chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Batch/Lot number: unknown), in right arm and on 14Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Anklylosing spondylitis" (unspecified if ongoing). Concomitant medication(s) included: COSENTYX; HYDROCHLOROTHIAZIDE; LISINOPRIL; NALTREXONE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: am still testing positive for covid; Unknown results, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had no known allergies. Patient received Paxlovid from 15Jun2022 to 20Jun2022 for treatment of COVID-19. She just finished her Paxlovid series. She started having a reoccurrence of heavy cough congestion and malaise after the 3rd to 4th dosing in the series. She finished her last morning dose this morning and she had very heavy flu-like symptoms. She was still testing positive for covid. Patient experienced above symptoms from 20Jun2022 and was recovering but did not receive any treatment medication for the same.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Arm started feeling really  sore where the shot was injected,  I then started feeling a very sore throat, I lost my voice, my stomach ached pretty bad. Over a course of 4 days I noticed the symptoms listed were getting worse. About  an hour and a half ago, my symptoms started to go away on their own.
The syringe came apart; Some of the dose dripped down; This spontaneous case was reported by a consumer and describes the occurrence of DEVICE CONNECTION ISSUE (The syringe came apart) and UNDERDOSE (Some of the dose dripped down) 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 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced DEVICE CONNECTION ISSUE (The syringe came apart) and UNDERDOSE (Some of the dose dripped down). On 18-Nov-2021, DEVICE CONNECTION ISSUE (The syringe came apart) and UNDERDOSE (Some of the dose dripped down) had resolved.      No concomitant and treatment information were reported by the reporter.  Patient got the booster dose yesterday. And while the pharmacist was administering the vaccine, the syringe came apart and some of it dripped down.   Reporter did not allow further contact
never had difficulty breathing like he did 3 days after the vaccine; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. An 82-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 22Jan2021 01:45 AM (Batch/Lot Number: EL3247) as 1ST DOSE, SINGLE for covid-19 immunization. The patient's medical history included High Blood Pressure (hypertension); COPD (chronic obstructive pulmonary disease) and drug hypersensitivity from an unknown date and it was unknown if ongoing. Concomitant medications included lisinopril; felodipime; XARELTO (rivaroxaban); hydrochlorothiazide; zinc; folic acid; Vitamin C; pravastatin sodium; ALLEGRA (fexofenadine hydrochloride); VITRN C (ascorbic acid, ferrous fumarate); atropin; TIMOPTIC (timolol maleate); REFRESH PLUS (carmellose sodium); REFRESH PM (paraffin, liquid, white soft paraffin); BREO ELLIPTA (fluticasone furoate, vilanterol trifenatate ); FLONASE SENSIMIST ALLERGY RELIEF (fluticasone furoate) taken for an unspecified indication, start and stop date were not reported. The patient's allergic conditions included Penicillin, Tetracycline, NSAID eye meds (drug hypersensitivity). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid 19 and was not tested for COVID-19 prior vaccination. On 25Jan2021 at 12:00, the patient reported that he "never had difficulty breathing like he did 3 days after the vaccine". The patient was treated with Prednisone 10 mg, Azithromycin 250 mg, Clonidine HCL .2 mg, Albuterol Sulfate 4 mg. On 04Feb2021, the patient underwent lab test for sars-cov-2 antibody test with nasal Swab which was revealed to be negative. The outcome of event was not recovered.  No follow-up attempts are possible. Information about batch number cannot be obtained.
Expired vaccine dose administered to 2 patients/ expired vaccine dose; Vial was left out of fridge for more than 12 hours; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine dose administered to 2 patients/ expired vaccine dose) and PRODUCT STORAGE ERROR (Vial was left out of fridge for more than 12 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine dose administered to 2 patients/ expired vaccine dose) and PRODUCT STORAGE ERROR (Vial was left out of fridge for more than 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine dose administered to 2 patients/ expired vaccine dose) and PRODUCT STORAGE ERROR (Vial was left out of fridge for more than 12 hours) had resolved.        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 provided.  No treatment information provided.
My menstrual cycle in December was 10 days long, which is very unusual for me (I'm pretty consistently at 5-6 days, no more, no less). I also had very random spotting at other times of the month in both December and January.
Case number PHEH2012US016069 is an initial spontaneous report received from a nurse on 09 Aug 2012. This report refers to a 12-years-old female patient. She was vaccinated with MENVEO vaccine (batch number: A11042) subcutaneously instead of intramuscularly on 09 Aug 2012. No other adverse reaction was reported following this medication error (wrong route of administration).
Redness and swelling at the injection site.  Pt also c/o itching and pain at the injection site.
pt recvd vax 2DEC92 & 4DEC92 AM began clenching & unclenching hands quickly, knees shook, eyes rolled back in head, unresponsive lasted 10 sec; pt slept most of 3DEC92; pt called clinic & advised to call MD; t38.1, collapse, sz;
The patient fainted after receiving the Pfizer covid vaccine shot. She was alert after about 1 minute. We called 911 and they checked her vitals. All her vitals were okay and she went home.
Woke up at appx 7:00 a.m. with headache. Began vomiting at 8:00 a.m. Vomiting/dry heaving and headache continued until approximately 9:30 a.m. when she fell asleep. Woke up around 10:30 a.m. feeling a little better. She was then able to sip pedialyte and eventually eat saltiness crackers. Headache continued until her stomach felt well enough to tolerate children's Tylenol.
Weakness & inability to lift arm, fatigue, sore throat; Weakness & inability to lift arm, fatigue, sore throat; Weakness & inability to lift arm, fatigue, sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Weakness & inability to lift arm, fatigue, sore throat), MUSCULAR WEAKNESS (Weakness & inability to lift arm, fatigue, sore throat) and FATIGUE (Weakness & inability to lift arm, fatigue, sore throat) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced OROPHARYNGEAL PAIN (Weakness & inability to lift arm, fatigue, sore throat), MUSCULAR WEAKNESS (Weakness & inability to lift arm, fatigue, sore throat) and FATIGUE (Weakness & inability to lift arm, fatigue, sore throat). On 04-Sep-2021, OROPHARYNGEAL PAIN (Weakness & inability to lift arm, fatigue, sore throat), MUSCULAR WEAKNESS (Weakness & inability to lift arm, fatigue, sore throat) and FATIGUE (Weakness & inability to lift arm, fatigue, sore throat) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications and Treatment informations were not provided. My arm hurt badly enough that it was difficult to use and I could barely lift over my head
Patient with a history of anaphylactic reaction to Advil developed a possible biphasic allergic reaction to Pfizer Covid vaccine (lot EN6208) given on 3/17. Patient initially had urticarial rash on 3/19  and it was treated with Benadryl and Solu-medrol. Patient was discharged on daily prednisone. However, patient returned on 3/21 with facial swelling, chest and throat tightness and shortness of breath. Prior to ED arrival, patient self-treated with EpiPen. At the ED, Benadryl, Pepcid, and Solu-medrol were given and continued for 2 days during hospitalization.  No further respiratory distress developed, but the patient still had intermittent itching and rash. Patient was discharged on tapered prednisone, Benadryl as needed and Pepcid.
The first symptoms I noticed was hives. Originally, they were concentrated on my head and neck. Then they did not go away with Benadryl or over the counter antihistamines. I went to the doctor the next day and they prescribed me Prednisone. They did 2 different blood tests, and the white blood cell count came back funny, and they think that was because I was still on the Prednisone. I was on that for 2 days. My reaction continued to worsen to the point where the hives covered my entire body. It was difficult for me to move. I went back to the doctor on Wednesday, and they put me on a much higher dose of Prednisone, and I will be on that for 3 weeks.
pt recvd 1st dose of Hep B vax on 10MAR92 & 3 1/2 hrs following vax pt exp shoulder ache @ inject site that radiated to both shoulders; also exp thigh pain & joint pain; forehead was damp & clammy & exp itching on nose, throat & eyes;
moderna arm: entire upper arm 12long x 3wide inch; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE REACTION (moderna arm: entire upper arm 12long x 3wide inch) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 026A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), CALCIUM and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE REACTION (moderna arm: entire upper arm 12long x 3wide inch). The patient was treated with CORTISONE at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (moderna arm: entire upper arm 12long x 3wide inch) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was also taking  "statin" as concomitant medication  Action taken with mRNA-1273 was not applicable   This case was linked to US-MODERNATX, INC.-MOD-2021-067651 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067651:Crosslinked with dose 1
Information has been received from a registered nurse concerning a patient who was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine. It was reported that the patient received second dose within 6 months of the first one. Subsequently, the patient experienced pain and swelling at the injection site. Unspecified medical attention was sought. The patients outcome was unknown. No product quality complaint was involved. No further information is expected. It was also reported that two additional patients were vaccinated and experienced adverse events, one with a dose of pneumococcal 23v polysaccharide vaccine (WAES0504USA01870) and the other with a dose of varicella virus vaccine live (WAES0504USA01871).
Muscle stiffness and pain near injection site; aggravated lymph nodes in injection arm; itchy and raised bumps near injection site; red rash in bullseye shape around injection site
Pt recv vax 11MAY98 and exp a sore right arm. It was reported that the nurse pulled the wrong vaccine from the refrigerator and gave the patient a double dose (1cc) in the left deltoid.
p/pt recvd vax appeared fine; started back to class & felt dizzy & was pale & cool to touch; BP systolic was 64; put head between legs; assisted to laying position; w/in 2-3 min stated felt better BP 118/78; c/o fatigue & wanted to go home;
This spontaneous report was received from a pharmacist via a company representative, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history or concomitant medications reported. On an unspecified date In November 2016, the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, route, lot # and expiration date were not reported) for prevention of shingles. On an unknown date in November 2016, after getting ZOSTAVAX, the patient had skin a reaction and fever that were recovered after 2 days. The causality between the adverse events and ZOSTAVAX was unknown.  No product quality complaint was involved (PQC). Additional information has been requested.
-Pt got Pneumo shot in AM from 1st MD 3/03/08 in (L) arm. When told Zostavax shot may sting, asked if could get in (L) arm as well. I consented. Pt developed redness, pain, swelling in left arm. Pt believes use of concurrent shots in same arm causes the reactions.
PATIENT WAS GIVEN HER FLU VACCINE IN HER LEFT ARM AT 2PM. A FEW MINUTES LATER SHE CALLED ME AND TOLD ME SHE WASN'T FEELING WELL. HER NECK AND SCALP BECAME RED. EYES WERE BLURRY. SHE FELT LIKE, "HER HEAD WAS GOING TO EXPLODE". BLOOD PRESSURE BECAME ELEVATED FROM HER NORMAL BP. CALLED 911. SHE STARTED TO FEEL BETTER BEFORE 911 CAME. SHE WENT TO GET CHECKED OUT AT HOSPITAL.
consumer reports that wife devel an enlarged (painless) lymph node on lt side of neck p/recvd vax; 2 wks p/vax devel 3 enlarged lymph nodes on rt side;
cold sensation on her left shoulder (injection site) going to her neck/ as if the coldness was travelling through her veins/ cold sensation was travelling throughout her body; cold sensation on her left shoulder (injection site) going to her neck/ as if the coldness was travelling through her veins/ cold sensation was travelling throughout her body; sharp shooting pain that travelled from her right shoulder to her neck, and then to her chest; sharp shooting pain that travelled from her right shoulder to her neck, and then to her chest; sharp shooting pain that travelled from her right shoulder to her neck, and then to her chest; This is a spontaneous report from a non-contactable consumer (patient) via Medical Information team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in the left arm (reported as left shoulder) on an unspecified date in Mar2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient said she received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine 3 weeks prior. Four or five hours after receiving the 1st dose of the vaccine (on an unspecified date in Mar2021), the patient felt a cold sensation on her left shoulder (injection site) going to her neck. She said it felt as if the coldness was travelling through her veins. The patient took paracetamol (TYLENOL) to treat the symptoms, and it went away after an hour. However, 2 weeks after the 1st dose (on an unspecified date in Mar2021), she felt a sharp shooting pain that travelled from her right shoulder to her neck, and then to her chest. The patient said the cold sensation was travelling throughout her body. The patient wanted to know if this was related to the vaccine. The patient was worried because her 2nd dose is on 05Apr2021, and she did not know if she should get it. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
w/in 12 hrs p/immun, pt exp a fever, muscle aches, joint pain & a total body rash which lasted 2 to 3 days;
pt recv vax 1997 & exp swelling of the arm which resolved w/in 48hr;
approx 2yrs p/vax pt exp chickenpox consisting of raised bumps, mild fever, itching. 16dec98 pt was dx w/chickenpox. addl info requested
On 5/5/00, had cellulitis of left arm where he received vaccine in. Pt told another provider that he though it was from an improper technique.
Swollen sore arm at injection site on left arm; left side of face also swollen; jaw pain, headache; fever, chills, difficulty lifting left arm above head; achy feeling in left shoulder; trouble sleeping due to discomfort and pain.
This case  was reported by a physician via a sales representative and described the occurrence of stinging at the injection site in a subject of unspecified age and gender who was vaccinated with TWINRIX (Glaxosmithkline). On an unspecified date the subject received unspecified dose of TWINRIX. At an unspecified time after vaccination with TWINRIX, the subject experienced stinging and burning at the injection site. This was also reported to be a product complaint as the reporter felt the events were related to a quality issue with TWINRIX injection. The outcome of the events was unspecified. It was reported that 10 subjects (including this one) experienced burning and stinging at the injection site following administration of TWINRIX from the same lot. Follow-up information was received on 04 November 2008, by a physician and described the occurrence of injection site stinging in a 31 year old female subject who was vaccinated with TWINRIX (Glaxosmithkline). On an unspecified date the subject received 1st dose of TWINRIX (unknown). On 1 October 2008, at an unspecified time after vaccination with TWINRIX, the subject experienced injection site stinging, injection site burning, possible irritating substance in lot AGABB128AB (product complaint). The lot was removed from further vaccinations. Upon follow-up the physician reported the subject was pregnant and experienced vaccine exposure during pregnancy. On 1 October 2008, the injection site stinging and injection site burning were resolved. The physician considered the events related to vaccination with TWINRIX.
This spontaneous report as received from a medical assistant refers to three patients of unknown demographics. On an unknown date in August 2017, the patients were vaccinated with improperly stored doses of VARIVAX injection, lot # N007930 with expiration date on 08-MAR-2018, reconstituted with properly stored sterile diluent (manufacturer unknown). Additional information has been requested. Sender's Comments: US-009507513-1709USA001401.
pt recvd vax 5JAN94 & prior to vax temp was 96.3; On 5JAN94 4 to 6 hrs following vax pt devel t101.8 & a bright red coloration on forehead, scalp & neck; also appeared to be less active;
Pain at the shoulder; Swelling at the shoulder; 1st dose March 10, 2020 and 2nd dose on October 1, 2020; Limitied range of motion at shoulder; Injection site Pain; Swelling; Hardness (Induration); Hot temperature (at injection site); Diarrhea; Fatigue; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 80-year-old female patient who received Herpes zoster (Shingrix) (batch number 453S4, expiry date 19th March 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 10th March 2020).   On 1st October 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 1st October 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site swelling, injection site induration, injection site warmth, diarrhea, fatigue and mobility decreased. On an unknown date, the patient experienced shoulder pain, swollen joints and drug dose administration interval too long. On an unknown date, the outcome of the injection site pain, injection site swelling, fatigue and mobility decreased were not recovered/not resolved and the outcome of the injection site induration, injection site warmth, diarrhea and drug dose administration interval too long were recovered/resolved and the outcome of the shoulder pain and swollen joints were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site induration, injection site warmth, diarrhea, fatigue, shoulder pain, swollen joints and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The pharmacist was reporting numerous adverse events that were reported by the patient.  The patient received Shingrix and experienced, injection site pain, swelling, induration and hot temperature at injection site.  The pharmacist reported that the patient experienced diarrhea 6 hours after vaccine administration which has resolved.  The pharmacist added, the patient continues to complain of fatigue, pain and swelling at the shoulder as well as limited range of motion of the shoulder.  Additionally, the pharmacist noted the patient has been to her doctor and they have ordered an MRI of her shoulder.  The patient received 2nd dose late, which led to lengthening of vaccination schedule. The reporter did not consent to follow up.
Patient reported that she has passed out from a vaccination in the past. After administering the vaccine, patient began to sweat and feel faint. I ran to get her a candy bar and some juice. During that time, the patient's husband and another pharmacist helped her to the floor. The patient took a few sips of Powerade and ate a candy bar. After about 15 minutes, the patient was able to get back up into the chair. She remained there for another 5 minutes before she left with her husband.
The 1st is an abnormally yellow-green vaginal discharge.  There is no odor, no burning, no itching, and no abdominal/pelvic pain.  It occurs 2-3 times a week and has the consistency and color or phlegm when I have a cold/flu.  I was worried and went to Planned Parenthood and got an STI workup and that all came back negative.  The 2nd is I am experiencing chronic full body pain in my joints and ligaments.  It started very mild and intermittent but over time since May has become worse and more consistent.  There has also been some joint swelling that comes and goes.  I am almost 52 and do have some bouts of pain that I associate with age but this is more pronounced and sudden in onset since the vaccine in April.