chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Thyroid cancer" (unspecified if ongoing). Concomitant medication(s) included: CYTOMEL, start date: 09Mar2010, stop date: 14Dec2022; SYNTHYROID, start date: 09Mar2010, stop date: 14Dec2022; CYMBALTA, start date: 09Mar2010, stop date: 14Dec2022; BUSPAR, start date: 09Mar2010, stop date: 14Dec2022; KLONOPIN, start date: 09Mar2010, stop date: 14Dec2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Known allergies noted as no. Patient received vaccine. Paxlovid was noted as COVID 19 treatment. Treatment start date was noted as 04Dec2022 and treatment stop date was noted as 11Dec2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
ARM SORENESS; LOW GRADE FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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. No concomitant medications were reported. The batch number was not reported. The company is unable to perform follow-up to request batch/lot no. On an unspecified date, the subject experienced arm soreness, and low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the low grade fever and arm soreness was not reported. This report was non-serious.
pt recvd vax; inject site where vax given was blue, swollen, very hot to touch;arm swollen from elbow to upper arm;PHN instructed to take pt to MD;will take to walking er today;f/u arm still bit swollen;pt has also been sick to stomack;
COVID-19 symptoms started 04/12/2022 at midnight with fever. Tested positive on 04/13/22 with home test and PCR on 15th. I ran a fever of 102 for 72 hours and only thing that broke it was Tylenol every 4-6 hours. I also had extreme fatigue, muscle aches, gastrointestinal symptoms, and pounding headache. Acute symptoms lasted for 2 weeks, fever lasted 72 hours, and after the 2nd week I could get of bed and would have little bits of energy and then fatigue instantly. I didn't seek medical care because I'm a EMS in my town and I had squad members drop me off some medications and I was trying to figure out about getting anti-viral medications but I just stayed in bed for 2 weeks. I do have lingering symptoms now like asthma, and my PCP prescribed me a steroid inhaler albuterol and it wasn't working so I they prescribed steroid inhaler which insurance won't cover and I have lingering breathing issues and fatigue still. The breathing issues have been ongoing since April and I'll wake up in the AM and it's not a productive cough but it's a wet cough. It feels like there's some inflammation still going on in the lungs because they're trying to clear it out.
No adverse effects; unspecified patients received improperly stored doses of PNEUMOVAX 23; This spontaneous report was received from a medical assistant, referring to a 85-year-old patient of unknown gender. No information regarding the patient's pertinent medical histories, concurrent conditions, concomitant therapies, drug reactions or allergies.  It was reported that on 09-OCT-2019, the vaccine pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was exposed to a temperature excursion with a lowest temperature below 36 Fahrenheit (F) degrees (30.5 F degrees) for 10 hours. There was no previous temperature excursions.  On 30-OCT-2019, the patient was vaccinated with the improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S029265, expiration date 31-MAR-2021 (dose, dose number, route of administration and anatomical injection site were not reported) for prophylaxis. The call was placed because of the Digital Data logger report. No adverse effects reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S029265; expirationdate: 31-MAR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1911USA001801: US-009507513-2005USA002426: US-009507513-2005USA002453: US-009507513-2005USA002454: US-009507513-2005USA002455: US-009507513-2005USA002456: US-009507513-2005USA002457:
Headache, Myalgia, Fever, NauseaVomiting,  Fatigue, Very painful and swelling on injection site that radiates to the back. Narrative:
Fell and separated her shoulder; Fell and separated her shoulder; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Fell and separated her shoulder) and JOINT DISLOCATION (Fell and separated her shoulder) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced FALL (Fell and separated her shoulder) and JOINT DISLOCATION (Fell and separated her shoulder). At the time of the report, FALL (Fell and separated her shoulder) and JOINT DISLOCATION (Fell and separated her shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No concomitant medications were reported. No treatment related information has been reported.
TDAP adacel 0.5 mL administered IM in L deltoid. Pt tolerated well. Lot u7561aa Exp 11/09/2024 NDC 492140089.   Tdap vaccine was given instead of the flu vaccine. NO adverse effects to patient or fetus at this time.
Within two weeks after the second dose of the vaccine I started to have some pain in the soft tissue behind my knees and some swelling in my legs. Within eight weeks of my vaccine I experienced a Migraine for two days. I had severe vomiting and nausea. In the middle of the day I felt like I was struck in the chest. I went to the hospital by Ambulance and I was diagnosed with a Heart Attack. I was taken to the Cath Lab and I was told that it was 99% Occluded. They told me that it was a Widow Maker. I had not had any problems with my heart before than and I had just been Hiking in May. I have been advised by my doctor not to take a Booster shot.
Now have COVID; Full blown case of Shingles that evening; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included discomfort (patient had discomfort in right side).   In November 2022, the patient received Shingrix. In November 2022, less than a day after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced covid-19. On an unknown date, the outcome of the shingles was unknown and the outcome of the covid-19 was not recovered/not resolved.   It was unknown if the reporter considered the shingles and covid-19 to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-DEC-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that he/she received Shingrix vaccine a month ago from reporting. The patient stated that when he/she went to receive Shingrix vaccine he/she had some discomfort in his/her right side. The patient reported that after received Shingrix vaccine he/she experienced full blown case of Shingles on that evening. The patient reported that he/she now had Covid. Additional supportive information: Follow-up would not possible as no contact details were available.
pt stated shot was very painful; pt was instructed to massage the arm & take APAP for discomfort;
Information has been received from a nurse referring to multiple unspecified patients of unknown ages and genders. There was no pertinent medical history, concurrent conditions, concomitant medications or drug allergies/drug reactions described. On 09-NOV-2015, 23-NOV-2015, and 09-DEC-2015, multiple unspecified patients received improperly stored product GARDASIL 9 lot # K026246 with expiration date of 28-JAN-2017 (strength, dose, frequency and route were not reported). No adverse effect was reported. This is one of several reports received from the same source.  Additional information has been requested.
On 18FEb93 devel t102-103; fine rash over trunk; rash disappeared over 48-72 hrs; fever responded to APAP; was irritable w/cough on 21FEB93;
Patient  is a 73 y.o. male patient of MD with history of CHF, chronic respiratory failure (3 L/min at baseline), COPD, DM 2, HTN, prostate cancer, paroxysmal A-fib, presented to Medical Center with shortness of breath found to have acute on chronic respiratory failure secondary to to COVID-19, COPD exacerbation and multifocal pneumonia   Acute on chronic respiratory failure with hypoxia and hypercapnia   Secondary to COVID, COPD exacerbation, PNA and pulmonary edema On 3L O2 NC at baseline, requiring BIPAP on admission Weaned to home 3L O2 NC BIPAP at bedtime Pulm following   Sepsis due to PNA, POA Multifocal Pneumonia Secondary to COVID-19 and Multifocal Pneumonia Afebrile, leukocytosis to 14.04k, lactate 2.0 CTPA (2/27) shows multifocal opacities L>R, pulmonary edema versus multifocal pneumonia Urine antigens pending Blood cx NGTD Continue Rocephin/Azithro, transitioned to Levaquin to complete 7 day course   Covid-19 Virus Infection Date of onset of symptoms: 1 week ago Symptoms present on admission: Cough, sputum production, shortness of breath Date of covid positive test: 2/27 Vaccination status: vaccinated Imaging: CT imaging shows multifocal opacities L>R, pulmonary edema versus multifocal pneumonia Oxygen requirements on admission: BiPAP Current oxygen requirements: 3L O2 NC (home requirement) Medical therapy: remdesivir, steroids, rocephin, and zithromax (changed to levaquin at discharge) Consultants following:  Pulm Anticipated special isolation end date: 3/5   COPD exacerbation Secondary to COVID-19, multifocal PNA Requiring BIPAP on admission, now weaned to home 3L O2 NC S/P Decadron, transitioned to prednisone with taper at discharge  Continue Symbicort and Duonebs   Acute on chronic HFrEF exacerbation  Medical noncompliance  Likely due to dietary non compliance Echo (2019) with EF 40-45% CT with findings of pulmonary edema Repeat echo (2/28) with EF 57% S/P IV lasix, transitioned to po lasix 40mg BID Continue home coreg, losartan, aldactone  Paroxysmal Atrial fibrillation Continue home Eliquis, carvedilol, sotalol Rate controlled   DM2 with hyperglycemia  A1C 8.6 Held home Glipizide Decreased home Lantus SSI   Hyperlipidemia Continue home lipitor
patient reports that she wasn't feeling the best; gave Moderna monovalent doses to two people who should have gotten the bivalent booster; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING ABNORMAL (patient reports that she wasn't feeling the best) and WRONG PRODUCT ADMINISTERED (gave Moderna monovalent doses to two people who should have gotten the bivalent booster) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057A22A) for COVID-19 prophylaxis.     Concomitant products included INFLUENZA VACCINE from 27-Dec-2022 to an unknown date for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Dec-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 27-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (gave Moderna monovalent doses to two people who should have gotten the bivalent booster). On an unknown date, the patient experienced FEELING ABNORMAL (patient reports that she wasn't feeling the best). At the time of the report, FEELING ABNORMAL (patient reports that she wasn't feeling the best) and WRONG PRODUCT ADMINISTERED (gave Moderna monovalent doses to two people who should have gotten the bivalent booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case contains information for the 1st patient out of 2 patients described by the reporter. The reporter is a nurse manager. Another nurse given Moderna monovalent doses to patient who should have gotten the bivalent booster on 27Dec2022. The patient reports that patient wasn't feeling the best, but could still make it to work. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-694810 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-694810:2nd patient out of 2
Patient was administrated with a 3rd dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number GL79C, expiry date 13th November 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose of Shingrix received on an unknown date) and Shingrix (2nd dose of Shingrix received on an unknown date).   On 16th June 2021, the patient received the 3rd dose of Shingrix. On 16th June 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The patient received with a 3rd dose of Shingrix , which led to extra dose administered. No adverse event was reported. The reported batch number gl796 was not found in sales data sheet, hence was updated to GL79C. The reporter consented to follow up.
I start noticing like acne on my arms and then on my belly after I got the second shot of the redness and breakouts kind of thing was all over my body.
Information has been received from a 64 year old female with hives from sulindac (WAES# 0805USA06072) and horse serum who in approximately March 2008, "about 2 months ago" was vaccinated with ZOSTAVAX. Concomitant therapy included IMDUR, atenolol, LIPITOR, oxybutynin, amitriptyline hydrochloride, furosemide, amlodipine besylate, isosorbide and aspirin. In approximately March 2008, "the day after the shot" the patient experienced a "very debilitating adverse reaction." The patient reported that the ZOSTAVAX gave her diarrhea, white stools and "tore up her stomach." No lab tests were performed. The patient reported that she sought unspecified medical attention. Approximately 4 days after stopping therapy, the patient recovered from the diarrhea, white stools and tore up my stomach. The patient also reported her experience from a pneumonia vaccine (WAES 0805USA06073). Additional information is not expected.
swelling in the face especially around the eyes especially when she wakes up; eyes are almost swollen shut; overall puffy; This spontaneous case was reported by a nurse and describes the occurrence of SWELLING FACE (swelling in the face especially around the eyes especially when she wakes up), EYE SWELLING (eyes are almost swollen shut) and PERIORBITAL SWELLING (overall puffy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product HYALURONIC ACID, LIDOCAINE (RESTYLANE L) for an unknown indication.    The patient's past medical history included No adverse event (no medical history reported.).   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and HYALURONIC ACID, LIDOCAINE (RESTYLANE L) (unknown route) dosage form. On an unknown date, the patient experienced SWELLING FACE (swelling in the face especially around the eyes especially when she wakes up), EYE SWELLING (eyes are almost swollen shut) and PERIORBITAL SWELLING (overall puffy). At the time of the report, SWELLING FACE (swelling in the face especially around the eyes especially when she wakes up), EYE SWELLING (eyes are almost swollen shut) and PERIORBITAL SWELLING (overall puffy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On an unspecified date, female patient was injected with Restylane Lyft (hyaluronic acid, lidocaine) via cannula into the cheek areas and complained of swelling in the face especially around the eyes, especially when she woke up. She stated that her eyes were almost swollen shut and she was overall puffy. She was vaccinated prior to the injection.  No treatment information was reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
48 hrs after vaccination developed headache, dizziness, nausea. Symptoms worsened over nex 48 hrs w/ T headache, nausea progressed to vomiting, dizziness (dysequilibrium and pressure). Seen in ER given IV fluids antiemetics, analgesic and gradually improving over next 4-5 days
SWELLING AND REDNESS FROM SHOULDER TO ELBOW, DIFFICULTY IN  MOVING SHOULDER AND ARM. STARTED 08/25, PT STILL HAS SOME SWELLING AND REDNESS AROUND ELBOW AREA. AS OF 8/28/2017, SHE WENT TO HOSPITAL AND GIVEN RX FOR AUGMENTIN.
3:40 pm - at 10 minutes after receiving vaccine pt reports feeling warm and dizzy. 3:49 pm pt evaluated by EMS BP 165/99 P 67 O2sat 100 % 4:14 pm EMS transported pt to the hospital
Patient reports having a knot at the injection site and has been experiencing  pain radiating down from left arm to left side of her body down to her toes. Patient says she experiences pain upon walking and is in constant pain.
14JUN fever 101.8, slept all day; 29JUN sore jaw; 1JUL called hosp talked to MD prescribed Lodine; 7JUL pt still sore jaw & can only open it the width of 2 fingers; family believes has vax tetanus;
Pt arm was swollen, red, itchy and has a pea size lump.  Patient unsure when it started.  Daughter states that she started complaining about it around 4/22/15.
Numbness and tingling all down my left arm all the way down to my finger tips on two of my fingers.  The injection hurt more than a normal shot and it feels as though there is nerve damage.
3 cm reaction at (L) deltoid - erythema, no pruritus, mild tenderness - no muscle tenderness.
Patient administered 0.5mL instead of 0.25mL booster 3rd dose. Patient called on 1/18/2022 and denied any problems since vaccination. A letter was sent to patient informing of dose administered.
Shortly after the vaccination, I had muscle pain, redness and swelling at the injection site. I woke up at 4:00 am 8-23-18 with headache, fever, muscle ache, nausea, stomach ache, and weakness.  I was unable to get out of bed to do anything but go to the bathroom. The fever broke about 4:00 pm, with the other symptoms lasting until the next day, 8-24-18. I was dizzy and nauseous through 8-25-18.
Fever; Chills; Sharp pain on top of head and right shoulder; Sharp pain on top of head and right shoulder; Felt like a pin was pricking right shoulder and right side of neck; My molars were on edge - both sides; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 05May2021 at 15:55 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history and no known allergies. 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. Concomitant medications included vitamins (MANUFACTURER UNKNOWN)) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 14Apr2021 at 16:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. On 05May2021 at 16:30, 35 minutes after shot the patient experienced sharp pain on top of head and right shoulder when the patient was driving home. This did not last more than a minute. Then, the patient felt like a pin was pricking on right shoulder and right side of neck. The patient molars were on edge both sides. The patient experienced all of these strange reactions while driving home in the car and were gone within 30 minutes. On 06May2021 at 09:30, beginning the next day the patient experienced fever and chills. The events did not result in doctor or other healthcare professional office/clinic visit, 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 sharp pain on top of head and right shoulder, pin was pricking right shoulder and right side of neck and molars were on edge both sides were recovered on 05May2021 at 17:00. The clinical outcome of the events fever and chills were recovered on an unknown date in May2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
This case was considered medically important. Information regarding Prevnar was received from a healthcare professional regarding a 3 year old female patient who developed pneumococcal sepsis and pneumococcal pneumonia. The patient received the third dose on an unspecified date. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day (intramuscular). On 09 Mar 2004 the patient developed pneumococcal sepsis and pneumococcal pneumonia. She was treated with intravenous Rocephin. On an unspecified date, the patient recovered. Results of a culture performed on an unspecified date revealed "serotype 9A, subtype 19A." No additional information was available at the time of this report.