chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tested positive for the COVID-19 virus; Tested positive for the COVID-19 virus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 11Mar2021 at 14:00 as dose 1, single (Lot number: EN6203), in left arm, on 30Mar2021 at 08:00 as dose 2, single (Lot number: EL3248), in left arm and on 13Dec2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 44 years, in left arm, all intramuscular 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), COVID-19 (medically significant) all with onset 29Jul2022, outcome "recovering" and all described as "Tested positive for the COVID-19 virus". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Jul2022) Negative; (29Jul2022) Positive; (30Jul2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course: If other vaccine in four weeks and other medications in two weeks were reported as no. No Covid prior vaccination and no known allergies. Covid was tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Approx. 4 minutes after vaccination pt noted to have his head back with bilat upper extremities elevated shaking loosely. When PHN approached him his eyes were rolled back then he lunged forward and ended seated on the ground. His eyes were open but with a forward blank stare. He did not respond verbally to questions at that time.  He was diaphoritic so PHN removed his sweater while staff called for EMS. PHN came to assist.  Pt had very large emesis.   Mom present and provided history and states no known hx  of seizures, no known medical history. No medications.  Pt verbal after approx. 2-3  min. Seemed disoriented to place and time. VS at 13:15 SaO2 97%, BP 155/88 and heart rate 107.  No resp. distress.  EMS arrived approx 13:20 VS using their equiptment HR 117 BP 123/81 SaO2 98%.  BGL 117 mcg/dl.  Pt began speaking clearly.  Stated that with episode he felt like  "I was in an alternate universe, I did not know where I was".  Pt  now oriented to person and place. Pt denied and tingling, itching or SOB.  Pt left with EMS staff and was taken by ambulance to ED.  MOC to follow in her own vehicle.  EMS  Left at 13:34.
received covid vaccine then contracted covid-19, 9 days after getting the vaccine; received covid vaccine then contracted covid-19, 9 days after getting the vaccine; This is a spontaneous report from a contactable physician.  A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on Dec2021 at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  It was stated, "received covid vaccine then contracted covid-19, 9 days after getting the vaccine, should he get his 2nd dose which is on Friday? Tested positive on the 30th, received monoclonal antibody infusion on the 31st. Any information regarding this?". The outcome of the event was unknown.   Information on the lot number has been requested.; Sender's Comments: Although, BNT162B2 vaccine immunogenicity is not in full effect after short time (9 days in this case) after first dose administration, a causal relationship between event "received covid vaccine then contracted covid-19" (coded to Drug ineffective / SARS-CoV-2 test positive) and BNT162B2 vaccine cannot be completely excluded.
Reaction to Pneumovax injection, swelling, itchy at site up to axilla left arm.
No adverse effects; An expired dose of PROQUAD that had no previous temperature excursions, was inadvertently administered to an unspecified patient; This spontaneous report as received from a registered nurse referring to a 5 year old male patient. The patient's concurrent condition included seasonal allergies. The patient was previously vaccinated with measles virus vaccine live (Enders-Edmonston) (+) mumps virus v (M-M-R) and varicella virus vaccine live (Oka/Merck) (VARIVAX). On 28-APR-2017 09:00, the patient was inadvertently vaccinated with expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) Human serum albumin (HSA)(lot # L024497, expiry date : 01-JAN-2017), for prophylaxis (expired product administered). On 09-MAY-2017 09:15, the patient was vaccinated with dose 5 of diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid(DAPTACEL) from lot C5117AA intramuscular in the right arm and dose 4 of poliovirus vaccine inactivated (vero)(IPOL) from lot L024497 subcutaneous in the right arm; for prophylaxis. Concomitant therapies included sterile diluent(Manufacturer Unknown) (Lot# and expiration date was unknown by the reporter). There was no previous temperature excursions. No adverse effects reported. There was no product quality complaint involved.  This is one of the several reports linked via same reporter link.
Moderate rash and itching on both ankles persisting for 6 days.  Itching primarily occurred during the evening.
Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown; Potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown) and POOR QUALITY PRODUCT ADMINISTERED (Potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover.) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 17-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown) and POOR QUALITY PRODUCT ADMINISTERED (Potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover.) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered POOR QUALITY PRODUCT ADMINISTERED (Potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover.) to be not related. No further causality assessment was provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown).    No concomitant medications information was reported.  Reporter stated that a site that administers the Moderna COVID-19 vaccine did not monitor the freezer temperatures where the Moderna vaccine is stored. The site had a data logger, but it was not set up to record. The HCP stated there is no freezer minimum and maximum temperatures to report as the temperatures were not recorded by the site. Therefore, it was unknown if a freezer temperature excursion actually occurred. There were no adverse events. Only the potential of a subtherapeutic dose due to poor freezer documentation following a freezer changeover was reported.   No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2022: Quality complaint number added.
Information has been received from a medical assistant concerning an 18 year old female patient who on 28-JUL-2010 was injected with the first dose of GARDASIL (lot #, route and injection site not reported). On 28-JUL-2010 the patient experienced dizziness. The patient had sought unspecified medical attention. Subsequently, the patient recovered from dizziness. Additional information has been requested. This is one of two reports received from a same source.
Arm pain a week after injection; Initial information received on 23-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves patient (unknown demographics) who experienced arm pain a week (pain in extremity), while he/she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient had no medical history, concomitant disease or risk factor.  Medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2035 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 non-serious arm pain a week (pain in extremity) (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It is unknown if patient physician provided consent to be contacted. It is unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.
Patient got first dose of Moderna Covid-19 vaccine on 8/20/21.  She already got Johnsen & Johnsen on 6/21/21 at a different place
I had to go for shot in my eye; 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 bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EYE DISORDER (non-serious), outcome "unknown", described as "I had to go for shot in my eye".  Additional information: I had my second shot on the 21st of April scheduled; I completely forgot to go; consumer might have been missed the second dose. can I make another appointment." When paraphrased the above concern, Consumer stated, "I had to go for shot in my eye that day and I just completely forgot the other shot. I need to get an appointment for my second shot and I went to old colony drive."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
sore shoulder; lethargy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 21Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 68 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, Anatomical Site of Injection: left arm, Route of administration: Intramuscular, Batch/Lot number: EN4202), administration date: 02Mar2021, when the patient was 67-year-old, for COVID-19 IMMUNIZATION, reaction(s): "sore shoulder", "Lethargy"; BNT162b2 (DOSE 2, Anatomical Site of Injection: left arm, Route of administration: Intramuscular, Batch/Lot number: EP6955), administration date: 23Mar2021, when the patient was 67-year-old, for COVID-19 IMMUNIZATION, reaction(s): "sore shoulder", "Lethargy". The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "sore shoulder"; LETHARGY (non-serious), outcome "unknown". Additional information: I rarely have even mild reactions (sore shoulder; a day of lethargy) after each dose.
Received Moderna vaccines on 3/13/21, 4/10/21 Tested positive for COVID by PCR on 8/25/21 Admitted to ICU on 8/25/21, intubated. Medical comorbidities include alcoholic liver cirrhosis a/p TIPS (2020), Type 2 Diabetes COVID pneumonia, liver failure.
2ND DOSE PFIZER COVID 12+ WAS GIVEN TWO WEEKS FROM FIRST DOSE.
Chills, numbness, tingling from shoulders to hands (tip of fingers), swelling of lymph nodes  Symptoms are getting worse since Wednesday
After 2 days the client noted redness, swelling, "hives" at the site of injection. She complained of soreness and feeling stiff at site. When examined one week later the redness had subsided except for small area under site. Client feels symptoms are improving.
FATIGUE, HEADACHE, MUSCLE PAIN, JOINT PAIN, CHILLS, AND  FEVER. 10:00 AM  TO  06:00PM  THAN  FINE
First dose, I was just tired the next day; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 15:30 (Lot number: EN6199) at the age of 41 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "known allergies_Amoxicillin". The following information was reported: FATIGUE (non-serious) with onset 23Mar2021, outcome "not recovered", described as "First dose, I was just tired the next day". The event "first dose, i was just tired the next day" was evaluated at the emergency room visit. Therapeutic measures were not taken as a result of fatigue.  Additional information: It was reported that, the patient was not pregnant at the time of vaccination. The patient did not receive other vaccine in four weeks. The patient did not receive other medications in two weeks. No covid prior vaccination and no covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Upset stomach a few hours after injection. Next day Saturday  left arm sore at shot area, and continued upset stomach. Sunday night slight cramping in stomach. Monday AM Full blown cramping , afternoon 99.2 fever, chills, hands cold continued  severe cramping. Took Tylenol. Tuesday slight cramping from stomach to rectum, normal temp. Wednesday  slight cramping comes and goes. Feeling  much better.
6th day after  (April 1) - in the evening, inflamed lump behind my right knee, couldn't bend the knee, pain with walking. went away  by Fri. night. Saturday( April 3)  in morning my right hand swelled up and I couldn't open or close my hand, painful, aching. Couldn't hold anything. It didn't go away, so I went to my Dr. on Monday April 9, he prescribed   6-day  pak of MethylPrednisolone  4mg per tab. By the 2nd day the swelling was slowly going down. Now at the  6th day, the swelling  is gone and I can move my hand normally.
Chest Pain (Diagnosed as Pericarditis) (persistent-continuing as of November 13) Light-headedness (intermittent - occasional onsets as of November 13) Fatigue (persistent - continuing as of November 13) Treatments - Indomethacin and Colchicine
2 hrs after GARDASIL vaccine had overall skin numbness and tingling ("pins and needles") feeling lasting about 24 hrs before resolved, (-) rash (-) edema.
I started feeling symptoms 2 hours after, nausea dizziness and sore arm. Second night was horrible. Fever, chills, nausea, headache,  muscle pain, fatigue, swelling/ heat/ redness at the injection site and the worst joint pain ever. My wrists and ankles hurt the most and I was having a hard time walking. I felt like my entire body was full of inflammation. Sinus headaches, bronchitis like feeling in my lungs and constipation. night of day 6 was the first time I could eat without Zofran. Still feel fatigue and like my lungs are inflammed.
I'm pregnant, 20 weeks, and my baby is still kicking.; minor sore arm; This is a spontaneous report from a non-contactable consumer reporting for herself. A 27-year-old female patient received second dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 14May2021 at 15:00 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced minor sore arm on May2021, reporter added, "i'm pregnant, 20 weeks, and my baby is still kicking" on an unspecified date. The mother reported she was pregnant when she received BNT162B2.  The mother was due to deliver on 30Sep2021. Reporter stated "I had a VERY minor sore arm but kept it moving so the soreness eventually went away. Other than that I didn't have a reaction to the vaccine. I'm pregnant, 20 weeks, and my baby is still kicking." Outcome of minor sore arm was recovered on May2021. The outcome of I'm pregnant, 20 weeks, and my baby is still kicking was unknown. The patient received first dose of BNT162B2 on 23Apr2021. The patient was not diagnosed with Covid-19 prior to vaccination and has not been tested for Covid-19 since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from a healthcare worker refers to a unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with ROTATEQ (dose and Lot# not reported) which underwent supported temperature excursions. No adverse experiences were reported. This is one of several reports from the same source. Additional information has been requested.
administered an expired dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 23-year-old female patient who received HAV (Havrix) (batch number H4H53, expiry date 30-JAN-2023) for prophylaxis.   On 08-MAR-2023, the patient received Havrix. On 08-MAR-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: administered an expired dose). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 9-Mar-2023 The adverse event contains all reported information. The reporter gave consent for safety team follow-up. The reporter consented to follow-up. The patient received an expired dose of Havrix, which led to expired vaccine used.
Significant pain and some swelling in left wrist (same arm as injection) began about 8 hours post injection. Pain and swelling has remained for 4-5 days. No doctor visit has been scheduled as of this submission.
Change in taste (not loss of) in food, coffee, and alcohol.  Foggy sensation in head.  Increase in metabolism leading to being warm all the time ( no sweating).  Two weeks after second vaccine and while experiencing the above symptoms, I had sudden palpitations with a rapid ventricular response ( 186 beats per minute), severe light headedness, ambulance transport to hospital leading to admission for two days.  This has never happened to me or any family members before.  Discharged from hospital after 2 days in normal rhythm.  Also at this time, taste has returned to normal and foggy feeling has improved.
Patient received two doses of Fluzone HD in one year, No AE; Fluzone High dose instead of giving pneumonia vaccine, No AE; Initial information received on 17-Dec-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves patient who was vaccinated with a dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE]  this year and also received another dose of same in 2019 instead of PNEUMOCOCCAL VACCINE.  It was a actual medication error due to extra dose administered and wrong vaccine administered.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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.
I had no  adverse events at all until yesterday when the injection site became very slightly itchy and I rubbed it a little.  This produced a red blotchy spot.  Today it is twice the size of yesterday.  I did apply moisturizing cream to the site yesterday morning prior to it being red.
Pt recv vax on 10/29/98; on 10/30/98 pt exp swollen upper lip & hives on shoulders & forehead
This spontaneous report as received from an office administrator via company representative refers to a female patient of unknown age. On an unspecified date, the health care professional gave the patient with one of the expired ZOSTAVAX (lot number, expiry date, dose and route were not reported) before realizing it that it was expired. It was probably a couple weeks past the expiration date. No concomitant medications were reported. The patient was advised to come back and get another one but was wondering if that was necessary or if it would still be effective in protecting the patient. It was unspecified if the patient unspecified if the patient sought medical attention. Additional information has been requested.
Not feeling very well; Fever; pain on the arm where the vaccine was administered which has markedly increased in intensity over time; This spontaneous case was reported by a non-health professional and describes the occurrence of MALAISE (Not feeling very well), PYREXIA (Fever) and VACCINATION SITE PAIN (pain on the arm where the vaccine was administered which has markedly increased in intensity over time) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (Not feeling very well), PYREXIA (Fever) and VACCINATION SITE PAIN (pain on the arm where the vaccine was administered which has markedly increased in intensity over time). At the time of the report, MALAISE (Not feeling very well), PYREXIA (Fever) and VACCINATION SITE PAIN (pain on the arm where the vaccine was administered which has markedly increased in intensity over time) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. The patient reported that he experienced fever during the first two days after administration, also not feeling very well. Gradually, he began experiencing pain on the arm  where the vaccine was administered, which has markedly increased in intensity over time and is still ongoing. He took oxycontin and other unspecified pain medication but was screaming from pain as the pain pills were not helping him.
I had acute appendicitis begin on 03/22/2021. I drove to the urgent care several hours, around 7PM, after I felt acute pain and was referred to the ER. I arrived at the ER around 8pm. At that point, a CT scan was completed to confirm the dx of appendicitis around 930PM. I went into emergency surgery at 1130PM. As of this writing, I am still recovering.
I had chest pain for about five days after receiving my second dose of the vaccine. It felt like intense and sporadic heartburn. I went to the ER on the third day of experiencing the pain, during which they performed an EKG and bloodwork in order to determine whether or not it was a heart issue. There were no significant results and the pain subsided two days later.