chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Report 20010078551 describes a 47 year old male who did not seroconvert following recipt of an injection of hep B vaccine. Conucrrent medical conditions included asthma. Concurrent medications included zafirlukast (Accolate). The vaccinee received hep B vaccine on 05/15/2000 and a second injection  on 06/16/2000. On 11/17/2000, he received Engerix B ped., rather than of Engerix B adult. On 01/08/2001, 52 days following receipt of the second injection of Engerix B, antibodies against hep B surface antigen were < 2 (positive, >10). Outcome of this event was not provided. The reporter indicated that the failure to seroconvert following receipt of Engerix B ped. could be associated with lack of efficacy, or could be associated with the pre-existing asthma, or to therapy with Accolate.
Case number PHEH2014US021379 an initial spontaneous report received from a nurse on 21 OCT 2014. This report refers to a 67 years old female patient. Her medical history and concomitant medications were not reported. It was reported on 21 OCT 2014, she was administered FLUVIRIN 2014/2015 (batch number: not reported) pre-filled syringe (PFS) which was at room temperature from 11 AM to 12:30 PM. The pharmacist stated that they leave their flu shots out at room temperature prior to administration. No adverse events reported following the inadvertent administration.
Night of vaccination - redness and swelling below injection of PNEUMOVAX 3" x 4" and warm to touch. Pt also began experiencing severe muscle aches in both legs and weakness in legs.
Patient came in stating she had pain after flu shot that lasted longer than expected, then progressed to sharp/shooting pain down the arm, then tingling in hand. Pt said went to MD and "shot hit a nerve". Pt states going to Physical Therapy.
Patient reports 24 hours post vaccination, a paralytic feeling - unable to get out of bed. He literally had to roll himself out of bed. Pt reports a severely stiffed neck. Pt sought medical attention, to where he was prescribed a muscle relaxant Pt reports symptoms gradually declined approx 2 days lateral. On 1/11/21 patient reports episodes of diarrhea after second Pfizer vaccination. Pt reports uncontrollable diarrhea for approx 2 - 4 days. Pt changed he changed his diet + took Immodium for relief. However patient now reports feeling of constipation to where his wife inserts suppositories that relieves constipation
1st dose in 2019, never got the 2nd dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose in 2019, never got the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 14-APR-2023 The reporter was the patient who stated she never got the second dose.  No other information provided. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
This case was reported by a nurse via call center representative and described the occurrence of feels awful in a adult female patient who received SHINGRIX for prophylaxis. In January 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced feels awful and influenza-like symptoms. On an unknown date, the outcome of the feels awful and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the feels awful and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient stated after 1st dose of SHINGRIX, she felt horrible and had bad flu like symptoms. The patient stated all symptoms resolved within hours to a day following vaccination. Did not collect the lot or expiration date of the vaccine. No additional details were provided. This case has been linked to the US2019GSK031922, reported for the dose 2 of the same patient.
Information has been received from a licensed Practical Nurse concerning a 6 year old male who on 10/08/99 was vaccinated with varicella virus vaccine live. On 11/28/2001, the pt presented to his physician's office with full-blown chickenpox. It was reported that the child had 50 to 60 pox all over his body including his scalp. Treatment included only observation and palliative treatment. No further details were provided and at the time of this report, the outcome of the event was unknown. Additional information has been requested.
Please see the following determination; Doses Administered from 4.6.2021 to 5.21.2021:Based on the information you have provided and the lack of temperature data, we are not able to conduct an analysis or guarantee the doses administered between 4/6/2021 and 5/21/2021 provided the necessary protection against a COVID-19 infection. Please continue with the original plan of action on revaccination and completing a VAERS Reports on the all clients you have identified.
I am the patient but I am also a primary care pediatrician.  On 11/6, I developed purpura on my legs and buttocks. I also developed swelling on my right palm. I took ibuprofen 400 mg q6 hours.  On 11/7, the right palm swelling improved but I developed swelling on the dorsum of the left hand, bilateral wrists and distal forearms, bilateral elbows and distal upper arms. I also developed a few purpura in the new areas of swelling and more purpura on the legs and buttocks. Continued ibuprofen.  On 11/8, all swelling noted the day before worsened and I also developed swelling on the dorsum of the right hand. There were also new purpura in all areas of swelling as well as areas that already had purpura. Went to Urgent Care clinic. I was prescribed a Medrol pack but instead started 60 mg prednisone that I had left over from a previous asthma exacerbation.  So far today on 11/9, all areas of swelling are improving and I do not see any new purpura though hard to tell in some of the areas heavily covered. I plan to take 40 mg prednisone today. Once swelling has completely resolved, I plan to switch to the Medrol pack.
This case was reported by a nurse via call center representative and described the occurrence of pain in a 57-year-old female patient who received SHINGRIX (batch number 32GR4, expiry date 4th July 2020) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown. Additional details were reported as follows: The healthcare professional reported that, the patient received a dose of SHINGRIX, which was reconstituted with a sterile diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. Follow up information received from nurse on 2nd August 2018: On 23rd July 2018, the patient received the 1st dose of SHINGRIX. Batch number and expiry date was updated. The healthcare professional (HCP) reported that the patient developed achiness, flu-like symptoms, chills and tiredness the day after administration of the 1st dose of SHINGRIX. These symptoms lasted approximately 1 week, although these symptoms abated, approximately one week after administration of the vaccine, the patient developed a full body rash, described as red and raised but not vesicular or itchy. This patient had a previous case entered for the administration of an improperly reconstituted dose of SHINGRIX. It was unknown if the reporter considered the pain, influenza-like symptoms, chills, tiredness, erythematous rash and raised rash to be related to SHINGRIX. The VAERS details were updated.
Pt came 6 days too early for their second dose of the Moderna vaccine. Our check in person informed her that she was too early and advised her to come back on Monday for her second dose to be in the proper window. The pt was given back her vaccination card and left to check in the next pt. A nurse, walked up to the car and administered the second dose to the pt. The pt did not say anything or stop the nurse.  LAFD and our charge nurses monitored her for an additional 15 minutes and released her after no symptoms were shown.
24 hours then he had a softball diameter swollen red blotchy area on his lt upper arm that was tender to touch.  This could have been allergic response/site infection/localized allergic reaction.  I marked his arm to outline the size, took his temperature instructed staff to take his temperature q 4 hours and give him Tylenol after checking his temperature for the discomfort.  Called his PCP office left message of above.  Office called back and instructed to take to the ED if increased in size outside of my marking within an hour and a half it was over an inch outside my markings.  He went to the ED.  They diagnosed as allergic reaction.  They gave him one time steroids by mouth and to take Benadryl 50mg q6 hours x 24.  Thankfully he had none of the more serious reactions of any breathing or swallowing difficulties.
a mass on collarbone to left arm; Pain that radiated from arm to neck/Bump that is painful; Horrendous headache; This spontaneous case was reported by a nurse and describes the occurrence of MASS (a mass on collarbone to left arm), PAIN (Pain that radiated from arm to neck/Bump that is painful) and HEADACHE (Horrendous headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003J21-2A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: J&J (J&J) on 16-Mar-2021. Past adverse reactions to the above products included No adverse event with J&J. Concurrent medical conditions included Fibromyalgia (Patient mentioned about having history of Fibromyalgia since 2010 but no medications taken) since 2010.    On 18-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2022, the patient experienced MASS (a mass on collarbone to left arm), PAIN (Pain that radiated from arm to neck/Bump that is painful) and HEADACHE (Horrendous headache). At the time of the report, MASS (a mass on collarbone to left arm), PAIN (Pain that radiated from arm to neck/Bump that is painful) and HEADACHE (Horrendous headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant mediations were reported. No treatment was taken. Patient took the shot.
i have all 3 got COVID-19 really bad; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (i have all 3 got COVID-19 really bad) in a  patient of an unknown age and gender 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 COVID-19 (i have all 3 got COVID-19 really bad). At the time of the report, COVID-19 (i have all 3 got COVID-19 really bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment information was provided.  Company Comment: This is a spontaneous case concerning a patient of unknown age and gender, with no relevant medical history, who experienced the unexpected, non-serious, AESI event of COVID-19. The event occurred an unknown duration after an unknown dose of mRNA-1273 vaccine administered on an unknown date for the indication of COVID-19 vaccination. At the time of report outcome of the event was Unknown. Further details about the event are not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This is a spontaneous case concerning a patient of unknown age and gender, with no relevant medical history, who experienced the unexpected, non-serious, AESI event of COVID-19. The event occurred an unknown duration after an unknown dose of mRNA-1273 vaccine administered on an unknown date for the indication of COVID-19 vaccination. At the time of report outcome of the event was Unknown. Further details about the event are not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Rash itching; Severe rash all over body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Rash itching) and RASH (Severe rash all over body) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PRURITUS (Rash itching) and RASH (Severe rash all over body). At the time of the report, PRURITUS (Rash itching) and RASH (Severe rash all over body) outcome was unknown.            No Concomitant medications were reported. Patient consulted dermatologist and seeking treatment but treatment information was not reported.  The action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-059450, MOD-2021-059458 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow up information received on 18-JUN-2021. Reporter's address and email id was updated. It contains non significant information.
Pt woke this a.m. with temp of 101 degrees, both arms very sore. Mom, patient just wanted to tell HD and make sure everything ok. No nausea/vomiting, no rash.
Red, hot, raised area of skin at site of injection. Patient went to ER and was put on antibiotics for skin infection. Presented 2 days post injection.
small knot at site for 4 days and then whole arm all way to finger tips swollen 4 sizes bigger. ER said a blood clot at point of shot. then whole body started swelling up.  Now in intensive care on  ventalator for  8 days
This spontaneous report was received from a licensed practical nurse referring to multiple unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with VARIVAX lot # M042858 with expiration date of 21-OCT-2018 and M042858 with expiration date of 13-JAN-2019 for prophylaxis. On an unknown date, the vaccine was incorrectly stored at a temperature of 6°F to 14°F. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported.
fever; Flu like symptoms; body aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administration date 05Jan2021 (Lot number: EK9231) at the age of 62 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First Dose of the Pfizer Covid Vaccine:  Given on 15Dec2020; Lot Number: EH9899.), administration date: 15Dec2020, when the patient was 62 years old, for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 06Jan2021, outcome "recovered" (07Jan2021), described as "fever"; INFLUENZA LIKE ILLNESS (non-serious) with onset 06Jan2021, outcome "recovered" (07Jan2021), described as "Flu like symptoms"; PAIN (non-serious) with onset 06Jan2021, outcome "recovered" (07Jan2021), described as "body aches". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
I am normally symptom free and in excellent health except for some osteoarthritis symptoms in my knee and wrist for which I receive physical therapy.  From this generally healthy state I experienced 9 days of symptoms. Nothing the first day then mild fever on days two through 4 accompanied by headache and backache. Symptoms stronger in the afternoon and evenings.  More severe backache on days 3 through 10.  Days 2 to 7 or 8 very tired.  Took hot baths to be warm all 9 days.   Was able to sleep.  Backache helped with heating pad.
Unable to move my left arm without excruciating pain; Fever of 103.4 degrees Fahrenheit; Uncontrollable body shaking; Mouth ulcers; Extremely painful headaches; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 26Apr2021 at 14:00 (at the age of 30-year-old), as a single dose for COVID-19 immunisation. Medical history included Hashimoto's disease and known allergies to latex and reflag (as reported). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient previously received hydrocodone (MANUFACTURER UNKNOWN), tramadol (MANUFACTURER UNKNOWN), cefalexin (KEFLEX); all for unknown indications from unknown date and experienced drug allergy. On 26Apr2021 at 17:00, after receiving the second dose of the vaccine, the patient was unable to move the left arm without excruciating pain. Later that evening, the patient experienced a fever of 103.4 degrees Fahrenheit, uncontrollable body shaking, and mouth ulcers. It had been two weeks since receiving the second dose and the patient was still experiencing mouth ulcers and extremely painful headaches. The event resulted in a doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events which included treatment with paracetamol (TYLENOL). Since the vaccination, the patient had been tested for COVID-19. On 01May2021, the patient underwent lab tests and procedures which included COVID-19 virus test via nasal swab and the result was negative. The clinical outcome of the event unable to move left arm without excruciating pain, fever of 103.4 degrees Fahrenheit, uncontrollable body shaking, mouth ulcers, and extremely painful headaches was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pfizer-BioNTech COVID-19 Vaccine: Pain at injection site, Fatigue, Dizziness
2 PTs vax w/ Engerix-B & 1 pt vax w/ Recombivax & exp failure to seroprotect.
No Direct Adverse event observed. During screening, patients are asked if they have been vaccinated with a COVID vaccine prior to receiving this dose. Patient did not identify previous vaccination with the Pfizer COVID-19 Vaccine prior to vaccination. It was determined that the patient did receive a Pfizer COVID vaccination 8 days prior on 8-11-2021
+redness, swelling, red papule 1cm x 1cm to lt wrist;
pt recv vax NOV95 & approx DEC97 pt exp herpes zoster;
17AUG93 approx 515PM pt recvd vax & 525PM pt fainted, lost consciousness for 5 seconds; VS BP 110/70, P68, R24; pt quickly regained consciousness @ 5:37  VS- BP 108/68, HR 60, R 20.
Sensation seeming to involve nerves or nervous system, radiating through back, shoulders, arms and hands. Started 24 hrs after first shot and decreased intensity and duration over next 3 wks till almost completely gone. Sensation began again less than 24 hrs. after second shot on 02/04/21 but much less severe than with first vaccination.   Tingling is as close as I can describe the sensation but not altogether accurate.
NONE RESPONSIVE, VOMITING, SEIZURE, SLIGHT REDNESS AT SIGHT. BILATERAL CEREBRAL STROKE WITH RIGHT SIDE WEAKNESS.
I began having symptoms of shingles (dermatome pain) on my right thorax beginning May 1, 2022 and broke out in the rash on May 4, 2022. Started Valacyclovir HCl on May 4, 2022.
Headache. Severe , burning, nerve pain in neck shoulders and both arms . Right arm swollen from elbow to wrists. Went to Dr.  on 3-19-21 . Told to return in 3 days if not better. They said pulse was ok so prob not a clot. I had pain for two weeks but did not return. At end of two weeks swelling gone . Still some residual pain in right arm, but not constant.
Experienced fever, chills, muscle soreness both at the injection site and in neck/back/shoulders, headache, fatigue, malaise, body/joint aches. Most symptoms lasted 24 hours from onset, fever was only about 12 hours. Treatment included Tylenol only. Currently pregnant, first pregnancy, no complications thus far, due 5/13/22.
Numbness and tingling in my arms and legs.; Numbness and tingling in my arms and legs.; tingling in my arms and legs.; Feels like I constantly have goosebumps.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Jun2021 12:00 (Lot number: EW0185) at the age of 30 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: IRON. Vaccination history included: Bnt162b2 (1st dose, Administration time:12:00 PM, Lot number: EW0186, lot unknown: False, vaccine location: Left arm), administration date: 18May2021, when the patient was 30 years old, for Covid-19 immunisation. The following information was reported: HYPOAESTHESIA (non-serious), HYPOAESTHESIA (non-serious) all with onset 08Jun2021 12:30, outcome "unknown" and all described as "Numbness and tingling in my arms and legs."; PARAESTHESIA (non-serious) with onset 08Jun2021 12:30, outcome "unknown", described as "tingling in my arms and legs."; PILOERECTION (non-serious) with onset 08Jun2021 12:30, outcome "unknown", described as "Feels like I constantly have goosebumps.". Therapeutic measures were not taken as a result of hypoaesthesia, hypoaesthesia, paraesthesia, piloerection.  Additional information: The patient had no other vaccine in four weeks and not tested for covid post vaccination.  Follow-up attempts are completed. No further information is expected.
Patient developed a mild fever Saturday night (flushed cheeks, very cranky), which developed and maintained though Monday morning. Tylenol brought the fever down but it would spike again as soon as the Tylenol wore off. He also complained of body aches (legs/feet/head) and said his belly hurt. Also developed runny nose and lethargy.
Pt presented with a red rash around the injection site, he stated that the he noticed the rash on 04/03/2019 and received the vaccine on 04/01/2019.
Developed a rash on the right arm down to the wrist.  Returned next day to doctor's office and prescribed steroids etc.