chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a elderly female patient who received SHINGRIX (batch number EH9Z7, expiry date 8th March 2021) for prophylaxis. On 27th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX.  Additional details were provided as follows: The age at vaccination was not reported however; it could be 75 or 76 years. The patient received SHINGRIX in left arm. The patient developed shingles following her 1st dose of SHINGRIX and her physician instructed her not to get her 2nd dose. The reporter was unsure of timing of shingles following SHINGRIX. The reporter consented to follow up. This case has been linked to case US2019003399, reported by same reporter.
We are all Dtaped. Aka vaccinated/Suspected vaccination failure; Think i have whopping cough; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received DTPa (DTaP vaccine) for prophylaxis.  On an unknown date, the patient received Tdap Vaccine. On an unknown date, unknown after receiving Tdap Vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and whooping cough (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and whooping cough were unknown.   It was unknown if the reporter considered the vaccination failure and whooping cough to be related to Tdap Vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient thought he or she had whopping cough right now.  The patient stated he or she got whopping cough from his/her son who was in daycare. He whooped last night. This case was considered as suspected vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming whopping cough were not provided. No further information was provided. This case linked with US2020AMR227460, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR227460:son's case
Red, knot in arm, felt hot about 10 pm night of vaccination -> next morning increased in symptoms and felt feverish. Hasn't taken any OTC meds.
Headache weak, fatigue, injection site redness, leg weakness Narrative: Pt reported the following ADRs post 2md COVID vaccine: weak, fatigue, injection site redness ,headache, leg weakness. Pt did not take any treatment medications. Symptoms resolved.  Other Relevant History:
09/03/21 The patient presents with SOB with unknown onset. Per nurse, Pt who was brought in by EMS for SOB with exertion and noted he has COVID-19 and is fully vaccinated. Reports that pt came in with 2 liters of nasal canula and his pulse ox rests in the 90s. HPI limited due to being a poor historian 2/2 dementia .  The onset was unknown.  The course/duration of symptoms is unknown.  Degree at onset unknown.  Degree at present unknown.  The Exacerbating factors is unknown.  The Relieving factors is unknown.  Risk factors consist of COVID-19.  Therapy today: none.  Associated symptoms: denies chest pain, denies fever, denies chills, denies cough, denies nausea, denies vomiting, denies abdominal pain,
Elevated heart rate in 130's. Burning eyes, red swollen itchy patch on arm of vaccine.
Patient received expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient received the second booster dose which got expired on 22-Jan-2022. Health care professional (HCP) mentioned that the incident occurred because of miscommunication as a coworker told that there were some lot number whose expirations dates had been extended.  No treatment drugs were reported.
An investigator reported that an unidentified child rec'd Prevnar and Pnu-Imune-23 vaccines on 2/4/02, as part of the GMA local study: evaluation of the immunogenicity of pneumococcal conjugate vaccine and routine pediatric immunizations in HIV-infected children treated with highly active anti-retrovial therapy (HAART). Post immunization, the child developed a vaccine reaction that was rated grade 3. According to the protocol, grade 3 adverse reactions require a clinic visit within 48 hrs of the event. This case was considered serious since vaccine reaction (grade 3) was medically important in this case. The investigator assessed the relationship between vaccine reaction (not expected per package insert) and Prevnar as possibly related. The investigator assessed the relationship between vaccine reaction and Pnu-Imune 23 as definitely related. The medical monitor assessment is unknown. Follow up: On 31JAN2002, the paitent developed pain at injection site meauring 5cm x 9cm, and induration at the injection site measuring 3cm x 6cm developed. The patient was treated with Tylenol and ibuprofen. Outcome details were not provided.
slight swelling, soreness and 2"X1" rash at injection site for one week; still a little sore Also, (self diagnosed) a supraclavicular lymph node on my right side swelled to pea size about the third or fourth day after the shot and is still swollen
double vision in one eye; soreness in his neck and shoulders; soreness in his neck and shoulders; This is a spontaneous report received from a contactable nurse from medical information team.  A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 14Jan2021 13:15 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NECK PAIN (non-serious), ARTHRALGIA (non-serious) all with onset Jan2021, outcome "unknown" and all described as "soreness in his neck and shoulders"; DIPLOPIA (non-serious) with onset 25Jan2021, outcome "recovered" (28Jan2021), described as "double vision in one eye".  Additional information: The patient had his first Pfizer COVID-19 vaccination on 14Jan2021 at 1315 and second on 04Feb2021 at 1315.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A series of several bumps have turned into sores inside of her mouth/ located on the right side of mouth inside the gum of her back bottom teeth and now turning into clusters of blisters; A series of several bumps have turned into sores inside of her mouth/ located on the right side of mouth inside the gum of her back bottom teeth and now turning into clusters of blisters; This is a spontaneous report from a contactable other healthcare professional (patient). A 27-year-old female patient  received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EJ1686), via an unspecified route of administration in left arm on 31Dec2020 at 02:45 PM at a single dose for Covid-19 immunization. Medical history included Covid-19. Prior to vaccination, patient was diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. Patient has no allergies to medications, food, or other products. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Jan2021 at 05:45 PM, the patient experienced series of several bumps have turned into sores inside of her mouth. They are located on the right side of her mouth inside the gum of her back bottom teeth. They are now turning into clusters of blisters. It was unknown whether treatment was received for the adverse events. Since the vaccination, patient has not been tested for COVID-19. The outcome of the events was not recovered.
Day of post-vaccination, my shot area bled. No pain, no initial adverse reaction.   Second day when I woke up at 5:00am, my arms was swollen, I was in pain for 2 weeks, no fever, I was not in my right sense of mind and I was bruised up on the shot area for 3 weeks.   Ice pack, Tylenol and massaging my arm with CBD lotion helped me.
This case was reported by a physician via sales rep and described the occurrence of rash in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient experienced the rash on her trunk within a few days of dosing. The patient also had slept pets she did not own. The patient did not go back for further treatment.
About 2 hours after injection noticed white ring about quarter sized encircling  injection site. Since that time hypo-pigmented region has not changed and color has not returned to that part of my arm.  A white ring remains at injection site.
1st dose on March 25th 2022, 2nd dose on Jun 9th 2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 35-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On 9th June 2022, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 9th June 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-JUN-2022 Reporter's Comments: The pharmacist called to report that a patient received a Twinrix second dose late and now she did not know when administer the third dose. The patient received 1st dose on 25th March 2022. The reporter consented to follow up by email. Additional Supportive Information:  The patient received a Twinrix second dose late, which led to lengthening of the recommended interval between vaccine doses. This was 1 of 2 linked cases, reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022089924:Same reporter
muscle aches, fatigue, headache, light headed, nausea at first, flushed face, sore arm, felt like bugs crawling inside of me (Sat and Sunday), Monday fatigue, light headed, flushing of face, small bumps on arms and legs (begining of rash), no itching.  Tuesday rash on legs and arms, big red welts with blisters with clear fluid in heads, moderate to heavy itching during night while asleep, scratched heads off of many of the blisers, bleeding occurred at blister site,  used Benadryl tabs (2) at approximately 0830hrs and itching became less but did not go away, blisters are still red with heads (where unpopped by scratching), open blisters have small scabs on head but swelling has not gone down,  light headed all day, weakness, tenderness at shot site and moderate muscle aches.
I was experiencing a mild RA flare w/ tendinitis going into the vaccine sequence. After 2nd dose my flare worsened to severe within a 9 day period. I had joint, muscle pain, swelling of fingers, hands. I lost much mobility, having gait issues and could not walk unaided ( a first in a flare). I do not take immunosuppressive infusions. Just NSAIDs. My doctor  prescribed a week of Prednisone. I am improving but having to build up strength to stand and walk. My flare continues but is abated. My muscles are weak.
1240 went to MD office c/o itching, nausea, h/a, vomited; MD prescribed meds;
They started at 08:00PM, I got a high fever - 102 and 103 - which lasted 24 hours and it caused me to have heart palpitations (lasted about 12 hours). I was getting chills and nausea and diarrhea - lasted about 24 hours. I was in a mental fog. I couldn't think clearly. I was having stomach pain. I was too out of it to really treat my symptoms - it was all I could do to go to the bathroom and take my temperature. At 36 hours, I called nurse advice line and I was feeling better - fever had gone down after 24 hours. The diarrhea though didn't stop and so I went to  URGENT CARE -  and they referred me to my to doctor and doctor gave me Vancomycin  - for ten days. That helped it to stop.
Pt came in to have 2nd vaccine pt started to notice her arm itching and saw hives PT alerted us and was taken in medical evaluation room where she was given 50 mg of benadryl Pts hives went away with no other reaction Pt left via POV
Tiredness; Headache; This is a spontaneous report from a contactable consumer. A 58-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jan2021 at 12:00 at single dose in left arm for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tiredness and headache on 12Jan2021 at 16:00. The patient did not receive treatment for the events. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has been tested for COVID-19 with Nasal swab on an unspecified date since the vaccination, with unknown result. The outcome of the events was resolved in Jan2021.   Information on the lot/batch number has been requested.
On the day of receiving vaccine, left arm became swollen, painful and red at the site of injection. Also, chest pain, chest tightness, weak arm, fatigue continues as of today since the vaccine.
expired dose of ACTHIB was inadvertently administered, with no reported adverse event; Initial information received on 26-Jul-2021 regarding an unsolicited valid  non-serious case received from a nurse and physician via Regulatory Authority (under reference 00697020).  This case involved a 2 years old female patient who received an expired dose of HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) inadvertently (expired product administered),   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP); PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and HEPATITIS A VACCINE (HEPATITIS A) [not produced by Sanofi Pasteur] (Lot number and expiration date were not reported) via unknown route in an unknown route for prophylactic vaccination.   On 26-Jul-2021, the patient received a 0.5mL dose of suspect ACT-HIB (lot UJ355AAA and expiration date: 24-JUL-2021; lot number (diluent) U6825AA and expiration date: 05-Dec-2021) via intramuscular route in the left thigh for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (same day latency).  It was reported that " what actions need to be taken."  At time of reporting, the outcome was unknown for the reported event.   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 the 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.
Seven days following immunization, felt sensitivity under both arms, in armpits. Next day developed bumps. Bumps became clear fluid filled blisters over the next 2 days. Blisters resolved over the next 10 days to 2 weeks.
Headache, muscle aches diarrhea felt very "sick" (3 day duration) Was going to go to ER but did not
Initial information received on 14-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 4 months old female patient who was mistakenly given the DTaP/IPV diluent component of PENTACEL without it being used to reconstitute the ActHIB portion. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient was vaccinated with PEDVAXHIB and PEDIARIX at the age of 2 months. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) and ROTAVIRUS VACCINE for Immunisation on an unknown date. On 12-Nov-2018, the patient received a 0.5 ml second dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number: C5408AB and expiry date not reported) via intramuscular route in the right thigh. It was a case of actual medication error due to inappropriate reconstitution technique because only the DTaP/IPV diluent portion of PENTACEL was given separately without it being used to reconstitute the ACTHIB portion. It was unknown if any adverse event occurred or not following the administration of vaccine. 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. Documents held by sender: none.
Tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TINNITUS (Tinnitus). At the time of the report, TINNITUS (Tinnitus) had not resolved.            No relevant concomitant medications reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow-up information received on 16-JUN-2021 and outcome of the event updated.
Onset of generalized urticaria facial, arms, legs, some truncal this a.m. with itching for one day given prescription for BENADRYL orally and betamethasone cream for follow-up in 24 hour possible contact dermatitis foliage.
Fever; sick; I developed Covid symptoms; I was tested Positive; This is a spontaneous report from a contactable consumer(patient). A 58-years-old female patient (weight (kg): 90.72, height (cm): 155) received bnt162b2 (BNT162B2, solution for injection, batch/Lot number not reported), first dose via an unspecified route of administration on 09Jan2021 as SINGLE DOSE, for covid-19 immunization. Patient was 58 years old at the time of vaccination. Medical history included thyroid disorder and asthma from an unknown date and unknown if ongoing. Concomitant medications included montelukast sodium (SINGULAIR), levothyroxine sodium (SYNTHROID), both taken for an unspecified indication, start and stop date were not reported. On 12Jan2021, patient developed Covid symptoms and on 18Jan2021, she was tested Positive. She had fever and became sick from all. The patient was not hospitalized and was seen in the emergency room. Her fever stopped at the end. The patient underwent lab tests and procedures which included blood test: unknown results on 2021 assuming its third Nerve Palsy at this point , computerised tomogram which was normal on 2021 , magnetic resonance imaging was negative  on 2021 it was not Aneurysm or brain tumor, Sars-cov-2 test: positive on 18Jan2021. The outcome of the event fever was recovering and for other events it was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Initial unsolicited report received from a healthcare professional on 06-Jul-2015. This case is linked with 2014SA151239, 2015SA105624, 2015SA015628, 2015SA105631. A patient (age and gender was not reported) whose medical history and concomitant medications were not reported had received a dose of FLUZONE ID (batch number UT4993BA, dose, route, site of administration were not reported) on 30 Oct 2014. Pre-existing physician diagnosed allergies, birth defects, medical conditions and illness at the time of vaccination were reported as none. On 30 October 2015, same day after vaccination, patient experienced that injection site was very sore which lasted almost a week, area around the injection shot was about a circumference of a highlighter, and patient also had fever. Laboratory investigations and corrective treatments were not reported. At the time of this report the patient outcome from the reported events was unknown. Documents held by sender: none.
I woke up in the middle of the night shivering even though it wasn?t cold in the house. The rest of the night I was hot, cold, and aching. Every single muscle and joint in my body hurt, it felt like I had been hit by a train. I could feel soreness down to the muscles in my hands. I could barely move, I couldn?t get comfortable. My head and neck hurt the worst, it was just so sore and painful and everytime I stood up, I would get a pounding sensation in my head. It went on like that for almost 12 hours. The next day I felt perfectly fine.
Nausea, muscle pain, redness, swelling, flu-like symptoms/feelings starting with nausea the evening of the shot and still occurring now but has improved. Has missed 2 days of work.
Severe adverse reaction with a severe rash all over body. Visited the emergency room on two occasions and they administered solumedrol and Benadryl intravenously.
Janssen COVID-19 Vaccine EAU Received Janssen Covid vaccine at 5pm on Thurs. 3/25  and  3 to 4 minutes after receiving the shot it felt like ice water was flowing through my legs only. It lasted a minute or so. At 2am on Fri. 3/26 woke up to nausea, SEVERE body aches, Severe headache, weakness. I could barely lift my legs or get up from the commode ,chills, and fever of 100.00. I had started taking Tylenol 500 to 1000 mg  around 6pm on 3/25 and continued every 4 hours. The pain from the body aches was so bad that Tylenol wasn't helping. My fever stayed in the 100's with 1000mg of Tylenol. I started seeing symptoms ease up on Saturday 3/27. I no longer had chills and fever but just mild body aches and fatigue.  Had diarrhea on 3/27.