chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 3-month-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  (lot # S013439 with expiration date 03-MAR-2021, lot # S013436 with expiration date 30-JAN-2021, and lot # S006050 with expiration date 12-DEC-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 ml (route not provided) as prophylaxis. No adverse events were reported.  This is one of several reports received from the same reporter  This spontaneous report as received from a other health professional refers to a patient of unknown age.    On an unknown date the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S006050, 2 milliliter for prophylaxis.       On an unknown date the patient experienced product storage error and no adverse event.    The outcome of product storage error and no adverse event is unknown.   The reporter considered product storage error and no adverse event to be not assessed to Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ).     {Additional information has been requested. / Additional information is not expected.}; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004545: US-009507513-2005USA004950: US-009507513-2005USA004951: US-009507513-2005USA004952: US-009507513-2005USA004953: US-009507513-2005USA004954: US-009507513-2005USA004955: US-009507513-2005USA004956: US-009507513-2005USA004957: US-009507513-2005USA004958: US-009507513-2005USA004959: US-009507513-2005USA004960: US-009507513-2005USA004961: US-009507513-2005USA004962: US-009507513-2005USA004963: US-009507513-2005USA004964: US-009507513-2005USA004965: US-009507513-2005USA004966: US-009507513-2005USA004967: US-009507513-2005USA004968: US-009507513-2005USA004969: US-009507513-2005USA004970: US-009507513-2005USA004971: US-009507513-2005USA004972: US-009507513-2005USA004973: US-009507513-2005USA004974: US-009507513-2005USA004975: US-009507513-2005USA004976: US-009507513-2005USA004977: US-009507513-2005USA004978: US-009507513-2005USA004979: US-009507513-2005USA004980: US-009507513-2005USA004981: US-009507513-2005USA004982: US-009507513-2005USA004983: US-009507513-2005USA004984: US-009507513-2005USA004986: US-009507513-2005USA004987: US-009507513-2005USA004988: US-009507513-2005USA004989: US-009507513-2005USA004990: US-009507513-2005USA004991: US-009507513-2005USA004992: US-009507513-2005USA004993:
no additional AE; vaccine was administered after expiration; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 23-MAR-2022, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter, lot #1707572, expiration date: 11-MAR-2022, route of administration defaulted to oral (strength was not provided) for prophylaxis (expired product administered). No adverse events were reported.
On 05/20/21 patient began experiencing tingling and limited mobility in her left leg. On 5/25/21 her face began to droop.
Information has been received from a physician concerning a 14 year old female who on 15-JUN-2007 was vaccinated IM in the right upper arm with a 0.5 mL dose of Gardasil (lot #657006/0188U) and vaccinated in the left upper arm with a dose of MENACTRA.  On 16-JUN-2007, the patient developed a vesicular, itchy rash on the right arm.  The rash was described as "poison ivy-like" and spread to the other arm and then to her abdomen.  The patient contacted the physician's office and spoke to a nurse.  On approximately 20-JUN-2007, "4 or 5 days after onset of symptoms", the patient recovered.  Additional information has been requested.
didn't have any side effects with either one other than a sore arm.; hurt a lot than covid shot; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm and pain. On an unknown date, the outcome of the pain in arm and pain were unknown.   It was unknown if the reporter considered the pain in arm and pain to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR071660   Additional Information: GSK Receipt Date: 27-APR-2022  Reporter's comment: This case was reported by a patient via Interactive Digital Media. The patient did not have any side effects with either one other than a sore arm.  The shingles shot hurt a lot more than the Covid shot. Additional supportive information:  For tolerance of 2nd dose refer case US2022AMR071660. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR071660:same reporter
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 at 10:30 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in right 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), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "Latex sensitivity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Mar2023) Positive, notes: First Positive (home test) Wed 15Mar2023 am; (18Mar2023) Positive, notes: faint positive; (21Mar2023) Negative; (23Mar2023) Negative; (25Mar2023) Positive, notes: strongly. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Binax Result: Positive; Binax Result: Positive; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 at 15:15 as dose 3 (booster), single (Lot number: Gj3277) at the age of 48 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Dec2021 at 13:00 as dose 1, single (Lot number: Elo140), in right arm and on 12Jan2021 at 12:00 as dose 2 , single (Lot number: El0140), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATIVAN; CYMBALTA; LUNESTA. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Oct2022, outcome "not recovered" and all described as "Result: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Oct2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Follow up information has been requested; Sender's Comments: Based on the available information in the case, the causal association between the events "COVID-19', 'vaccination failure' and the suspect drug BNT162B2 cannot be excluded.
Assessment and Plan Patient is a 65 y.o. male patient of CNP with history of COPD, DM Type 2, obesity presented to Hospital with SOB, subsequently found to have COVID-19 infection   COVID PNA CXR: Mild patchy opacities within the lower chest Vaccinated with J&J Symptom onset: 11/09/2022 Tested positive: 11/11/2022 Baseline O2 requirement: 3L Current O2 requirement: 4L Anticipated end of isolation: 11/21/2022 On solumedrol due to COPD exacerbation, transition to oral prednisone, plan long taper 40 mg x 1 week, 30 mg x 1 week, 20 mg x 1 week, 10 mg x 1 week Completed PO Azithromycin during hospitalization due to COPD with increased sputum production   COPD Exacerbation Continue steroid and albuterol Had increased sputum production on presentation, completed course of azithromycin during hospitalization Continue supplemental O2, wean as tolerated   Paroxysmal A Fib with RVR Likely due to above Continue rate control with BB Resume Eliquis  Chronic heart failure with preserved ejection fraction Previous echo (5/13/2021) LVEF 50% ±5% Continue oral furosemide, BB, ACEi   Chronic Hypoxic Respiratory Failure Uses 3L of O2 at baseline, currently on 4 L Continue to maintain saturation >90%   DM Type 2 with Hyperglycemia Chronic Insulin use Continue ISS Lantus increased due to hyperglycemia from steroid use   OSA/OHS Morbid Obesity Resume BIPAP   Chronic Pain syndrome Resume Norco   BPH with Chronic indwelling foley  Last changed a week ago Continue to monitor
Pfizer-BioNTech COVID-19 Vaccine EUA Lymph node swelling  in left arm pit- side that vaccine was given.
Mother reports reaction from vaccine causing swelling, redness and rash to left upper arm requiring treatment by ER.  Prescribed Cephalexin 250mg 1.5 tsp twice a day for 10 days and Zyrtec syrup 1 tsp everday.
Patient returned to the pharmacy on 9/12/18 at 9:30am complaining of persisting pain and inflammation in her right arm where she received the PREVNAR vaccine. Feels like the pain is not improving. Explained to the patient that it was not common for her pain to still persist and not improve after 6 days. Notified patient that I would report the incident to my incident report system at pharmacy and our claims department. Also will notify her doctor of the adverse event. Patient stated she wanted to report the event to me so I could be aware of the incident and that she would visit her doctor's office if she doesn't feel better in the next couple of days.
Eczema all over her body; This case was reported by a consumer and described the occurrence of eczema in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th May 2021, the patient received the 1st dose of Shingrix. On 28th May 2021, 14 days after receiving Shingrix, the patient experienced eczema. On an unknown date, the outcome of the eczema was not recovered/not resolved.   It was unknown if the reporter considered the eczema to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient had received Shingrix in the left arm.and two weeks after vaccination, the patient developed eczema.   The patient had eczema all over her body and was told by her dermatologist that she will have it for the rest of her life.  The reporter stated that she did not plan on getting her second dose because of eczema. The reporter did not know the lot number or expiration date. The patient consented to follow-up and gave permission to contact dermatologist.
Within hours of the vaccine noted bruising and area has "fever", but with no induration or swelling noted.  Patient states that her arm is sore, but has good ROM
Patient received booster vaccination.  Patient was brought to ED with confusion.  Patient admitted to hospital with Covid, dehydration, and acute metabolic encephalopathy.
Approximately 24 hours post shot I experienced severe joint pain in most all joints.  Shortly after onset of joint pain experienced severe chills.  Those symptoms persisted for approximately 12 hours after which I continued to experience injection site pain, but began to experience pain with some numbness that radiated from the injection site distally down my arm and into my pinky and ring fingers on my left hand.  No other symptoms.  As of today the injection site pain persists as does the pain and numbness in my pinky and ring fingers, but I get the feeling that it is getting slightly worse.  The pain and slight numbness is present when I awake, but gets worse throughout the day.  Some evenings there is considerable discomfort.
The day after vaccination, patient developed arm soreness at injection site, headache, nausea, diarrhea, myalgias, chills, and fatigue.
I had Maderna,  At shot I got dizzy and sweaty, only lasted about 5 minutes, next day just itchy and soar, it gradually got more swollen, hard and red.  Nurse at work told me to complete this form.
Zostavax was inadvertantly administered instead of varicella vaccine. Patient has not reported any adverse signs or symptoms.
heart was palpitating like having a heart attack; heart was palpitating like having a heart attack; throwing up; very weak; her legs won't work; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient also received first dose of BNT162B2 (unknown lot number and expiration) on unspecified date for COVID-19 immunization. The patient experienced relatively severe reaction to the second dose. The patient mentioned that she couldn't get out of bed for 5 days, was throwing up, very weak, her legs won't work, and mentioned that her heart was palpitating like having a heart attack. The patient is feeling okay now. The patient is recovering from the events.   Information on the lot/batch number has been requested.
He has cancer treatment, and we were seeing the physician. He had a CAT scan with contrast and came home no problem on Saturday morning. on Sunday he seemed overall tired and stated he didn't feel well. I took his temperature, and it was 101 so I gave him Tylenol and the temp would come down to 100 but once the Tylenol wore off the temp would go back up. I kept giving him Tylenol because he had no other symptoms other than being tired. Couple of days later I called the Dr. to see if the CT scan with contrast would have an affect like this on this and they said no. He was going to work with the fever and taking Tylenol. This went on for a week and a half and started complaining about legs hurting really bad, no energy.  We went to the ER and his platelets were low, COVID test was negative. A week later checked blood again and platelets were back to normal. He was admitted on a Friday.  He was in the hospital for some time with fever.  They tried different antibiotics and then gave him Doxycycline antibiotic and it was effective, and the fever went away. Primary care said that he most likely was bit by a tick from before or recently.
patient complained of chest tightness/ respiratory (not cardiac/ angina type pain per client) c/o slightly light-headed but Los of consciousness, Deanies and radiating arm, jaw shoulder or neck pain.  Skin warm and dry to touch, color WNL  Pulse ox above 98%
no symptoms; a shipment of PNEUMOVAX 23 was due to be delivered on 2/26/2020 but was not delivered until 2/27/2020; This spontaneous initial report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided. This report concerned 1 patient and 1 combination product.      On 26-FEB-2020, the shipment of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (lot # S029542, expiration date 10-JUN-2021) was due to be delivered, but was not delivered until 27-FEB-2020. Consequently, the patient was vaccinated with a dose from a late shipment of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot # S029542, expiration date 10-JUN-2021 (dose, route of administration were not reported) for prophylaxis, on 04-MAR-2020. The patient experienced no symptoms.  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: S029542; expirationdate: 10-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; 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-009507513-2003USA005134: US-009507513-2003USA004890:
allergic reaction.  mouth lips tongue and throat swelling.  was still able to breathe and speak freely but lasted the entire day.  gums tingling all day.  (swelling was enough to smooth out upper lip wrinkles)
Rash on trunk; onset 8PM 19FEB91 p/immun rec'd earlier that afternoon itching; No fever, no convuls, no dysuria reported by mom;
After the vaccination, I experienced pain and tingling/numbness in upper arm radiating to under the arm. Throughout the day and into the night I had pain, redness, itching and swelling at injection site. The next day (21st) a hard lump developed under the skin where I had the  injection. I also had a headache and muscle aches. I didn't take any medication for the pain and discomfort as I was told it was beneficial to let the reactions occur without drug interaction or interference.
Shortness of breath, stomach issues, muscle aches and pain, headaches, rapid heart rate,  nausea, vision problems.
606 doses were given after expiration date; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (606 doses were given after expiration date) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  On 03-Nov-2021, the vial was placed in the refrigerator. The vial did not undergo any temperature excursion and the patient had no adverse event.  The reporter also said that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.  No treatment information was provided.   This case was linked to MOD-2022-491837 (Patient Link).
On 11JAN93 pt was seen @ ER due to a convuls, tonic, 2 min w/eyes rolling back; had low grade fever on 9 & 10JAN93;
Patient received 2nd dose over 60 days after 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 2nd dose over 60 days after 1st dose) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 2nd dose over 60 days after 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 2nd dose over 60 days after 1st dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Red arm down to elbow with itching that started the day after the vaccine and it lasted 3-4 days. Patient used hydrocortisone over the area. Patient also developed a fever.
Bexsero prescribed to a 61-year-old; This non-serious case was reported by a nurse via sales rep and described the occurrence of drug prescribing error in a 61-year-old patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced drug prescribing error (Verbatim: Bexsero prescribed to a 61-year-old). The outcome of the drug prescribing error 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: 30-Mar-2023 The sales representative reported on behalf of a nurse.  This was reported to first line specialist, no further details was provided, second line specialist forwarding details to safety per case notes. Callback attempt was made to nurse but she did not answer.  No further details were available. A patient without a spleen was prescribed Bexsero, which led to drug prescribing error.
FEVER, CHILLS, BODY ACHES, RED, WARM RASH AT INJECTION SITE, CELLULITIS OF R ARM.
Started feeling nausea and chills could not get warm. Lasted about 36 hours.
11:55 skin became warm, flushed & blotchy over entire body 5min p/vax given;12:00 T97.6 no improvement in condition;inj site pink;blotchy cash becoming raised;rash & redness;resp rate 37;
This spontaneous report as received from a medical assistant reports that some unspecified patients on an unspecified date may have received a pediatric 0.5mL RECOMBIVAX HB (lot number H011183, expiration date 31-JAN-2015; 0385AE, 08-NOV-2014) (dose, frequency and route not reported) that from 22-MAR-2013 to 26-MAR-2013 some vials of RECOMBIVAX HB had been exposed to 0 degrees Celsius for 96 hours and had developed a filmlike coating inside the vial. The medical assistant reported that some vials were clear, with cloudy sediment that resuspends, and that others were essentially clear, with the same resuspending sediment, but also appeared to be coated with a film-like substance. The solution was reported to be clear, and maybe thinner than expected. No adverse effects reported. A product quality complaint has been filed for appearance change of vaccine. This case is linked to MARRS # 1303USA013510, 1304USA000422, 1304USA001054. Additional information has been requested.