chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt like crap; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 16-JUN-2023, the patient received Shingles vaccine. On 17-JUN-2023, 1 days after receiving Shingles vaccine, the patient experienced feeling abnormal (Verbatim: felt like crap). The outcome of the feeling abnormal was not reported.   It was unknown if the reporter considered the feeling abnormal to be related to Shingles vaccine.     It was unknown if the company considered the feeling abnormal to be related to Shingles vaccine.   Additional Information: GSK receipt date: 17-JUN-2023 This case was reported by a patient via interactive digital media. The follow-up could not be possible as no contact details were available.
Rash that has spread from my shoulders and neck to my back, chest,  trunk, calves, and forearms; My nose and cheeks are red; The rash itches and with scratching has become more inflamed in some spots; The rash itches and with scratching has become more inflamed in some spots; This is a spontaneous report received from non-contactable consumer, the patient. A 73-year-old elderly male received the first dose of BNT162b2 (solution for injection; Lot EL8982 expiry not provided) as a single dose via unspecified route in the right arm on 01Feb2021 at 08:30 (at 73-years-old) for COVID-19 immunisation. Relevant medical history included depression. Concomitant medications included unspecified multivitamin for seniors. The patient previously received mirtazapine and experienced an allergy. The patient denied receiving any other vaccination within four weeks prior to the COVID vaccine. The patient also denied being diagnosed with COVID prior to the vaccination. On 02Feb2021 at 07:00 the patient experienced a rash that spread from his shoulders and neck to his back, chest, trunk, calves and forearms. The patient stated his nose and cheeks are red. The patient also stated that the rash itches and with scratching has become more inflamed in some spots. There was no treatment received for the events. On 22Feb2021 at 08:45 the patient received his second dose of BNT162b2 (solution for injection; Lot EN6200 expiry not provided) as a single dose via unspecified route in the left arm for COVID-19 immunisation. The patient denied being tested for COVID since being vaccinated. The outcome of the events, rash that spread from his shoulders and neck to his back, chest, trunk, calves and forearms, nose and cheeks are red, and rash itches and with scratching has become more inflamed in some spots was not recovered.    No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with a dose of improperly stored ROTATEQ (lot # M042169, expiry date: 22-JUN-2018; lot # M044398, expiry date: 16-JUN-2018) (dosing regimen and frequency unknown) for prophylaxis. No adverse effects were reported. The temperature excursion was 9 degree C to 25 degree C for 1 hour 35 minutes. The temperature excursion was detected by digital data logger. No previous temperature excursions were reported. No product quality complaint (PQC) was involved. Lot number M044398 is an invalid lot number for ROTATEQ. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000705: US-009507513-1709USA000706: US-009507513-1709USA000707: US-009507513-1709USA000708: US-009507513-1709USA000667.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No medical history and concurrent conditions of the patient were reported. On 20-AUG-2015, the patient was vaccinated with improperly stored VARIVAX (Merck) (lot # L008270 and expiry date: 11-FEB-2017) (dose, route and site of administration was not reported) and no adverse experiences were reported. The outcome of incorrect product storage was unknown. No further information was provided. This is one of several cases reported by the same reporter. Additional information has been requested.
For over 2 weeks: Knuckle pain, trigger finger like symptoms, knee pain, knee radiating heat, tendon pain in knee
This morning around 9:30am, a staff from clinic came to pick up a pediatric Pfizer vial. I dispensed the adult Pfizer vial in error. I did not realize my mistake until my colleague alerted me to the incorrect LOT number on the log sheet in the afternoon. I immediately contacted my manager so that we can alert the clinic about the error. The staff from clinic confirmed that the dose was already given, however the LOT that he confirmed was the pediatric vial one. However, I double checked our log to verify the count on our end, and I found that we had 1 extra pediatric vial and 1 less adult Pfizer vial. I brought this to my manager's attention and we again called clinic and discovered that the prefilled labels are used when administering vaccine doses. We escalated the matter up the chain of command, and the clinic manager and patient will be notified about the dose that was given.   After discussion with (name) we were informed the Grey cap Pfizer vial was diluted with 1.3 mL NS prior to dose being drawn up. We believe the following dose was administered based on volume of drug in the vial and volume reconstituted:   Grey cap, NDC: 59267-1025. The vial is: 30 mcg/0.3 mL, 2.25 mL vial, including overfill (or 225 mcg/2.25 mL)    The vial was reconstituted with 1.3 mL based on RN report: 225 mcg/3.55 mL or 6.3 mcg/0.1 mL
This spontaneous report was received from a healthcare worker and refers to a 4 year old patient of unknown gender. The patient's concurrent conditions, past medical history were not reported. On 16-DEC-2015, the patient was vaccinated with an improperly stored M-M-R II (lot # K021151, expiry date 02-NOV-2016, dose, strength, vaccination site, dose number unspecified). Concomitant medications were not provided. No adverse effects were reported. Product quality complaint (PQC) was not reported. On 26-JAN-2016, a phone call was placed to the physician. The physician was unavailable at the time of call. The phone call was transferred to the Certified Medical Assistant (CMA). The C.M.A. was unable to place specific lot numbers for each of the reported vaccines that experienced a temperature excursion; M-M-R II, ROTATEQ and VAQTA, with the information already supplied for patient identifiers, date of birth and date of vaccination, at this time. The C.M.A will need to review the records. This is one of the several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 16-FEB-2017 at 08:21, the patient was vaccinated with improperly stored ZOSTAVAX injection (lot # M020902) ( expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA000237: US-009507513-1704USA000485: US-009507513-1704USA000486: US-009507513-1704USA000487: US-009507513-1704USA000488: US-009507513-1704USA000489: US-009507513-1704USA000491: US-009507513-1704USA000492: US-009507513-1704USA000493: US-009507513-1704USA000494: US-009507513-1704USA000495: US-009507513-1704USA000496: US-009507513-1704USA000497: US-009507513-1704USA000498: US-009507513-1704USA000499: US-009507513-1704USA000500: US-009507513-1704USA000501: US-009507513-1704USA000502: US-009507513-1704USA000503: US-009507513-1704USA000504: US-009507513-1704USA000505:
anaphylaxis ended up in the hospital; swelling of the throat; tingling; numbness; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (anaphylaxis ended up in the hospital), PHARYNGEAL SWELLING (swelling of the throat), PARAESTHESIA (tingling) and HYPOAESTHESIA (numbness) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced ANAPHYLACTIC REACTION (anaphylaxis ended up in the hospital) (seriousness criteria hospitalization and medically significant), PHARYNGEAL SWELLING (swelling of the throat) (seriousness criterion hospitalization), PARAESTHESIA (tingling) (seriousness criterion hospitalization) and HYPOAESTHESIA (numbness) (seriousness criterion hospitalization). At the time of the report, ANAPHYLACTIC REACTION (anaphylaxis ended up in the hospital), PHARYNGEAL SWELLING (swelling of the throat), PARAESTHESIA (tingling) and HYPOAESTHESIA (numbness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.  It was reported that patient was on late 20s.  Company Comment: This spontaneous case concerns a female patient in her late 20s, with no reported medical history, who experienced expected, serious (hospitalization and medically significant) event of anaphylactic reaction together with unexpected, serious (hospitalization) events of pharyngeal swelling, paraesthesia and hypoaesthesia, after receiving a dose of mRNA-1273 on an unknown date.  Hospitalization details including clinical course, concomitant medications, and treatment details were not reported.  The outcome of the events was unknown.  The benefit risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient in her late 20s, with no reported medical history, who experienced expected, serious (hospitalization and medically significant) event of anaphylactic reaction together with unexpected, serious (hospitalization) events of pharyngeal swelling, paraesthesia and hypoaesthesia, after receiving a dose of mRNA-1273 on an unknown date.  Hospitalization details including clinical course, concomitant medications, and treatment details were not reported.  The outcome of the events was unknown.  The benefit risk relationship of mRNA-1273 is not affected by this report.
Tremors lasting for 2 hrs; occured 12 hrs after dose was given and resolved; did not reoccur also had a sore left deltoid. Patient had no fever during tremors.
Patient had hypersens reaction to first dose of COVID-19 Pfizer vaccine. Patient became nauseous, rigors, dizzy, flushed, throat discomfort. Epi pen given x1, Zofran ODT given. IV placed. Patients symptoms persisted. Patient transferred to ED.
pt recv vax & the following day devel redness, swelling & warmth @ inj site; pt was treated w/ASA, DPH q 4 hr, & ice compresses @ the inj site;
Was talking with husband and commented that I felt a wave of tired coming over me. Immediately following the statement I was having difficulties speaking, slurred speech, and my body felt weighted. This lasted 2 minutes. This experience happened two more times so we left for the ER. Another episode happened while checking in the ER and they responded as if I was having a stroke. A 5th episode happened while in the ER waiting for a room and a 6th time after admission in the room with a nurse. This last episode was at 1:00pm on 3/5/2021. I could feel each of these coming on.
Patient fainted and unconscious less than 10 seconds.  Patient flushed and admitted she had not eaten since the am. No further treatment required.
t102 36 hrs p/vax large indurated area w/warmth @ site of vax; also exp myalgias/h/a, & stiffness in neck & has 4x5 cm mass-reactive lymph node in rx axilla;
patient is on around the clock tylenol and ibuprofen and reports a fever of 100.9 today 2/22/2021
Information has been received from a registered nurse concerning a 4 year old Caucasian female with no known allergies who on 10/08/1997 was vaccinated  with varicella virus vaccine live. Concomitant vaccination included a first dose of MMRII subcutaneously in the right arm on 10/08/1997. There was no illness at the time of vaccination. The registered nurse reported that on 05/14/2001, the pt developed  50+ lesions on the trunk, legs, and scalps and face and was diagnosed with chicken pox. In follow-up, the registered nurse reported that the pt developed "some macular and some vesicular lesions on face and trunks" the pt was treated with diphenhydramine hydrochloride (Benadryl) and calamine lotion for itching. The registered nurse reported that no other symptoms were present. The pt subsequently recovered. No further information is available.
Client  presented to vaccination site on 03/03/22. The client reported that she received a 1st dose of Pfizer COVID vaccine on 02/10/22. Client stated about 2 hours after receiving the Pfizer COVID vaccine she vomited, felt dizzy, weak, and had a severe headache. Client stated symptoms lasted through the night and resolved when she woke up the next morning. The client did eat before receiving the first dose and ate today. Client denied any other symptoms of anaphylaxis. Client did not follow up with any providers and did not take any medications for symptoms. Client denied any chronic medical conditions, medications, or allergies. Client has a history of a rash after taking Tylenol. Vitals taken by, EMT on 03/03/22 were BP 112/70, HR 96, and O2 98%.  RN submitted a medical consult via message to clinical project coordinators requesting to proceed with the Pfizer COVID vaccine. Per Dr., approval to proceed with Pfizer COVID vaccine was obtained from medical consult team via message from  clinical project coordinator. Client received Pfizer COVID vaccine, LOT#: FK9895 on 03/03/22 at 1038 by RN. The client did not report any symptoms during the 15 minute observation period.  RN educated client on possible adverse reactions and when to seek EMS. Client verbalized understanding. Client left vaccination site at 1100 unassisted and with a steady gait.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 22-MAY-2013, the patient was administered with a dose of VARIVAX (Merck) (Lot # 670799/0975AA, expiry date 17-JUN-2013) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Swelling, warmth, fever, nausea, chills,diagnosed on 10/19/2015 with cellulitis and treated with Keflex and prednisone.
Information has been received from a physician concerning an 17 year old female who on 02-JAN-2009 was vaccinated with the first dose of GARDASIL. Within a couple of hours the patient became dizzy. Eight hours later she experienced nausea and vomiting. She also had a rash that lasted 2 to 3 days. At the time of reporting, the patient recovered from the events. No further information is available.
Two months post vax, this pt developed chickenpox with approximately 80 lesions. Unspecified medical attention was sought.
Body went numb 5min after. Heart rate jumped to 165, had a weird taste, transported to ER, burning chest, chest pressure, stabbing chest pain. Head had pressure, head went numb, felt like I was dying. No history of reaction to vaccines or injections. Heart palpitations. Feet would go numb, very fatigued, extremely dizzy, blurred vision. Only a EKG was done which returned normal. Chills/ very hot as if I have a heating blanket  on. Feeing as if I had fiberglass in my throat. Some difficulty breathing. Feeling if an out of body experience as if everything was moving fast but slow at the same time. Pounding heart beat, numbness in stomach. Was discharged after EKG and told it was a anxiety attack.
8 doses given today after vial was punctured 30May2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (8 doses given today after vial was punctured 30May2021) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (8 doses given today after vial was punctured 30May2021). On 01-Jun-2021, EXPIRED PRODUCT ADMINISTERED (8 doses given today after vial was punctured 30May2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Vaccine was stored beyond its expiry date; Gave a vaccine that expired 06July2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave a vaccine that expired 06July2022) and PRODUCT STORAGE ERROR (Vaccine was stored beyond its expiry date) in a 20-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 046L21A) for COVID-19 prophylaxis. No Medical History information was reported. On 14-Jul-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Gave a vaccine that expired 06July2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored beyond its expiry date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Gave a vaccine that expired 06July2022) and PRODUCT STORAGE ERROR (Vaccine was stored beyond its expiry date) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medications was reported. The vial was initially stored in the refrigerator on 22-Jun-2022. The vial does not undergone any temperature excursions. No treatment medications was reported.
Patient received her 2nd COVID-19 pediatric vaccine. Within minutes, she started feeling lightheaded and color faded from her face. She sat outside the immunization room (where I am told she started convulsing with her eyes rolled back). Once I reached the patient, she already started to regain consciousness. At that point, she became clammy and started to vomit. She also stated her head was hurting and felt tired. I grabbed a cool damp cloth and applied it to her forehead. I got water for her to sip. The emergency team arrived and confirmed all vital signs were within normal range. Patient taken to the hospital where her mother said she received multiple tests.
This spontaneous report as received from a physician refers to an unknown number of patients of unknown ages and gender. On an unknown dates the patient may have received improperly stored VARIVAX (Merck) and PROQUAD (Merck) over an unspecified time frame that could have been up to a year. No adverse event were reported. Additional information has been requested.
Mother of pt called into MD's office on 5/30/01 to report pt had reaction to injection. Had injection at 16:00 and at approx. 19:30, had difficulty to breathe, hard time to take breath in. (Pt has history of allergy, but stated it wasn't that). Was light-headed. On 5/30/01, in the AM, pt vomited and had a headache. When parent reported it, it was 15:00 on 5/30/01. Per parent, pt is now better. No local reaction at injection site. Tolerated 2 other Hep-B vaccines, well.
Patient had some shortness of breath@ 10:30am , 10 minutes after receiving vaccination, pulse=88, blood pressure=118/80.  Patient rested on cot with feet elevated x 10 minutes and had 1 bottle of water, patient reports having come straight from working night shift and di not have much water while working, patient reported feeling better after 10 minutes, pulse=84, blood pressure =130/80 while sitting up at 10:45am, patient requests to go home and reported she no longer had any shortness of breath or other concerns at this time.  Patient left clinic at 10:55am.
experienced cough; phlegm; chest was squeezed; throat irritation; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on 05Mar2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, a 66-year-old patient received her first dose of COVID-19 vaccine from Pfizer-BioNTech today, a couple of hours ago (between 10:15 am and 12:00 pm local time). Patient have experienced cough, she have phlegm, she feel as if her chest was squeezed, throat irritation, the patient was constantly coughing and was hard for her to talk, after this call she was going to call her doctor. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Pt c/o "severe swelling" from shoulder to elbow "severe itching" localized to arm, arm felt "very hot", redness. Tx benadryl, naprosyn (prn) Augmentin 75mg B ?, Darvocet 1-2 po Q 4-6 hrs. Pt states only took the Augmentin.
I started having rectal bleeding - sign of an UC flare.  Had been in remission for ten plus years.  This began 2 days after my #2 Covid Vaccine.  I continue with the rectal bleeding and urgency today after several courses of both oral and rectal medications.
The patient was inadvertently injected with the Pfizer COVID19 vaccine, but he was supposed to receive Shingrix. There is no adverse reaction to report. The patient was dosed with the correct vaccine within 30 minutes. The patient was counseled about the incident by the immunizer.
Patient came in to get 1st dose of Adult COVID 19 Vaccine, Pfizer brand. The tech inject 0.3 ml pfizer syringe into right deltoid at - 6:08pm and the patient then got up and sat down in waiting area chair where he then fainted after sitting there for 1 minute at -6:10pm. Patient was on floor for 3-5 seconds and regained consciousness where he stated," what happened?" Medical professional asked him to stay on the floor and he wanted to sit on the chair  he cut his upper left eyebrown 1/4th inch and was bleeding a bit, aling with a cut 1/2 inch on upper left shoulder. He sat and applied pressure to eyebrow and bleeding stopped. He drank water and waited with medical professional for paramedics which arrive-6:18pm & took patient outside on stretcher.
This spontaneous report as received from a healthcare worker (also reported as CMA - certified medical assistant) refers to a patient of unknown age and gender. On 01-AUG-2012 the patient was vaccinated with first dose of RECOMBIVAX HB 10 mcg/ml, 1 ml, intramuscular, site of administration not reported). On 30-OCT-2013 the patient was vaccinated with second dose of RECOMBIVAX HB. No adverse events reported. Additional information has been requested.
2/9/21: 11:10 am - Received vaccination  2/9/21: 10:30 pm - Fatigue and chills  2/10/21: 5:45 am - Fatigue, body aches, chills, fever 99.6 2/10/21: 8:00 am - Fatigue, body aches, chills, fever 101.9 Symptoms lasted through 2/10/21.  2/11/21: asymptomatic except body aches