chrisvoncsefalvay/vaers-outcomes huggingface dataset:
weakened/second shot (it) knocked her out for a month; very bad cough; every bone hurt; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakened/second shot (it) knocked her out for a month), COUGH (very bad cough) and BONE PAIN (every bone hurt) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037AZ1B and 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (Stage 4 Cancer) since 2019.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weakened/second shot (it) knocked her out for a month), COUGH (very bad cough) and BONE PAIN (every bone hurt). At the time of the report, ASTHENIA (weakened/second shot (it) knocked her out for a month) had resolved and COUGH (very bad cough) and BONE PAIN (every bone hurt) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication include chemotherapy. Treatment medication include medication for chest relief to get the mucous out.  Patient's cancer spread to kidney ,then to stomach , then to brain around the end of 2020 and beginning of 2021. Now patient is able to walk and got some strength.
Breakthrough case admission after 3 vaccines Moderna 3/11/21 Lot# 044A21A;  Moderna 4/8/21 Lot# 025B21A;  Moderna 12/4/2021 Lot # 029H21B
Started out as shaky hands/full body tremors; torso muscle spasms; severe body pain; couldn't move legs with extreme pain; couldn't move legs with extreme pain; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 16:45 (Lot number: EN6199) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: TRAZODONE; ROSUVASTATIN; PRAMIPEXOLE; METFORMIN; GLIPIZIDE. Past drug history included: Morphine, reaction(s): "drug Allergy". Vaccination history included: Bnt162b2 (Dose 1, lot number=ER8732, administered in the right arm on 10Mar2021 at 05:00 PM), administration date: 10Mar2021, when the patient was 60 years old, for COVID-19 Immunization. The following information was reported: TREMOR (hospitalization, disability) with onset 31Jul2021 08:00, outcome "not recovered", described as "Started out as shaky hands/full body tremors"; MUSCLE SPASMS (hospitalization, disability) with onset 31Jul2021 08:00, outcome "not recovered", described as "torso muscle spasms"; PAIN (hospitalization, disability) with onset 31Jul2021 08:00, outcome "not recovered", described as "severe body pain"; PAIN IN EXTREMITY (hospitalization, disability), MOBILITY DECREASED (hospitalization, disability) all with onset 31Jul2021 08:00, outcome "not recovered" and all described as "couldn't move legs with extreme pain". The patient was hospitalized for tremor, muscle spasms, pain, pain in extremity, mobility decreased (start date: 2021, discharge date: 2021, hospitalization duration: 3 day(s)). The events "started out as shaky hands/full body tremors", "torso muscle spasms", "severe body pain", "couldn't move legs with extreme pain" and "couldn't move legs with extreme pain" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of tremor, muscle spasms, pain, pain in extremity, mobility decreased. Clinical course: Started out as shaky hands, then couldn't move legs with extreme pain, torso muscle spasms, full body tremors, severe body pain. AE(s) resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. No. days hospitalisation: 3. AE(s) treatment received: Anti-seizure meds, Neurologist, Neurologist sub specialist. Additional information included: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19.
Became light headed, nauseated, emitted x 2. Face flushed/Skin on arms flushed. No redness, bruising or edema at injection site. (Right Deltoid), Fingers on left hand felt tingly. Bilateral lower extremeties felt tingly, diaphoretic. B/P 132/84, HR 84, R 22, Temp. 97.4. FSBS 98. Pulse Oximetry 100%. Gave Benadryl 25 mg po at 4:05pm. Was seen by Dr. Went to clinic for follow up exam. Phenergan was given there for nausea.
Booster; Joint pain; Muscle pain; I have infringement and I couldn''t rotate it because cuff causing my shoulders; Vaccine triggered my stupid problem with the rotated cuff and infringement; I have the little bit of sinus but it seems to triggered the pain out of the blue; Muscle spasms at the injection site; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster) single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "voice incomprehensive" (unspecified if ongoing); "shoulder movement" (unspecified if ongoing); "voice distortion" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain"; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain"; JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown", described as "I have infringement and I couldn''t rotate it because cuff causing my shoulders; Vaccine triggered my stupid problem with the rotated cuff and infringement"; SINUS PAIN (non-serious), outcome "unknown", described as "I have the little bit of sinus but it seems to triggered the pain out of the blue"; MUSCLE SPASMS (non-serious), outcome "unknown", described as "Muscle spasms at the injection site".  Additional information: Patient completed 3 doses of the Pfizer, have joint pain, muscle pain, patient think in September did third dose (Booster dose). Patient was retired other health provider (Hence reporter type captured in the tab). Patient have a problem with whatever have and then infringement and couldn't rotate it because cuff causing my shoulders. I haven't had it because of that I had to retire, so I haven't had this problem in 9 years but when I had the vaccine I have the little bit of sinus but it seems to triggered the pain out of the blue, and I am having little muscle spasms at the injection site. Is it possible that the vaccine triggered my stupid problem with the rotated cuff and infringement because it just it's been going on for a couple of weeks, should not realize that third dose. Will it just, Is this possible that it triggered I haven't had a problem in years, then out of the blue. I was reviewing the side effects and I am having a problem; It really triggered after my booster.  Follow-up: This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
COVID-19, mRNA, LNP-S, PF, 30 mcg/0.3 mL dose 04/13/2021      EW0158 Pfizer  COVID-19, mRNA, LNP-S, PF, 30 mcg/0.3 mL dose 05/04/2021      EW0171 Pfizer  AE: Pt received above vaccines; second dose was given on 05/04/21, rash appeared on 05/07/21.  Pt presented to Primary Care office on 05/21/21 w/c/o cycling rash x 2 weeks, starts w/eruption of raised hives that enlarge, then flatten and remain pink and blotchy sometimes w/central clearing then fading; as areas clear others appear, the rash has been consistently cycling x 2 weeks, not getting worse, not getting better, and is itchy. Pt is taking Benadryl w/o relief. Denies any new exposures, no new detergents, outside exposures, no new lotions, deodorants, etc. Has no hx of allergies, feels fine other than "weird rash that won't go away"  Tx: Advised pt to take daily antihistamine, will add prednisone.  Start prednisone 10 mg tablet 2 tablets every day for 14 days Send for allergy referral High level of suspicion for serum sickness type reaction r/t COVID vaccine, it is concerning that this has lasted 2 weeks, will refer to allergist for further eval. Though pt is at a virtually negligible risk for sig effects from COVID, he got the vaccine bc is making us" and natural antibodies are not recognized.  Outcome: pt has had refill of prednisone as rash is still erupting to date, awaiting allergist appt 07/07/21 for further eval
This spontaneous report as received from a medical assistant refers to a 24 year old patient of unknown gender. On 06-JAN-2016, the patient was vaccinated with the first, improperly stored dose of GARDASIL 9 (dose, anatomical location and route of administration were not provided, lot # L016429 with expiration date 09-SEP-2017). The second, improperly stored dose of the vaccine was administered on 28-MAR-2016 (lot number L037339 with expiration date: 09-FEB-2018). The vaccine underwent temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt received 2nd dose moderna covid vaccine on march 25th and has felt fatigue, dizziness and headache starting 4 days after the dose until today when she is presenting to the urgent care (4/2/2021). Pt has been taking tylenol with no relief. Reports symptoms gradually improving. Not feeling dizziness anymore. Prescribed Amoxicillin-Pot Clavulanate Tablet, 875-125 MG, 1 tablet, Orally, every 12 hrs, 7 days for acute left otitis media.
Initial report received from a health care professional (nurse) on 01 Sep 2010: This child was vaccinated with MENVEO (batch number 022011), 0.5 ml intramuscularly on 22 Aug 2010. On 31 Aug 2010, the child experienced severe neck pain, tightness in chest, fever (temperature 102 F) and vomiting. The child was treated with antibiotics. The outcome of the event was reported as completely recovered.
Patient became dizzy & nauseous shortly after receiving a flu & shingrix shot. She took a generic Zofran she had, but minutes later she was having trouble breathing & started to wheeze. After I administered Epinephrine, pt. was able to breath & speak within a minute or so. 911 was called as soon as breathing problems started, & evaluated pt. when they arrived.
A nurse reported the occurrence of "excessive" injection site swelling in a 5 year old vaccinee of unspecified gender who received Infanrix. The subject's medical history, concurrent conditions, and concurrent medications were not specified. On an unspecified date, the vaccinee received the fifth injection of Infanrix (531A2). Subsequently, the subject developed "excessive" injection site swelling. The reporter stated that the event was probably related to Infanrix administration. As of 3/27/02, the outcome of the event was unknown.
3/19 - 3/24/21;  HOSPITALIZATION  for small hematoma/bleed in Cerebellum
Did not take Vivotif every other day; Spontaneous report received on 09DEC2019.  A pharmacist reported that a female consumer "did not take Vivotif every other day" (PT: Inappropriate schedule of product administration). She was receiving oral Vivotif for typhoid fever prophylaxis. On 03DEC2019 and 05DEC2019, the consumer took the first and the second dose of Vivotif respectively, and then she did not skip a day and took the third dose on 06DEC2019. On 08DEC2019, she took her last dose. Action taken with Vivotif with respect to the reported event was not applicable. Outcome of the reported event was unknown.  Company Comment: A consumer did not take Vivotif doses every other day (Inappropriate schedule of vaccine administration). Considering the mature of the event, the causality of the event is assessed as not related.; Sender's Comments: A consumer did not take Vivotif doses every other day (Inappropriate schedule of vaccine administration). Considering the mature of the event, the causality of the event is assessed as not related.
Pt stated after 4-5 hrs after receiving flu vaccination  she developed rash that hurt all over her body and they hurt.
Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP). A 13-year-old (non-pregnant) female patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: FC3183) and as dose 2, single (Lot number: 301308A) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant) with onset 24Apr2022, outcome "recovered", COVID-19 (medically significant) with onset 24Apr2022, 6 months 29 days after the suspect product(s) administration, outcome "recovered" and all described as "Tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Apr2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Additional information: The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not have COVID-19 nor any symptoms associated with COVID-19 prior vaccination.
Client presented to health department for HPV dose #2. Discussed immunization history/recommended vaccinations. Reviewed immunization record and noted Hep A incomplete. Looked incorrectly at the HPV line to see the recommended due date of 8/12/2018 and prepared and administered the Hep A dose too soon. Discussed mistake with parent/client. No reaction noted/reported. Discussed next due dates for each immunization in series and encouraged to call/return with any noted reaction.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 28Nov2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 75 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 08Feb2021 at 12:00 as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing), notes: P.E., High blood pressure; "Pulmonary embolism (PE)" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31May2023) Negative, notes: Tested Negative; (02Jun2023) positive, notes: tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid started from 24May2023 to 29May2023, over the counter severe cold symptoms by Tylenol.  Clinical course: Patient had no known allergies. Adverse event reported as tested Negative on 31May2023 then on 02Jun2023 started with cold symptoms and tested positive for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 27-JAN-2014 the patient was vaccinated with one dose of ZOSTAVAX 19400 PFU in each arm (dose, indication, lot #, expiration date not reported), one of the doses was administered intramuscularly instead of subcutaneously. No adverse effects were reported. No PQC. Additional information has been requested.
Information has been received from a consumer concerning her son who had been developmentally disabled and who was vaccinated approximately in 1976 with a dose of MMR II when he was 5 years old. Concomitant medication included asthma medication (unspecified). In approximately 1977 when the patient was in first grade he was diagnosed as mentally handicapped, but his I.Q increased every year so the diagnosis needed to be changed. Later when he was between 11th and 12th grade the patient was diagnosed with autism. It was reported that "since he received the vaccination prior to 1979 he would have received MMR not MMR II". The patient's mother did not remember if he was revaccinated. At the time of reporting the patient still had "social issues" and he could not look at someone when is talking to them. She stated that since her son had been developmentally disabled since birth she did not know if the event was related to the vaccine. Upon internal review autism was considered to be another important medical event. No further information is available.
cramping with menstrual cycle; Bloating; Period heavier and longer; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the right arm on 09Apr2021 at 11:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included vitamin c (MANUFACTURER UNKNOWN); vitamin d (MANUFACTURER UNKNOWN) and zinc (MANUFACTURER UNKNOWN); all for unknown indication from unknown date and unknown if ongoing. On 18Apr2021, the patient experienced period was heavier and longer than it had been in 6 years. She also experienced bloating and cramping with menstrual cycle which was highly out of the ordinary for the patient. The events did not result in a visit to the doctors or other healthcare professional office/clinic, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events period heavier and longer, bloating and cramping with menstrual cycle was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Information has been received from a pharmacist concerning a female customer who came in and stated that she had been vaccinated with a dose of ZOSTAVAX and three weeks later broke out in shingles. It was unspecified if medical attention was sought. No outcome was reported. No further information is available. Follow-up information has been received from the pharmacy that stated "I did not administer the shot-patient told me about adverse drug reaction (ADR)". No more information was available. No further information is expected.
Employee description of symptoms are as follows :Chills , hot flashes sweating,  runny nose, pain at injection site and shortness of breath. time of  symptoms is as follow 03/01/2023  8:00AM.  Employee states" no use of OTC medication  just went to sleep "
Vaccine given on 9/27/00. Reported to employee health nurse on 10/2/00. Had a large, area around injection site of firm, swollen, painful to touch and reddened. Pt had some kind of accident at work to right arm.
I had a non itching rash that developed on my body two weeks after the vaccine. At first I did not worry about because it was not itching. I honestly thought it may be poison ivy because I am an outdoors type person. Once it started to spread all over my body I sought medical attention. I was prescribed two topical steroid medications clobetasol propionate cream 05% and triamcinolone acetonide cream 0.1% to use.
itching like fire; swelling and spreading down to the bridge of his nose, over his eye lids and on both sides of his face in front of his ears.; The doctor advised he should not take the second vaccine shot; red rash in his hair and down his forehead in a "V" to the top of his nose / rash was getting worse; general bad feelings; fever / temperature ranged between 100.8 to 101.2.; bad chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (general bad feelings), RASH ERYTHEMATOUS (red rash in his hair and down his forehead in a "V" to the top of his nose / rash was getting worse), PRURITUS (itching like fire), SWELLING (swelling and spreading down to the bridge of his nose, over his eye lids and on both sides of his face in front of his ears.) and PYREXIA (fever / temperature ranged between 100.8 to 101.2.) in a 78-year-old male patient 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 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced FEELING ABNORMAL (general bad feelings), PYREXIA (fever / temperature ranged between 100.8 to 101.2.) and CHILLS (bad chills). On 21-Apr-2021, the patient experienced RASH ERYTHEMATOUS (red rash in his hair and down his forehead in a "V" to the top of his nose / rash was getting worse). On an unknown date, the patient experienced PRURITUS (itching like fire), SWELLING (swelling and spreading down to the bridge of his nose, over his eye lids and on both sides of his face in front of his ears.) and PRODUCT DOSE OMISSION ISSUE (The doctor advised he should not take the second vaccine shot). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 milligram; VALACYCLOVIR [VALACICLOVIR] at a dose of 1 gram; CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) at a dose of 1 dosage form and HYDROCORTISONE (HYDROCORTISONE 1% IN ABSORBASE) for Adverse event, at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL (general bad feelings), RASH ERYTHEMATOUS (red rash in his hair and down his forehead in a "V" to the top of his nose / rash was getting worse), PRURITUS (itching like fire), SWELLING (swelling and spreading down to the bridge of his nose, over his eye lids and on both sides of his face in front of his ears.), PYREXIA (fever / temperature ranged between 100.8 to 101.2.), CHILLS (bad chills) and PRODUCT DOSE OMISSION ISSUE (The doctor advised he should not take the second vaccine shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, Body temperature: 100.8-101.2 (High) temperature ranged between 100.8 to 101.2.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medications were reported.