chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Stated of fever, Chills, Dizziness and emesis.  Stated of taking Tylenol and it was ineffective.
neck ache; Canker in the mouth is painful/Big canker in her mouth on left hand side/bothering in the mouth is painful; enlarged lymph nodes in her underarm, under chin, neck and breast; really sore in the breast area from nipple to back; really sore in the breast area from nipple to back; Tingling numbness under eye and cheek; Tingling numbness under eye and cheek; really tired; soreness of arm; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (really tired), PAIN IN EXTREMITY (soreness of arm), NECK PAIN (neck ache), LYMPHADENOPATHY (enlarged lymph nodes in her underarm, under chin, neck and breast) and BREAST PAIN (really sore in the breast area from nipple to back) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced FATIGUE (really tired) and PAIN IN EXTREMITY (soreness of arm). On 29-Mar-2021, the patient experienced LYMPHADENOPATHY (enlarged lymph nodes in her underarm, under chin, neck and breast), BREAST PAIN (really sore in the breast area from nipple to back), BACK PAIN (really sore in the breast area from nipple to back), HYPOAESTHESIA (Tingling numbness under eye and cheek) and PARAESTHESIA (Tingling numbness under eye and cheek). On an unknown date, the patient experienced NECK PAIN (neck ache) and APHTHOUS ULCER (Canker in the mouth is painful/Big canker in her mouth on left hand side/bothering in the mouth is painful). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FATIGUE (really tired), PAIN IN EXTREMITY (soreness of arm), NECK PAIN (neck ache), LYMPHADENOPATHY (enlarged lymph nodes in her underarm, under chin, neck and breast), BREAST PAIN (really sore in the breast area from nipple to back), BACK PAIN (really sore in the breast area from nipple to back), HYPOAESTHESIA (Tingling numbness under eye and cheek), PARAESTHESIA (Tingling numbness under eye and cheek) and APHTHOUS ULCER (Canker in the mouth is painful/Big canker in her mouth on left hand side/bothering in the mouth is painful) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
td administered on 01/29/09 left deltoid area.Returned to clinic 02/02/09 with complaint of left deltoid redness 6in/5in, erythema with warmth and slight induration.
palms of hand and feet itching; pressure ears; vagina slight burning; tongue thick; voice changing; complete body turned red; body shake; This is a spontaneous report from a contactable consumer. A 64-years-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EM9809), via an unspecified route of administration in left arm on 19Feb2021 at 16:00 pm at single dose for covid-19 immunisation. No other vaccine in four weeks. Medical history included tinea pedis, bottom foot condition (itching), pruritus. No known allergies. concomitant medication(s) included simvastatin (simvastatin), calcium (calcium), curcuma longa (turmeric [curcuma longa]), acetylsalicylic acid (baby aspirin, cyanocobalamin (b12 [cyanocobalamin]). The patient previously took simvastatin 10 mg. The patient was not tested covid positive post vaccination. On 19Feb2021 at 19:30, the patient experienced palms of hand and feet itching, pressure ears, vagina slight burning,tongue thick and voice changing,complete body turned red. Had body shakes. The events assessed as non-serious. She went to the emergency room/department or urgent care. Therapeutic measures of Benadryl, Zyrtec, Pepcid were taken. The outcome of the events were recovered.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 07-NOV-2013, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance the intended purpose of the long-term prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 30-AUG-2016, the patient was treated for a vesicular outbreak, which was diagnosed as or shingles. The patient was prescribed valacyclovir hydrochloride (VALTREX), prednisone and neosporin for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX vaccine for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Patient came to the ED with shortness of breath and was found to have Covid pneumonia.  Patient was admitted to the hospital and treated with remdesivir.
Patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported. In April 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) outcome was unknown.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The date of vial initially stored in the refrigerator was unknown.  Dates of administration of vaccine were reported as 2 doses on 05-Apr-2022, 13 doses on 06-Apr-2022, 2 doses on 07-Apr-2022 and 4 doses on 08-Apr-2022.  The vial did not undergo any temperature excursions.  No treatment information was reported.
No further AE. No PQC; RN calls to report MMR II Lot#u013035 exp 4/23/2023 administered to a patient. No further AE.  No PQC; This spontaneous report was received from Other Health Professional and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 08-AUG-2023, the patient started therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, one time, lot #u013035, expiration date: 23-APR-2023, administered for prophylaxis (strength, and route of administration were not provided).  On an unknown date, RN called to report MMR II Lot#u013035 exp 4/23/2023 administered to a patient. No further AE.  No PQC.  Lot Number u013035 is valid for V205c with albumin status rHa.
Developed nausea 1-2 hours after vaccine. Developed mild muscle aches and cramps later that day. Symptoms gone by next day except residual site soreness. Asthma has worsened and is using Albuterol inhaler 1-2 times daily since second dose. Woke up 1/19/21 at 3am. Developed temperature then was diaphoretic. Vomited. Developed SOB, tachycardia, and wheezing.
This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a 63-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included fibromyalgia. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced very sore arm for a month and a half following the vaccination and finally subsided. The nurse said patient had a history of fibromyalgia so she was not sure if her fibromyalgia contributed to the pain. The patient just went in for their 2nd dose of SHINGRIX and had got it on the other arm.
Had temp of 102-105, sz activity; when got to ER was treated for convuls also had double ear infect; has not had any sz since this time; pt is not on any anti-convuls med @ present;
Asthma; Condition aggrevated; Inappropriate schedule of vaccine; Cold; Cough lingered; This case was reported by a consumer via call center representative and described the occurrence of cough in a 78-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis.   Concurrent medical conditions included asthma (since 5 years of age, very well controlled).   On 20th February 2019, the patient received the 1st dose of Twinrix. On an unknown date, the patient received the 2nd dose of Twinrix. In March 2019, less than a month after receiving Twinrix and not applicable after receiving Twinrix, the patient experienced cough. In July 2019, the patient experienced cold. On an unknown date, the patient experienced asthma, condition aggravated and incomplete course of vaccination. On an unknown date, the outcome of the cough was recovered/resolved and the outcome of the cold, asthma, condition aggravated and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the cough, cold, asthma and condition aggravated to be related to Twinrix.  Additional details were provided as follows: This case was reported by the patient herself. The lot number/expiry date or any other vaccine details were unknown. In early March 2019, the patient started experiencing cough. At the time of reporting, less than 6 months after the 1st dose of Twinrix, patient just caught a cold and cough lingered. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, missed the 2nd dose due to her asthma and a terrible lingering cough, which led to incomplete course of vaccination. Lingering cough stopped 6 weeks ago of reporting date. The reporter consented to follow up but declined to provide responsible physician's information.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Patient was not having any known allergies. Concomitant medication(s) included: ESCITALOPRAM OXALATE oral. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient was treated with Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300112282 Same patient, different drug/event;
Injection site hot; Injection site became  itchy; Injection site became red; Injection site became swollen; Felt very low in energy; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Felt very low in energy), VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE PRURITUS (Injection site became  itchy), VACCINATION SITE ERYTHEMA (Injection site became red) and VACCINATION SITE SWELLING (Injection site became swollen) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced ASTHENIA (Felt very low in energy). On 20-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site became red) and VACCINATION SITE SWELLING (Injection site became swollen). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Injection site hot) and VACCINATION SITE PRURITUS (Injection site became  itchy). On 14-Apr-2021, ASTHENIA (Felt very low in energy) had resolved. At the time of the report, VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE PRURITUS (Injection site became  itchy), VACCINATION SITE ERYTHEMA (Injection site became red) and VACCINATION SITE SWELLING (Injection site became swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided by the reporter.
On November 8th, 2022, I woke up about 2:00AM with a bad headache and nausea and nasal congestion. I called into work and stayed in bed all day. I then had muscle aches. I also had ear pain. Those symptoms got better on Saturday but returned in two days. They lasted about 3 more days. I took some over-counter medications. For this health event I saw a telehealth doctor on November 13 and 16, 2022 and went to the urgent care on November 16, 2022. I also had a very bad, dry cough that seemed to more a throat irritation than a chest cough. I was diagnosed with a respiratory infection. The COVID-19 infection began on November 26, 2022. I had a slight headache and took a rapid test, and it was positive. Within two days I had more symptoms of muscle aches, headache and nasal congestion. These symptoms lasted for about a week. I continued to test positive until December 4, 2022.
This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received the first dose of BNT162B2 (COVID-19 VACCINE, lot number: ER8727) via an unspecified route of administration on 05Apr2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient had the first shot on Aril 5th and he had a little outbreak of shingles. He had a little reaction, a single outbreak across his chest. Patient asked if he should continue to take the second dose. Patient stated that he was just curious about the dose and whether to take second dose. The reaction was minor and he went to see his primary doctor and it was not serious, just 5 little dots. Outcome of event was unknown.  No follow-up attempts are needed. No further information is expected.
mass on her arm; Information has been received from a physician via a sales representative, concerning a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not provided.   On unspecified date, the patient received a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), (dosage information was not provided) for prophylaxis.  It was reported that one month after the vaccination, the patient called to the physician informing about a mass in her arm. At the time of the report, the patient's outcome and the relatedness between the event and suspect therapy were not provided.
90% LOSS OF VISION IN ONE-EYE; BURNING EYE; FOGGY VISION; This spontaneous report received from a consumer (company representative) concerned a 43 year old male. 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: Unknown) dose, start therapy date were not reported 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 an unspecified date, the patient experienced 90% loss of vision in one-eye, burning eye, and foggy vision because of which patient visited his physician. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the burning eye, foggy vision and 90% loss of vision in one-eye was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210436318.; Sender's Comments: :20210436363-covid-19 vaccine ad26.cov2.s-90% loss of vision. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Syncope 3 times in 20 minutes time span on Sept 9, 2021, 1-day after receiving Shringrix at the doctor's office.  Went to E.R. of the nearby hospital.
Headache, Fever 102.5 for 10 hours, hip joint pain,  upper teeth hurt, kidney pain 400 mg Motrin @9:30 am
This spontaneous report was received from a nurse regarding a female patient of unknown age. There was no information on pertinent medical history and drug reactions or allergies. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, dose number, frequency, product lot#, expiry date, route not reported). There was no information on concomitant medications. The nurse reported that on an unknown date, the patient developed shingles after receiving vaccination with ZOSTAVAX. There was no product quality complaint involved. The patient sought medical attention by visiting the office. There was no intervention done to prevent the serious criteria. The outcome and causality was unknown. Additional information is not expected as the reporter cannot be contacted for follow up.
5 minutes after receiving the shot my heart started racing and beating erratically. I felt nauseous and lightheaded. I was sitting down the whole time. I waited hoping it would calm down, it did not. After about 10 minutes I asked for help.  My blood pressure was taken and it read 180 over 120. My heart rate was 117 and felt like it was flipping inside my chest.  I had waves of nausea.  The EMTs stayed with me, and brought me water.  It calmed down a little about 10 minutes later. I was asked if I wanted to go to the hospital and I declined.  I did drive home and emailed my doctor.  A Nurse Practitioner called.  I wasn't dizzy or nauseas any longer. I went in to the clinic to have my blood pressure checked again and this time it was within normal range.  The episode lasted about 3 hours from start to finish.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. In 2012, patients were vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot number not reported) that was improperly stored. Nurse reported that PNEUMOVAX 23 was exposed to temperature as low as -1C for several occasions from January of 2012 to July of 2012. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. No treatment information was reported. At the time of report, patient's outcomes were unknown. This is one of several reports from the same source. Additional information has been requested.
Headache in forehead within 2 hours of injection. Muscle aches and stiffness starting at about 2 hours after injection.
Four weeks after I got the first dose of the vaccine I started to have fluid leakage. I was 31 weeks pregnant. My water did not break but it was leaking out. I am hospitalized and plan to remain until delivery.   Due this summer with Second pregnancy
Information has been received from a 35 year old female patient with no drug reactions/allergies and no pertinent medical history for VARIVAX (Merck), a Pregnancy Registry product, who on 22-NOV-2011, was vaccinated with the first dose of VARIVAX (Merck) (route not reported). There was no concomitant medication. The same day, on 22-NOV-2011, a pregnancy test at the doctor's office was negative. The patient ovulated on 26-NOV-2011. A home pregnancy test on 10-DEC-2011 was positive. The patient repeated the home test and it was again negative. The patient telephoned the doctor and would see her on 13-DEC-2011. At the time of the report, the patient outcome was unknown. The last menstrual period was 12-NOV-2011. Estimated delivery date would be 18-AUG-2012. Follow-up information was received from the nurse practitioner on 25-JAN-2016. It was reported that the patient had undergone scheduled C-section (Caesarean section) (medically significant) at 35-36 weeks (premature delivery) of pregnancy and delivered a male infant weighing 3130 grams and 18 3/4 inches in length. The APGAR score was reported as 9/9 at 5 mins. No information was provided regarding the health status of the infant or congenital anomalies. The reason for the patient's scheduled C-section and she reported that the patient had a history of a Myomectomy in 2011 prior to vaccination. The outcome of the events caesarean section and the premature baby was reported as recovered. The relatedness of the events "scheduled C-section" and "premature delivery" with the suspect product VARIVAX (Merck) was unknown. Upon internal review the term "scheduled C-section" and "premature delivery" was considered as medically significant. The case was linked to another case via same parent child link. Additional information is not expected as no further information was not available. Events and narrative updated.
Above patient was given his 2nd Varicella vaccine at the health dept this AM in (R) arm. About 30 minutes after vaccine was given, patient complained of dizziness, double vision, leg weakness and wheezing started about 45 minutes after vaccine was administered. Mom brought child to my office for evaluation.