chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 21 year old female who 2 years prior, in 2008 was vaccinated with 3 doses of GARDASIL (dates, site of injection and lot numbers unspecified). On 20-JUN-2010 papanicolaou smear (PAPs) was performed and revealed atypical squamous cells of undetermined significance (ASCUS), HR HPV positive and cervical intraepithelial neoplasia I (CINI). Biopsy revealed CINI within normal limits. At the time of the report, the outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Information has been received on 09-MAR-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. During 2013, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, the patient was treated by a physician for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Large 8cm by 20 cm area of redness, induration, pain around injection site.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with an unspecified number of improperly stored doses of ROTATEQ (lot # K023532, expiration 21-JUN-2016, dose was not reported) orally (incorrect product storage). The vaccines were stored in temperature of 33F for 9 hours and 50 minutes. GARDASIL 9 appeared in the product list, however no improperly stored doses of GARDASIL 9 were administered. No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
No side effects reported; HCP reporting administration of PNEUMVAX 23 to a 6 week and 3 day old patient. No side effects reported. See request cases 02400107 and 02400128. No additional AE/PQC.; This spontaneous report has been received from an other health professional referring to a 6 weeks and 3 day old male patient. The patient's pertinent medical history, concomitant medications and drug allergies/reactions were not provided.      On 02-JUN-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # U034712, expiration date 30-JUL-2023 for prophylaxis (strength, dose and anatomical location were not provided) (product administered to patient of inappropriate age). No side effects reported. No additional AE/PQC.
pt states she went down hill once she got home after taking vax.  She felt nauseous but no vomiting, had diarhea, had chills, fever, joint pain, exploding headache and was dizzy.  Her left arm is sore.  She has had these symptoms almost 3 days.  She is feeling better as of today.
Six hours after the vaccine, I had the chills that quickly turned into UNCONTROLLABLE & SEVERE body shaking, a headache, SEVERE back and neck pain and elevated resting heart rate (96). I took 2.5mg of Ambian thinking that if I could just fall asleep, I would sleep it off. After an hour of non-stop symptoms, I fell asleep for about an hour only to wake up  with the severe neck and back pain and headache still present. The body shaking had subsided.   The next day, I was tired but fine.
Bells Palsy; numbness (R side of face); Sinusitis; right eye watering non-stop; pain right side of face; This case was reported by a lawyer and described the occurrence of bell's palsy in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no reaction on previous exposure to drug. Concurrent medical conditions included hyperlipidemia.   On 24th September 2020, the patient received the 2nd dose of Shingrix (unknown). On 28th September 2020, unknown after receiving Shingrix, the patient experienced sinusitis, watering eyes and facial pain. On an unknown date, the patient experienced bell's palsy (serious criteria GSK medically significant) and numbness facial. On an unknown date, the outcome of the bell's palsy, numbness facial, sinusitis, watering eyes and facial pain were unknown.   It was unknown if the reporter considered the bell's palsy, numbness facial, sinusitis, watering eyes and facial pain to be related to Shingrix.
After the injection I started having slight nausea.  At the first night around 8:30pm I started having pain at the injection site.  I took Aleve for pain Friday morning. I started having severe pain to both armpits around 10am. Then around 11am I had severe chills and body aches. My temp was 101. I took some ibuprofen at that time. Then at noon my head started hurting and I had pain even in my fingers. I took more Aleve at 1pm. Around 3 I started to feel some relief.  That evening at 6:30 my symptoms worsened and I had chills so severe my whole body was shaking. I took some extra strength Tylenol and fell asleep. My husband work me around 9pm and I had a fever of 103. I took a shower and cooled down to 101.9. He kept watch over me all night and I slept very hard.  I woke up Saturday 8am with extreme fatigue and my lips began peeling when I brushed my teeth. I noticed I had swelling to all of my limbs and my face. My injection site was also swollen and painful including both armpits.  I stayed in bed all Saturday except for using the restroom.  I had no fever Saturday. Just aches and some dizziness and my brain was a little slower than usual. I also had almost no appetite.  I woke up around 8 Sunday morning with lessened body aches. Injection site swollen still but smaller about size of quarter instead of 50 cent piece. Still very tired. I wore my Apple Watch and it clocked my heart rate at low 50s while I as sleeping. I?m usually low 80s when I?m sleeping. Also Friday my watch clocked my heart rate at 110s while I was sitting still.  Appetite still less than normal. Brain still a little slow but I was able to leave the house for a bit.  It?s 8pm and I?m more alert but still not 100%.
knot under my skin at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE NODULE (knot under my skin at the injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 an unknown date, the patient experienced VACCINATION SITE NODULE (knot under my skin at the injection site). At the time of the report, VACCINATION SITE NODULE (knot under my skin at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Headache and fever, fatigue. Three days later my arm is still swollen, red and feels feverish. Also itches intermittently.
Right jaw locked up, could talk and eat, just painful.  It clicked back on June 29.
Unable to move shoulder much; Injection site very sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 11:45 (Lot number: EL3247) at the age of 58 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergy to cats and rabbits" (unspecified if ongoing). Concomitant medication(s) included: ACETAMINOPHEN, start date: 2021. Vaccination history included: Bnt162b2 (Batch/lot number: EL3247, Date of start of drug/ time: 22Feb2021 11:00 AM, Anatomical Location: Arm Left, Dose Number: 1), administration date: 22Feb2021, when the patient was 58 years old, for Covid-19 immunization, reaction(s): "Sore throat", "Cough increased", "Upper respiratory infection".  The following information was reported: MOBILITY DECREASED (non-serious) with onset 15Mar2021 16:00, outcome "recovering", described as "Unable to move shoulder much"; VACCINATION SITE PAIN (non-serious) with onset 15Mar2021 16:00, outcome "recovering", described as "Injection site very sore". Therapeutic measures were not taken as a result of mobility decreased, vaccination site pain.  Additional information included: Events started about 4 hours after injection. Peaked at about 12 hours after injection. It was slowly improving at 30 hours post injection and was still unable to raise arm. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.   No follow-up attempts are possible. No further information is expected.
Pt tested positive for COVID on 10/29/2021.  Over the past several days she has been beoming more SOB and tachycardica. No fevers or chills.  Patient referred for mono Clonal Antibody treatment. She is instructed to return to the ED if her condition deteriorates in any way.  Pt is to be managed as an outpatient.
24 hours after vaccine given, pt develops blisters on both legs, rash, fever.
off label use; Other vaccine same date vaccine date 27Dec2021; Patient died within 24 hrs of vaccination; booster; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 68 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 27Dec2021 (Lot number: FL3197) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation; hepatitis b vaccine rhbsag (yeast) (ENGERIX-B), administration date 27Dec2021 (Lot number: 5397F) as unk, single. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid (Dose Number: 2, Batch/Lot No: EN6204, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 19Mar2021, when the patient was 67 years old, for Covid-19 immunization; Covid (Dose Number: 1, Batch/Lot No: EN6203, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 26Feb2021, when the patient was 67 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (death, medically significant) with onset 27Dec2021, outcome fatal; OFF LABEL USE (death, medically significant) with onset 28Dec2021, outcome fatal; PRODUCT USE ISSUE (death, medically significant) with onset 28Dec2021, outcome fatal; DEATH (death, medically significant) with onset 28Dec2021, outcome fatal. It was unknown if therapeutic measures were taken as a result of immunisation, off label use, product use issue, death. The patient date of death was 28Dec2021. The reported cause of death was Unknown cause of death. It was not reported if an autopsy was performed. Additional Information: Patient died within 24 hrs of vaccination.; Sender's Comments: Based on the available information in the case, the causal association between the events immunization, off label use, product use issue, death and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Unknown cause of death
right deltoid red, swollen and warm to touch, ice pack to area 15 minutes q 2hours
Top of Right shoulder has been very soar and painful. This is week 3 of symptoms. My range of motion is limited and I have swelling on the top of my shoulder as well.  Can hear popping  and clicking in my shoulder when I try to do range of motion as well.
The day after the shot, I began to feeling lightheaded and started forgetting what I was saying before I could complete a sentence. I had a severe headache and pain on the left-side of my body. My leg is still sore to this day. I don't know who to talk to. I keep having random moments of forgetting things.
Breastfeeding post vaccination; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Breastfeeding post vaccination) in a female patient of an unknown age 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. On an unknown date, the patient experienced EXPOSURE VIA BREAST MILK (Breastfeeding post vaccination). At the time of the report, EXPOSURE VIA BREAST MILK (Breastfeeding post vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug was not reported.  Treatment medication was not reported.  The patient wanted to know if breastmilk samples are being collected. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Mar-2021 and was forwarded to Moderna on 11-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Breastfeeding post vaccination) in a female patient of an unknown age 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. On an unknown date, the patient experienced EXPOSURE VIA BREAST MILK (Breastfeeding post vaccination). At the time of the report, EXPOSURE VIA BREAST MILK (Breastfeeding post vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug was not reported.  Treatment medication was not reported.  The patient wanted to know if breastmilk samples are being collected.
SEVERE CHILLS; This spontaneous report received from a vaccine facility concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included cerebral palsy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 vaccinated on right arm at 12:55 PM for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced severe chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe chills. This report was non-serious.
Around 3 hour after receiving both vaccines, the patient developed swelling to her lower lip and tingling in her tongue. She then developed around 8 hours later a singular blister inside her bottom lip. The swelling was alleviated with famotidine and diphenhydramine but the blister remained and the swelling continued into the next day requiring additional doses of famotidine and diphenhydramine.
swelling; red; soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness), INJECTION SITE SWELLING (swelling) and INJECTION SITE ERYTHEMA (red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE PAIN (soreness). On 21-Feb-2021, the patient experienced INJECTION SITE SWELLING (swelling) and INJECTION SITE ERYTHEMA (red). On 16-Feb-2021, VACCINATION SITE PAIN (soreness) had resolved. At the time of the report, INJECTION SITE SWELLING (swelling) and INJECTION SITE ERYTHEMA (red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant information  provided. Treatment included Tylenol
Temperature ranging up to 102.6; body ache; headache; extreme weakness; cough; sleepiness; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for Injection, Lot Number: EN6198) via an unspecified route of administration in arm left on 05Mar2021 at 15:15 (at the age of 54-year-old) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for Injection, Lot Number: EM9809) via an unspecified route of administration in arm left on 12Feb2021 (at the age of 54-year-old) at 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had no known allergies. Patient did not have covid prior vaccination. Patient has not tested covid post vaccination. On 06Mar2021, the patient experienced Temperature ranging up to 102.6, body ache, headache, extreme weakness, cough, sleepiness. Patient did not receive treatment for the adverse events. The patient underwent lab tests and procedures which included body temperature: 102.6 on 06Mar2021. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
She got lightheaded and dizzy and had passed out in the chair as mom and I were holding her up and then had a few uncontrollable full body jerks while being passed out  and she was passed out for about 45 seconds total and when Dr had walked in she had come to already, I gave her apple juice and crackers and she waited about ten minutes to leave until she felt she was ready
No adverse effects were reported; patients were administered one dose each of improperly stored Rotateq; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 27-MAR-2019, the patient was vaccinated with one dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R016790, expiration date: 20-APR-2020 (also reported as 04-APR-2019) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of above 9 degrees Celsius (8.5 degrees Celsius) for 7 hours 1 minute. The digital data logger was involved in recording the temperature excursion details. Previous excursions were reported as above 9 degrees Celsius (9.6 degrees Celsius) for 33 minutes.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA008857:
This spontaneous report as received from a Certified Registered Nurse (CRN), concerns a female patient with 65 years old, with no known allergies and none adverse events following prior vaccination. The reporter stated that on 24-JAN-2013 at 16:25 hours, the patient was vaccinated with the first dose of ZOSTAVAX (Lot # H013943, expiration date not reported, in the right upper arm) resuspended in Diluant (Lot number H011543). No other cosuspect or concomitant medications were reported. On 24-JAN-2013 at 16:30 hours, the patient experienced a 10x12 cm red raised area. The reporter stated that on 28-JAN-2013 the patient was rechecked and it was observed that the size and red color of the raised area continued. No laboratory tests were performed. At the time of this report, the outcome of patient is not recovered. Additional information is not expected.
This spontaneous report as received from a Registered Nurse refers to unspecified number of patients of unknown age and gender. The patients' medical history was not provided. It was reported that on unknown dates, the patients might have received doses of improperly stored PNEUMOVAX 23 lot number K021030, expiration date 22-JUN-2016 (dose and route of administration not reported). The vaccines were exposed to the following conditions: temperature 30.49F for 48 hours (the worst case scenario) at least 5 times. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
12pm started feeling fatigue and sickness throughout body. 3pm nausea. 6pm body aches and chills. Slept horribly like I was getting the flu. Up at 4:30am to go to work. Still fatigue, nausea, chills and some little bit of upper back pain, between shoulder blades. Went home early today from work.
MA received order for HPV vaccine, picked vaccine from refrigerator and brought to RN for reverification.  MA had picked a vial of Hep B vaccine.  MA/RN failed to notice wrong vaccine.
vaccine given after expiration date due to temperature change in storage; vaccine given after expiration date due to temperature change in storage; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given after expiration date due to temperature change in storage), PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine given after expiration date due to temperature change in storage) and NO ADVERSE EVENT (no adverse event) in a female patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 048L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given after expiration date due to temperature change in storage), PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine given after expiration date due to temperature change in storage) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine given after expiration date due to temperature change in storage), PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine given after expiration date due to temperature change in storage) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular use) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular use), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (vaccine given after expiration date due to temperature change in storage) and PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine given after expiration date due to temperature change in storage).    Concomitant medication was not provided.  It was unknown if the patient experienced any additional symptoms/events.  Treatment information was not reported.