chrisvoncsefalvay/vaers-outcomes huggingface dataset:
62 YOM who had his first shingrix vaccine 2 months ago (8/13/2020). The following day developed hearing loss in his right ear which recovered after 3 days. He has normal hearing now.
Patient experienced chills, low grade fever and injection site discomfort. Patient took Tylenol. Patient died 37-38 hours after receiving vaccine.
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 12-month-old patient of unknown gender. On 12-JUN-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N031492 (expiration date 02-MAY-2020) and a dose of VARIVAX lot number N021720 (expiration date: 10-AUG-2019) (doses, routes and anatomical locations of administration were not provided for both vaccines) for prophylaxis. This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Patient c/o fever 101 degrees to 104 degrees starting 2 days after vaccination and lasting 5 days. C/o herpetic outbreak from chin to inside nostrils covering chin, mouth and nose. Continues coughing today and verbalizes slight improvement with herpetic outbreak.
(Adverse reaction) vesicles in (R) shoulder at the site of vaccine. When the pt was ready to go to ER the patient started to have abdominal pain.
This case was reported by a physician and described the occurrence of allergic skin reaction in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced allergic skin reaction. On an unknown date, the outcome of the allergic skin reaction was unknown. It was unknown if the reporter considered the allergic skin reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the SHINGRIX vaccine and developed a topical allergic reaction. The patient had photos of allergic reaction and was ready to provide them. This case has been linked with US2018GSK093091, reported by the same reporter.
immed burning pain rt deltoid;devel swelling, erythema, & itching w/in 1hr;
81 year old lady with PMH on HTN, DM per reports. Patient is AOx3 on exam, however her history is poor. She states she is here just because she needs to be checked up on. Says she is weak but says this is a chronic issue. Per reports, her family normally helps her out, however they have been unable to due to COVID infections. She was checked on today, found to be in bed covered in urine, feces, food, and leaning to the right. Due to a concern for a stroke she was brought to the ED. She reports no fevers, chills, ShOB, says she has had some cough from time to time that is productive of sputum. no chest pain, palpitations, no nausea, vomiting, swelling. She has constipation. no dysuria but she does have incontinence. Says her legs are weak, says they have been weak for a while, not getting around well on her own. Spoke with daughter on the phone. The patient lives with her daughter and their family who all have COVID. She states that she has been getting weaker over the past month, that she has had to help her get out of chair and to the bathroom, and she can use the bathroom on her own. The patient does not allow the patient's husband to help her too much. When her daughter was self quarantining for COVID, the patient would not allow the husband to take care of her, and due to this, she has just been sitting in chair and not doing anything for a few days. They have been trying to get her in some sort of facility, and had a home health nurse come in and evaluate her, and at that time the nurse was concerned for a stroke, thus she was brought into the ED.  On arrival, patient temperature 97.2°, heart rate 101, blood pressure 149/81. Her labs are relatively unremarkable save for a glucose of 131. UA negative. COVID+ in the ED. CXR without acute disease. CTs of the head without acute hemorrhage, does have atrophy and chronic small vessel disease, CTA of the head without any significant carotid, vertebral artery issues, does have an enlarged thyroid, does also show a PE withing the right main pulmonary artery and proximal right lower lobe segmental pulmonary arteries.  PT IS INPATIENT AT THIS TIME.
Flared up rhumatism and muscle disease. Muscles swollen and achy, still snd hard to move. Chills. Site of injection swollen sore and the impression on bandaid on arm. Told to take mefication dicoflenic. No help. All doctors outof office on Friday
Covid 19. I tested positive on September 20, 2022 I experienced a cough; for 2 days aches and pains for 2 days; fatigue; and a runny nose. I was taking zinc and probiotics for my symptoms.
On 3/24/21, just three days after receiving my second Pfizer vaccine, I started noticing excruciating pain in my left calf.  I managed the pain with Tylenol, but as it continued to get worse and debilitating, I saw my doctor on 3/30/21 who immediately scheduled an ultra sound.  On 3/31/21 at 9:00 am, I had the ultra sound and the results were DVT (BLOOD CLOT).  SEE DETAILED RESULTS IN ITEM 19.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 11:01 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 11:01 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 67.61 years.  Concomitant products were not provided.  On 20-Mar-2021, Excursion time was 09 AM , temperature was 34 and Excursion time was 10 PM, temperature was 37, total doses given for the day was 184, Condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Mar-2021, vial was moved to clinic on 20-Mar-2021.19 vials were sent to clinic. Vaccine BUD date was 08-Apr-2021.  On 20-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 30, 11 AM: 41, 12 AM: 45, 1PM: 44, 2 PM: 44, 3 PM: 44, 4 PM: 44 and 5 PM: 43.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Patient approx 15 weeks pregnant at time of vaccination. Patient was seen at local health dept. 7/23 and received Varicella, Tdap, and PPD (positive).  From  health department documentation reviewed  over phone documentation reflects patient answered she was not pregnant or concerned about pregnancy status..
Chest pain, Diff breathing. 05/31/2007 MR received from overseas hospital written in German.   DX: Myocarditis nach Pocken-und Milzbrandimpfung.
Had a Brain Stroke- 3 days after the shot- did a battery of test and can not determine- why I had a stroke. no family history or any issues prior too the shot. Left Hand and left foot tingles and feels different, Left foot is painful all the time, Doctor prescribed,  Gabapentin 800mg for pain.
seizure; loss of energy; flu-like symptoms; bouts of nausea; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9266), via an unspecified route of administration at the age of 73-year-old at arm left on 27Feb2021 02:45 PM at single dose for COVID-19 immunisation. Medical history included epilepsy. Concomitant medications in two weeks included allopurinol; zonisamide; vitamin D and glutathione. There was no other vaccine in four weeks. There was no covid prior vaccination and no covid tested post vaccination. The patient had Pfizer COVID vaccine Sat, 27Feb2021 afternoon. Then 24 hrs after vaccine had loss of energy with flu-like symptoms and bouts of nausea on 28Feb2021 6:00 PM. Then at 4a.m. early Monday 01Mar2021 morning had seizure. There was no treatment for events. The event seizure was serious for being medically significant. The outcome of events was recovering.
Patient called 1/20/20 and said her arm has hurt since she received the vaccination. It has been sore and she has trouble lifting her arm above her shoulder.
Cellulitis (R) arm s/p vaccines, local reaction only. Rx'd Keflex 125 qid X 10 d. Prescribed on 6/28/02. Adverse event onset date is unknown.
Initial misuse report received from a healthcare professional on 24 October 2013. The cases were received on 21 March 2014. It was reported FLUZONE was administered 0.25 ml to 5 year old instead of 0.5 ml dose. No adverse event was reported. List of documents held by sender: none.
I forgot to dilute the vial for Pfizer-BioNTech covid 19 (5-11yrs) old before administering it to a 9 yrs old girl and my co-worker pharmacist found out before she gives the second dose and told me about it. So I am reporting to VAERS right after I gave the vaccine.
a pregnant patient got VARIVAX within one month of conceiving; Information has been received from a physician referring to a female patient of unknown age. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. The patient was pregnant.  On an unknown date, the patient received varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose detail, route, lot # and expiration date were not reported) within one month of conceiving for prophylaxis (exposure during pregnancy).   The last menstrual period (LMP) and the estimated date of delivery (EDD) were unknown. The pregnancy outcome was pending. The fetal outcome was unknown.
Initial misuse report received from a nurse on 01 November 2013. The 38-year-old patient had received DAPTACEL (route, site not provided). Reporter stated that patient received DAPTACEL to 38 year old patient instead of ADACEL. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
He went to the hospital for cardiovascular problems and cholecystitis and was under treatment after the first dose. 2/26/2021 at around 11:00 pm she was complaining of high blood pressure, uncontrolled vital signs, uncontrolled sugar, at 6:00 am she has passed away. They certify respiratory failure.
This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, patients were vaccinated with improperly stored MMR II (therapy type rHA) lot # L015282, expiry date: 30-APR-2017 (dose, route and site of administration were not reported). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
the arm where I received the shot is sore; A spontaneous report \was received from a Consumer concerning a  51-Years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced soreness on left arm where she received the shot.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On 24th Dec 2020, prior to the onset of the event, the patient received their first of dose of mRNA-1273 (lot/Batch No: 039K20A) intramuscularly in the left arm  for prophylaxis of COVID-19 infection.  On 24th Dec 2020, the patient experienced the soreness on her left arm where she received vaccine.  Laboratory details not provided.  She used to treat with  Bengay on the area for soreness.  Action taken with mRNA-1273 in response to the events was not reported.
left eye felt blurry, floater and some distortion; left eye felt blurry, floater and some distortion; left eye felt blurry, floater and some distortion; very frustrated; This is a spontaneous report from a contactable consumer (patient). A 46-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown), via an unspecified route of administration in left arm on 04May2021 at 13:00 (at the age of 46-years-old) at dose 1, single for COVID-19 immunization. Medical history included COVID. The patient has no known allergies. Concomitant medication was reported as none. There were no other vaccines in four weeks. Vaccine facility type was reported as urgent care center. She was not tested for COVID post vaccination. On 10May2021 at 08:00, the patient started to feel some problems with her left eye. Her left eye felt blurry, with a floater, and some distortion. She did not take it seriously because she thought her eye contact lenses needed to be changed or cleaned by then. She does not have any ocular disease history before as well as in her family. She has been very frustrated from May2021 since it happened. The time of vaccination was definitely correlated to the problem on set. She received the second dose of the vaccine on 25May2021 at 13:00. Therapeutic measures were taken as a result of the events and included treatment with unspecified infusion and medication. The events resulted in emergency room/department or urgent care and doctor or other healthcare professional office/clinic visit and were reported to have caused disability or permanent damage. The outcome of the events was not recovered.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Fever of 103.9, body aches, fatigue,  chills, headache, joint pain, lack of appetite, redness/pain/swelling/itching at injection site.  Sore arm from elbow to shoulder
Information has been received from a physician concerning a 66 year old male with Barrett's disease, hypercholesterolemia, diet controlled type 2 diabetes mellitus and drug allergy to PERCOCET and PERCODAN who on 10-JAN-2011 was vaccinated intramuscularly with his second dose of 0.5 ml PNEUMOVAX 23 (lot # 665925/0932Z) on left arm. Concomitant therapy included LIPITOR, PRILOSEC, KADIAN and aspirin. On 11-JAN-2011 the patient woke up "in the middle of the night" with severe pain in his left arm, the patient reported to the physician that he also felt like all of his joints "were on fire" and that he felt warm all over. He couldn't get up, and had great difficulty moving at that same time. This lasted about 5-6 minutes. In the morning of 11-JAN-2011 the patient was experiencing aching in his left arm, but was feeling better than he did last night. The physician reported that this patient had previously had a dose of PNEUMOVAX 23 (dose, indication, lot # not reported) some time in 1993. The TYLENOL was given as a treatment for adverse events. There was no laboratory diagnostic study performed. The patient sought a medical attention by a phone call. At the time of reporting, the patient was recovering. Follow-up information was received from the physician concerning a 66 year old white male patient with type 2 diabetes mellitus, peripheral vascular disorder and increased lipids who on 3:00 pm 10-JAN-2011 was vaccinated intramuscularly with his second dose of 0.5 ml PNEUMOVAX 23 (lot # 665925/0932Z) on deltoid in left arm. On 11-JAN-2011 the patient experienced pain in his left arm, injection site was ok and no pain, both legs and arms paralyzed for 5-6 minutes, then joints felt like they were on fire. Upon internal review, both legs and arms paralyzed for 5-6 minutes was determined to be an other important medical event. The patient recovered on 11-JAN-2011. No further information is available.
This spontaneous report as received from two pharmacists refers to a patient of unknown age and gender. On 28-FEB-2014, the patient was vaccinated with a dose of improperly stored ZOSTAVAX, lot # J007854, expiration date 28-SEP-2014 (dose and route not reported) that was exposed to 38F for 576 hours, Dates of excursions: 01-FEB-2014 to 28-FEB-2014. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Itchy welts appeared 8 days following vaccination. Welts grew and spread down upper arm below deltoid injection site. There was some soreness in the area. Sx began to dissipate after 2 days. Gone by the end of 3rd day. Used hydrocortisone to alleviate itchiness.
hives, caladryl & DPH, eyes itch, neck, head, arms, stomach, back, chest p/vax;
sore shoulder; lethargy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 23Mar2021 as dose 2, single (Lot number: EP6955) at the age of 67 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Site and route of injection: Anatomical site of injection: Left Arm, Route of administration: Intramuscular, Batch/Lot number: EN4202), administration date: 02Mar2021, when the patient was 67-year-old, for Covid-19 Immunization, reaction(s): "sore shoulder", "lethargy". The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "sore shoulder"; LETHARGY (non-serious), outcome "unknown".  Additional information: It was reported that the patient had contracted COVID 3 mos. After his 5th dose (Bivalent). He rarely had even mild reactions (sore shoulder; a day of lethargy) after each dose.
Post ea Anthrax vax (1,2,& 3) flushed, itchy all over, chest tight. Within 2 days, maculopapular rash, some papules fluid filled, fever, nausea, resolves over 6 wks. Follow-up: 6/2/00 LM on pt's machine to intro. myself and ask her to Fax back the consent form I'll mail today. Let her know we are interested in whether she had Sx's after any subsequent Anthrax vacc. 6/6/00 Return call from pt. Has been on ALBUPENT inhaler prn and THEODUR 300mg tid since flu vacc. in '86. Since Anthrax vacc. series began in 5/99, the chest tightness has increase and she is on ALUPENT daily plus the THEODUR 300 tid. She has had no further Anthrax since the 9/26/99 3rd one due to MD's recommendation. The body - wide blisters persist as does a "burned" appearance to her face and neck. She will Fax all records pertinent to the eval. of these symptoms.
Info has been received from a physician concerning a 19 month old male with Hemophilia (factor B deficient) and a hematoma on his forehead who on 8/23/05 was vaccinated, SC, in the right thigh with a 1st dose of MMRII (lot 649239/0030R). Concomitant therapy the week of vaccination included anti-hemophilic factor (as drug) for the treatment of the hematoma on his forehead. Illness at the time of vaccination included a viral upper respiratory tract infection. On 9/2/05, the pt developed a generalized measles-like rash. The rash started under his arm and spread to the trunk area. No fever was present. Unspecified medical attention was sought. diphenhydramine tannate (Dytan) was provided to treat the rash. There was no product quality complaint involved. Follow-up info from the physician indicated that on approximately 9/1/05 (previously reported as 9/2/05), 9-10 days after vaccination, the pt developed a maculopapular pink rash on his trunk and proximal extremities. There was no itching, fever, irritability or vomiting. No lab or diagnostic tests were performed. The pt's outcome was recovered. It was noted that the pt had no adverse events following prior vaccination. Additional info is not expected.
This spontaneous report was received from a Licensed Practical Nurse via company representative referring to a female patient of unknown age. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 intramuscularly (dose, lot# and expiration date were not reported) for prophylaxis. On an unspecified date after administration, the patient returned to the office and the arm which had received the vaccination was in a sling. The patient could move her arm sideways but she could not move it up and down and that was why the patient had put her arm in the sling. The physician did not provide any treatment but advised the patient to remove the sling and to apply warm compresses to her arm. The physician encouraged the patient to "try and get movement with her arm". The outcome of the event and the relatedness between the event and PNEUMOVAX23 were not reported. Additional information has been requested.
Chills, nausea, vomiting, malaise, sinus congestion, tender/red area at injection site. Felt so weak he missed 4 days of work.
Significant side effects.  Fever, body aches, exhaustion and fatigue, body rash: face,  neck, chest, back, both shoulders, left arm.