chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Three weeks after 2nd shot on May4  I stood up and got dizzy.Im still dizzy four days later.Vomited while awake four 48 hours off and on.Went to urgent care Thursday May 6 2021 received medicine for nausea.Cant drive or walk outside because I get dizzy when I move my head side  to side Is this a known side effect and when will it  go away? Was diagignosed with stomach virus. Dont know if thats correct.
The patient was administer this vaccine for the second time in 2 month. Fluzone hd on 10/04/2021 and fluad 01/28/2022 she states she is feling dizzy since then.
This spontaneous report has been received from a Registered Nurse refers to a 12-year old patient of unknown gender. The patient's medical History, concurrent conditions and concomitant therapies were not reported. On 07-SEP-2017, the patient received an improperly stored dose of GARDASIL 9 (lot # N000326, expiration date 14-OCT-2019; dosing details unknown) for prophylaxis. The temperature excursion occurred on an unknown date at a temperature of 35.4 Fahrenheit (F) for a time frame of 8 hours. The previous temperature excursion was at 34.9F for a time frame of 2 hours. The call was because of a data logger. No adverse effects were reported. Sender's Comments: US-009507513-1710USA004063.
feels crummy; Chills; a little headache; Low grade fever; a lump under her arm/has a lump under her right arm, this is also the injection site arm/swollen lymph node; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 61-year-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration, administered in Arm Right on an unspecified date as single dose for covid-19 immunization (age at vaccination: 61-year-old). Previously the patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration, administered in Arm Right on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date post vaccination, the patient woke up with chills in the morning, a little headache and a low-grade fever. The patient also reported that there is a lump under her arm, her right arm, the same arm she received her vaccine in. The lump is not at the injection site, it is under her armpit. The patient also felt crummy. The outcome of the events was reported as unknown at the time of report.  Information on the lot/batch number has been requested.
Weakness, Pain in left arm, increased BP, difficulty breathing, increased HR, admitted to ER, increased temp., EKG and monitored for 6 hrs with no could not find any cause for symptoms.
Pt came today  08/06/21 for second dose Moderna when he is supposed to be getting on  08/16/21
This spontaneous report was received from a registered nurse, refers to an unknown number of patients, of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with improperly stored doses of GARDASIL, (lot#, expiration date, dosage and route were not reported). Concomitant therapy was not reported. No adverse effects reported. No product quality complain was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Rt deltoid area was very swollen, hard, warm and red.  There was pain in the rt waist when turned rt or lt.
Woke up Dec 24 with fatigue, chills, fever of 100.5, and phlegm, shortness of breath and cough. Tired throughout day and fever lasted til 6pm. Took Tylenol and Ibuprofen to break fever and chills. Recovered on Dec 25.
pt recv vax & began vomiting @ 1330PM;pt vomited x 2;advised to see PMD or ER ASAP;denies rash or difficulty breathing;
Headache, Myalgia & Fever Narrative:  Shaking, chills, temp 100.6, weak, muscle aches (legs, back) and "bad" headache. Painful arm that is also red in color
Nurse at the pharmacy administered the wrong vaccine to the patient. Patient was to get Fluarix but received Flublok. No adverse events, patient was just informed a different flu shot was given.
This case was reported by a nurse to a sales representative and described the occurrence of an injection site reaction in a pt who received Engerix B. The nurse reported that several patients experienced an injection site reaction following  the administration of Engerix B, however no patient identifiers were provided. On an unspecified date, the pt received a dose of Engerix B (dose number not specified). At an unspecified time following the administration of Engerix B, the pt experienced an injection site reaction characterized by burning and stinging. The outcome of the event is unknown. The nurse stated that she, "noticed more burning and stinging at site of injection with Engerix B compared to Recombivax."
3rd dose of Moderna. Approximately 5-7 days I began having chilblain type lesions on four of my toes. My physician ordered a biopsy and the report suspected vaccine induced chilblains/COVID Toe. Lesions were purple/black, were painful, and continued for approximately three months before they began to subside. As of today, 6/2/22, I still have two extremely small areas that continue to have pain to the touch. I have also had a host of other lingering physical and psychological symptoms since vaccination which may be unrelated but are unusual: episodic low energy, decrease in psychological  motivation, strange physical sensations in chest/trunk, episodic general lassitude, increased cold intolerance, and episodic anxiety.
onset of dizziness and fatigue 24 hours after vaccine (1/30/2021).   48 hours after vaccine (1/31/2021), developed cough and low grade fever.  Symptoms continued to progress with continued cough, fatigue, and generalized weakness with shortness of breath.  Had O2 sat of 88% with activity on 2/9/2021 and went to emergency department and was diagnosed with pneumonia.  Treatment started for community acquired pneumonia with Amoxicillin and Azithromycin.  Patient discharge home from emergency department
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Dec2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment start date 08Feb2023 to 13Feb2023. Other medication in 2 weeks: product Herbal tea (01Feb2023 to 08Feb2023), Enzymes (start date 14Sep2022 to 08Feb2023). Patient has no known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
GAVE ZOSTAVAC S.C. ON 4-30-12..NEXT DAY COMPLAINED ABOUT ITCHING AND SWELLING. TOLD TO USE ICE LOCALLY AND TAKE BENADRYL. NEXT DAY SHE WENT TO HER DR. DUE TO THE LARGE AREA AND HEAT IN THE SHOT AREA. PT CAME BY THE PHARMACY AND WE OBSERVED 2" X 2" CIRCLE WITH HARDNESS, SWELLING AND FEVER.
Per patient mother, raised, hard, red circular induration developed on the left thigh. Measurement in office today about 30 mm in diameter.
PCR on 05Jan2022 covid test result=Positive; PCR on 05Jan2022 covid test result=Positive; dose received 3; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 47 year-old male patient received bnt162b2 (BNT162B2), administration date 14Dec2021 (Lot number: FF2589) at the age of 47 years as dose 3 (booster), single, administration date 22Mar2021 (Lot number: EL3247) as dose 2, single and administration date 01Mar2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 14Dec2021, outcome "unknown", described as "dose received 3"; VACCINATION FAILURE (medically significant) with onset 05Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 05Jan2022, outcome "recovered" (Jan2022) and all described as "PCR on 05Jan2022 covid test result=Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Jan2022) positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of covid-19. Clinical course: The patient experienced nasal congestion and was in contact with covid positive family members, and then the patient got positive result for Covid PCR test on 05Jan2022. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Immunization, drug ineffective and covid-19 and BNT162B2.
I started having a lot of pain in my right leg. I could actually feel and see that my veins were swollen. It progressed and started moving around. I started having chest pain and headaches. I ended up at ER. They gave me pain meds and did a CT Scan and ultrasound, which were both clear. The next day, I was walking around and my hand and arm started hurting and then went numb. My right wrist was swollen to twice its size. I went to care and they told me to go back to the ER. They eventually did another ultrasound, but the swelling had gone down by then. A few hours later, my left arm started to swell and lasted for about 4 hours. From there, I had pain in my arms and legs for a few days after that, but then I was fine.
Information has been received from a nurse, referring to an adult patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 25-JUN-2018, the patient inadvertently received a pediatric/adolescent dose of VAQTA lot # N026997, expiration date on 10-NOV-2018, 0.5 ml, once, intramuscularly (anatomical location was not reported) for prophylaxis. No adverse events were reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same source. Sender's Comments: US-009507513-1807USA001764.
Sore Arm with both vaccinations; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm with both vaccinations) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm with both vaccinations). At the time of the report, PAIN IN EXTREMITY (Sore Arm with both vaccinations) outcome was unknown. Not Provided          Concomitant product use was not provided.  Treatment information was not provided. Action taken in response to mRNA-1273 was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-081630, US-MODERNATX, INC.-MOD-2021-081770 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Non significant info received. TCR form attached. No new information was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081630:Same patient, First Dose US-MODERNATX, INC.-MOD-2021-081770:This case is for the reporter's husband
Large red rash noticed on the armpit of the arm vaccinated.  Red around the outside and normal skin color in the inside of the circle.
After 24 hours, developed a mild cough.  Four hours later, developed a low grade fever 99.6 degrees which lasted 12 hours.  Then fatigue for two days.
Approximately 2 minutes after vaccination, patient began to feel dizzy and lightheaded. Brought back in exam room, made her lay down on bed, BP was 102/62 which patient states is lower than her normal. Skin was pale and dry. She laid for about 10 minutes with no improvement, began having nausea. Propped her legs up with a wedge. This is when patient states, "Do you think this is a vasgovagal reaction? I have had one before when giving blood and have had tilt table tests done." Informed her that based on her symptoms it does appear to be a vasovagal reaction, and that most of the time the feeling passes withint 15-30 minutes. Brought patient a water and powerade and informed her to try to hydrate and rest until it passes. Monitored BP: 12:35 PM: 102/62, 12:50 PM: 98/60, 1:15 PM: 112/68. At 1:15 PM patient felt like sitting up and pink color had returned to her cheeks. Slowly raised the HOB over the course of 10-15 minutes. Pt eventually sat all the way up and skin went pale again, BP dropped to 96/60 at 1:25 PM. Layed patient back down and propped her legs up again. Asked if she had any family members that could come to her and she did not at this time. Pt began to feel more nausea, lightheaded and like passing out. Ambulance services called to the clinic, report given to paramedics, patient transferred to Hospital. Patient was pale, alert/oriented x3 when being trasferred via stretcher.
Medical assistant called to report an AE.   The patient experienced fever, diarrhea and vomiting after receiving third dose of ROTATEQ (Lot 1742476   3/18/2023) .  The patient received the dose on 3/23/2022 and within 8 hours after the vaccination, t; Medical assistant called to report an AE.   The patient experienced fever, diarrhea and vomiting after receiving third dose of ROTATEQ (Lot 1742476   3/18/2023) .  The patient received the dose on 3/23/2022 and within 8 hours after the vaccination, t; Medical assistant called to report an AE.   The patient experienced fever, diarrhea and vomiting after receiving third dose of ROTATEQ (Lot 1742476   3/18/2023) .  The patient received the dose on 3/23/2022 and within 8 hours after the vaccination, t; This spontaneous report was received from a medical assistant referring to a 6-month-old female patient. Concomitant vaccines included diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL), pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) and influenza vaccine (reported as FLUZONE). The patient had no pertinent medical history and no drug reaction/allergy.  On 30-NOV-2021, the patient received the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ). On 24-JAN-2022, the patient received the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ). Regard to both doses of vaccines, route: oral, indication: prophylaxis, strength, frequency, lot # and expiration date were not reported. The patient did not have any symptoms after receiving the first two doses. On 23-MAR-2022, the patient received the third dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1742476 and expiration date 18-MAR-2023, strength and frequency were not reported) orally for prophylaxis.   On the same day within 8 hours after the vaccination, the patient experienced 15 vomiting episodes for 90 minutes. The patient went to an unspecified emergency room and was released without hospitalization. It was also reported, the patient experienced fever, diarrhea and vomiting on 23-MAR-2022. The patient received ondansetron (ZOFRAN) as treatment. The outcome of the evens was recovered. The causality of the events was not reported.
Chills, uncontrollable shivering, fever, nausea and light headedness
had the 2 shot vaccine Developed a mild case of shingles; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, between 1 and 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient had 2 Shingles shots 18 months before the day of reporting. The patient developed a mild case of shingles two weeks before the day of reporting. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were not provided.
cough; runny nose; discomfort in throat; depressed; fatigued; arm was sore; stomach ache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm was sore), ABDOMINAL PAIN UPPER (stomach ache), FATIGUE (fatigued), DEPRESSED MOOD (depressed) and RHINORRHOEA (runny nose) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm was sore) and ABDOMINAL PAIN UPPER (stomach ache). On 18-Mar-2021, the patient experienced FATIGUE (fatigued). On 22-Mar-2021, the patient experienced DEPRESSED MOOD (depressed). On 23-Mar-2021, the patient experienced RHINORRHOEA (runny nose) and OROPHARYNGEAL DISCOMFORT (discomfort in throat). On 26-Mar-2021, the patient experienced COUGH (cough). On 18-Mar-2021, VACCINATION SITE PAIN (arm was sore) and ABDOMINAL PAIN UPPER (stomach ache) outcome was unknown. At the time of the report, FATIGUE (fatigued), DEPRESSED MOOD (depressed), RHINORRHOEA (runny nose), OROPHARYNGEAL DISCOMFORT (discomfort in throat) and COUGH (cough) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment drugs included
Paraesthesia, in the form of prickling sensations on the skin, began one week after injection (04/25/2021). It occurred randomly and sporadically across my whole body, but most commonly in the legs. This symptom has continued (intermittently) up to the time of this reporting.  Roughly two weeks after injection (05/01/2021), intermittent muscle weakness and vertigo began. The muscle weakness was primarily in my legs and arms, on both sides, and created a sensation that the limbs were limp/floppy or that the hand/foot was unusually heavy. What I describe as vertigo was not dizziness or the perception of spinning, but rather a sensation of being off-balance or having an unsteady head. When present, the vertigo was triggered by motion of the head (e.g. the motions caused by walking). The muscle weakness is generally worse at night. The vertigo had ceased by 05/30; muscle weakness eventually became persistent, and continues up to the time of this reporting.  An additional symptom that eventually appeared is occasional tensing and soreness of various muscle groups in the legs and arms, as if they have been intensely exercised (but they have in fact not been exercised). This also continues up to the time of this reporting.  On the night of 05/14 through the morning of 05/15, I experienced exceptionally serious muscle weakness and vertigo. The vertigo made it nearly impossible to go to sleep, because the beginning of sleep would trigger a sensation of falling that would cause me to immediately awaken. In the morning, my calf muscles were so weak that it could be difficult to stand up for more than a few minutes at a time, and they would sometimes shake with the effort. These symptoms gradually improved over the course of the following day.  I had additional "attacks" on the night of 5/20 through the morning of 05/21, and the night of 05/29 through the morning of 05/30. Again, these led to serious leg weakness that improved gradually during the subsequent day. A persistent low level of leg muscle weakness eventually developed.  On 06/14 I began an attempted treatment with a 10-day prednisone course. Outcome still future and therefore unknown.
Swollen upper lip lasted 24 hours, took some allergy relief medicine which seem to help.
pt c/o h/a beginning on 26MAR97 about 315Pm;pt recv vax 26MAR97 AM & h/a reported as migraine h/a;pt took migraine protocol @ home;MD recommended returning home & repeating migraine protocol 27FEB97;
Patient was 22 minutes into her 30 minute monitoring period after receiving Moderna COVID-19 Vaccine and complained of itching around her neck. Visible rash around her neck. Generalized rash on her trunk, left arm, and redness in both ear lobes. EMS was called. Pt ambulated to cot. BP at 05:15pm was 140/90. One dose of 0.5mg/(0.5mL) epinephrine administered to right anterolateral thigh. BP at 05:23pm was 160/110. Pt began to shiver and was cool to the touch, blanket placed. EMS arrived at 05:30pm and left with Pt at 05:38pm. Pt talking/laughing throughout event. Pt taken to hospital. Benadryl was given and was observed for 2 hours then discharged.
Started vomiting on 11-12-18, took to ER on 11-13-18 had U/S then Ba Enema. Dx. with intussusception. Discharged on 11-16-18.
*Please note, I know it was a pneumonia and flu vaccinations. I cannot find sheet with exact formula/vaccination name/manufacturer. My left arm turned hard, scalding hot to touch, couldn't move it, wipe, or drive. Also, could not change or put clothes on, or take them off . Arm also swelled up not fitting in sleeves, I could get on. Morning of 11/9/17, after being up all night debating urgent care or ER, I Felt like I had weights and excruciating pain pulling, my arm down every time attempting to lift it. Had a horrid migraine and 102 degree fever. Couldn't work that Thursday or Friday. Finally my mom took me to urgent care and I was prescribed steroids.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 22-FEB-2016 the patient was vaccinated with an improperly stored dose of VARIVAX (lot # L024250, expiration date 30-JUN-2017, dosage and route not specified). It was reported that the vaccine was stored at -13.7 degree Centigrade for 15 hours. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.