chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was found to be duplicate of the case US2019GSK030864. Case US2019052585 would be deleted and all the future corresponding information to the present case would be submitted to US2019GSK030864 (case of record).
Fever to 100.8, Nausea and vomiting, Pleuritic chest pain which was worse when supine and improved with sitting up. Symptoms started within 24 hours of the vaccination. Symptoms improved a few hours the initiation of treatment with anti-inflammatory agents.
area @ inject site 2 1/2 wide x 3 long area is red & hot to touch; referred to pvt MD;
Starting on day 7 post vaccine swelling, raised red mark(size of  silver dollar, extreme itching, and right elbow and shoulder soreness.
3"X 2.5" raised area with fever, pain, and swelling at injection site. Given ice and tylenol .
Developed an itchy rash around my wedding ring finger on morning of 8-23-22, spread to backs of both hands by that evening and over the course of the next 13 days, rash got worse, sandpaper like hives and red raised welts on forearms tops and bottoms, also calves of both legs.  Very itchy and stinging pain.  Called Dr. on 8-26-22 and was prescribed a Medrol dose pack course of 6 days.  Today is day 5 of treatment and still no improvement.  Called my dermatologist office, but still waiting on his advice if to see me or continue current treatment.  I sent him pictures and details of vaccine admin. Using ice packs to relieve itching and Benadryl creams for spot treatment. Today is day 21 since my vaccine.  No other such reactions to previous 3 Covid vaccines, all Moderna brand.
dizziness; vomiting; muscle aches/pains; headache; fatigue/tiredness; fever; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 03Apr2021 at 10:00 (at the age of 38-years-old), as a single dose for COVID-19 immunisation. Medical history included diabetic, fibromyalgia and fatty liver. Concomitant medications included insulin detemir (LEVEMIR), metformin (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) and trad (as reported); all for unspecified indication from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 13Mar2021 at 09:45 (at the age of 38-years-old), as a single dose for COVID-19 immunisation. Prior to the 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. The patient had no known allergies to medications, food or other products. On 03Apr2021 at 18:30 the patient experienced vomiting, muscle aches/pains, headache, dizziness, fatigue/tiredness and fever. It was unknown if the patient received any treatment for the reported events. The clinical outcome of the events vomiting, muscle aches, headache, dizziness, tiredness and fever were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pat developed fever 102, localised swelling at site of injection 24 hrs after injection she was Rx 1st w Benadryl but when she developed fever she was given Zosyn IV and discharge on Clindamycin 1300 mg qid x 10d
9/26/09 Reports temp 101 degrees with chills and dizziness at 20:00. 9/27/09 Temp 99.3 degrees. Encourage fluids at 07:30. Temp 98.2 degrees. States has feeling of a "cold". Had fluids in PM and 7-8 hours sleep. 9/28/09 Reports all signs and symptoms resolved.
Patient received a vaccine that had Expiration date Mar 06, 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine that had Expiration date Mar 06, 2021) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062G20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine that had Expiration date Mar 06, 2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine that had Expiration date Mar 06, 2021) outcome was unknown.        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.   No concomitant drug details were reported. No treatment details were reported.
Whole body ached, fever, sweating. Headache, difficulty walking due to muscle pain. Patient feels "hot" inside but not to touch. Local reaction - 2 days later - site of injection is red, inflamed, hot to touch. (T-97.4 BP-104/71 WBC 13.2).
came to ED for shortness of breath, transferred to another facility  Diagnoses   Acute respiratory distress syndrome (ARDS) due to COVID-19 virus  Acute systolic CHF (congestive heart failure)  Cough  Hypoxia  Elevated troponin level  Paroxysmal atrial fibrillation  D-dimer, elevated  SOB (shortness of breath)
Throat closing up, dizzy, blurry eyes, returned to doctors office and was sent to Emergency Room.
a 28 week old patient received the first dose of Rotateq; Information has been received from the nurse concerning a 28-week-old patient. The patient's gender, concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not provided.  On 10-SEP-2021, the patient received the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), 2 milliliter, (lot # reported as 1077487, expiration date on 23-MAR-2022), for prophylaxis purposes (product administered to patient of inappropriate age).  Lot # 1077487 is not valid for Rotavirus Vaccine, Live, Oral, Pentavalent.
I had a minimally sore injection sight the morning I had the vaccine. As the day went on I began to feel joint pain in my back. Around 2:00pm I began to feel chills. Around 5:00pm I registered a temperature of 99.1. My usual temperature is 96.7. I then had trouble staying asleep,  had intense joint pain in my back, hands, and feet, which I treated with Tylenol around 11:00pm. I experienced  heavy night sweats where I woke up at 5:15 am being soaked.  The symptoms I felt overnight felt just like what I had when I was sick with Covid 19 in December 2020.  My temperature had returned to normal by 6:00 am.
Fever of 102+, excruciating body pain that nothing helped including percocet, tylenol,  motrin, was unable to life my head 2 inches off my pillow, needed help to get to bathroom, and was unable to get out of bed due to all of the above for 3 days. 3 days before fever reduced.
Treatment of COVID-19; Treatment of COVID-19; Vaccine brand: Pfizer / BioNTech; Vaccine dose number: 3/ vaccine brand: Other Moderna; Vaccine dose number: 4; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 09Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 23Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 30Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure; "High cholesterol" (unspecified if ongoing); "Obesity" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; HYDROCHLOROTHIAZIDE; OMEPRAZOLE. Past drug history included: Tylenol, reaction(s): "Known allergies: Tylenol", notes: Known allergies: Tylenol; Ibuprofen, reaction(s): "Known allergies: Ibuprofen", notes: Known allergies: Ibuprofen; Aspirin, reaction(s): "Known allergies: Aspirin", notes: Known allergies: Aspirin. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Apr2022, outcome "unknown", described as "Vaccine brand: Pfizer / BioNTech; Vaccine dose number: 3/ vaccine brand: Other Moderna; Vaccine dose number: 4"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "recovered" (2022) and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient took Paxlovid for 5 days, starting on 20Oct2022, started feeling better after 3 days, although patient have consistently still had a bit of congestion and fatigue, but last night woke up and coughed for a couple hours, patient was more congested and have had diarrhea at the time of the report  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
pt recv vax; c/o redness,swelling, itching; minimal pain non-radiating lt deltoid; advised to apply ice;
No adverse event; Patient received Moderna Covid-19 Bivalent vaccine vaccine past the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 Bivalent vaccine vaccine past the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis.     The patient received vaccines in the 4 weeks prior to COVID-19 vaccine.     On 14-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 Bivalent vaccine vaccine past the 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 Bivalent vaccine vaccine past the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 Bivalent vaccine vaccine past the 30 day beyond use date).    Dosage text for suspect product was reported as unknown.  Concomitant drugs were not reported. It was reported that the vaccine was delivered to the hospital on 20-Sep-2022. The vaccine was administered to 5 patients on 14-Nov-2022, 2 patients on 15-Nov-2022 and 2 patients on 22-Dec-2022. Treatment medications were not provided.  This case was reported for patient 3 of 9.   This case was linked to US-MODERNATX, INC.-MOD-2023-725025 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-725025:Master case
No adverse event; Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in a 39-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 065F21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    No concomitant medications were reported. The patients age was reported as 39 Year 10 Month. Treatment information was not provided.
No adverse effect; an unspecified number of patients may have been administered an improperly stored doses of MMRII; This spontaneous report was received from a physician referring to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history and drug reaction/allergies were unknown. Concomitant therapies included sterile diluent. On an unknown dates, the patients may have been administered an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) of lot # S005249  with expiry date 20-FEB-2021 (dose, strength, dose number, route of administration unspecified) for prophylaxis (product storage error). On an unknown date, the vaccines were exposed to the temperature of 11.73 Celsius for 4 hours and 30 minutes. There was no previous temperature excursion and digital data logger was involved. No adverse effects were reported.   Follow up information was received from physician on 07-NOV-2019.     No vaccine adverse reaction were reported. The only had to recall patients because no data available for temperature excursion. On 23-OCT-2019, during office site visit temperature excursion were noted. 10, measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) doses (Lot # R000550, expiry date: 08-JAN-2020) were stored to 24.08 degree Celsius. Since no data exists were (illegible doc) to revaccinate. No adverse reaction noted.    This is a non-valid case due to lack of patient identifiers.  Follow up information was received from the physician on 08-APR-2020.   This information refers to a 03-year-old female patient. On 27-MAR-2019, the patient was administered with an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) with Lot number R000550.  This is one of several cases received from the same reporter.  This case was previously considered non-valid, but upon receipt of follow-up it was determined that the case is now valid as the patient demographics were obtained.; Sender's Comments:  US-009507513-1910USA016114:
soreness in the arm; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 27Jan2021 at a  single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had a very tiny soreness in the arm in Jan2021 and its already gone. The patient recovered from the event in Jan2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient was given prime dose on  2/19/21, lot # 010AZ1A, and then given boost dose on 2/24/21 lot  #016M20A.  Patient was contacted on 2/2521 once error was discovered.  Reports feeling fine with no side effects
Increasing difficulty breathing, followed by major asthma attack on Thursday. On Friday, was put on a nebulizer and prescribed Advair, Pro-Air, Proventil, Singulair and Vospire.
Initial unsolicited case received from a consumer (Patient herself) on 12 Dec 2016. This case involves a 62 year old female patient who was vaccinated with a dose of FLU SHOT (INFLUENZA VACCINE) (Batch number, expiry date, route and site of administration was not reported) on an unknown date, and the patient was prescribed an Study medication possibly ALIROCUMAB (PRALUENT) (Batch number, expiry date, route and dose was not reported) injects q 2 weeks for over a year ago on an unknown date. The patient medical history includes high cholesterol. The patient concomitant medications were not reported. On an unknown date after the vaccination the patient developed experiencing mild flu or flu-like symptoms/ tests for the flu were negative. It was reported as the patient started experiencing mild flu or flu-like symptoms on Wednesday 07 Dec 2016 which became full blown on Friday 09 Dec 2016 and it was reported as the patient said she had to go to the hospital for a morphine shot on Friday 09 Dec 2016 and again yesterday 11 Dec 2016 and the patient told that the physician in the hospital said that the tests for the flu were negative, and the patient got her flus shot 6 weeks ago and it was reported as the patient had nasal congestion since she started the study medication but she can tolerate it and She was advised to contact her healthcare provider about her symptoms. She said she will contact the nurse about her symptoms before she takes her next injection of the study medication. The patient any other lab tests and corrective treatment was not reported. The outcome of the event was unknown. List of documents held by sender: none.
Patient stated redness and soreness at injection site. informed this is common side effect listed in literature. Stated since she didn't experience this with first shot of series wanted adverse effect reported.
Seizure occurred about 22 hours after vaccine. Unclear if related to the vaccine or recent changes in medications. Patient does not typically have generalized clonic-tonic seizures but had a 2.5 minute GTC seizure the day after vaccination.
PARALYSIS OR G-B SYNDROME. PARALYSIS 10-31-2016. VACCINE 10-04-2016.
I developed atrial fibrillation which is ongoing several months later; This is a spontaneous report from a contactable Physician.   A 32-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685) on 22Dec2020 at single dose via an unspecified route of administration  on left arm for COVID-19 immunization. Relevant medical history included colitis ulcerative. Concomitant medications included mesalamine. On 31Jan2021 developed atrial fibrillation which is ongoing several months later. Treatment received included  metoprolol, sotalol. At the time of the reporting the patient had not yet recovered from the events.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
This spontaneous report was received from a certified medical assistant and referred to a patient of unknown age and gender. The patient received first injection dose of GARDASIL (lot #, expiration date, strength, dose and frequency were not reported) on 08-MAY-2007 and on 19-JUL-2007 received second dose of GARDASIL (lot #, expiration date, strength, dose and frequency were not reported). It was reported that the patient waned to received a third dose now. No adverse symptoms were reported. Additional information has been requested.
Patient presented to the ED and was subsequently admitted for TIA on 2/21/2021. He also had an ED visit on 3/10/21 for peripheral edema.
Migrane within 24 hrs Dizziness immediately  Tmj / jaw pain/ cracking/ stiffness next day Sore arm Aching muscles next day
8/13/2021: Patient 37w 6d gestation with EDD 8/28/2021. Pt presented with regular, painful contractions every 1-2 minutes with some bloody mucous discharge, but no leakage of fluid. Pt desires repeat cesarean delivery with tubal ligation.  Patient tolerated Cesarean procedure well. COVID-19 test had not resulted prior to procedure, as it was considered urgent/emergent. No postop/postpartum problems. 8/15/2021: Patient given first dose of Pfizer COVID-19 vaccine. Pt stated that she feels like her "left side of face feels tingly/numb." Vitals WNL. Around 1443, patient stated that she started to have a headache. Earlier today, patient discharged postpartum c-section.
This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (still in bed) and HEADACHE (Really bad headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, A47A21A and 023M20A) for COVID-19 vaccination. Patient has never tested positive with COVID 19. Concurrent medical conditions included Migraine, Anxiety, Depression, Asthma, Allergy, Sleep problem, Allergic to cats and Pollen allergy. Concomitant products included ALPRAZOLAM (XANAX) for Sleep disorder, MELATONIN for Sleep problem. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BEDRIDDEN (still in bed) and HEADACHE (Really bad headache). The patient was treated with SUMATRIPTAN (IMITREX [SUMATRIPTAN]) for Headache, at an unspecified dose and frequency. At the time of the report, BEDRIDDEN (still in bed) had not resolved and HEADACHE (Really bad headache) outcome was unknown. It was reported that patient probably took Xanax to try to sleep. This case was linked to MOD-2022-561631 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 06-May-2022: Follow-up document received includes no new information.
Pt woke up with hives the next morning after the 2nd dose in the series only.
Initial report received on 10 November 2006 from the patient who is also a health care professional. A 47-year-old female patient had inadvertently received a left deltoid, intramuscular injection of Daptacel, (product not recommended for use in this age group). lot number C2630AA, on 01 September 2006. This product was administered instead Adacel. The following day, the patient experienced muscle soreness. No testing or examination by a physician was required. The patient took nonsteroidal anti-inflammatory medications as needed. The patient recovered from the event within 96 hours.  The reporter in this case is the same as the reporter in cases 2006-02409, 2006-03044, 2006-03045, 2006-03046, 2006-03047, 2006-03048, 2006-03049, 2006-03050, and 2006-03051.
36 hrs after vaccine parents noticed reddened area in (R) deltoid about 2x2 in, pain. Seen in office about 49 hrs after injection with warmth swelling in (R) deltoid 4 inch x 4 inch area. Pt has mild diarrhea x2 days.
Patient received the vaccine on 05/12/2022 at 5 pm. Felt fine until the following day when she woke up and stood out of bed around 11 am. At that time, patient lost consciousness and fell forward. She hit her face on the ground resulting in a facial fracture. She was taken by ambulance to a hospital where they triaged her. She was told she had a fracture on her upper jaw between front teeth. They could not find a specific reason as to why the she fainted. She  also experienced a slight fever, which lasted a few days after the vaccine, as well as, a cough that lingered up to 35 days after the vaccine. Patient still has a lingering cough.
On 2/24/00 at 2:00 the pt developed a fever of 105. The most recent information received on 7/7/00 reports the outcome of the event as recovered.