chrisvoncsefalvay/vaers-outcomes huggingface dataset:
"Two years ago", in 5/99, the vaccinee received her 1st dose of Lymerix, without adverse event. "One month later", in 6/99, she received her 2nd dose of Lymerix. "Two months later", in 8/99, the pt experienced joint pain in her neck, spine, wrists, feet, hips and shoulders. A doctor visit was required. The pt stated that her physician had suggested that she had osteoarthritis. X-rays were performed. The pt spoke with the radiologist, who reportedly told her that she did not have osteoarthritis. Multiple sets of unspecified lab tests were performed, and the pt stated that they all came back "unremarkable." As of 5/16/01, the outcome of the event is unresolved. The follow-up states that she had arthralgia in the knees in 1995. At that time her Lyme titer was negative. There was no illness at the time of vaccination. The vaccinee's mother had osteoarthritis in her fifties. On 05/18/1999, she received her second dose of LYMErix. Five months later on 10/05/1999, the vaccinee experienced joint pain in her hands, neck, spine, wrists,feet, hips, and shoulders. The pt was treated on 11/22/1999 with aspirin, ibuprofen and glucosamine/chondroitin. The LYMErix immunizatin series was discontinued due to the adverse event. The reporting physician stated that the adverse event was mild in intensity and was possibly related to LYMErix. However, he reported that it could also be associated with the pt's family history of osteoarthritis. As of 06/22/2001, the event was ongoing.
Patient sat down after his vaccine and shortly after reported that he was feeling warm and a little sick to his stomach. He was immediately given a cold bottle of water and moved in front of a fan. He then continued to look more pale and stated that his vision was blurry. He was then noted to become unresponsive with his eyes rolled back in his head. He was lowered to the ground by myself and a couple of nurses. He was shaken and his name was called until he slowly came around. Vitals signs were taken and his BP was noted to be low. A cold cloth was placed on his forehead. He was monitored on the ground for about 15 minutes as he came around. He began speaking normally and laughing. He was assisted to sit in a chair where he was monitored for another 15 minutes. He then reported that he was feeling good with no residual symptoms. His significant other left with him and drove him home.
pain in both feet; burning sensation in both feet; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8730) via an unspecified route of administration in the arm left on 02Apr2021 at 09:45 as a single dose for COVID-19 immunisation. Medical history included shellfish allergy. Concomitant medications included hydrocortisone injection (CORTIZONE) in both feet for an unknown indication on 26Mar2021 and meloxicam (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6202) via an unspecified route of administration in the arm left on 12Mar2021 at 15:30 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 13:00 the patient experienced burning sensation and pain in both feet after having the COVID shot. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if patient received any treatment for the events. The patient was asking could this be reacting with the cortisone injection received on 26Mar2021. The clinical outcome of the events pain and burning sensation in both feet was not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. There was no information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies provided. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot#, expiration date, dose, anatomical location and route of administration were not reported) frequency reported. On an unknown date after vaccination, the patient developed a large knot at the injection site. The outcome of the event was reported as recovering. The patient sought medical attention and visited an office. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Within 5 days she had Covid; Within 5 days she had Covid; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient. An 88-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid" (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 "Within 5 days she had Covid". The event "within 5 days she had covid" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: they prescribed Paxlovid for her. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course details: The patient went upstate for the holidays with her family and within 5 days she had Covid. She had Covid before and she have had the two booster shots. She had the Immuno as treatment that is very effective for Covid (Monoclonal Antibody) when she got the virus for the first time. She absolutely had no side effects and she wouldn't have known she had it, if she had the test. She mentioned that she had began coughing so she went to a clinic (urgent care clinic) and prescribed her with Paxlovid.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I?ve had three shots now with all three shots I experienced a slight headache the night after the shot. But after the first shot I have ringing in the ears at has been persistent for the last year and a half.
This spontaneous report was received from a registered nurse refers to a patient of unknown age. On 30-SEP-2013, the patient was vaccinated with a dose of PROQUAD which was exposed to 50 Fahrenheit for 32 hours which was not supported. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Patient was born in Venezuela.  We do not know where she rec'd varicella vaccine.  No fever, mild break-through disease-11 lesions.
Red, swollen area to right arm, at injection site down to bend of arm (elbow).
KIDNEY FAILURE; ONE HEART ATTACK; GENERAL HEALTH PROBLEMS; RIDDLED WITH BLOCKAGES/BLOCKAGE IN A VEIN OF BRAIN; BLOOD PRESSURE (BP) HAD BEEN UNMANAGEABLE; This spontaneous report received from a patient and from a company representative via social media concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: At the time of vaccination, the patient was 135 pound healthy with zero heart disease, nor kidney issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, dose and start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced one heart attack, kidney failure, general health problems, riddled with blockages/blockage in a vein of brain, and blood pressure (BP) had been unmanageable. Patient experienced one heart attack and learned abut the blockage in vein of brain. Patient was riddled with blockages. Reporter stated that, "I am having all kinds of health problems because of your vaccine" and "Your vaccine is killing me. Heart disease and kidney failure. I had zero concerns with either prior to receiving your poison. What will you do about it. Besides try to bury me and my complaint. Thanks for the death sentence". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the general health problems, one heart attack, kidney failure, riddled with blockages/blockage in a vein of brain and blood pressure (BP) had been unmanageable was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000298807, 90000298815. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria as records 90000298815 and 90000298807 are duplicate reports of medical adverse events for the patient related to the vaccine. There is no product quality issue described in the reported information) based on the PQC evaluation/investigation performed. This case is a duplicate of 20231001068 and 20231000937.; Sender's Comments: V0: 20230970754-one heart attack, kidney failure. The event 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. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
02/25/2021  Pfizer-BioNTech COVID-19 Vaccine EUA 02/26/2021  Mild soreness at site of injection 1 day after first shot; soreness only on that day - no longer sore 02/27/2021  Fever 100.2 degrees F and fatigue 2 days after first shot; took (2) 325mg of Tylenol gel caps and rested/slept
itchiness at the injection site; redness at the injection site; rash at the injection site; Palpitation; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitation), INJECTION SITE PRURITUS (itchiness at the injection site), INJECTION SITE ERYTHEMA (redness at the injection site) and INJECTION SITE RASH (rash at the injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PALPITATIONS (Palpitation). On 22-Feb-2021, the patient experienced INJECTION SITE PRURITUS (itchiness at the injection site), INJECTION SITE ERYTHEMA (redness at the injection site) and INJECTION SITE RASH (rash at the injection site). At the time of the report, PALPITATIONS (Palpitation), INJECTION SITE PRURITUS (itchiness at the injection site), INJECTION SITE ERYTHEMA (redness at the injection site) and INJECTION SITE RASH (rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021 at 10:36 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Mar-2021 at 10:27 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 60.53 and 60.62 .  Concomitant products were not provided.  On 14-Feb-2021, excursion time was 09 AM, 10AM, 11AM, 02 PM and 03 PM  and temperature was 32, 32, 32, 35 and 32 respectively, total doses given for the day was 162, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vial was moved to clinic. Vaccine BUD date was 10-Mar-2021.  On 21-Mar-2021, excursion time was 09 AM, 10AM, 11AM, and temperature was 34, 32, 34 respectively, total doses given for the day was 94, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 16-Mar-2021, vial was moved to clinic on 21-Mar-2021. 10 vial was moved to clinic. Vaccine BUD date was 15-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Her left arm (arm of administration) hurt like the dickens when they gave her the booster dose and still hurts; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Her left arm (arm of administration) hurt like the dickens when they gave her the booster dose and still hurts) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045JKA, 002B21A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Her left arm (arm of administration) hurt like the dickens when they gave her the booster dose and still hurts). At the time of the report, VACCINATION SITE PAIN (Her left arm (arm of administration) hurt like the dickens when they gave her the booster dose and still hurts) had not resolved.            Concomitant drugs were not reported.  Treatment medications were not provided.  It was reported that patient had broken heart syndrome after Dose 2. Her left arm (arm ofadministration) hurt like the dickens when they gave her the booster dose and still hurts but not as bad as after the 2nddose.  The LOT number for booster dose was reported as 045JNA or 045JKA.   This case was linked to MOD-2021-403062, MOD-2021-403128 (Patient Link).
Total blindness in rt eye; started w/intense pain behind rt eye, then blurred vision; dx as optic neuritis; treated w/meds for 3 days; 23NOV93 back @ work; vision is coming back, but still seeing shadows;
About 4 weeks ago, I started to have swollen glands, a sore throat, fever of 99.3 and 101.F lasting  two full weeks. I went to get tested and had a negative strep test, flu test and COVID test. These tests were done at an ER. I work in a clinic and someone also at my office had this kind of virus, symptoms and she also tested negative for COVID. I have recovered from my symptoms.
Client (DOB: 10/24/1969) received Novavax COVID vaccine Lot# 4302MF023 in left arm at 10:00 am. At 10:20 am client complained to PHN of a "headache." Client reported discomfort 2/10, located behind the eyes. Client denied blurry vision, throbbing, denied feeling nauseous. Client denied itchiness, denied cough, skin dry and appropriate to Ethnicity. Client alert and oriented to person, place, time and situation, sitting in her walker/chair. Client reported history of HTN, Asthma, not taking any medications. Client reported gets headaches from the sun, and "may have had it before vaccine was given." Client reported history of face swelling and allergy to fish. At 10:25 am PHN gave client water and client stood up and walked to sit in the shade. Vitals taken at 10:30 am: BP 170/100, RR 20, 95% SPO2, 80 bpm. Client denied headache getting worse, staying the same, denied nausea. Client reported anxiety anytime she is around police and was very nervous. BP checked again at 10:35 am 10 minutes after sitting, legs uncrossed: BP 158/99. Client reported at 10:40 am headache was gone. BP re-check at 10:48 am: 140/90. PHN educated signs and symptoms of high blood pressure, risks, and when to seek emergency services. PHN referred to mobile street team, client has an appointment tomorrow at 9 am. Client walked away at 10:50 am, steady gait, completed observation period.
Two days post vax pt experienced an injection site reaction characterized by redness and tenderness.  The area was hard to touch.  ER physician diagnosed cellulitis vs allergic reaction to DT booster. Pt was treated with Keflex.
immed pain in deltoid muscle p/inj;pain cont still in deltoid region only;seen by MD x2
This patient after receiving Pediarix and Prevnar has had a rash appear on the face and neck.  This has happened every time she has recieved these immunizations at 2,4 and now 6 months. CDC stated that no action needed to be taken. No treatment was administered.  The CDC stated that it is an unsual reaction to have occur with either of these immunizations.  Therefore this reaction is not life threatning and should not prohibit this patient from receiving any further immunizations.  The risk of any of the diseases out weighs the risk of the rash.
Face completely swollen  Benadryl was administered Patient was breathing and talking with out further issues.
Significant bruising 4 days, petechiae, given IVIG - increased platelets.
M.A. misinterpreted order for Hep B and administered GARDISIL (HPV) vaccination. PCP notified - no harm to patient
No adverse effects; Calling to report a temperature excursion; This spontaneous report was received from a Medical Assistant, refers to a patient of unknown age and gender. Information regrading the patient's pertinent medical history, known allergies, concurrent conditions and concomitant therapies was not provided.      On an unknown date, the patient was vaccinated with hepatitis b vaccine (recombinant)(RECOMBIVAX HB) (strength, route, dose, lot # and expiration date were not provided) for prophylaxis.         On 16-NOV-2020, it was found that hepatitis b vaccine (recombinant)(RECOMBIVAX HB), experienced a temperature excursion. The reported stated that the patient had no adverse reactions. Information regrading the temperature excursion in which the vaccine was involved was not provided.  This is one of several reports received by the same source.; Sender's Comments:  US-009507513-2011USA010974: US-009507513-2012USA002962:
Patient complains of fatigue since the completion of the Moderna series. He has experienced a 5 pound weight gain. Pt has felt tired and fatigue that prevents him from working. Some days he experiences extreme fatigue and has difficulty speaking without getting shortness of breath. He has also developed anxiety and has difficulty falling asleep and wakes up throughout the night.
Headache; Deep red rash on the crease of her right arm by the elbow; Soreness under the breast; Itching; Rash spreading to her neck, chest, breast; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), RASH ERYTHEMATOUS (Deep red rash on the crease of her right arm by the elbow), BREAST PAIN (Soreness under the breast), PRURITUS (Itching) and RASH (Rash spreading to her neck, chest, breast) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced HEADACHE (Headache), RASH ERYTHEMATOUS (Deep red rash on the crease of her right arm by the elbow), BREAST PAIN (Soreness under the breast), PRURITUS (Itching) and RASH (Rash spreading to her neck, chest, breast). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of UNK dosage form; Cortisone cream at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache), RASH ERYTHEMATOUS (Deep red rash on the crease of her right arm by the elbow), BREAST PAIN (Soreness under the breast), PRURITUS (Itching) and RASH (Rash spreading to her neck, chest, breast) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment meds: Advil, Cortisone cream, Benadryl.
2 year old male patient was administered dose of QUADRACEL with no reported adverse event; Initial information received on 27-Apr-2021 regarding an unsolicited valid non-serious case received from a physician via nurse.  This case involves a two year old male patient who received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (Product administered to patient of inappropriate age).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  On 21-Apr-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot C5851AA and expiry date: 25-Mar-2023) (Frequency: once) via an intramuscular route in the left thigh for prophylactic vaccination.  It was a case of actual medication error due to inappropriate age at vaccine administration (same day latency).  At the time of report 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 holder's compliance with the requirements set out in the 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.
pt recv vax 6NOV98 & w/in 12hr devel a fever of 103 w/shaking chills, myalgia & general fatigue;