 102.  At 4:10pm pt. stated, "The metallic taste is going away, I feel ok to go home."  At 4:12pm pt. went home with family members.
No additional AE reported.; Improperly stored vaccines were administered; This spontaneous report was received from a registered nurse concerning a 25-year-old female patient. The patient's medical history, concurrent conditions, and concomitant medications were not provided.   On 21-MAY-2022, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (rHA) (M-M-R II) lot # U007684, expiration date 09-MAR-2023, for prophylaxis (Dose, route of administration, and anatomical location were not provided); which was improperly stored at 13.8 Celcius degrees for 7 hours and 30 minutes (Product storage error). No additional adverse events were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA007635: US-009507513-2205USA007519: US-009507513-2205USA007519:
administered past the 30 day refrigeration time; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) to be possibly related.    No concomitant medication was provided.  First shot info: Expiration date: 31OCT2021, Date refrigerated: 20APR2021 Temperature changes (in F): 40-42  No treatment medication was provided.
The day after I had pain in my right side that worsened over time. During the night I started to wonder if I might have appendicitis. When I awoke I couldn't get out of bed to get dressed. I called to my husband and asked him to take me to the emergency room right away. Severe right upper quadrant pain, was constant, aching, and non-radiating. Some nausea, no vomiting. Pain was not worsened or improved by anything. no other symptoms. moderate to severe tenderness with palpitation. Received 2 doses of morphine. Lab work, and a computerized tomography abdominal and pelvic CT scan with contrast. Diagnosed as probable acute diverticulitis. Underlying neoplasm not excluded. Follow up and ultrasound recommended. I spend 2 weeks in bed, mostly sleeping. I was too weak and in pain to get up, too tired to even want to watch TV, or read. Visited my gastroenterologist on March 5 for follow up on 3/5/21. I was still weak, and right side still hurt, especially when taking a deep breath. He ordered an ultrasound.. At a second follow up on 3/12/2021. He showed me photos from the endoscoples I had a 1 1/2 years earlier on 2/7/2019 and 6/24/19 showing NO DIVERTICVULA ON MY RIGHT SIDE and the results of my ultrasound, which showed "NUMEROUS SUBCENTIMETER ECHOGENIC FOCI THROUGHOUT THE ENTIRE LIVER" he doubted I had had diverticulitis, and ordered a CT LIVER SCAN WITH AND WITHOUT CONTRAST. My insurance denied my application for that test, and since by that time (March 23) I was feeling fine, I didn't press for it. After reading that side effects from the covid vaccine could affect different area of the body, and since my symptoms occurred a day after my first covid shot, I am inclined to believe what I experienced was a result of the vaccine.
Janssen COVID-19 Vaccine EUA - approximately 11-12 hours after receiving the vaccine, I began to have severe body aches (felt like I'd been hit by a bus), skin sensitivity (meaning, my skin actually hurt without being touched), simultaneously had a fever while shivering uncontrollably with extremities that were freezing.  Also had the symptoms of a panic attack, which may have been an actual manifestation of panic, or may have been related to the vaccine and simply mimicked a panic attack.  Most of these symptoms resolved by mid-morning, but extreme fatigue continued throughout the next 2 days.
nausea; vomiting; joint and muscle pain; joint and muscle pain; Mild back pain is lingering; This is a spontaneous report from a contactable consumer. This 68-year-old female consumer (patient) reported that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: En6202and Expire Date: unknown) in left arm via unspecified route of administration on 02Mar2021 at 10:30 as1st dose, single dose for Covid-19 immunisation. Facility type vaccine was reported as Pharmacy or Drug Store. Patient's medical history was not reported. Concomitant medications (other medications included in two weeks) included atenolol and atorvastatin. No other vaccination was administered in four weeks. Patient stated that 'About 28 hours after the injection I had nausea and vomiting, joint and muscle pain. Mild back pain is lingering.'' Events occurred on 03Mar2021 at 06:00 pm. No treatment was given for the AEs. Patient did not have covid prior vaccination and was not tested for covid post vaccination. The outcome of event was Recovered/Resolved with Sequel without treatment on an unspecified date in Mar2021.  No follow-up attempts are possible. No further information is expected.
Localized reaction with redness & swelling @ injection site, radiating heat.  check non-sotp crying > 3 hours (or more) post injection.
06/21/2013 @ 3pm - noticed slight fever. 06/22/2013 @ 10am - temperature of 101.6, given infant acetaminophen @ 6:30 pm - temperature of 103.8, taken to ER @7pm temp of 104.2, given infant acetaminophen in ER @745pm Seizure & temp of 105.3, given IV & antibiotics fever was reduced & patient was sent home. 06/24/2013 @ 845am - temperature of 105.6, taken back to ER chest X-ray from 6/22 showed bilateral pneumonia. 06/27/2013 fever is gone & patients appetite is returning. Patient has follow up appointment on 07/01/2013. Similar occurrence happened one year prior after vaccination.
Feeling nauseous and very tired.  Went to bed, vomited once, 20 hours later was feeling well enough to get up but very weak.  Had the same reaction last year (2018).
Fever >100.4, Chills,  Muscle or body aches,  New loss of taste or smell,  Runny nose/Congestion,  Cough (new onset or worsening of chronic cough),  Shortness of breath or difficulty breathing,  Nausea or vomiting,  Headache,  Abdominal pain, Hospitalized, "She also said the CDC called her because she was a rare case that had a bad reaction to the Pfizer -One symptoms she had from the vaccine was that her hands developed blisters -PUI is now uses a oxygen machine at home and still feels she's a rare case because she's vaccinated but has been severely sick -"
Pt had anaphylactic reaction. Pt had immediate complaint of not being able to breath. Given Epi-Pen and Benadryl 50mg. Hospitalized for 24 hours observation. Flaccid paralysis RUE. Refer to Hospice, Continue MS Contin 15mg. Hypothyroid; continue current dose. Pt had a anaphylactoid reaction to pneumovax. Admit to SCU for 24 hour admit. 10/12/06 Received medical records from hospital which did NOT include D/C summary.  T/C to hospital to request & they will send when available.  Patient admitted to hospital 10/2/06 with DX: acute allergic reaction & acute anaphylactoid reaction to pneumovax.  Had been seen on date of vax for hospital d/c follow up when she developed acute SOB & back pain.  Received epi & IM benadryl & S/S resolved but was admitted for 24 hour observation & monitoring.  O2 sat on 2L/nc was 96%. Received IV steroidsd in hospital.   PMH: colon ca with liver mets (patient referred to hospice) Also included was H&P from 9/21/06 admission for complaint of RUQ abdominal pain.  Patient had right hemicolectomy 5/06 for colon ca./ss 10/27/06 Received hospital d/c summary which reveals patient seen in clinic for hospital f/u appointment & routine check of health maintenance noted had not had pneumovax.  Given & immediately developed SOB & back pain.  Given epi & Benadryl IM & s/s began to resolve within 2-3 min.  Admitted for 24 hour observation.  Given IV steroids & monitored for sequela.  No further complications occurred. Final dx: anaphylactoid reaction to Pneumovax; colon cancer w/mets to liver.
Numbness and tingling in face, tongue, and hands. Fatigue. Pre-syncope.