chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 32 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), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (Feb2023) Positive, notes: Still testing positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Vaccine. Other medication in 2weeks was received.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
she has bursitis; This is a spontaneous report received from a non-contactable reporter (Consumer) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 19Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single (Lot Number: Not provided)), administration date: 23Feb2021, for Covid-19 Immunisation. The following information was reported: BURSITIS (non-serious) with onset 2021, outcome "unknown", described as "she has bursitis". Therapeutic measures were taken as a result of bursitis.  Additional Information: The patent said that she had bursitis and received a cortisone injection 3 days after the second dose. She wanted to know if this was okay and if the vaccine was still going to be as effective.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Not feeling well in general. Redness at immunization site. Swelling from site to elbow on left arm. Symptoms noted on 12/15/2014.
Had out shots and got the Flu; Initial information was received on 06-Dec-2022 regarding an unsolicited valid non-serious social media case received from a patient.  This case involves a patient with unknown demographics who had out shots and got the flu after being vaccinated with Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza vaccine (produced by unknown manufacturer) (with unknown strength, dose, route, administration site, lot number and expiration date) for prophylactic vaccination.  On an unknown date the patient had out shots and got the flu (influenza) (unknown latency) following the administration of Influenza vaccine.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown.
Within 15-minutes of vaccination, the patient reported a "scratchy" sensation in their throat. They were monitored on-site by EMS. No documentation provided suggesting allergic reaction that needed treatment.
Information has been received from a 40 year old female with hypercholesterolaemia and a history of female genital operation concerning on 04-SEP-2007 she was vaccinated with the first dose of VARIVAX (Merck) (lot no. not reported) via intramuscular route.  Site of injection was not reported.  On 24-OCT-2007, she was vaccinated with the second dose of VARIVAX (Merck) (lot no. not reported) via intramuscular route, site of injection was not reported.  Concomitant therapy included LOVASTATIN (manufacturer unknown), vitamin D (unspecified), Omega fatty acids (unspecified) and calcium (unspecified).  On 22-NOV-2007 the patient experienced unspecified hives that were treated by numerous unspecified medical personnel with unspecified medications.  The patient fully recovered from the hives in several weeks.  In December 2007, the patient experienced eye infection.  The outcome of eye infection was unknown.  On 05-JUN-2008 the varicella titer was negative and the reporter considered this to be vaccine failure.  The patient went to physician's office and sought unspecified medical attention.  No other symptoms or treatment  reported.  No product quality complaint involved.  No other information available from the reporter.  Additional information has been requested.
Received 1st vaccine on 12/30/2020. Had the usual redness and hard area around the injection site. On 01/11/2020 started having increased pain around the site  as well as redness. Also noted that the redness, edema and increased warm to touch started to spread on 01/12/2021 and 01/13/2021. Used ice because of the pain which also helped to decrease the redness and warmth. Started to improve by 01/14/2021. The spread of the redness, edema was 9 inches by 3 inches.
Patient was given flu vaccine twice this flu season. 1st dose given 01/05/2023 and the 2nd doses given 03/03/2023.  Patient's mother informed of error by medical provider and confirmed understanding. No adverse reaction reported.
Injection arm got hot with a big red circle in the injection site; injection arm started itching; Injection arm got swollen; Big red circle in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Injection arm got hot with a big red circle in the injection site), INJECTION SITE PRURITUS (injection arm started itching), INJECTION SITE SWELLING (Injection arm got swollen) and INJECTION SITE ERYTHEMA (Big red circle in the injection site) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Systemic lupus erythematosus (Lupus).    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced INJECTION SITE WARMTH (Injection arm got hot with a big red circle in the injection site), INJECTION SITE PRURITUS (injection arm started itching), INJECTION SITE SWELLING (Injection arm got swollen) and INJECTION SITE ERYTHEMA (Big red circle in the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, INJECTION SITE WARMTH (Injection arm got hot with a big red circle in the injection site), INJECTION SITE PRURITUS (injection arm started itching), INJECTION SITE SWELLING (Injection arm got swollen) and INJECTION SITE ERYTHEMA (Big red circle in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant product was reported
patient stated left arm has been sore for 9 days, and sore when moving arm from left to right. patient has not reported any redness at injection site.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent condition, medical history or concomitant medications were not reported. The nurse reported that on 20-MAY-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K009953, expiry date 03-APR-2016 (dose and route of administration unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
a 71 year old female presented to clinic for the first of 2 c-19 vaccines. She verbalized nervousness. She stated she felt well today; afebrile, denies n/v/d, malaise or fatigue.  No known sick contacts. Daughter with her. Much discussion about which arm to vaccinate and how it will affect her ability to watch TV tonight [staying with mom to be watched for any vaccine reaction. Mom is 96].  I admin Moderna covid vaccine into left delt  at 7:40 and continued chatting with patient/ daughter.  Daughter going to drive mom to the grandmother's house for the evening, has left her own car somewhere.  PT asked if she has to go to the waiting room to wait or if she could just wait in exam room? I reminded her several others waiting and she is suppose to wait out there. She stated she didn't think she could make it, starts to slide sideways in her seat.  Never losing consciousness, never falling to floor, her head lolled back and her speech began to slur.  I put her feet up in second chair and pulled her arms into her lap. Called to reception for help, had her call 911 and obtain E kit.  PT was still speaking/ rambling. + pallor, weakness.  Obtained VS at 7:47pm [WNL: 118/74, 69, 18 97% on RA].  Color began to improve without any intervention. by the time EMS arrived, PT was able to stand and to speak clearly. She declined to go to hospital for further evaluation.
This spontaneous report was received from a nurse and refers to a 2 year-old patient of unknown gender. There was no information about the patient's pertinent medical history, drug reactions or allergies provided. On 21-JUN-2017 at 09:37, the patient was vaccinated with improperly stored second dose of VARIVAX, one unspecified dose in the left thigh (lot # M042495 with the expiration date of 19-OCT-2018, route of administration was not reported), for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). No adverse effects were reported. The patient was concomitantly vaccinated with a dose of VAQTA. Administered dose of VARIVAX experienced the temperature excursion between 9 and 25 Celsius degrees for 2 hours and 16 minutes. Digital data logger was involved. There were no previous temperature excursions reported. Additional information is not expected as the reporter had no further information to provide. Sender's Comments: US-009507513-1706USA009938.
COVID-19; COVID-19; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in left arm for COVID-19 immunization; BNT162b2 (BNT162B2), on 26Mar2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 16Apr2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunization; elasomeran (MODERNA COVID-19 VACCINE), on 23Dec2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 25Apr2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for COVID-19 immunization. The patient's relevant medical history included: "Chronic obstructive pulmonary disease" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing); "Known allergies: Mold" (unspecified if ongoing). Concomitant medication(s) included: TRELEGY, start date: 26Apr2020. Past drug history included: Asprin, reaction(s): "Known allergies: Asprin". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 23Dec2021, outcome "unknown", described as "Interchange of vaccine products "; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive. Therapeutic measures were taken as a result of vaccination failure and COVID-19 which was PAXLOVID.  Clinical information: It was reported that the patient had treatment of COVID-19 (noted in 2023) which was PAXLOVID which was from 12Feb2023 until 17Feb2023.   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.
Seizure (tremors in arms, legs and chest/shoulders). Rapid, irregular breathing.
After the flu shot (Monday morning), I developed typical flu symptoms the next day with hoarseness, sore throat. Wednesday, the symptoms were getting worse with cough and fatigue. I thought all these were just normal minor flu shot reactions and thought it would go away soon.  Thursday, it got worse, I had headache in addition to the previous symptoms, plus coughing. I somehow realized the flu shot had compromised my immunity. Starting from Friday until Sunday, for three days I had continuous headache, fatigue, severe cough and green mucus, kind of infection with streptococcus, which was very common when immunity compromised. I could not get up for these three days, headache without appetite. I took Azithromycin (to treat a potential streptococcus infection) as well as Tylenol. The eighth day (next Monday), my headache got better, I did not cough that much, but would have lots of thick mucus in the nose until now (the tenth day, Wednesday), it continues. I went back health unit, the physician was out of office, I talked to the nurse, who did not understand why but doubted it might be caused by a coincidental cold or flu not yet protected by the flu shot on time. I am not aware of any apparent catch of flu from my working or other environment the day got flu shot. Also I never had such a severe symptoms before, and I felt great the day I was taken the flu shot. As a doctor of medical science and an immunologist myself, I documented what has happened without going to a physician office during the weekend when I was most sick. I think the symptoms I reported are associated with the flu shot, but how exactly to interoperate it, I am not sure. Hope the report will add some information to any known adverse events who might be interested and looking for. Is the vaccine I received fully inactivated?I might got flu from the shot. Or does the flu shot compromise immunity in some degree or incur allergy in certain population?
Nausea; Reddness at site; joint pain and swelling at elbow.
Patient states running nose and cough, couldn't sleep (insomnia), pain across hips.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A2117) 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. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-033484 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-033484:Mother Case MOD21-043047
Vaccine was administered and within 2 minutes the patient was having a anaphylactic reaction.  Unable to breath and red on the trunk. Epipen was administered at 1:15 and 911 was called.
Fever x's 14+ hours, arm pain and redness,  swelling of extremities,  systemic itching, facial swelling,  chest pain,increased heart rate, difficulty breathing
RN gave a second dose of Pfizer without thoroughly screening the patient's vaccination card to verify type of vaccine.  After the vaccination was given the patient was given education on Pfizer vaccine and the patient reported she had received Moderna for her first dose on  3/5/2021.   The patient was provided education per CDC guidelines regarding interchangeability of vaccines.  Patient did not report any side effects or symptoms at the time of event.  Education and reinforcement provided to the nurse regarding verification of vaccine.   Safety officer was informed and incident report completed.
15 minutes; dizziness,nausee urgent onset of soft stool,  ,itchy ears ,,blurry vision, 30 min; swollen throat , itchy eye's, itchy shin, upper body hives..45 min to 1 hour ; right side numbness and tingling ,, left side bone joint pain ,sore throat,, about 2 hours after  shortness of breath, chest tightening,,,,, rapid heart rate,,,..2.5 weeks after still severe left arm. nerve pain, limited range of motion, pain mostly worse while body at rest,,vision changes.
I started hurting; swelling; This is a spontaneous report from a contactable consumer reporting for herself. A 74-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on 01Mar2021 (at the age of 74-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced or started hurting, swelling on an unspecified date. She took the COVID vaccine on 01Mar2021 and was off the medication for 7 days. Patient could feel the difference, she started hurting and swelling. The Patient was currently taking Xeljanz XR 11 mg. Patient stated that when she took COVID vaccine, her doctor suggested that to stay off of the Xeljanz for one week, but she was over them at the time of this report. Patient was prescribed Xeljanz XR 11 mg tablets. Clinical outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe chills - lasting about 2 hrs. Vomiting. Aching all over. More chills next eve. Lasted 3 days.
CHILD BROKE OUT IN WHELPS (PAINFUL AND ITCHING) STARTING THE DAY AFTER IMMUNIZATION. WHELPS MOSTLY ON ARM OF IMMUNIZATION, BUT ALSO ON OTHER ARM AND BACK. CHILD ALSO HAD LOW GRADE FEVER.
02/04/2013 began complaining of upper abdominal pain/tightness and nausea only after eating. These symptoms continued daily for about 7-10 days. The abdominal pain and nausea then became constant and worse after consuming any amount of food and constant fatigue set in.  On 02/18/2013 doctor was visited and blood was drawn; all tests were negative. Zantac 75 was prescribed, taken daily, with no help. Nausea, fatigue, and abdominal pain persisted with fatigue increasing over time.  On 02/27/2013 doctor was visited again with further tests ordered. Doctor recommended Omeprazole and Claritin (for observed post-nasal drip).  As of 03/01/2013 there has been no change with continued fatigue, nausea, and upper abdominal pain/tightness. Patient is always "tired", has little appetite but does consume food at meal time although small quantities; always feels worse after eating.
He has a history of COPD  but after taking the vaccination, he no longer has wheezing or congestion or raspiness.
Pt states when woke up next morning after vaccine had ringing and tingling in both ears.  She was seen at an urgent care diagnosis was possible allergic reaction after receiving MMR vaccine
Pt reports that 4 days after she received SHINGRIX a blister on her right eye and blisters in her mouth came out. Her joints are still achy until now and her right elbow is still hurting.
Second dose experienced pain in the feet and went to ER; Red 2 inch round spot which felt hard to touch; Red 2 inch round spot which felt hard to touch; Bad flu like symptoms; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFLUENZA LIKE ILLNESS (Bad flu like symptoms), PAIN IN EXTREMITY (Second dose experienced pain in the feet and went to ER), ERYTHEMA (Red 2 inch round spot which felt hard to touch) and INDURATION (Red 2 inch round spot which felt hard to touch) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 043B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL for Blood pressure, POTASSIUM for an unknown indication.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (Bad flu like symptoms). On 15-May-2021, the patient experienced ERYTHEMA (Red 2 inch round spot which felt hard to touch) and INDURATION (Red 2 inch round spot which felt hard to touch). On 17-May-2021, the patient experienced PAIN IN EXTREMITY (Second dose experienced pain in the feet and went to ER). At the time of the report, INFLUENZA LIKE ILLNESS (Bad flu like symptoms), PAIN IN EXTREMITY (Second dose experienced pain in the feet and went to ER), ERYTHEMA (Red 2 inch round spot which felt hard to touch) and INDURATION (Red 2 inch round spot which felt hard to touch) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-May-2021, Ultrasound scan: normal (normal) No blood clots were detected.         Treatment information included paracetamol given by doctor but the patient did not take it. Action taken with mRNA-1273 in response to the events was not applicable. The patient was also tested for electrolytes and the result was normal   This case was linked to MOD-2021-177506 (Patient Link).
Provider Dr ordered Covid Pfizer ages 6 months to 4 years old, Pt was given wrong vaccine. . Pt was injected with Pfizer for 5-11 years old 0.2 ml were given, pt left the clinic with no signs or symptoms it was not until later that we realized wrong dose was given. Dr.  was Notified. . Nursing Director Advised,
Severe ongoing headache in the lower back of head/neck and across forehead.  Level. 7 continuous pain that is constant and pressure/vise-like.  24/7 x 6 weeks now with no reduction in pain level.
Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA284722, 2018SA284723, 2018SA284724, 2018SA284725, 2018SA284726, 2018SA284727, 2018SA284728, 2018SA284729, 2018SA284730, 2018SA284731, 2018SA284733, 2018SA284732, 2018SA284734, 2018SA284735, 2018SA284736, 2018SA277767, 2018SA284721, 2018SA284755, 2018SA284751, 2018SA284752, 2018SA284746, 2018SA284747, 2018SA284748, 2018SA284749, 2018SA284753, 2018SA284754 (same reporter). This case involves a 12-year-old patient (gender not reported) who was vaccinated with a dose of FLUZONE QUADRIVALENT (lot number UJ025AC and Exp. date 02-Oct-2018) via intramuscular route in the left deltoid on   02-Oct-2018, which was outside of the recommended temp range (below 32F).  The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage. No information about any adverse event 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 Directive and Module VI of the Good Pharmacovigilance Practices. 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. List of documents held by sender: none.