chrisvoncsefalvay/vaers-outcomes huggingface dataset:
other zoster-related conditions; herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 08-DEC-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). At the time of vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through the patient's healthcare provider that zoster vaccine live (ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced the patient to be vaccinated. Alternatively, on or about the same date, the patient's healthcare providers included but not limited to a healthcare provider, relied on the warning label affixed to the zoster vaccine live (ZOSTAVAX) vaccine, believed that it was effective in preventing shingles on a long-term or permanent basis that it did not carry any significant risks of adverse effects. On an unknown date, reported as subsequent to the inoculation, the patient was treated for herpes zoster and other zoster-related conditions. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffered ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles and ill-defined disorder were not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Patient expired on 1/12/2020 of unknown cause. Patient was found unresponsive next to his father in father's bed. Patient was pronounced dead in ER.
The patient initially presented to the ED on 10/7/21 with complaints of chest pain and SOB which was intermittent and present for 4 days. She also noted palpitations and increased heart rate .  Evaluation showed CT Chest with bilateral upper lobe segmental pulmonary emboli. Overall clot burden mild. No evidence of right heart strain.  D-Dimer elevated at 593 Pt was initially treated with Eliquis (apixaban).
This spontaneous case, initially received from other health professional (pharmacist) on 20-Sep-2018, concerns 40-year-old, adult female patient. The patient's historical condition included breast feeding. The patient had no concomitant medications. On 19-Sep-2018, the patient (underage of 65 years) was administered FLUAD (TIV) [dose: 0.5 ml, anatomical location: deltoid, batch number: 250785, expiry date: 30-Apr-2019 and route of administration: not reported] (explicitly coded as inappropriate age at vaccine administration). It was reported that the patient was given a wrong flu vaccine as the patient was supposed to be given a flu vaccine that was appropriate for a 40-year-old (explicitly coded as wrong vaccine administered). The patient did not experience any adverse event. The reporter assessed the case as non-serious. Follow-up received on 09-Oct-2018 from other health professional: It was reported that the patient had no known post-partum complications or disorder, therefore post-partum disorder was deleted from other relevant history. The patient did not experience any adverse event. The narrative was amended accordingly. Non-significant follow-up on 30-Oct-2018 from other health professional: It was clarified that 'gave wrong flu vaccine' meant that the patient was supposed to be given a flu vaccine that was appropriated for a 40-year-old, but instead gave the FLUAD. Narrative was amended accordingly.
No other AE; ROTATEQ was administered to patients after the excursion occurred; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 08-NOV-2021, the patient was vaccinated with dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 time dose, lot # 1742081, expiration date 18-JUL-2022 (exact dose, route of administration, anatomical location were not reported) for prophylaxis.  Administered dose of vaccine has been stored in the temperature of 35.0 degrees Fahrenheit (°F), 35.1 F, 35.3 F, 35.2 F, 34.9 F for 53 minutes (cumulative). There were no previous temperature excursions reported. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA001754: US-009507513-2112USA001755: US-009507513-2111USA004488:
Systemic: Dizziness / Lightheadness-Mild, Additional Details: Patient reported feeling dizzy/lightheaded approximately 5 minutes after administration of vaccine. Patient looked pale. 911 was called for assessment. Patient was assessed by paramedics. Patient reported feeling better and was not taken to emergency room. Patient stayed around pharmacy area for about 30-45 minutes after the paramedics left. Patient tried walking around to see how he felt and eventually left on his own.
confirmed case of mumps in an age-appropriately vaccinated student; Information has been received from a company representative referring to a child patient of unknown gender. Information about concurrent condition, concomitant medication, drug reactions/allergies and medical history was not provided.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route, lot# and expiration date were not reported) for prophylaxis.      On an unknown date, the patient experienced mumps (reported as a confirmed case of mumps in the age appropriately vaccinated student).  The outcome of mumps was unknown. The causality between the event and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported.
The patient was administered Hep B peds/adol dose instead of Hep B adult.
Developed generalized rash (erythema multiforme)within 10 days of getting immunizations, self limited, no treatment
Don't want to eat anymore; Stomach starts to hurt; Loss of appetite; Tired; Headache; Nausea; This spontaneous case was reported by a patient and describes the occurrence of EATING DISORDER (Don't want to eat anymore), ABDOMINAL PAIN UPPER (Stomach starts to hurt), DECREASED APPETITE (Loss of appetite), FATIGUE (Tired) and HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced EATING DISORDER (Don't want to eat anymore), ABDOMINAL PAIN UPPER (Stomach starts to hurt), DECREASED APPETITE (Loss of appetite), FATIGUE (Tired), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, EATING DISORDER (Don't want to eat anymore), ABDOMINAL PAIN UPPER (Stomach starts to hurt), DECREASED APPETITE (Loss of appetite), FATIGUE (Tired), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.            No concomitant medications were provided. No treatment details were provided.
After taste in mouth; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). This consumer reported similar events for two patients. This is 1st of two reports. A 68-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (age at vaccination 68-year) in Right Arm on 05Feb2021 15:00 as dose 1, single for COVID-19 immunization. Medical history included Meniere's disease from an unknown date and unknown if ongoing. Concomitant medications included Multi Vitamins; rosuvastatin calcium (CRESTOR); furosemide and sertraline taken for an unspecified indication, start and stop date were not reported. The patient was having no known allergies. As reported the patient was not tested COVID, prior and post vaccination. On 05Feb2021 15:30 the patient experienced after taste in mouth, strong immediately after vaccine. No treatment was received. The clinical outcome of the event was recovered on an unspecified date of 2021.  Information about lot/batch number has been requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021157099 Same reporter/drug/event, different patient
The patient reported to the vaccine administrator on 04/30/05 that following vaccine administration he became "very yellow" and did not want to take any further doses.  He did not make an attempt to report this event or seek medical treatment.
40 mins after receiving the vaccine the right side of my throat, ear, forehead and arm went numb.  The right site of my body started tingling. Burning , red, swollen and itching at the injecting site.. Area around injection site was the size of a softball  very painful, itchy, burning sensation, swollen,  and red.  I took Benadryl
I didn?t notice immediately, but afterwords, I begin to hear  ringing in my ears. Over the months, it?s gotten a lot worse. I recently contacted my Hearing professional, to see about the possibility of increasing my volume on my hearing aids. The tinnitus seems to be getting worse.
Moderate pain at injection site. for 3 days.  Injection site very swollen for 3 days. Very sleepy for 2 days. Swollen Neck Lymph node on left side of neck noticed  on Wednesday, February 18. Swelling much worse Thursday Februarys 19, late evening. Noticed bruising on lower stomach Thursday Feb. 19.  I have no income and no money to go to the doctor to have  these checked out. Do you know where I can get some money to  have my lymph node checked out and to have a blood platelet test?  Thank you. I might die from not getting the blood platelet test.
Allergic reaction Exposures: SHINGRIX 8/11/18 Rash: left shoulder onset day after injection. Itching: mild Pain: mild Throat swelling / difficulty breathing: no Wheezing: no Facial swelling: no Pain: mild Fever: no Mucous membrane involvement: no.
arm bothers her; This is a spontaneous report from a Pfizer-sponsored program A. contactable female consumer (patient) reported that a female patient of an unknown age received 1st doe of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unwon route on 10Apr2021 10:00 for Covid-19 immunization. Medica history and concomitant drug were not provided. She put ice on her arm and took paracetamol (TYLENOL) on "Saturday" because her arm bothers her until 11Apr2021 but she was okay a of 12Apr2021. Outcome of the event was resolved.    No follow-up attempts are needed. No further information is expected.
A PUNCTURED JANSSEN COVID-19 VACCINE VIAL WAS USED 40 MINS PAST ITS 6 HOURS TIME RANGE; POTENTIAL ADMINISTRATION ERROR EXPIRED JANSSEN COVID-19 VACCINE; This spontaneous report received from a pharmacist concerned a 65 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809 and expiry: 07-MAR-2022) dose was not reported, administered on 27-OCT-2021 15:45 for prophylactic vaccination. No concomitant medications were reported. On 27-OCT-2021, the patient experienced potential administration error expired janssen covid-19 vaccine. On an unspecified date, the patient experienced a punctured janssen covid-19 vaccine vial was used 40 mins past its 6 hours time range. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the potential administration error expired janssen covid-19 vaccine and a punctured janssencovid-19 vaccine vial was used 40 mins past its 6 hours time range was not reported. This report was non-serious.
PT VACCINATED IN OUR CLINIC ON 7/13/06. PT RETURNED HOME AND STARTED TO EXPERIENCE SWELLING OF THE MOUTH AND FEELING OF A CLOSING AIRWAY. PT WENT TO THE ER AND WAS TX'D ON 3 VISITS AND RELEASED FROM THE HOSPITAL YESTERDAY 7/23/06. PT CALLED CLINIC AND SPOKE WITH NURSE TO LET HER KNOW THAT THE REACTION OCCURRED. PT WAS TOLD TO RETURN TO THE ER TO BE REEVALUATED DUE TO PROLONGED FEELING OF AIRWAY CLOSURE.
Client reports shortly after the shot, it is hard to pinpoint when it started a knot came up on (L) arm where the injection went in and had some swelling. It gradually kept getting worse. I can't lift my (L) arm up and I can't put it behind my back (to fasten my bra). Reports soreness after flu shot. States pain shoots down her (L) arm. States went to her doctor and he recommended sports medicine. Client states.
Immediately after vac developed a burning & tightness in throat, wheezing & salivation. To ER treated for anaphylaxis w/ Epinephrine & diphenhydramine & unspecified steroids. Symptoms resolved w/in 1-2 hrs. MD felt condition due to vax.
Patient developed palpable purpura and joint swelling consistent with IgA vasculitis (formerly known as Henoch Schonlein Pupura). No treatment required. He will require weekly follow up to assess blood pressure and development of proteinuria to screen for renal involvment
Patient experienced irregular (fast) heartbeats around 6 months ago. Seemed to resolve, then started again 1 week after 1st COVID vaccination.
I was fine for a couple of days and as my husband was healing I was asking if his arm hurt and his was fine and mine just hurt. I went to the Doctor because I'm anemic and I couldn't get up that night off of the couch and I had to get a b12 shot and my arm locked. They said they couldn't give me shot because of my arm and they had to send me to ER and they determined it was due to vaccine and they injected it into the wrong area of arm that caused frozen shoulder and my shoulder locked and I'm in constant pain. I went to physical therapy and Dr. told me they think it's due to shot and they injected the vaccine into a calcium deposit in arm. Now my arm is sore with frozen shoulder and I've had two cortisone shots and it doesn't seem to be helping. After a year I might have to have surgery. I can't even sleep on that arm anymore. Now I can't use my arm. I don't think I had reaction from actual vaccine but the way it was administered.
My left arm where the injection was had swollen three times the normal size; Swelling; Dizzy; I used cold compress to stop itching and swelling; Lymphadenopathy; Arm Pain; Vomiting; Headache; Diarrhea; Muscle pain; Joint Pain; Nausea; Rash at the injection site; rash on the arm; Fever of 99.9; Fever of 101; This is a spontaneous report from a Contactable Consumer reported for self. This 52-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in Arm Left on 28Jun2021 17:00 at the age of 52-year-old as DOSE 1, SINGLE for covid-19 immunisation. Medical history included COVID. Concomitant medication included hormone medication, It is Best 3 milligram, T 2 Milligram topical cream (Name not confirmed hence not captured in tab) and taking Progesterone 200mg. She felt great for 12 hours, like 5 O' Clock the next day (29Jun2021 5:00) left arm where the injection was had swollen three times the normal size. She had started getting a fever of 99.9 (29Jun2021) and she started getting dizzy, nausea, vomiting and diarrhea. It persisted for 14 days, the swelling on 29Jun2021, the headache, the muscle pain, the joint pain, the fever of 101 and the rash at the injection site and the lymph node, lymphadenopathy, diarrhea, vomiting and arm pain on 29Jun2021. So, every side effect that was documented as a side effect, had a rash on the arm that look like a flower and its incitingly. Treatment included took Benadryl to stop swelling but don't know if it helped, it took 4 days for the swelling to stop and used cold compress to stop itching and swelling. Lab data included had a full hormone panel and CBC Diffs (Unclear and not clarified) test were normal. Cholesterol and sugar were great, everything was great, except hormone. Outcome of the event Arm Pain, Lymphadenopathy, Rash at the injection site; rash on the arm, Joint Pain, Muscle pain, Headache, Diarrhea, Vomiting, Fever of 99.9; Fever of 101, Swelling was recovered in Jul2021. Outcome of other events was unknown.  Information on the lot/batch number has been requested.
Tinnitus in Right ear became much louder within 24 hours of vaccine One week after vaccine I developed a rash around the vaccine location.  It is mostly gone 3 weeks later.
pt reported tongue swelling 10mins after receiving vaccination. He reports this happened after his first dose as well (but was not reported to healthcare facility). Vitals were WNL, attending provider assessed, 50mg PO benadryl given.
shingles; Information has been received regarding a case in litigation. It referred to a female patient (pt) of unknown age. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.      On an unknown date in 2015, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) as prescribed and/or administered by a healthcare provider, for the long-term prevention of shingles and/or zoster-related conditions (strength, route, frequency, lot/batch # and expiration date were not reported).         Subsequent to the zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a physician for shingles (herpes zoster) and was hospitalized due to it (dates not reported). It was reported that the pt would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.  The outcome of herpes zoster was not reported.   The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
2 days post. site of MCV4 injection became red, itchy, tender and warm to touch. Red area 7 cm x 5 cm and irregular in shape. Diarrhea 1 day post injection also c/o headache.
Patient fainted after Hep A given. Initially quite pale and shaky, but improved within 10 mins. MD had patient lay down on exam table, cool drink of water and cool washcloth for her head. BP 104/70 HR 72 after Hep A prior to Hep A 124/73 HR 72.
Immediately upon being injected, my right arm began to bleed.  Almost immediately I began to experience extreme pain radiating from the injection sight, down my arm  to my elbow, up to my shoulder and across my back, right to left.  The pain was not "injection sight"pain.  I had very limited range of motion in my right arm. The pain was so severe I had to go to my doctor's office and have him prescribe pain meds.  Over the counter pain meds did nothing.  Here we are, 2 1/2 months later and I still have limited motion in my right arm and pain. I believe I have developed SIRVA.
This spontaneous report was received from a license vocational nurse refers to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patients were vaccinated with an unspecified doses of GARDASIL 9 lot # L016428 and expiration date 30-JUL-2017, (route of administration an anatomical location were not reported), which were exposed to temperatures outside of the recommended range. No adverse experience has been reported. There was no product quality issue involved. This is one of several cases from the same reporter. Additional information has been requested.
Vaccines were kept frozen until they are ready for administration means they would be in fridge about 1-3 days; administered moderna vaccines beyond the use date and/or expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered moderna vaccines beyond the use date and/or expired) and PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration means they would be in fridge about 1-3 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered moderna vaccines beyond the use date and/or expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration means they would be in fridge about 1-3 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered moderna vaccines beyond the use date and/or expired) and PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration means they would be in fridge about 1-3 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Vaccines were kept frozen until they were ready for administration which meant they would be in the fridge about 1 to 3 days. They tend to store 1 to 3 bottles in the fridge to thaw out and was ready for the patients when needed. At worst case scenario they would have been in the fridge for about week if no one came in to be vaccinated.  No treatment information was reported.
A non-serious spontaneous report of "received expired product" was received from a health professional concerning a 14-year-old male patient, subsequent to FLUMIST.  Neither relevant medical history nor concomitant medications have been reported. The product expired on 02-Feb-2010. The patient received the expired FLUMIST on 03-Feb-2010. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Initial unsolicited report received from a Pfizer via nurse via consumer on 08 Feb 2017. Manufacturer report number: 2016547894. This case involves a female patient (age not reported), who was vaccinated with dose of TETANUS TOXOID (Unspecified) (batch number, expiry date, dose, route and site was not reported) on an unspecified date. The patient's ongoing illness, medical history, risk factors and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient was allergic to tetanus. The patient's laboratory data and corrective treatment was not reported. The outcome of the event was not reported. List of documents held by sender: none.
Fever, chills, racing heartbeat, headache, muscle pain, weakness, diarrhea, muscle and joint pain.