chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Oct2021 at 14:00 as dose 3 (booster) single (Lot number: FC3592) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". 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: Patient had no known allergies. Treatment of COVID-19 as Paxlovid, started from 26Jul2022 to 01Aug2022.
Patient contacted me on 11/30/05 re:  the pneumonia shot she received on 11/28.  She stated her rt. arm was hurting and that there was a red welp. going under her arm pit.  I suggested that she elevate the arm: apply a ice pack and call me back and her family physician if not any better.  On 11/30/05 I attempted a follow-up call; there was no answer.
Still feeling tired; Tested positive for COVID; Flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), SARS-COV-2 ANTIBODY TEST POSITIVE (Tested positive for COVID) and FATIGUE (Still feeling tired) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms). On 23-Jan-2021, the patient experienced SARS-COV-2 ANTIBODY TEST POSITIVE (Tested positive for COVID). On an unknown date, the patient experienced FATIGUE (Still feeling tired). The patient was treated with ASCORBIC ACID (VIT C) at an unspecified dose and frequency; COLECALCIFEROL, MENAQUINONE-7, PHYTOMENADIONE, RETINOL PALMITATE, TOCOPHEROL, TOCOTRIENOLS NOS (VITAMIN D COMPLEX) at an unspecified dose and frequency and ZINC at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), SARS-COV-2 ANTIBODY TEST POSITIVE (Tested positive for COVID) and FATIGUE (Still feeling tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jan-2021, COVID-19: Test positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other treatment medications include Lots of Fluids. No relevant concomitant medications were reported.; Sender's Comments: Based on the natural history of COVID-19, and the established information about the mRNA-1273 vaccine, a causal association between the event of tested positive for COVID and the product use is assessed as unlikely,  The other events are assessed as symptoms of the COVID-19 and not due to the vaccine  Hence, also assessed as unlikely related with mRNA-1273 vaccination
sore arm; Initial information received on 19-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who experienced sore arm after receiving vaccine INFLUENZA VACCINE.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date, the patient received unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunization). Information on the batch number was requested.  On an unknown date the patient developed sore arm for 2 days (pain in extremity) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.   It was unknown if there were lab data/results available.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event pain in extremity.
ACUTE NON ST ELEVATION MI 1/31/2023  &  1/26/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
RIGHT DELTOID PAIN; HEADACHE; FATIGUE; ITCHING 3 INCHES BELOW  AND 3 INCHES ABOVE THE ELBOW; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: 29/JAN/2023) dose was not reported, administered on 06-APR-2021 10:45 on right deltoid for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, treatment medications included: paracetamol. On 06-APR-2021 11:45, the subject experienced itching 3 inches below and 3 inches above the elbow. On 06-APR-2021 13:55, the subject experienced headache. On 06-APR-2021 13:55, the subject experienced fatigue. On 07-APR-2021 03:30, the subject experienced right deltoid pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from itching 3 inches below and 3 inches above the elbow, headache, and fatigue, and had not recovered from right deltoid pain. This report was non-serious.
Patient has history of anaphaylyxsis, she pre medicated at home this morning with Zyrtec 20 mg and Famotadine 40 mg prior to going to F13 clinic for her covid vaccination. Patient stayed an hour after vaccine administration to be monitored. She came to ER for further monitoring and allergic reaction concerns and received 2 doses of 25 mg diphenhydramine. She was reporting itching of her trunk and arms, itchy throat, and hot flashes. She was monitored in ER, she maintained airway and stayed on RA the entire visit.
Vomited on Wednesday, 8/7/13. Severe body aches, red band/swelling almost entirely around injection site arm.
When I woke that morning I had cold symptoms like congestion, sore throat.  The next day I had a fever, congestion with sore throat it felt more like flu symptoms that day and day 3 and 4 were like cold symptoms and I had weeks of exhaustion.  I took a home test for COVID-19 on the 16th and it was negative and when I took another home test on the 17th it was positive.  I spoke with my physician after I tested positive.  We talked about Paxlovid and I decided to just take over the counter with Nyquil day/night and Zycam and that was it.   I had symptoms for probably 4 days and the exhaustion lingered for longer.
Skin rash developed soon after second vaccine shot. Itches. Tiny bumps (like boils) began to appear, multiplied. Rash area expanded, down right arm and across upper chest. Very uncomfortable
Injection given at 2:00 pm. Next morning I had severe back pain in the lower right side. this lasted two days and subsided as days went by. today is the 10th of march and I am still in pain although it has gone from severe to 2 out of 10.
She has swelling at the injection site and surrounding area. She has redness at the injection and a large surrounding area. She states pain and soreness around the area.
On 9/1/00, complained of fatigue, chills and temperature of 100.7F. Took Tylenol at 20:15. Temperature was 100.3F. On 9/2/00, complained of red "blotches from head to toe" through 9/13/00 PM. All symptoms resolved on 9/3/00 PM.
This spontaneous report as received from a pharmacist refers to a 59 year old female patient with no pertinent medical history or drug allergies. On 05-APR-2013 the patient was subcutaneously vaccinated with a dose of 0.65ml ZOSTAVAX (lot number J000783, expire date 30-APR-2014). There was no concomitant medications. On 06-APR-2013, the patient returned to the pharmacy complaining of swelling, redness and itching at the injection site. The Pharmacist measured the site and it was 3 inches across the upper arm where the injection was given. The patient returned today (on 08-APR-2013) and stated that she had pain, more swelling and redness as well as the site being hot to touch. The site was now 12 inches across the upper arm. The pharmacist also noted that the skin of the arm appeared to be getting rough and changing in texture. The patient was advised to see an unspecified physician. The unspecified physician prescribed an unspecified antibiotic for a diagnosis of cellulitis. The adverse events were reported as not improve. The relatedness for the events to ZOSTAVAX was unknown. Additional information has been requested.
Pt. states Increased pain at injection site with aches in joints plus shortness of breath with mild exertion beginning in the afternoon and gradually worsening. Temperature increase to 100.2F around 1900 followed by rigors and rapid increase in temperature. Despite 500mg Tylenol following this with continued increase in temperature to 104.9 by 2200, after which it began to decrease and was 101.5 by the AM of 02/26/2021 with generalized aches and malaise, rhinitis persisting for the next 24 hours. S/S had largely resolved completely by 02/28/2021, with mild rhinitis remaining for 2 days after 02/28/2021.
Swelling started day after injection no systemic symptoms. Soreness at site (L) delt). Improving since yesterday.
Breakthrough COVID + Symptoms began 4/5, her COVID PCR was positive on 4/8/21.
Patient came in for vaccination one week early. The assigned Medical Assistant administered the vaccination 0.1 mL intradermally on left forearm before realizing this. She reached out to me as the site supervisor I spoke to medical leadership. The reassured us that according to the guidelines if the patient is not immunocompromised the vaccination should create proper immunity. The patient was informed of the early vaccination and what the guidelines stated.  They were offered a re-administration in 28 days if they felt unsure and was also offered to speak to a provider, but they declined. Vaccination card given.
On 11/05/08, pt. had swelling and discomfort at injection site.
timely worsening of patient's known diagnoses of cervical radiculopathy, psoriasis, and oral HSV. Also with shoulder pain, fatigue, menstrual cramping, bleeding, migraines since vaccine series
The evening of 1/9/2022 the patient began experiencing an itchy rash on her neck and head. Over the next 24 hours she developed itchy spots over her whole body. Her sister received the same vaccine (pfizer booster) and was experiencing similar symptoms with the same timetable. The patient did not have any issues with the first two vaccines; she also reported starting to use a new body lotion within the two weeks prior to the symptoms starting.
Improperly stored vaccine administration in reference to temperature excursion; This spontaneous report has been received from a reporter concerning a currently 4-year-old patient of unknown ethnicity. The patient's concurrent conditions, allergies/reactions, medical history and concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) 0.5 milliliter (Lot # S031703 with expiration date on 06-APR-2021; route of administration not repoted) for prophylaxis; which had been exposed to temperature excursions (-9.5 celsius (C) for 8 hours and 53 minutes; and -10.1C for 6 hours and 40 minutes) (no previous temperature excursions reported). The call was made through a data logger.
Rash/The rash is mostly on her chest, and up her neck and stomach/rash on her neck , chest, and ears.; since the booster she has been breaking out in hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2), administration date 17Dec2021 (Batch/Lot number: unknown) at the age of 75 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (First Dose, She was fine with the first and second dose of the COVID vaccine., Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Second dose, She was fine with the first and second dose of the COVID vaccine., Manufacturer unknown), for COVID-19 Immunization. The following information was reported: RASH (non-serious) with onset 17Dec2021, outcome "not recovered", described as "Rash/The rash is mostly on her chest, and up her neck and stomach/rash on her neck , chest, and ears."; URTICARIA (non-serious) with onset 17Dec2021, outcome "not recovered", described as "since the booster she has been breaking out in hives". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash, urticaria.  Additional information: Reporter seriousness for Rash was unspecified. Patient tried to go to doctor and doctor advised to take Benadryl but it didn't work. She doesn't like taking pills. She doesn't have the lot/expiration for the Benadryl. She doesn't know the dates or lot/expirations for any of her vaccines. She doesn't have that information on her at this time. The rash showed up the same week of the COVID booster. She stayed at the place for almost half an hour. The night of the COVID booster, is when she started feeling the rash on her neck , chest, and ears. Sometimes it is worse than other times. Every medication she is on she has been on for a long time. She just doesn't know what she is dealing with.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Injection Site Soreness and Fever day 1 Narrative:  Other Relevant History:
Patient called the pharmacy 5/3 to report that the area around where he got Shingrix on 5/1 had become red, swollen, sore, and slightly raised-- an area about the diameter of a baseball-- which started sometime the previous night.  Counseled him to monitor this and to use a cold compress/ice pack and possibly OTC benadryl to treat this reaction.
THIS WAS THE COVID BOOSTER SHOT FOR INDIVIDUALS OVER 65. LYMPHNODE UNDER LEFT ARM EXTENDING  DOWNWARD, AROUND THE LEFT SIDE OF NECK  WERE SORE AND SWOLLEN. SWELLING IS GOING DOWN AND THE SORENESS IS ALMOST GONE.
HEART POUNDING  (RESTING HEART RATE SHOT UP FROM MY AVERAGE 48 TO 95 AND POUNDING); MASSIVE ACHES; CHILLS; FEVER; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. 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 not reported, batch number: Unk) dose was not reported, administered on 23-MAY-2021 for prophylactic vaccination.  The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAY-2021, the subject experienced heart pounding (resting heart rate shot up from my average 48 to 95 and pounding). On MAY-2021, the subject experienced massive aches. On MAY-2021, the subject experienced chills. On MAY-2021, the subject experienced fever. Laboratory data included: Heart rate (NR: not provided) AVERAGE 48 TO 95 AND POUNDING. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart pounding (resting heart rate shot up from my average 48 to 95 and pounding), fever, massive aches and chills was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Beginning in approximately the middle of May 2021, I began having issues with rashes and itchiness, followed by pain at the area that was itchy. On June 3, 2021 I photographed the reaction because it worsened- my back was entirely broken out in a red rash with raised white areas from scratches, and bumpy hives. This increased in frequency to approximately 3x per week for about 3 weeks until it became a daily occurrence. If I ignore the rash that eventually develops into hives/urticaria, I notice that I eventually get very achy joint pain. The joint pain can be avoided if I take fexofenadine (24hr) at the first sign of the rash. Since June, I have not been able to go more than 12-36 hours without needing to take fexofenadine. I sought care from an allergist who informed me that I could take 4x the recommended OTC dosage of fexofenadine if needed. Beginning 2 weeks after the Moderna Booster shot, I needed to take double the recommended OTC dosage of fexofenadine because my symptoms worsened.
6 x 3 area of redness, swelling doctor suggested cold compresses and BENADRYL.
pt recv vax 17AUG96 & 20AUG96 pt devel a blotchy, red blistered rash that did not itch, but was sensitive to touch;md described experience as "painful skin" and "marked dermatographism";
I had symptoms of a yeast infection and the over the counter medication did not work. It was a strange coincidence in timing because it was within a week of my vaccine. The doctor cultured and she did not recommend any treatment.  It lasted about four days and then became better. I only used medication for 48 hours which did not seem to help.
Came in contact with someone with covid on Saturday and now caller has covid; Came in contact with someone with covid on Saturday and now caller has covid; Came in contact with someone with covid on Saturday and now caller has covid; This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date in Mar2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced came in contact with someone with covid on saturday and now caller has covid on Mar2021. Reporter stated that received first covid vaccine 2 weeks ago and came in contact with someone with covid on Saturday and now caller has covid. Caller would like to know if he can still get the second covid vaccine or will he have to start completely over. Transferred due to getting covid after getting the first covid vaccine. Due to their being a few callers ahead asked to see if the caller would mind waiting in the waiting que and the next available medical professional would be happy to answer your question. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date in Mar2021. The seriousness of the events drug ineffective, COVID-19 was reported as serious (medically significant). The outcome of the events was unknown.
Swelling and redness at site of left thigh immunization. Worsened after 24 hrs. No fever. Swollen 5 cm in diameter with small urticarial lesion. Gave BENADRYL 1/2 tsp. Q6H.
Fever, headache, body aches 1 day after vaccination Localized reaction of erythema, warmth, and pain at vaccination site Generalized maculopapular rash to all extremities, chest, abdomen, back, and face
Severe soreness at site of injection, enough to awaken pt from sleep. Site (R arm) sore, R axilla, R scapular area sore, extension of arm difficult, raising arm difficult. Slight tingling R little finger. No erythema, swelling, loss of function or systemic complaints.
I had the first dose of the vaccine for COVID 19 on 1/7/2021 and since I experience strong itching all over the body sporadically. Almost always it starts on my back and axilla and then spread throughout my body. I have had it on the sole of my feet, on my legs specifically. It is a strong itch. There are days where it is stronger than others. To alleviate the itching symptoms, I take a Benadryl 50mg, this is the only way I feel relief.
receiving a double dose of Ipol. We have a baby that received Ipol and Kinrix which also contains IPV.; Initial information received on 15-Jul-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 6 months old male patient who was vaccinated with 0.5 ml dose of IPV (VERO) lot P1a242m via intramuscular route in the left thigh on 12-Jul-2019 and also receive DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID [KINRIX] not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE), HEPATITIS B VACCINE (HEPATITIS B VACCIN) and HIB VACCINE (HIB VACCINE) on 12-Jul-2019.  It was as actual medication error case due extra dose administered. The patient was receiving a double dose of Ipol. "We have a baby that received Ipol and Kinrix which also contains IPV.  At the time of reporting, no adverse reaction 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 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.  List of documents held by sender: none.
Nauseua, lightheadedness, fatique, muscle pain, injection site pain, low fever
I received the injection on Wednesday, by Saturday I was feeling very sick. I had a fever of around 102.5 on average and was feeling very weak. By Monday I was so weak I had to go to the doctor. In the dr. office I had a syncope event with tongue out, convulsions. Dr called 911 and was transported to the hospital via ambulance. The dr at the ER tested for Covid (negative) and stated this was a moderate adverse reaction to the vaccine. It took me a full 8 days to be able to not sleep all day and get some strength back.
Skin sensitively to clothing touching both left and right forearms.  There is no visible rash.  I have had similar problems with the drugs list #10.  Has been 14 days today and still have the same amount of sensitively as the first day. I have never had any problems with flu vaccines or pneumococcal vaccine that I have been given over the years.