chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After 1 hour facial swelling; After 45 minutes cheeks red; After 30 minutes face felt very hot; Stronger pain at injection site than with yearly flu shot; This is a spontaneous report from a contactable consumer (patient, self-reported). A 62-year-old female patient (who was not pregnant at time of vaccination), received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration, in Arm Left, on 25Jan2021 13:15, as single dose for COVID-19 immunization, at hospital. Medical history included Allergy to All pain relievers and anti-inflammatory drugs and over the counter, allergies to penicillin and Allergies to sulfites all types. Patient was not allergic to Keflex injections, but allergic to the pull form. Concomitant medications included amlodipine, fluticasone propionate (FLONASE), famotidine (PEPCID AC), calcium, colecalciferol (CALCIUM/VIT D) and one a day multi vitamin (within 2 weeks of vaccination). Patient previously took cefalexin (KEFLEX), Bacitracin, Neomycin, Lidocaine, Prednisone; had allergies with these all medications. Historical vaccine included influenza vaccine (FLU SHOT) and had Pain at injection site. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. After 30 minutes of vaccine, face felt very hot. After 45 minutes cheeks red. After 1-hour facial swelling. Took 1 Benadryl tablet after noticing swelling. Heat and redness then faded. Facial swelling reduced over the next 24 hours without more Benadryl. Stronger pain at injection site than with yearly flu shot, for which patient was not received treatment. Seriousness of the events was reported as non serious. Outcome of the events was recovered in Jan2021.  Information on the lot/batch number has been requested.
Patient passed out in the chair while waiting for her 15 minutes to be up. She did not fall from the chair, she passed out where she was sitting. She did it so subtly that she thought she fell asleep. The only reason she/we knew she passed out was that she urinated on herself while in the chair. We gave her a piece of candy and water, and she said she felt fine right after. She stayed for an additional 10 minutes and again said she felt fine, she wanted to get home and change.
Severe chills, extreme fatigue,  severe pain in joints, muscle pain, nausea, loud ringing in ears. Sill have pain in both hips 6 days later but it is FINALLY beginning to subside.
Approximately three minutes after receiving the vaccine the patient fainted. Complained of feeling a little warm, otherwise no other complaints. Recovered quickly and had no sequala.
BlurredVision, Headache, Myalgia, Diarrhea,  NauseaVomiting,   dry mouth  Narrative:   Other Relevant History:
This spontaneous report as received from a nurse refers to a 8 year old female patient with latex allergy, OMNICEF allergy and no pertinent medical history. On 23-MAR-2011 and 23-MAR-2011 the patient was vaccinated with VARIVAX (Merck) dose 1 and dose 2 (lot no, dose, route not reported) respectively. There was no concomitant medication. On 15-APR-2014, the patient had a rash. The patient sought medical attention via calling to office. No treatment was given for the event. No lab diagnostics studies were performed. The outcome of rash was reported as not recovered. Additional information has been requested.
Within 18 hours of vaccination developed severe headache which woke from sleep, nausea /vomiting and brief fever.  Has had persistent intermittent headaches, stomach aches and fatigue in the 2 weeks following vaccination.
received a dose of Pentacel in error instead of prescribed Adacel, no adverse event; 66 years received a dose of Pentacel in error, no adverse event; Initial information regarding an unsolicited valid non-serious case was received from an other health professional via Medical Information (Reference number- 00448734) and transmitted to Sanofi on 27-Jan-2021.  This case involves a 66-year-old male patient who received a 0.5ml standard dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] [lot UJ267AA, expiry date: 04-Jun-2021] once via an intramuscular route at left deltoid for prophylactic vaccination in error on 27-Jan-2021 instead of prescribed DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (wrong product administered, product administered to patient of inappropriate age).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  No other vaccine was given concomitantly.  This was an actual medication error case due to wrong vaccine administered, inappropriate age at vaccine administration (latency same day).  The reporter wanted to know if the dose would be valid  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
1wk p/vax pt devel a fever 103 which did not respond to APAP or Ibuprofen;rash devel all over the body;pt taken to clinic;pt seen by MD dx roseola;
Redness in joint areas, pt states they are "hives". Also related redness and swelling of eyes and facial swelling. Denies shortness of breath and other emergent symptoms.
bulging eyes; Mild allergic reaction; metallic taste in mouth; pounding headache; red ears; face/neck rash; fatigue; dizzy.; Sore arm; This is a spontaneous report from a contactable consumer (patient).   A 62-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Left Arm on 23Mar2021 12:00 (Batch/Lot number was not reported), at the age of 62-years at vaccination, as SINGLE DOSE for COVID-19 immunization.  Medical history included enlarged aorta, high blood pressure, asthma, eggs and corn allergy. Concomitant medication included lisinopril taken for an unspecified indication, start and stop date were not reported; losartan taken for an unspecified indication, start and stop date were not reported; amlodipine taken for an unspecified indication, start and stop date were not reported; budesonide (PULMICORT) taken for an unspecified indication, start and stop date were not reported; cyanocobalamin, ferrous sulfate, folic acid, serine (RESCUE) taken for an unspecified indication, start and stop date were not reported. On 23Mar2021 12:00, the patient experienced mild allergic reaction, started with metallic taste in mouth and pounding headache before leaving (pharmacy name withheld) after 15 min wait period, red ears, face/neck rash, "bulging eyes". No respiratory issues. Subsided after <1 hour but still feeling fatigue and dizzy. The patient also had sore arm. Still thrilled to get it. The outcome of the events was recovering.  No treatment was received for the events.  Information on the lot/batch number has been requested.
Anaphylaxis Narrative: Pt reported trouble swallowing around 20 minutes into the observation period and was transferred to the treatment area in the vaccine clinic. Vital signs were assessed by a Registered Nurse and a Physician. Oxygen saturation was noted to be 88% on 2 liters of O2 by nasal cannula. Verbal order received at 10:03am from Physician and EpiPen administered to right thigh with improvement of symptoms. She was transferred to the Emergency Department (ED) via stretcher. In the ED, she was re-dosed with an EpiPen secondary to her airway type symptoms. She was reevaluated after 15 minutes and received Solu-Medrol, Pepcid, Benadryl IV, as well as IV fluids. She also received Ativan for her generalized jitteriness and anxiety. She improved and felt significantly better at approximately 11:43am. She was monitored for 3 hours in the ED and was discharged home at 3:34pm in good clinical condition and advised to continue to take Benadryl as needed. She carries and EpiPen on her person and was advised to return immediately if symptoms return.
Pt needed Hepatitis A - # 1 dose Merck & Co 0627AA. Given instead Hepatitis B - pediatric = adolescent use manufacturer GSK AHBVB972DA 7-6-13.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 25-AUG-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally as prophylaxis (lot # 1660991 with expiration date 27-APR-2021) (strength, dose and frequency were not reported).  The improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
I had my vaccination on 10/03/2022. I started to not feel well on 11/10/2022 and was diagnosed with Shingles on 11/11/2022. I was prescribed antiviral medications which I took for 1 week. I am still on medication for pain on 01/04/2023 as the pain is unbearable.
Infant had low grade fever the day after vaccination On 9/13/2020 he developed rash c/w hives, hich persisted into the next day
Patient administered with vaccine past the BUD (17-Feb-2023); No adverse event; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered with vaccine past the BUD (17-Feb-2023)) 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. 065H22A) for COVID-19 prophylaxis.     Patient did not report any medical history or conditions, allergy, concomitant diseases and risk factor (including any previous COVID-19 diagnosis). The patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered with vaccine past the BUD (17-Feb-2023)) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered with vaccine past the BUD (17-Feb-2023)) 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 administered with vaccine past the BUD (17-Feb-2023)).    No concomitant medications were provided. The vaccines were administered between 13-Mar-2023 to 05-Jun-2023. Patients received the vaccine either as the 3rd, 4th or 5th dose. No treatment medication was provided. This case contains information for the 17th of 20 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-727707 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727707:Master Case(Patient 1)
Vaccine was expired on Oct, 12, 2022. Have been unable to contact patient, and patient will be notified that he needs to been re-vaccinated 6 weeks from 12/15/2022.
Fever, 101 degrees,  starting 4:30 pm 3/22/2021, muscle aches, chills.  Fever 101 down to 100 by end of day 3/23/2021.  Fever gone 3/24/2021, just fatigue.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 04May2022 as dose 4 (booster), single (Lot number: FX9893) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not receive other medications in two weeks. The patient had no known allergies. The patient receive Paxlovid for Treatment of COVID-19 on 16Jul2022 and stopped on 21Jul2022. On 23Jul2022 at 05:00 PM, the patient have a sore throat, runny nose, cough, body aches, very tired, and did not receive treatment for this.
MULTIPLE BLOOD CLOTS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced multiple blood clots, and was hospitalized on unspecified date. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of multiple blood clots was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20220306318-Covid-19 vaccine ad26.cov2.s-Multiple blood clots. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
pt recv vax & devel hard swelling/lump x 1wk @ site of pneumonia shot;reporter states both shots were administered one right p/the other, 1 in each arm;
Patient had 2nd dose today. While the patient was here he indicated that he wanted the vaccine in his right arm this time because approx. 1 week after getting his vaccine in his left arm he started having intermittent pain in his upper left arm where he had received his first dose. He did not seek any medical treatment for this condition. When asked for further details he stated that he would have a sensation of being stung by a bee or feeling a needle going into his muscle whenever he thought about having gotten his shot. However he also said that when he exercises that area of his arm is more sore than his right arm and occasionally when he would lay down after he felt a "little tingling" in his left deltoid region for a while.
Extreme very painful abdominal pains, like a painful gastritis after first shot; Gas pains after first shot; Severe diarrhea, running to the bathroom all night; It was such a severe pain, I though I was going to pass out; Anything that went into my body run like water; Sore arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Extreme very painful abdominal pains, like a painful gastritis after first shot), GASTRITIS (Gas pains after first shot), DIARRHOEA (Severe diarrhea, running to the bathroom all night), PAIN (It was such a severe pain, I though I was going to pass out) and DEHYDRATION (Anything that went into my body run like water) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] and VITAMINS NOS for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced ABDOMINAL PAIN (Extreme very painful abdominal pains, like a painful gastritis after first shot), GASTRITIS (Gas pains after first shot), DIARRHOEA (Severe diarrhea, running to the bathroom all night), PAIN (It was such a severe pain, I though I was going to pass out), DEHYDRATION (Anything that went into my body run like water) and VACCINATION SITE PAIN (Sore arm at injection site). On 18-Mar-2021, ABDOMINAL PAIN (Extreme very painful abdominal pains, like a painful gastritis after first shot), GASTRITIS (Gas pains after first shot), DIARRHOEA (Severe diarrhea, running to the bathroom all night), PAIN (It was such a severe pain, I though I was going to pass out), DEHYDRATION (Anything that went into my body run like water) and VACCINATION SITE PAIN (Sore arm at injection site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to  INC.-MOD-2021-077647 (E2B Linked Report).; Sender's Comments:  INC.-MOD-2021-077647:1st dose
Patient developed L arm paresthesia at Day 7 after vaccine.  Symptoms seem mild.
Information has been received a healthcare worker concerning a 48 year old male patient who on an unspecified date was vaccinated with a dose of MMR II as an adult. Subsequently, on an unknown date the patient experienced negative rubella titer. The patient sought medical attention via office visit. At the time of the report, the patient's status was unknown. Follow-up information has been received from a physician. It was reported that the patient did not have an adverse reaction to a dose of MMR II. It was also reported that the patient was afraid he would get an adverse reaction to MMR II because he received one dose in 1979 and the listing of serious events of the vaccine state that he is at higher risk for serious events getting a second dose. Follow-up information has been received from the healthcare worker. It was reported that the patient never completed the MMR II series and there was no adverse effect involved. Additional information is not expected.
Redness measured 2.5 x 1.75 in diameter. No fever-No itching. No warmness. Site cool/dry to touch.
This spontaneous report as received from a physician refers to a 35 year old male patient. Medical history, drug allergy were none. The patient was vaccinated with first dose of M-M-R II during childhood on an unknown date and received a booster dose of M-M-R II for work related vaccination on an unknown date in January 2013. Dosage and lot information was not provided for either doses. Concomitant medications were none. The physician had called to report that this patient had presented with negative titers for measles on 04-MAR-2014 even after receiving first dose of the vaccine in child hood and a booster dose last year. The outcome of event negative titers for measles was reported as not recovered/not resolved. The patient had sought medical attention by seeing the physician. Additional information has been requested.
PATIENT COMPLAINED OF GENERALISED PRURITUS WITH FIVE MINUTES OF RECEIVING VACCINE. NO RESPIRATORY DISTRESS,VITAL SIGNS WERE STABLE. NO VISIBLE RASH OR URTICARIA SEEN. BENADRYL ADMINSTERED AND SYMPTOMS SUBSEQUENTLY RESOLVED. PATIENT OBSERVED AT THE HEALTH UNIT FOR ABOUT 4 HOURS TILL SYMPTOMS RESOLVED. NO OTHER INTERVENTION OR MEDICATION REQUIRED TO BE GIVEN
04/22/22 presents to ED for "Abdominal pain and vomiting". PMHx of "abscesses and fistulas"
No additional adverse effect reported; the patient received one improperly stored dose of PROQUAD; Information has been received from a nurse prescriber referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 25-FEB-2020, the patient received one improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), lot # S012532 and expiration date 20-OCT-2020 for prophylaxis (dosage schedule, anatomical location and route of administration were not reported) (product storage error). The vaccine was reconstituted with properly stored sterile diluent (STERILE DILUENT) (lot number and expiration date were not reported).  The administered dose of the vaccine experienced a temperature excursion of 6 degrees Fahrenheit (°F) to 14°F (5.69F)  for 1 second, as recorded by a data logger. There was a previous temperature excursion of 6°F to 14°F (5.81F) for 28 minutes. No additional adverse effect was reported.
At 5pm of day of vaccination onset headache and muscle aches worse in right mid back. Also area of redness and firmness left lateral arm at injection site and it itches. On exam 8cm x 7.5cm redness and induration lateral arm and CVA tenderness on right. Treatment cool packs to vaccine site. Alternate Motrin 800mg with Tylenol 1000mg q 3 hours PRN. Temperature 99.2, Pulse 99.
fully vaccinated with pfizer on 2/5/21 and 2/26/21 and admitted to hospital on 11/28/21 with covid
At time of injetion, the patient stated it hurt, but left stating she felt fine and was just sore. Today, 10/16/19 (injection given yesterday) a caretaker came in and showed me pictures of her arm with redness on the exterior portion of her arm (injection site) and it went downward a few inches below the injection site. She also showed me pictures of brusing on the inside portion of her arm. She stated she could move it fine but that it was just very sore and she was concernced about the redness and bruising. I stated the redness was most likely an injection site reaction, but the bruising was probably secondary to her fall eariler in the week; however its not 100% certain.
Immediately after vaccination, pt had arm, neck and facial pain, which improved, but did not go away. Rash developed on her abdomen this evening. Recommended benadryl and close observation for anaphylaxis and medical attention if it continues to spead.
Had a small almost unnoticeable amount of tinnitus previously except at night, after injection night of the Tinnitus in right ear became very load noticeable all  most the day and a fullness in my ear even when cleaned out. Went to Dr office and they noticed no issues inside my ear and so prescribed Fluticasone but through to today, 2/18/22 the ringing has not got better but with help of the prescribed nasal spray the fullness in right ear is better, sometimes the sound will travel into the left ear as well.
pt recv vax 7MAR96 & 27MAR96 pt devel two raised erythematous lesions on back & one @ the inj site;pt recovered;no further details were provided;