chrisvoncsefalvay/vaers-outcomes huggingface dataset:
exhaustion; chills; joint pain; This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 11Apr2021 (at the age of 43-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history and did not take any concomitant medications. The patient had no known allergies to medications, food or other products. 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 11Apr2021, the patient experienced exhaustion, chills and joint pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events exhaustion, chills and joint pain was not recovered at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Moderna COVID-19 Vaccine  Allergic reaction happened about 2:30 min after the injection, with eyes swelling, right eye more than half covered. Congestion, runny nose, itchy back of tongue and palate. I consulted with my healthcare provider (Dr, not the pharmacy that administered the shot) to know what to do and since I didn't have any noticeable breathing problem, she advised to take some Benadryl and monitor. Lot number was handwritten so 1st, 2nd, fifth and sixth characters have been interpreted as above. first character could be a O, 0 or D. Second and sixth character could be a I or 1. Fifth character could be a 2 or Z.
This is a spontaneous case, initially received from a pharmacies on 15-Oct-2018 (initial and follow-up 1 combinedly processed), concerning a 55-year-old, adult, female patient. On an unspecified date, FLUCELVAX QIVc was stored at a maximum temperature of 56 F for 8 hours following a power outage (explicitly coded as incorrect product storage). On 13-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252668, expiry date: 30-Jun-2019) which underwent temperature excursion (explicitly coded as product administration error). No adverse event was reported. The reporter assessed this case as non-serious. Non-significant case amendment (15-Oct-2018): The term 'administration error' was replaced with 'product administration error' in narrative and ease comment.
Shoulder injury from vaccination, presents with shoulder bursitis, that started 2 days after vaccine, cannot move arm more than 5 degrees laterally or anteriorly. . No change in strength
It itched and came up as hives and swelling on her hands; It itched and came up as hives and swelling on her hands; It itched and came up as hives and swelling on her hands; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 79-years-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCIE, Solution for injection, Batch/Lot Number: EN5318; Expiration Date: 31May2021), via an unspecified route of administration, administered in Arm Right on 02Feb2021 (Age at vaccination: 79-years-old) as single dose for covid-19 immunization. (Vaccination facility: hospital). Medical history included allergic to Penicillin from an unknown date and unknown if ongoing. There were no concomitant medications. She gets a flu shot every year. It was reported that patient got first shot 02Feb and she received the second one 27Feb. She ended up swelling in face and got like great big hives on her throat and neck and in both hands. She did not know what it was, she went to the doctor they were not sure she got the paper out and was reading and it said injection site swelling and throat and everything and she went again today to the doctor and they came to the conclusion that it probably was the vaccine. It did not put her in the hospital or anything and she is glad she got it but the doctor told her to report it. The swelling and hives started 3-4 days later. It started on her hands after the first dose it itched and came up with hives on her hands and they were swollen and she wondered what bit her and she went to the doctor and he looked and said he did not see any bites. After the first one was when it happened with her hands they could not figure it out what it was. The doctor checked real good and said he could not see any bites it was just hives and swelling. Adverse events resulted in Physician Office it was 10Mar, her face was all swollen and she went to the doctor. Before that she went with her hands. The outcome for the events was reported as resolved on an unspecified date.   No follow-up attempts are possible. No further information is expected.
Patient reported itchiness across arm and back but no rash or other skin reaction. The reaction occurred about 24 hours after injection and has last until now.
This literature marketed report was received from the authors and refers to 18 adult patients of an unspecified age and gender. The patient's medical history was not provided. Methods: 11,533 email invitations delivered to members of the Immune Deficiency Foundation database requesting participation in an online survey about zoster, influenza and varicella experiences. Data from 881 individuals age 19 years old or older with Common Variable Immunodeficiency (CVID) (N=760; mean age 54 years old; 83% Female; 92% of specific origin) or Hypogammaglobulinemia (N=121; mean age 54 years old; 83% Female; 93% of specific origin) were analyzed. On an unspecified dates, close to one fifth (18%, n=105) of adults age 50 or older with CVID or Hypogammaglobulinemia (N=568) had received Zoster Vaccine Live (manufacturer unknown) (reported as shingles vaccination; strength, dose, route of vaccination, lot number and expiration date were not provided). The authors stated that after the first vaccination of zoster vaccine live (manufacturer unknown), 18 patients developed mild side effects like skin rash and muscle pain. No side effects were reported after receiving the booster vaccination and no hospitalizations were reported as a result of receiving zoster vaccine live (manufacturer unknown). The outcome of the events was not provided. Sender's Comments: US-009507513-1807USA000966.
moderate headache, fever (100.1F), joint aches, and fatigue, soreness at site of injection
After the side effects that were anticipated [chills, sweats, body aches], a very bad case of vertigo set in. I have struggled with vertigo from time to time in the past. It's been 3 1/2 weeks of on/off symptoms which are sometimes debilitating because of the dizziness and nausea.
I had thyroid cancer and I have no thyroid; The initial case was missing the following minimum criteria: [unspecified product]. Upon receipt of follow-up information on [14Jul2022], this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THYROID CANCER (medically significant), outcome "unknown", described as "I had thyroid cancer and I have no thyroid".  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Patient is a 25 y/o male whom after being vaccinated and being  informed about 15 min. observation period, lost consciousness.  Client's head was supported until he regained consciousness and was helped into a wheelchair and taken to the private recovery area where EMS took his vitals.  BP 70/40, pulse 58, Glucose 88, Resp. 16, normal mentation.  Patient diaphoretic, complaining of nausea and dizziness.  Client was then transported by EMS staff from recovery area @ 12:33pm and taken to Coral Springs Hospital Emergency Room.
Chills, fever, body ache, headache, muscle pain, muscle soreness, injection site: swollen, diarrhea
Breakthrough case admission After 4 vaccines Pfizer 3/24/21 Lot# EP6955;  Pfizer 4/14/21 Lot# EW0164;  Pfizer 11/15/21 Lot# 32030BD; Pfizer 5/25/22 Lot# FK9894
Large, very painful red swelling at injection site, chills, fatigue, joint pain, headache.
Information has been received from a practice manager and a healthcare worker, concerning a patient of unknown age and sex. On 23-APR-2012, the patient was vaccinated with a dose of VARIVAX (Merck) (dose, route and frequency were not reported) (lot #: 670322/0608AA. Expiration date: 26-APR-2013) that was improperly stored in a refrigerator for more than 72 hours. There were no adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Headaches, chills, muscle and joint pain, vomited x 1, low grade fever, sore throat, mild enlargement nodes under throat, itchy rash starting in neck area and then progressing through body.
w/in 24 hr pt exp chills, fever, soreness in upper arm; w/in 48 hr redness & swelling in upper arm spreading to elbow; w/in 72 hr sneezing, sore throat, cough upper arm more painful & itching; sx cont for 8 more days; tx Tavist 1, Vantin
Hospitalized 11/7/2021; COVID-19 positive 11/7/2021; fully vaccinated  Discharge Summary MD (Physician) Surgery BRIEF OVERVIEW: Discharge Provider: MD Primary Care Provider: MD Admission Date: 11/7/2021 Discharge Date: 11/08/2021    DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Small bowel obstruction (HCC) [K56.609]   HOSPITAL COURSE: Patient was seen at the emergency department for crampy abdominal pain, nausea and vomiting.  CT showed a chronic bowel obstruction and patient was transferred to hospital for further management.  Patient was incidentally found to be COVID positive and the monoclonal antibody infusion clinic was contacted.  Patient met criteria and was given the monoclonal antibody during her inpatient stay.  Patient was unable to tolerate placement of an NG tube but was still having bowel movements.  A gastrografin challenge was performed which showed passage of the contrast into the colon.  Her pain improved and she was able to tolerate regular food prior to discharge.  Although she has a known history of Crohn's disease, patient had no leukocytosis or signs of active crohn's disease on CT.  Given the chronic nature of the obstruction with evidence of fecalization expect an acute on chronic exacerbation of a possible crohn's stricture which should be investigated further.
Pt was vaccinated with Pfizer brand of covid vaccine given intramuscular at his left deltiod administered by   LVN today 04/29/21 at 3:36 pm. At 03:48 pm I, RN (EOA) noticed pt was pale and diaphoretic, came near to pt and asked how he is doing pt verbalized he is okay, when I was about to move out he eventually stated that he is dizzy and nauseous. I took initial set of vitals at 03:49 pm BP 100/60mmhg, PR 60 bpm, RR20 cpm, Temp 96.1F, Spo2 98% at room air. I called for admin assistance from admin assisted me in monitoring  the patient together with another RN. Pt was given water and felt relieved. Ice packs was placed on pt's nape and made him relaxed. Pt had no complaints of chest pain and SOB. Pt had no history of DM, no HTN, no known allergies and had not gotten any flu shot for long time. Pt also verbalized that he hadnt slept well for the past 2 days related to job adjustment and hadnt eaten since yesterday that might have contributed to his complaints of dizziness Reapeat set of vitals were taken at 3:58 pm BP 100/80, PR 64 bpm, RR 18 cpm, SPO2 99% at room air. Pt stated he is back to normal and no more complaints of dizziness or nausea. Pt refused to call 911 as well. at 4:06 pm latest BP 126/88 mmhg. At 4:20 pm pt was assisted by me  RN to his car with resolved dizziness and nausea. Pt was advised to have an appointment with primary physician for wellness check and health teaching was given related to side effects of vaccine and when to contact 911. Pt verbalized understanding and is appreciative of the care provided.
chills Narrative: patient developed chills at 15 minutes after vaccine administration that slowly resolved without intervention
Customer stated arm was red and hard for approximately 1 and 1/2 weeks, redness went down arm and also had a migraine.
Pt was behind in DTAP #5. Pt is 12yrs old and should of gotten TDAP instead. Pt is fine. The school is not wanting to let Pt. in do to he did not get a TDAP.
Narrative: 25 yo F that received dose #1 of the Moderna COVID-19 vaccine on 3/10/2021 (Lot#: 026A21A; Exp Date: 8/26/2021) around 08:30. Pt contacted Facility on 3/30/2021 to report symptoms following vaccination. Pt reports arthralgia starting later that day following vaccination in her hands (fingers, wrists), knees, and feet (toes, ankles). Pt also reports pain in shoulders and elbows bilaterally. Pain is constant 8/10, denies swelling or redness of joints. Denies fever/chills. Adverse effects interfering with her ADL's. Pt has been taking OTC NSAID (ibuprofen 800mg) as directed based on package label. Following assessment by provider, recommend continuation of OTC NSAID in addition to OTC acetaminophen. Reaction classified as moderate as intervention/treatment recommended.
back pain was gone; like someone had take a baseball bat to my body; flu symptoms; sweat through all my clothes; headache; body aches; fever of 103 or 104; This spontaneous case was reported by another health care professional and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (back pain was gone), PAIN (like someone had take a baseball bat to my body), INFLUENZA (flu symptoms), HYPERHIDROSIS (sweat through all my clothes) and HEADACHE (headache) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (lost sense of taste and smell.) from April 2019 to May 2019 and Back pain (prescribed with steroids around June 2019 which helped) in May 2019.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced PAIN (like someone had take a baseball bat to my body), INFLUENZA (flu symptoms), HYPERHIDROSIS (sweat through all my clothes), HEADACHE (headache), MYALGIA (body aches) and PYREXIA (fever of 103 or 104). On 07-Apr-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (back pain was gone). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. On 07-Apr-2021, PAIN (like someone had take a baseball bat to my body), INFLUENZA (flu symptoms), HYPERHIDROSIS (sweat through all my clothes), HEADACHE (headache), MYALGIA (body aches) and PYREXIA (fever of 103 or 104) had resolved. At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (back pain was gone) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Body temperature: 103 or 104 (High) fever of 103 or 104.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were given.   This case was linked to MOD-2021-402849 (Patient Link).
inadvertent administration of Pfizer bivalent COVID19 vaccine to 10 year old
vaccine expired on 19-Nov-2018 was administered to patient on 23-Feb-2019; vaccines experienced multiple excursions was administered to patient; Initial information received on 02-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA125041, 2019SA125047, 2019SA125008, 2019SA125094, 2019SA125087, 2019SA125072, 2019SA125066 and 2019SA125054 same reporter.  This case involves a 4 years old female patient who received vaccines DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation; and TUBERCULIN PPD (TUBERCULIN PPD) for Tuberculin test received on 23-Feb-2019.  On 23-Feb-2019, the patient received a 0.5 mL dose of suspect IPV (VERO) lot N1K931M, expiry date- 19-NOV-2018 via intramuscular route in the deltoid nos.  On 23-Feb-2019, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to incorrect product storage and expired vaccine used.  This was reported to the Agency- Fluzone Quadrivalent, Daptacel, ActHIB, Pentecel, IPOL, Adacel, Menactra. The vaccines experienced multiple excursions. 1st excursion excursion: 13Feb2019-14Feb2019 was out of range for 8 hours and 45 mins was at 1.56 degrees C. for the Fluzone Quad, Daptacel and ActHIB. 2nd excursion: 13Feb2019 9 hours 15 mins 1.56 degrees C. 3rd Excursion: 15Feb2019-22Feb2019 was out of range for 9 hours 30 mins at 1.56 degrees C. 4th excursion: 13Feb2019-22Feb2019 was out of range for 13 hours at a temperature of 1.18 degrees C for the Daptacel, Menactra and Adacel 5th excursion 13Feb2019-25Feb2019 were out of range for 24 hours and 15 mins at a temperature of 1.18 degrees C. Fluzone Quad and Pentacel 6th excursion 22Feb2019-26Feb2019 out of range for 23 hours 45 mins at 1.18 degrees C. Fluzone Quad, Pentacel and Daptacel 7th excursion: 13Feb2019-26feb2019 out of range for 33 hours and 4 mins at 1.18 degrees C for Adacel, Menactra, Ipol, ActHIB, Dapatacel, Pentacel and Fluzone Quad  It was unknown if any adverse event was occurred.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  Documents held by sender: none.
Starting about 5pm he noted aches in his legs and lower back and was cold. The aches have now spread to entire body along with chills and fatigue. Nasal drainage and congestion are also noted and were present on date of vaccination.
Big red itchy and red round bump around site of injection. Sore throat, muscle aches, body pains. Lower neck pain. And pain up and down left arm which is the same arm I got the vaccine in.
guillain barré syndrome; Initial information was received on 28-Sep-2021 regarding an unsolicited valid serious case from a consumer/non-healthcare professional via social media.  This case involves (unknown age) female patient who experienced guillain barré syndrome (guillain-barre syndrome) when received INFLUENZA VACCINE.  The patient's past medical treatments, vaccinations, concomitant medication 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 a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (suspension for injection, lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious guillain barré syndrome (guillain-barre syndrome) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and hospitalized for this event.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  The event outcome was unknown for guillain barré syndrome.  There will be no information available on the batch number for this case.; Sender's Comments: This case concerns a (unknown age) female patient who experienced guillain-barre syndrome (unknown latency) after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. There is no further information regarding patient's medical condition at the time of vaccination and laboratory tests ruling out other alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Employee's R arm began aching a couple of days(10/12)after receiving (10/9)the influenza vaccine. Thought pain would disapate but instead R shoulder became involved. Seen in Office 10/25 with mild swelling anterior medial aspect of rt shoulder and limited ROM.
Information has been received from a medical assistant concerning a female who was vaccinated with a dose of PNEUMOVAX 23. Subsequently the patient experienced fever and swelling. Lot number and number of doses of PNEUMOVAX 23 received not provided. At the time of this report, the patient recovered from the adverse events. The patient sought unspecified medical attention. No further information is available.
Headache for 3 hours; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache for 3 hours) and CHILLS (Chills) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concomitant products included DICLOFENAC POTASSIUM for Pain in hip, METFORMIN, CLOPIDOGREL, METOPROLOL SUCCINATE, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN/HCTZ), SIMVASTATIN, MELOXICAM and METHOCARBAMOL for an unknown indication, SERTRALINE HYDROCHLORIDE (SERTRALINE HCL).    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced HEADACHE (Headache for 3 hours) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 650 milligram. On 19-Feb-2021, HEADACHE (Headache for 3 hours) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to INC.-MOD-2021-162334 (E2B Linked Report). This case was linked to MOD-2021-162161 (Patient Link).; Sender's Comments: INC.-MOD-2021-162334:Crosslink
Child received Prevnar in right thigh on 1/14/08 and Pediarix left thigh at about 1000. At 1800 mother noted hives from head to toe. Gave child Benadryl. Hives were gone by am. On 1/15/08 left thigh was red and warm. On 1/16/08 thigh was red, warm, swollen and hard. Evaluated on 1/17/08. Mother had been giving the child Motrin without improvement. 1/17/08 8cm diameter of swelling, erythema and induration noted left thigh. Allergist gave mother Keflex. On 1/18/08 Mom stated redness and swelling were improved. On 1/22/08 all symptoms were resolved. Mother never gave the pt Keflex.