chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Nov2021 at 10:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: HYDROXYCHLOROQUINE; LEVOTHYROXINE; ATORVASTATIN; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Past drug history included: Septra, reaction(s): "known allergies: Septra"; Norco, reaction(s): "known allergies: Norco". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (2022) Negative; (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 28Jun2022 to 02Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
The patient woke up with numbness and tingling in lip. Could still move all facial muscles. No pain. No other symptoms noted. Called the patient 5 hours later, itching on back noted, lip still numb. No rash or other symptoms noted. Pt took OTC dose of BENADRYL for itching.
Severe joint pain, severe muscle pain, fever 100.5, swelling in joints, and headache started at around 2pm of the same day of vaccination and continued into the night. Took 600mg of ibuprofen every 4 hours to control pain. After second round of ibuprofen pain was tolerable. Day 2: when going off of ibuprofen severe pain returns with limited mobility again. Will continue ibuprofen for day 2.
unknown   The Beyond Use Date was 3/17/2023. pt. received vaccine on 4/24/23.
A week later after vaccine she was totally fine. All of a sudden she has rashes all over her body. Red during vaccination. The rashes have not gone away. My daughter has been itching like crazy. I have given her Zyrtex. Given her the vaccine to go to school she's changed a lot. It's not responding to any medications that has to do with allergies. Itching through the night keeps us awake at night. Some doctors said it could have been triggered by the MMR vaccine.
hives on arms; Rash is still ongoing and a bit itchy; Broke out with a rash/hives, on arms, face and chest; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (Broke out with a rash/hives, on arms, face and chest), URTICARIA (hives on arms) and RASH PRURITIC (Rash is still ongoing and a bit itchy) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Fluid retention, Rheumatoid arthritis and Asthma. Concomitant products included METHOTREXATE, APIXABAN (ELIQUIS), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and DIURETICS for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (Broke out with a rash/hives, on arms, face and chest), URTICARIA (hives on arms) and RASH PRURITIC (Rash is still ongoing and a bit itchy). The patient was treated with LORATADINE (BENADRYL 24 FLASH) ongoing since an unknown date at an unspecified dose and frequency and HYDROCORTISONE (HYDROCORTISONE cream) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, RASH (Broke out with a rash/hives, on arms, face and chest) and RASH PRURITIC (Rash is still ongoing and a bit itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
I actually am having a hard time lifting up my arm. Cannot put any pressure on the arm or take off clothes in shower. I cannot carry my son. I cannot lift anything. I cannot put my arm in pocket or jacket. If I get beyond 15-30 degrees abduction, I cannot do very well. Beyond that I can.
pt recv vax & w/in 2 days post vax & exp a stiff neck & a stiff ankle;sx resolved;
Starting at about 5pm (5 hours after vaccination) patient experienced fatigue, headache, low-grade fever (37.5C) and mild pain at injection site. Starting at about 11pm, patient experienced chills and shivering. Chills persisted for a few hours, other symptoms persisted for approximately 24 hours after onset.
This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question), PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question) and NO ADVERSE EVENT (No adverse event) in a 36-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.       Concomitant medications details was not reported.  Reportedly, the pharmacist called to discuss a temperature excursion that occurred several days ago in the freezer. The patient received vaccine from a vial that underwent a temperature excursion in the freezer.  The patient received the booster dose.  All the vaccines were found to be viable.  Treatment details was not reported.
approx 2hr p/vax @ daycare prone in crib, caregiver noted flopping arms-pt rolled over-both arms jerking, eyes rolled back in head w/drool on face;grasping resp but pink;stiff;smiled @ caregiver then sent to sleep;p/sz mom found pt aroused
Administered covid vaccine outside 12-hour range of puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered covid vaccine outside 12-hour range of puncture) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised (patient is immunocompromised so got the 3rd dose).   On 29-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered covid vaccine outside 12-hour range of puncture). On 29-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Administered covid vaccine outside 12-hour range of puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported.  No treatment information was provided by the reporter.  Initially, vial was stored in the refrigerator, on 21Sept2021 and was  first punctured: on 28Sept2021 @ 4PM and  vial stored post puncture in room temperature (RT), not  undergone any temperature excursions. and totally vial exposed to 21 hours of room temperature.  Patient has reported that he has no allergies to any medications, food, and other products.  Also reported that he has never been diagnosed with COVID-19, positive.  In addition, said that he didn't report any adverse effects and  as per manufacture, he took third dose on opposite arm (i.e., right arm).   Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: Follow up received on 04-Oct-2021 and included reporter's contact information (Address). On 06-Oct-2021: Follow up received on 06-OCT-2021 and included race and ethnicity.
Onsite EMS evaluated patient ad determined that she was light-headed, responsive, but not lucid. Patient was transported to medical center.
Fever to 103.  Local redness and swelling at site of injection with pneuovax.  Malaise, headache started within 6 hours on injection.
Papular "pox-like" rash developed on back and face five days after administration of MMR, Varicella, and Hib vaccines.  All lesions appears to be in same stage of healing.  No fever or other symptoms.  No treatment other than Aveeno baths and moisturizers.
Painful and swollen lymph node under left armpit. Swollen left and painful left pectoral. Injection site was the left shoulder. Additional symptoms are HA for 24 hours.
VZV given on 8/20/10. Rash appeared on 8/24/10 - first on (L) arm, then (R) arm, then neck area. Saw MD on 8/28/10 was given BENADRYL 50 mg q 6 hrs. TAGAMET 600 mg BID, Prednisone 70mg x 2 daily. Rash subsiding according to pt. Almost gone on arms, still some on neck.
RASH AND SWELLING AT INJECTION SITE SHORTLY AFTETR INJECTION ON 9/30/21.  AS OF TODAY 10/6/21, SWELLING IS GONE, RASH IS STILL THERE
achy joints; mild sore throat; nausea; Fever; chills; shaking; Headache; This is a spontaneous report from a contactable consumer (patient).  A 31-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 18Feb2021 11:45 (Batch/Lot Number: EL3247) as age at vaccination of 31-years-old, as single dose, for covid-19 immunisation. Medical history was none; the patient had no allergy. Patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 28Jan2021 03:00 PM (Batch/Lot Number: EL3247) for covid-19 immunisation. There were no concomitant medications. The patient did not receive other vaccine in four weeks and did not receive other medications in two weeks. Starting at 2 AM on 19Feb2021, the patient experienced achy joints then fever, chills, shaking, headache, nausea and mild sore throat were all experienced.  Therapeutic measures were taken as a result of the events and included administration of ibuprofen. The patient had not covid prior vaccination and was not covid tested post vaccination.  The patient was recovering from the events.   Follow-up attempts completed. No further information expected.
her blood pressure increased yesterday; nauseous as all crap; had a minor headache; arm pain; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (age: 58; unit unspecified) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number and expiration was not reported), dose 2 via an unspecified route of administration on 02Mar2021 as dose 2, single for covid-19 immunisation. Medical history included sinusitis (natural sinus trouble) from an unknown date and unknown if ongoing, blood pressure abnormal from an unknown date and unknown if ongoing. Concomitant medication(s) included clonidine taken for blood pressure abnormal (1 clonidine in the morning and night), start and stop date were not reported. Previously, received PFIZER-BIONTECH COVID-19 VACCINE (Batch/Lot number and expiration was not reported), via an unspecified route of administration on unspecified date as dose 1, single for covid-19 immunisation and experienced arm pain with her first injection and placed a heat pack on it, in which the pain subsided. The patient received the second dose of the Covid vaccine on 02Mar2021 (yesterday). The patient stated that she got up on 02Mar2021 (last night) to do her newspaper route and felt ''nauseous as all crap, had a minor headache, and arm pain''. The arm pain subsided once she placed a heat pack on her arm as therapeutic measure for arm pain. The patient also experienced arm pain with her first injection and placed a heat pack on it, in which the pain subsided. The patient was taking ''blood pressure medicine (1 clonidine in the morning and night)''. The patient stated that her normal blood pressure was 140/90 and her normal temperature was 96.7 degrees Fahrenheit. The patient wasn't having any trouble before the vaccine and only had natural sinus trouble. The patient stated that her blood pressure increased on 02Mar2021 (yesterday) and she took her second dose of clonidine a little early around 3 o'clock as therapeutic measures, in which her blood pressure went down. The patient asked if there was any evidence of blood pressure increasing after receiving the vaccine or could her pain cause her blood pressure to increase. The outcome for arm pain was recovered in Mar2021, and for her blood pressure increased yesterday was recovered in Mar2021, outcome for rest all events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
intense headache and general malaise followed by a fever of 101.6.  Chills and rash over torso and neck.  Rash persists 48 hours later.
This spontaneous report was received from a consumer referring to three of her sisters of unknown age. On unknown date, the patients were vaccinated with zoster vaccine live (manufacturer unknown) (reported as "shingles vaccine") for prophylaxis. On unknown dates, the patients experienced herpes zoster. The outcome of herpes zoster was unknown. This is one of two reports received from the same source. Sender's Comments: US-009507513-1708USA002224.
Angioedema; wheezing; throat pruritis; This literature-non-study case was reported in a literature article and describes the occurrence of ANGIOEDEMA (Angioedema) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   LITERATURE REFERENCE:  Polyethylene Glycol and Polysorbate Skin Testing in the Evaluation of COVID-19 Vaccine Reactions. Annals of allergy, asthma & immunology. 2021     Concurrent medical conditions included Allergic rhinitis.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANGIOEDEMA (Angioedema) (seriousness criterion medically significant), WHEEZING (wheezing) and THROAT IRRITATION (throat pruritis). At the time of the report, ANGIOEDEMA (Angioedema), WHEEZING (wheezing) and THROAT IRRITATION (throat pruritis) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included antihistamines and steroids. Lab test included a skin test and the result was negative. The vaccine outcome was minor lip/tongue tingling. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded   This case was linked to MOD-2021-075534 (E2B Linked Report). This case was linked to MOD-2021-075577 (Patient Link).   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded MOD-2021-075534:Same Literature Article
Rash & Thrombocytopenia at the site of Injection. Fever and Headache
Within a couple of hours of the injection, I experienced numbness on the left side of my face most and then a little on the left side of my body. (Same side as the injection). It passed within a couple of hours but I am still experiencing some mild twitching on my left cheek. It's more annoying than anything but wanted to report it since the vaccine is still in trial.
child was given an expired flu vaccine of a December 2020 expire date with no adverse event; Initial information was received on 07-Jan-2021 regarding an unsolicited valid non-serious case from a physician via other health care professional.  This case involved a child patient of unknown age who child was given an expired INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (PRE-FILLED SYRINGE) of a December 2020 expire date (expired product administered) (lot number: unknown and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  Medical history, Past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  It was an actual medication error due to expired vaccine used (latency: unknown).  At the time of report, no adverse event was reported.  It was not reported if the patient received a corrective treatment.  Disclaimer: This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC 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.  There will be no information available regarding batch number in this case.
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. On 04-JUN-2014, the patient was vaccinated with GARDASIL (0.5 ml, lot#J011272, expiration date: 21-APR-2016) intramuscularly which underwent a temperature excursion. No adverse events were reported. At the time of the report action taken with GARDASIL was unknown. This is one of several reports from the same source. Additional information has been requested.
This spontaneous report was received from a 52 year old registered pharmacist (who is the patient) regarding himself. The patient has sulfur allergy. On an unknown date, the patient experienced itching in the thumb and wrist area of his hands and arms after preparation and administration of live ZOSTAVAX. The patient stated every time he prepares live ZOSTAVAX and administers the vaccine that he experiences itching about a half an hour later but eventually itching resolves after washing his hands with soap and water. The patient stated that he wears latex free gloves during preparation and administration of live ZOSTAVAX. Additional information has been requested.
A day after receiving the vaccine, I developed bumps on both side of my tongue. I have photos that I am able to provide. I showed them to the doctor and she said due to how new the vaccine was she was unable to determine if they were related. The bumps took a few months. I still have remnants of the bumps. I took my booster vaccine and I then developed additional bumps on both of my hands. The bumps went away after about a month. There are still red spots on my hands to date. I also developed issues with heart palpitations about 1 month ago. I am getting an extra beat every 5 seconds. I am currently wearing a heart monitor for about 10 days.
Narrative:  Per RN: "Patient came in on 6/15/21 to the clinic reporting 60+ medication and food allergies and asking for the Janssen vaccine. Patient has had anaphylactic reactions to yellow jacket stings and a typhoid vaccine in the past, but received the flu and pneumonia vaccine without incident. After checking ingredients in the typhoid vaccine and discussing the case with a RN, decision was made to allow patient to receive vaccine. Pt stated he understood the risk, and he and his wife were prepared with their own Benadryl and epipen. Janssen vaccine given at 0915, at 0925, patient said he was itchy and took some of his own benadryl, 25 mg. Pt was offered clinic benadryl, but declined. At 0932, patient reported difficulty swallowing and promptly administered his own epipen in left thigh. Emergency medical response was called at this ime and arrived within 1 minute. Vitals were taken and ambulance was called. Pt had no issues breathing, O2 sats stable, and lung sounds clear. Continued to report difficulty swallowing that was not worsening. Ambulance arrived at 0955 and transported patient to hospital. Per follow up with patient's wife on 6/16, patient was given antihistamines at the ER and stayed for a couple of hours. He is now home with body soreness and lethargy, taking Benadryl q6." Per Primary care f/u on 6/18/21: "Pt arrived w/o severe resp. distress. Pt. had sig upper airway sx. c/w anaphylaxis. Pt treated aggressively with epi and additional meds. Pt had no evid to suggest pharyngeal abscess, no evid. of pneumonia or indication of ptx. no evid arrhythmia on monitor/EKG, no evid by hx or eval to suggest aspirated f.b. Given resp. sx, pt required epi to break sx. quickly. pt. was placed in a room and on a monitor upon arrival. IV started We monitored the patient. During the hour the symptoms began to resolve. The patient had no further respiratory symptoms I discussed possible causes of anaphylaxis. They also understood they should F/U with PCP within 1-2 days, Rx written. Today, spoke to patient over the phone. He is doing well, he continues to take Zyrtec and Zantac. He is no longer taking Benadryl. He denies any swelling. He does continue to have a sore throat but no swelling reported. He was talking in full sentences over the phone with no evidence of respiratory distress. He is doing well otherwise and happy that he at least was able to get the vaccination to limit his risk for developing Covid."
Talked to pt. 7-30-10; 4 days ago developed headache, worse with eye movement, fever and "really achy", also nausea 4-5 days ago; on 7-29-10 had red splotchy raised rash - large splotches on torso progressing to small on lower half of body - no itching.