chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of sickness in a 67-year-old male patient who received SHINGRIX for prophylaxis. On 11th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 12th October 2018, 1 days after receiving SHINGRIX, the patient experienced sickness, pain in arm and injection site erythema. In October 2018, the patient experienced injection site itching. On an unknown date, the outcome of the sickness, pain in arm, injection site erythema and injection site itching were recovered/resolved. It was unknown if the reporter considered the sickness, pain in arm, injection site erythema and injection site itching to be related to SHINGRIX. Additional details were reported as follows: After getting the vaccine, the patient felt sick for 1 to 1.5 days, his arm was sore for a week and the patient had redness at the injection site for a couple weeks. A week and a half (10.5 days) after the vaccine, the redness became itchy. On 23rd January 2019, the got his second dose of SHINGRIX. The reporter consented to follow up.
Pt has shots on 7-20-11. Mom said she noticed pt's (R) arm on area where VZV was given was swollen, red, & warm to touch. Noticed this on 7-21-11. Gave her TYLENOL, BENADRYL po  & put warm cloth to it.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In or around 2011, the pt was vaccinated with ZOSTAVAX for routine health maintenance and for its intended purpose: the prevention of shingles (strength, dosage schedule, route, lot number and expiration date were not provided). On an unspecified date, a few months after vaccination, the pt developed terrible skin lesions across her buttocks and backside and the lesions spread into her groin region. She also developed chronic shingles episodes, severe neuropathic pain into her hips, groin, feet, and toes. The pain was so severe that she was unable to wear socks or close-toe shoes of any kind or remain seated in a car or on a plane. As a direct and proximate result of ZOSTAVAX vaccine, the pt suffered serious injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The pt also suffered incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the time of the report, the pt had permanent nerve damage and ever-present neuropathic pain (not recovered). The reporter considered herpes zoster and postherpetic neuralgia to be related to ZOSTAVAX. Upon internal review, the events herpes zoster and postherpetic neuralgia were considered disabling due to sustained, severe and permanent personal injuries. Additional information has been requested.
H/a, not feeling well 5-10 min p/immun collapsed to floor; did not lose consciousness;
Both immunizations provided in same arm. Pt experienced redness, swelling, fever & irritation. Followed up w/ physician and was given antibiotics and is recovering.
Redness and swelling at site 6 1/2 cm wide 4 cm long fussy for 24 hours. Mom not sure if the pt had fever or not.
pt recv vax & devel  x 2-3 days upper resp sx, sz activity-coma;head Ct & MRI w/bilat thalamic hemorrhage;all w/u negative; p/18 days in hosp pt disch to rehabilitation facility w/response only to tactile stimuli;
just a little bit / had some side effects; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (just a little bit / had some side effects) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Shingrix (2nd shot had received recently and within 30 seconds patient knew he was sick and knocked on patient ass and was in bed for 4 days.) in 2022 and Shingrix (1st shot sore arm.). Past adverse reactions to the above products included Pain in arm with Shingrix; and Sickness with Shingrix. Concurrent medical conditions included Immunosuppression NOS (arthritis). Concomitant products included ETANERCEPT (ENBREL) for Immunosuppression.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (just a little bit / had some side effects). At the time of the report, VACCINATION COMPLICATION (just a little bit / had some side effects) outcome was unknown. Not Provided          On an unknown date, patient had received 1st shot of moderna vaccine and no side effects were observed. On an unknown date, patient had received 2nd shot moderna vaccine and experienced a little bit of fever. On an unknown date patient had received 3rd shot of moderna vaccine and experienced sick for 2 to 3 days with headache and fever.   Treatment medication was not provided by the reporter.   This case was linked to MOD-2022-669885, MOD-2022-669886 (Patient Link).   Reporter did not allow further contact
Severe body aches, chills, tachycardia, fevers, night sweats about 10 hours post 1st dose lasting through the night. Severe headache, nausea, blood tinged urine 24 hours post 1st dose (Moderna). Of note, I had a prior infection with COVID in April and my symptoms from the vaccine are almost the same as then.
In May, I suffered transient ischemic attack TIA, as a result of that I started taking blood pressure medication. I was not taking blood pressure medication prior to the medication.
Dose administed 1 day after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administed 1 day after expiration date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administed 1 day after expiration date). On 26-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Dose administed 1 day after expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-271671 (Patient Link).
at 13:13 patient felt faint BP 120/72 HR 90 POX 98%. rested briefly with legs elevated. Denied PMH, never had respiratory or s/s of anaphylaxis. recovers with out incident 1336 BP 120/70 HR88 POX 99%
fever; vomiting; This spontaneous report was received from a physician via a company representative, referring to a 4-month-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 19-APR-2022, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (manufacturer unknown) oral liquid, orally, lot #U037808, expiration date: 26-MAR-2023, (strength was not provided); the patient also was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) injection, lot number reported as "EW2019", expiration date: 15-APR-2024, (strength and route of administration were not provided) and with a dose of diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) injection, 0.5 milliliter, lot #U7125AA, expiration date: 15-JUL-2024 (strength and route of administration were not provided); all vaccines administered for prophylaxis.  On the same date (19-APR-2022), the patient was taken to emergency room due to fever (body temperature showed 105 (units not provided)) and vomiting. It was reported that the patient was hospitalized on an unspecified date due to the events. On an unknown date in 2022, the patient recovered from the events. No treatment was given for fever or the vomiting.  The causal relationship between fever and vomiting with rotavirus vaccine, live, oral, pentavalent (manufacturer unknown) and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was unknown and the causal relationship between the aforementioned events and diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) was reported as related.
Severe allergic reaction resulting in very large welt approximately 3 inches in size and swollen for a week. Arm pit lymph nodes were swollen and very painful as well. I contacted my physician and they recommended Benadryl OTC. I also had severe headache, chills, nausea, fever, tingling down left arm and numb hand. Residual pain in armpit lymph nodes lasted over a week and I still have sensitivity and sore to the touch on 9/27/21, almost 3 weeks later.
I felt fine the night before. When I woke up on 10/13/2017 and got out of bed, I was very lightheaded and had to sit back down on the bed. I was very lightheaded all day, any movement would make my head spin, but still able to walk - slowly - around to house. Our house has a flight of stairs and head would spin whenever I would start up or down the stairs. I mainly laid on the couch all day. The next couple days was better. I was still lightheaded but not as much. My head would spin if I made quick/normal movement (like getting up out of bed) so I still was moving slowly, but noticed I could go down about 4 stairs before my head would spin. On 10/16/2017 I could go down about 8 stairs before my head would spin. I called my Primary Care Physician's office and spoke with his nurse. She did say that my lightheadedness could be a reaction to the flu vaccine, so I thought I would wait to see if my symptoms got better since I have no other problems - no headache, pain, numbness, tingling - to make me think I'm having any other problem. On 10/23/2017 I can get out of bed for the first time without being lightheaded. And still can go down about 8 stairs before my lightheadedness hits. So I have been using the number of stairs I can go down as a measure of getting better.
Prolonged fatigue, stomach ache, headache, confusion, vertigo, disoriented, dizzines,s fainting every day. Weakness all the time. She is staying in bed all day and can not stand up without these problems. She sleeps all day. She is not herself and can not function.
herpes keratitis of the left eye; neurotrophic keratitis; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 64-year-old patient of unknown gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  On or about 18-AUG-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, route of administration and anatomical location were not reported) by a healthcare provider at the hospital, for the long-term prevention of shingles and zoster-related conditions.         On an unknown date, the patient was treated by a healthcare provider at the hospital, and patient sought subsequent treatment from a physician for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: herpes keratitis of the left eye and neurotrophic keratitis of the left eye.  The outcome of the events was unknown. The reporter considered the events to be related to Zoster Vaccine Live(ZOSTAVAX).     Upon internal review, the event of herpes keratitis of the left eye was considered to be medically significant.
One week later injection site became more red, swollen, itchy and very lumpy. Almost like cottage cheese under the skin. Now less swollen but still itchy and red.
He received Kinrix and Proquad on the left arm and noted swelling redness for 3 days up to the elbow.  It has now resolved but noticed  redness on the bad aid site. No fever.
pt recvd vax @ noon;noted red/swelling arm 1/2hr later cont to swell;pt wife call MD ofc & was seen 4-430PM;given Medrol;swelling devel 4-5" circle around inj & extended down to elbow red, hard to touch & warm
Hep B outdated 1/11/04, given on 3/3/04 vaccine to be readministered.
Approximately 2 weeks after his 2nd vaccine dose he noticed some back tightness & inability to catch his breath after activity.  He presented to the hospital with back tightness and inability to catch his breath on 4/26. He is currently still hospitalized at time of this report but in the last 26 days of hospitalization he was found to have severe coronary artery disease with non-viable heart tissue resulting in a destination left ventricular assist device (Heartmate 3) that was placed on 5/12. He had a v-fib arrest on 5/8 & is now awaiting to have an internal defibrillator placed prior to discharge, but is awaiting his coumadin level to be therapeutic prior to placement. Prior to this hospitalization patient was very active with work, biking, going to the gym, traveling & taking care of rental properties.
dizziness, lightheadness, weakness, offered water, juice, observation done, symptoms resolved
This spontaneous report was received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with an expired dose of MMR II (lot #: 667431/1008Z, expired date: 28-JUL-2012) (route, dose not reported) on 20-AUG-2012. No adverse symptoms reported. Additional information has been requested.
Initial information received on 12-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA344670, 2018SA344665, 2018SA344687 and 2018SA344689 (same reporter). This case involves an adult patient (age and gender was not reported) who was vaccinated with a dose of FLUZONE QUADRIVALENT (lot number and expiry date was not reported) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage. It was not reported whether the patient experienced any adverse events. The doses are considered to be non-valid and should be repeated. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
intermittent nausea the night of vaccine, severe nausea for four days after the vaccine, severe inflammation and tightness in the upper and midback area for four-five days and tightness and inflammation around ribcage on both sides and tightness underneath ribs on both sides mostly the right and around stomach area.  worsening of inflammation tightness and burning in across my back more in the center and both sides of my spine as well as inflammation across the rest of my back.  Had to double up on my hydrocortisone tablets which are taken for my adrenal insufficiency in order for it to slowly improve.  Still had residual effects into the following weekend but mildly improving.   THIS WAS MY 1ST VACCINE OF THE PFIZER FORMULA.   AFTER TALKING TO HEALTH DEPT, THEY SUGGESTED THAT I FILE THIS WITH YOU.   MY NEXT VACCINE IS SCHEDULED THIS SATURDAY ON JUNE 12, 2021 at 2:30 or sooner.
DAY 1   - HIGH FEVER ( UNDER CONTROL WITH THE USAGE OF TYLENOL) DAY 2 - PALPITATIONS (MILD) DAY 3-DAY 5 - PALPITATIONS DAY 6 - WOKE UP AT 3:30 AM DUE TO PALPITATIONS (AND ABNORMAL SINUS RHYTHM)   WENT TO THE ER.   RELEASED OH HER OWN INSISTENCE
dizzinessand lightheaded; Vision slightly blurred; BP elevated to 144/96; Slight nausea for remainder of day; This is a spontaneous report from a contactable nurse reporting for herself.  A 45-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 23Dec2020 14:00 at a single dose for COVID 19 vaccination. The facility where the most recent COVID-19 vaccine was administered was a hospital. The patient was not pregnant at the time of vaccination. There was no other vaccination administered in the 4 weeks prior to COVID-19 vaccination. Medical history included multiple sclerosis from an unknown date and unknown if ongoing. There were no allergies to medications, food, or other products.  The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported; the patient did receive other medications within 2 weeks prior to COVID-19 vaccination.The patient experienced dizziness and lightheaded, noticed about 30 minutes after vaccine. Vision slightly blurred. BP elevated to 144/96. Slight nausea for remainder of day. The events occurred on 23Dec2020 at 14:45 pm. No treatment was received for the events. The patient recovered from the events dizziness, lightheaded, vision slightly blurred, BP elevated to 144/96, and slight nausea on an unknown date in Dec2020. The patient was not COVID-tested post vaccination.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
A spontaneous report was received from a healthcare professional concerning a patient, of unknown gender and age, who received Moderna's COVID-19 vaccine subcutaneously. The patient's medical history was not provided. No relevant concomitant medications were reported. On 03 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) for prophylaxis of Covid-19 infection. The nurse was given the mRNA-1273 vaccine subcutaneously instead of intramuscularly (IM). No further information was provided. No treatment information was provided. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The event was considered resolved on 03 Feb 2021.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273.  There were no reported adverse events associated with this case.
Started feeling poorly and tired. I did run fever for 6 days, lost my sense of smell, headache. The highest fever was 102.0 but it did vary throughout the day and night. I did go to the local clinic and was prescribed PAXLOVID for 3 days because of the horrible side effects. I started feeling better in about a week.
Patient complain of pain in her arm at injection site. She had quarter size redness and swelling which resolved in 2 or 3 days after the injection but she still has pain. Pain began about one week after injections.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: EW0150), on 21Apr2021 as dose 2, single (Lot number: EW0162) and on 18Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 42 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant) with onset 11May2022, outcome "unknown", COVID-19 (medically significant) with onset 11May2022, outcome "recovering" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11May2022) Postitive; (16May2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. From 11May2022 to 15May2022, the patient had Paxlovid (Lot number: FY0461) as treatment of COVID-19. Clinical Course: Relapse of Covid symptoms tested positive 11May, started Paxlovid treatment same day, symptoms ended on 13May, ended treatment on 15May. Tested negative on 16May. Symptoms returned on 19May. The patient had no known allergies and no other medication in 2 weeks.
She got her vaccine, had no problems.  She was woken up with severe pain on her left side.  Took some medicine and went back to bed.  The next morning she got up and was fine.  Then she ended up going to the hospital on 6/13/21 as one of her clients felt that she had double pneumonia.  She went to the hospital and was told she had double pneumonia to ER was kept 24 hours and when she was seen and testing was done they said that she would have to have an ICD in her heart.    They then was admitted to hospital for 7 days.  She was put next to the ICU as they said she had a bad heart.  She had multiple tests run on her and medicines.  She was discharged on 6/20/21.  She left the hospital with a life vest for 3 months.  Her cardiologist is and her CVS surgeon is Dr.  She then had a stent put in in October of 2021 and her heart was functioning at 20%, and now a year later it is only functioning at 26%.  He wants her to go and be put on the donor list for a heart transplant.  She did not have any heart issues prior to the vaccine.
I feel achy; feel unsteady; This case was reported by a consumer via call center representative and described the occurrence of pain in a 68-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received the 2nd dose of Shingrix. In January 2020, 7 days after receiving Shingrix, the patient experienced pain and unsteadiness. On an unknown date, the outcome of the pain and unsteadiness were not recovered/not resolved.   It was unknown if the reporter considered the pain and unsteadiness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 68 years old. The patient experienced achy and unsteady after receiving 2nd dose of Shingrix. The reporter wanted to know long after injection can general symptoms show.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Severe, Systemic: Seizure-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Medium, Additional Details: Patient fainted, seized for less than a minute and then vomited. 911 was called. Patient was examined and felt normal after medics left the store.
Patient received J & J Covid vaccine 4/9/21 and immediately had pain at site. THe next day had swollen upper arm around site. The swelling has been gradually going down- now has a quarter size lump there that is tender to  touch. Pain c use of right arm.
Headache: onset 8 hours after booster dose, lasted for 72 hours, moderate in severity.  Left adnexal lymphadenopathy  : vaccine given in L deltoid, onset within 8 hours after booster dose, lasted for 5-7 days,  moderate to severe swelling, looked like a chicken egg protruding from armpit.  Fatigue: onset 8-12 hours after booster dose, lasted 3-4 days, moderate-to-severe.  Full body arthralgia: onset 8-12 hours after booster dose, severe, lasted for 4-5 days, pain felt in back, hips, legs, neck, hands, nearly every joint.  Nausea and loss of appetite: onset 24  hours post booster, lasted for 2-3 days, moderate severity.  Eczema on webbing between fingers bilaterally: onset 1 week after booster dose, lasted 2 weeks, moderate severity. Delayed LH surge: onset 19 days after booster, cycle day 1 on 12/18/2021, typically have LH surge on day 14-15 of menstrual cycle, LH surge delayed to cycle day 17.