chrisvoncsefalvay/vaers-outcomes huggingface dataset:
MODERNA VACCINE THAT WAS OPENED ON 7/27/21 AND NOT DISCARDED WAS USED FOR THE FIRST VACCINATION IN ERROR.  UNKNOWN IF ANY ADVERSE EFFECTS
Pt received vaccination on 2/27/2021 and noticed lymph node swelling and pain on 03/04/2021, then presented to the Urgent Care on 03/05/2021
Day of vaccination: 9:15 pm - experienced chills and inability to sleep. Next Day: 1:00 am - chills and fever of 100.3 F. Blood pressure measured by wrist cuff device 225/100 (normally 130/80). Heart Rate 110 BPM (normally 70). SpO2 92% (normally 98). Paced in the house for 2 minutes and Sp02 was at 95%. Continued monitoring vitals. 3:00 am - Blood pressure at 145/90, Temperature at 99.3 F. Still experiencing chills. 4:00 am - Finally able to sleep. 10:00 am - Woke up, all vitals normal. Occasional Chills. Took a sick day from work. 3:00 pm - Felt better for the rest of the day. 2 days after vaccination 8:00 am - alternating chills and sweating. Temperature seemed normal. Took a sick day from work. 5:00 pm - no further symptoms.
Large, red, painful, lumps on left arm into axillary area, states arm very painful and swollen, shirt sleeve tight, noted diarrhea as well. Denies fever, denies SOB. Pt advised use Tylenol, cold pack and Benedryl or visit local ER for further eval and treatment.
This spontaneous report as received from a nurse refers to a 5 months 27 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 9dose and strength unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
BCG-itis; Literature Report:   Information has been received from the authors of a published literature article, titled as stated above, regarding a male patient of unknown age who was part of the authors' retrospective study aiming to identify the molecular basis of a syndromic form of severe combined immunodeficiency (SCID) and to perform genomic, molecular, biochemical, structural modeling, and in vitro disease modeling studies to analyze deleterious effects of the PAX1 variants identified.  The patient's medical history included allogeneic hematopoietic stem cell transplantation. Concurrent conditions included combined immunodeficiency (SCID), otofaciocervical syndrome type 2, fail to attain T cell reconstitution, PAX1 gene variation, born to consanguineous parents, severe bilateral microtia, postauricular sinuses, and micrognathia. He suffered from chronic diarrhea, recurrent respiratory infections, exfoliative dermatitis, and lymphadenopathy.   Un an unknown date the patient was vaccinated with a dose of BCG vaccine (manufacturer unknown) (route, and dosage information was not provided) for prophylaxis.  On an unknown date, the patient experienced regional dissemination of Bacille Calmette-Guerin (BCG-itis),   The outcome of the adverse event was unknown.  However, the authors reported that the patient died at 1 year of age.    Upon internal review, disseminated Bacillus Calmette-Guerin infection was considered to be a medically significant event.   A copy of the published article is attached as further documentation of the patient's experience.  This is one of two reports from the same literature article (case no. 2305USA009605). ; Sender's Comments:  US-009507513-2305USA009605:
Low grade fever, bodyaches, fatigue, injection site pain, severe stabbing pain left axilla area
Case number PHEH2014US016193, is an initial spontaneous report from a nurse received on 11 Aug 2014. This report refers to a 17-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. He was administered MenA powder component of MENVEO (batch number: A14023) reconstituted with sterile water instead of Men-CYW-135, intramuscularly on 11 Aug 2014. No adverse event was reported following the administration error (wrong solution used in drug reconstitution).
Entire right leg has swollen up and is very red.  Child complains frequently that it hurts.  The leg is very hot to the touch.  Bruising appears around the injection site.  Child has been given ice packs to reduce swelling and burning sensation and Tylenol for the pain.
delayed cutaneous hypersensitivity - aka COVID Arm. Red rash at injection site with radius of 1 inch, hot to the touch, occasional hot flashes continuing 2.5 days after second vaccination, began 36 hours after second vaccination.
This spontaneous report was received from a pharmacy technician and refers to an unspecified amount of unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. The patients were vaccinated with an improperly stored dose of RECOMBIVAX HB lot # N009802, expiration date 19-DEC-2019, intramuscularly (strength and dose were not reported) for prophylaxis from a time period starting 28-AUG-2017 until 07-SEP-2017. The administered doses of the vaccine experienced a temperature excursion of 47° Fahrenheit to 77° Fahrenheit (48F) for time frame of 30 minutes. There was no previous temperature excursion and no data logger. No adverse effects were reported.
improperly stored vaccine; This spontaneous report was received from a medical student referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.  On 03-JAN-2022, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) (strength, dose and route of administration were not provided; lot #T034380, expiration date not reported, but upon internal validation established as 08-JAN-2022) for prophylaxis (product storage error). The administered dose of the vaccine experienced a temperature excursion in 66.66 Fahrenheit degrees (F) for 14 hours and 30 minutes. There were multiple previous temperature excursions.
Severe pain in L deltoid, nausea, H/A, fatigue, weakness, generalized achiness
there is about 4 to 5 spots about a quarter size on his left forearm; it does itch; a rash appearing on his left arm where he got the initial shot; It is raised little bumps; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (there is about 4 to 5 spots about a quarter size on his left forearm), VACCINATION SITE PRURITUS (it does itch), VACCINATION SITE RASH (a rash appearing on his left arm where he got the initial shot) and VACCINATION SITE SWELLING (It is raised little bumps) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH MACULAR (there is about 4 to 5 spots about a quarter size on his left forearm), VACCINATION SITE PRURITUS (it does itch), VACCINATION SITE RASH (a rash appearing on his left arm where he got the initial shot) and VACCINATION SITE SWELLING (It is raised little bumps). The patient was treated with ALOE VERA (topical) for Vaccination site irritation, at a dose of UNK doage form and CAMPHOR, PHENOL (CAMPHO-PHENIQUE) for Vaccination site irritation, at a dose of UNK dosage form. At the time of the report, RASH MACULAR (there is about 4 to 5 spots about a quarter size on his left forearm), VACCINATION SITE PRURITUS (it does itch), VACCINATION SITE RASH (a rash appearing on his left arm where he got the initial shot) and VACCINATION SITE SWELLING (It is raised little bumps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
This case was considered medically important. Information regarding PREVNAR was received from a physician regarding a 3-month-old female patient who experienced "Staph pneumonia." At 2 months of age, the patient received a dose in Jul-2007. Relevant medical history was not provided. Indication for PREVNAR was immunisation. Product was administered in Jul-2007. Dose regimen was 0.5 mL 1 time per day (intramuscular). Concomitant medications were not reported. The patient experienced "Staph pneumonia" (drug ineffective) in Aug-2007. Staphylococcal pneumonia resolved. No additional information was available at the time of this report.
evidence of endothelial inflammation and anterior chamber cells and KP on endothelium; evidence of endothelial inflammation and anterior chamber cells and KP on endothelium; evidence of endothelial inflammation and anterior chamber cells and KP on endothelium; This is a spontaneous report from a contactable physician. A 62-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK9231), via an unspecified route of administration on 18Jan2021 at single dose for covid-19 immunisation. Medical history included diabetes and graft was 2.5 years old, partial thickness transplant (deep anterior lamellar keratoplasty) for treatment of keratoconus. Concomitant medication included trazodone, rosuvastatin calcium (CRESTOR), zolpidem tartrate (AMBIEN), gabapentin, metformin. No COVID prior vaccination. Known allergies: Buspar. The patient previously received first dose of bnt162b2 on 28Dec2020 for COVID-19 immunization and experienced Cornea transplant rejection and inflammation/subepithelial infilatrates noted 1 week after the first vaccine. No other vaccine in four weeks. The patient experienced after 2nd vaccine, evidence of endothelial inflammation and anterior chamber cells and KP on endothelium. Clinical course reported as: Cornea transplant rejection. Graft was 2.5 years old. Partial thickness transplant (deep anterior lamellar keratoplasty) for treatment of keratoconus. Signs of inflammation noted one week after each vaccine. Subepithelial infilatrates noted 1 week after the first vaccine. Resolved with Pred Forte. However, after 2nd vaccine, evidence of endothelial inflammation and anterior chamber cells and KP on endothelium noted on follow-up examination. Placed on stronger topical steroid with Durezol. Patient asymptomatic during entire process and this was found on routine follow-up exam and not because patient noted any symptoms. Vision not affected. Outcome of events was recovering. The doctor's office appointment was a routine appointment unrelated to receiving the vaccine. The temporal relationship with the COVID vaccine was reconstructed by the patient afterwards after thinking about it in retrospect. No COVID tested post vaccination.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
miscarriage; pregnant patient received BNT162B2; pregnant patient received BNT162B2; This is a spontaneous report from a non-contactable consumer. This consumer (patient) that a 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: en6201) at the age of 34-years, via an unspecified route of administration on 20Feb2021 at single dose for COVID-19 immunisation. Medical history was not reported. Patient was pregnant at time of vaccination, last menstrual date was 21Jan2021. No other vaccine in four weeks, no COVID-19 prior vaccination. Concomitant medication included ustekinumab (STELARA). The patient experienced miscarriage on an unspecified date (on 03Feb2021, as reported). The pregnant patient received BNT162B2 on 20Feb2021. No COVID-19 tested post vaccination. Outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021238716 Same product and AE , different patient
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 24May2022 as dose 4 (booster), single (Lot number: Ff2590) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: FLOMAX [TAMSULOSIN HYDROCHLORIDE]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive, notes: indication=Treatment of COVID-19; (unspecified date) Positive, notes: COVID rebound. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: patient had a Covid-19 rebound (cold-like symptoms, running nose, headache, sneezing, fever, cough) on 03Oct2022 after treatment with Paxlovid from 17Sep2022 (as reported).
Morbiliform itchy rash on dorsum of forearms/hands starting approx. one week after Pfizer booster shot.
Pt here for Johnson and Johnson vaccine, c/o ?faintness? at approximately 1520, a few minutes after vaccination, presented with pallor. No LOC noted. PT denies s/s beyond feeling of faintness. At 1520, BP sitting was 88/60, HR was 88, RR was 18, SPO2 was 99% on RA. PT accepted juice, water, transferred herself to cot requiring minimal assistance and laid with feet elevated. PT reports that she ?feels better? laying. Pt reports a history of similar responses after blood draws. VS at 1530: BP 100/60 laying, HR 60, SPO2 98% RA. At 1532, PT sat at edge of cot without difficulty, pallor greatly improved. VS at 1532 were: 102/68 sitting, HR 62, Spo2 99% RA. PT reports she fee?s ?97% better?. At 1537, PT is able to stand without difficulty, transfers from cot to chair without requiring assistance. PT reports that her baseline BP is typically ?low?. PT educated on vasovagal responses, verbalized understanding. At 1544, BP is 104/70 standing, HR 58, SPO2 99% RA, PT is able to stand and says she feels ?normalish?. At 1549, PT is walking without difficulty, reports she is at baseline, and that she feels ready to exit. VS at 1549: BP 104/62 standing, HR 56, SPO2 99%RA. Color is improved and PT denies further concerns. PT exited facility accompanied by friend at 1553.
COVID 19 Treatment; COVID 19 Treatment; Dose 1: Pfizer BioNTech, Dose 2: Pfizer BioNTech, Dose 3: Moderna; 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 23Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 28May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 44 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Connective tissues disorder" (unspecified if ongoing); "mast cell disorder" (unspecified if ongoing); "history of spontaneous cerebrospinal fluid leak" (unspecified if ongoing); "asthma" (unspecified if ongoing); "Pots" (unspecified if ongoing); "tachycardia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Fibrin glue, reaction(s): "Known allergies: Fibrin glue"; Paxlovid for COVID-19, reaction(s): "Paxlovid rebound". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Oct2022, outcome "not recovered", described as "Dose 1: Pfizer BioNTech, Dose 2: Pfizer BioNTech, Dose 3: Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid.  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 59 year old female patient with penicillin and AVELOX allergy. The patient was not pregnant. On 23-AUG-2013, the patient was vaccinated with ZOSTAVAX injection (lot # J001698; Exp. date: 08-MAY-2014) (route and dose not provided). On 25-AUG-2013, 2 days after administration, the patient reported a redness appearing at and around the injection site. The red rash was not raised and did not hurt or itch. The reporter commented that a 4" length and shape was similar to that of the band-aid which had been used to cover up the injection site. No treatment was given. At the time of the report, the outcome of the events was reported as recovering. Additional information has been requested.
Hospitalization for Sepsis due to left lower lobe pneumonia on dates 7/29/2023-7/31/2023. Treated with dexamethasone, baricitinib, Remdesivir, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
swelling and redness at or near the elbow after receiving the Pfizer-BioNTech Covid 19 Vaccine (gray cap); swelling and redness at or near the elbow after receiving the Pfizer-BioNTech Covid 19 Vaccine (gray cap); This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: JOINT SWELLING (non-serious), ERYTHEMA (non-serious), outcome "unknown" and all described as "swelling and redness at or near the elbow after receiving the Pfizer-BioNTech Covid 19 Vaccine (gray cap)".  Additional Information: Anatomical Site of Vaccination was reported as deltoid muscle. Patient had swelling and redness near her elbow after receiving the Pfizer-BioNTech Covid 19 Vaccine (gray cap). She wanted to know the incidence of the Adverse Events for patients who are 60 years and older. Patient had swelling and redness at the elbow. Reporter just knew the NDC, it was the grey cap one, the middle of the NDC was 1025.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
could not sleep; tender to touch at site of injection / intense pain at site of injection; generalized body aches; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 6th October 2020, less than a day after receiving Shingrix, the patient experienced injection site pain and general body pain. On 20th October 2020, the patient experienced difficulty sleeping. On 12th October 2020, the outcome of the general body pain was recovered/resolved. On an unknown date, the outcome of the injection site pain and difficulty sleeping were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, general body pain and difficulty sleeping to be related to Shingrix.  Additional details were provided as follows: The reporter called to request information about the adverse reaction experienced by the patient. After the administration of Shingrix in unknown deltoid, the symptoms appeared soon and it was tender to touch at site of injection and then generalized body aches began. First set of symptoms recovered after a few days, number of days was unspecified (presumed to be less than a week by agent). The tenderness at injection site and generalized body aches were recovered on 12th October 2020. Two weeks after the injection, an intense pain at site of injection presented, specially at night and patient could not sleep due to this since it intensified at night. By the description of the patient, reporter compared it to muscle pain like an aching throb. The reporter consented to follow up. The reporter could not specify side of site of injection at the moment of reporting.
Patient developed fever, fatigue, irritability, sore throat, nasal congestion, diarrhea and vomiting two days post-vaccination. She was brought in for medical care and the doctor thought the child had H1N1 infection although she was never tested.
Pain and swelling in her left upper arm at the injection site; Pain and swelling in her left upper arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Pain and swelling in her left upper arm at the injection site) and VACCINATION SITE PAIN (Pain and swelling in her left upper arm at the injection site) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol. Concomitant products included FUROSEMIDE and LISINOPRIL for an unknown indication.   On 25-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Pain and swelling in her left upper arm at the injection site) and VACCINATION SITE PAIN (Pain and swelling in her left upper arm at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (Pain and swelling in her left upper arm at the injection site) and VACCINATION SITE PAIN (Pain and swelling in her left upper arm at the injection site) outcome was unknown.            Relevant concomitant medications also included cholesterol pills (she did not provide name). Action taken with mRNA-1273 in response to the events was not applicable.
I started not feeling well the Saturday after the vaccine . I just had some sniffles and I was tired. But I have chronic allergies so at first I thought it was that. That afternoon I started by throwing up. And within an hour and a half I had a temperature of 100 and aching so bad I had to beg my husband to take me to urgent care. My 7 o?clock we were at urgent care and I was diagnosed with Covid. By then I was totally sick to my stomach with vomiting and diarrhea. Headache chills
I have been experiencing pain and loss of mobility because of pain. It has become worse as weeks have passed. I went to the doctor and was put on prednisone for seven days and meloxicam. The steroid did not help. I am not able to use my right arm to perform most daily tasks, such as scrubbing, carrying anything very heavy, reaching up or reaching around. I believe this is a brachial plexus injury. I am trying to get into my PCP for further treatment/referral to a neurologist.
Per mom, patient woke up the next morning w/ a red rash that extended from his left thigh above the injection site to the left shoulder.