chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had the vaccine, got shingles/Suspected vaccination failure; Shingles; Had more shingles vaccination; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt date: 01-MAR-2023 Reporter's Comment:  This case was reported by a patient via interactive digital media. The patient had the vaccine and still got shingles but thank it was mild considering how bad it could have been. Since then patient had more shingles vaccination The follow-up could not be possible as no contact details were available. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The patient received more shingles vaccination which led to extra dose administered. The event extra dose administered was coded conservatively as follow up was not possible and it was unclear how many doses of shingles vaccine the patient received.  Being conservative, the GSK Receipt Date entered on the case was 01-Mar-2023 as this was the oldest date in the source document, though the Date the Author Published the Social Media 2 Mar 2023.
Sudden, intense itchiness and discomfort at site and surrounding area (including intramuscular) of injection site with surface (approximately 2 inches in diameter around injection site) that became hot, reddened, and raised
reports that a 7-month old patient received menquadfi with no reported adverse event; Initial information received on 08-Sep-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 7-months-old male patient who received meningococcal A-C-Y-W135 (T conj) vaccine [Menquadfi] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 13V (CRM197) (Prevnar 13); and Rotavirus Vaccine for Prophylactic vaccination (immunization).  On 08-Sep-2023 at 09:00 hours, the 7-month old patient received 0.5 mL dose of suspect meningococcal A-C-Y-W135 (T conj) vaccine, solution for injection (batch number: U7616AB via intramuscular route in the upper thigh NOS for Immunization with no reported adverse event (product administered to patient of inappropriate age) (same day latency).  Reportedly, the MENQUADFI was given in error because the staff mixed up the vaccines.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 48 year old male. Initial information was processed along with the additional information received on 06-MAY-2022. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 27-AUG-2021 to right arm for prophylactic vaccination. The age at time of vaccination was 48 years old. No concomitant medications were reported. On 04-JAN-2022, the patient experienced headache and mild fever of 99.3 degree Fahrenheit. On the same day, the patient had tested positive for covid-19 in a Binax rapid antigen test which indicated suspected covid-19 infection and suspected clinical vaccination failure. On 06-JAN-2022, the patient recovered from headache and mild fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000229574.; Sender's Comments: V0:20220509386  -Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
03/06/2021 Tested posted with Rapid swab test at pharmacy.  Had second test that did a saliva test and those were negative
Caller reported expired vaccine administered.  No additional information provided.  No additional AEs or PQC reported.; Caller reported expired vaccine administered.  No additional information provided.  No additional AEs or PQC reported.; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug allergies or reactions, and concomitant medications were unknown by the reporter.  On 26-OCT-2022, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0.5 milliliter administered intramuscularly (IM) in the right (Rt) deltoid (vaccination scheme frequency was not provided; valid lot number T036820, with an expiration date of 01-JUL-2022) administered as prophylaxis (expired vaccine used). No additional adverse event (AE) or product quality complaint (PQC) were reported.
Skin hives. On exam, <1cm, discrete wheals. Lasted about 4-5 days. Benadryl was used.
This medically confirmed literature report (initial receipt 24-Aug-2015) concerns a 15 year-old female patient. On an unspecified date, the patient received Influenza virus vaccine (manufacturer and batch number not provided) via the intramuscular route. On an unspecified date, the patient experienced flu-like symptoms such as malaise, fever, and rhinorrhea within a week after inoculation. The patient did not complain of taste dysfunction. The SIT (Smell Identification Test) score was 18/40 which was not suggestive of malingering (<6). The patient was diagnosed with anosmia. The PEA (phenyl ethyl alcohol) test scores were -2.00 left, -2.75 right and -2.75 bilateral. The Whole-Mouth test identification test score was 98% correct. The outcome was not reported. Reporter's comments: The authors reported that this was a rare occurrence in an adolescent individual. The smell dysfunction was not attributed to any one season's vaccination program and they were presented to the center over the course of 10 years. The patients attributed the chemosensory/olfactory disturbances to an influenza vaccination. As with the SIT and the olfactory tests, neither the influences of ever having had an influenza vaccination nor the total number of lifetime inoculations were associated with the test measures. The present study suggested the possibility that, in rare cases, influenza vaccinations may be associated with olfactory dysfunction. In these patients whose smell loss was attributed to causes other than influenza vaccinations, the magnitude of vaccination influences was too weak to overcome the primary basis for their loss. There were no associations apparent between quantitative smell or taste test scores and reports of having one or more lifetime influenza vaccine inoculations. The benefits of receiving an influenza vaccine would seem to clearly outweigh its potential side effects.
Patient received Moderna Covid-19 vaccine that underwent a temperature excursion; Patient received Moderna Covid-19 vaccine that underwent a temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014B22A and 058F21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Janssen (Dose no: 1 andBatch no 1808980.) on 09-Apr-2021. Past adverse reactions to the above products included No adverse reaction with Janssen.   On 23-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jul-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) 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 weight was reported as unknown. It was reported that, the nurse had discovered temperature excursions of the Moderna COVID-19 vaccine. The temperature in the refrigerator that the Moderna COVID-19 vaccine reached 13.1 degrees Celsius on 28-Jun-2022. Further nurse stated that, none of the vaccine in the refrigerator underwent two different temperature excursions.  It was reported that the patient received Moderna Covid-19 vaccine that underwent a temperature excursion. The temperature excursion was not known at the time of administration of the vaccine. The temperature excursion was found out about after a review of the temperature datalogger on the refrigerator that the Moderna Covid-19 vaccine was stored in. The nurse had used the online temperature excursion tool and was comfortable that her patient's doses were valid and that the affected vaccine was viable for future doses. The side effects after the doses was reported as unknown. No treatment medications were reported.
Patient passed out 5 minutes after being vaccinated. She came to after a few minutes. She did not have an anaphylactic reaction.
Patient complained of having pressure in chest, reports he has history of this before. Refused ER transport and cleared by EMS
PATIENT STATED THAT THE DAY FOLLOWING THE INJECTION, SHE HAD REDNESS/SWELLING THAT EXTENDED ALL THE WAY DOWN TO HER ELBOW, HEADACHE (FELT ON LEFT SIDE OF HEAD ONLY), JAW PAIN (FELT ON LEFT SIDE ONLY - ALMOST UNABLE TO OPEN MOUTH), FATIGUE & MALAISE.
1/27/21-red rash noted below injection site LA spreading around arm with pain noted. 1/28/21-Went to ER & received Benadryl & Pepcid. LA from shoulder to wrist was swollen, painful & itchy. 1/30/21-Rash was gone and arm felt fine. 1/31-21-4 pm that day rash was back on LA, area  hot to touch, swollen & painful, felt woozy. Noted itching on torso, back, arms & head. Went back to ER & given topical cream. 2/1/21-Now has a slight rash on RA & back reddened. States she is getting 3/4 of her normal breath. (She has asthma).
I got it that morning at 9am ,that evening I started to have chills and fever to 103. It continued through the night until the next day. I was having serve muscle pains and difficult walking my myself.  This lasted about 22 hours.  I contacted my Doctor but did not go in.
Initial information received on 27-Mar-2019 regarding an unsolicited valid non-serious case received from a non-healthcare professional via phone. This case is linked to case 2019SA087184 (same reporter). This case involves a female patient (age not reported) who experienced burning throughout their bodies, while he received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On an unknown date of Nov-2018, the patient received a dose of suspect Influenza Quadrival A-B Vaccine (lot number, expiry date, dose, dose in series, route and site of administration were not reported). On an unknown date, the patient developed a non-serious burning throughout their bodies (burning sensation) following the administration of Influenza Quadrival A-B Vaccine. No Lab data was reported. Final diagnosis was burning throughout their bodies. It was not reported if the patient received a corrective treatment. The outcome of the event was not reported. Documents held by the sender: none.
Covid vial was taken out of fridge 4/18/23 at 7:50 a.m . Over the time limit.
on or about February 22, 2022, I began to notice swelling in my neck and soreness in my lymph glands. I made an appointment with my primary physicians office. she was not available so I took a different dr. she prescribled antibiotics amox-clav 875-125. I took those and did not get any relief. I made another appointment and got to see my regular dr. she put me on clyndamiacin. still no relief. was  checked by a dentist for abscess no infection found. went back to first dr for follow up and got referred to another Dr. he said my lymphasites were doing their job . said if any changes to call him.
Rash from Shingles vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On 26th February 2022 08:58, unknown after receiving Shingles vaccine, 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 Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The reporter stated there was rash from the shingles vaccine. Follow up would not be possible as contact details were not provided.
This spontaneous report was received from a healthcare professional and refers to a 44-year-old male patient. The patient denied any pre-existing physician diagnosed allergies, birth defects or medical conditions. On 23-NOV-2016 at 01:48 p.m., the patient was vaccinated in the private's doctor's office/ hospital with the first dose of PNEUMOVAX23 (lot # M006141) (dose was not provided), intramuscular in the left deltoid for prophylaxis. There was no illness at the time of vaccination. Concomitant therapies included FLONASE. On 23-NOV-2016, he experienced a sharp pain in the left wrist and there was a drawing that pointed to the left wrist of the patient. The outcome of the event was reported as recovered, on an unknown date in November 2016. The relatedness between the event and PNEUMOVAX23 was not provided. Additional information has been requested.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 63-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 63, in left arm, on Aug 2, 2021, at 15:45, single dose, for COVID-19 immunisation. No medical history or concomitant medications reported. The patient experienced fatigue (extreme fatigue continued from first vaccine), onset Aug 3, 2021, at 09:00, with outcome of not recovered. Relevant laboratory tests and procedures available in the appropriate section. No therapeutic measures taken as a result of fatigue. Follow-up (Oct 25, 2021): This follow-up submitted to notify the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information expected.
R deltoid swollen, warm, tender, slight erythema and pruritus. No associated lymphadenopathy, lymphangitis. Improved somewhat w/out intervention but still present so father, who is a nurse, brought patient in for evaluation today.
Fever; Chills; Pain in left deltoid; Red rash in left arm; This non-serious case was reported by a nurse via sales rep and described the occurrence of fever in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number EN939, expiry date 31-OCT-2024) for prophylaxis.   On 14-MAR-2023, the patient received Bexsero (left deltoid). On 15-MAR-2023, 1 days after receiving Bexsero, the patient experienced fever (Verbatim: Fever), chills (Verbatim: Chills) and localized muscle pain (Verbatim: Pain in left deltoid). On 16-MAR-2023, the patient experienced red rash (Verbatim: Red rash in left arm). The outcome of the fever, chills, localized muscle pain and red rash were resolved (duration 24 hrs).   It was unknown if the reporter considered the fever, chills, localized muscle pain and red rash to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the fever, chills, localized muscle pain and red rash to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   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-APR-2023 Reporter was a nurse  Nurse reported that female patient received Bexsero vaccine in her left deltoid then 24 hours later the patient started with fever, chills and pain in left deltoid. Reporter also informed 48 hours after the administration the patient experienced a red rash in her left deltoid.  All symptoms went away in 24 hours.  The reporter was consented to follow up.
Six days after the shot (Thursday morning 07/15) my left armpit was sore. The following evening (Friday 07/16) I noticed red bumps/rash on my upper arm where the injection site was; it resembled and insect bite. Throughout the evening, the red bumps turned into a painful, itchy rash with hot-to-touch hard lump, that was about the size of a quarter. The next day (Saturday 07/17) the rash had progressed and worsened; it is very hot to touch, large lump under skin, swollen, very red. The area had grown to consume most of my upper arm. Later Saturday afternoon, I began to feel very hot, took my temperature and had a fever 100.00 and decided to go to an urgent care. I was diagnosed as an allergic reaction and cellulitis. I was giving three shots: 1. Decadron and the other two shots were Clindamycin.  I will begin Clindamycin capsule tomorrow.
Severe shoulder and arm pain with swelling after 2nd dose of Covid vaccine. Unable to use left arm at all for 2 weeks and then slowly got more mobile. Six weeks after still had limited mobility and pain. Made a doctor appointment and was diagnosed with frozen shoulder and prescribed prednisone and specific exercises. Was told if this doesn?t work will have to have shots in my shoulder and physical therapy.
itching sporadically all over her body/it was on her foot, then shoulder, then knee, then back, then face/It was like spot itch; rash with welts on her chest; The caller arm is sore; rash with welts on her chest; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown) dose 2, via an unspecified route of administration on 14Mar2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. She received the 2nd dose of the Pfizer covid vaccine 14Mar2021 (yesterday.) On 15Mar2021, she woke up in the middle of the night with itching sporadically all over her body, but not at the same time. At one point it was on her foot, then shoulder, then knee, then back, then face. She was still experiencing that. It was like spot itch. One time the itch was in-between the toes, then on her face, then on her stomach, it kept changing all over her body. She now has a rash with welts on her chest. Her arm was sore. She wanted to know if she can take Benadryl. The outcome of events was unknown.  Follow-up attempts completed. No further information expected.
heavy cough, fever & chills;finally, chills stopped on 11NOV96, cough still w/pt;
Lymphatic swelling in neck, underarms, primarily and other sites so badly I could not wear a bra or put my arms down. Simultaneously development  of lateral left thigh neuropathy so bad the pain hurt when walking.  Put on course of strong 800mg ibuprofen to help with inflammation and additional monitoring of thigh. Eventually after about 2 months the lymphatic swelling went down and began physical therapy for thigh and back compression hoping it was neurological. Thigh persists to the present with minor improvements with continued bilateral poly neuropathy development and frequent full body inflammation.
I began to feel nauseous and shaky within 20 minutes. I was dizzy, but almost more feeling like my thoughts were jumbled and I had a hard time speaking. I began to get a terrible headache and then began vomiting. I was shaking and out of breath. I was terrified because this was something I had never felt before. The symptoms began to fade within 4 hours and then I experienced the "normal" side effects, such as arm pain and tiredness.
lower back pain; body aches; Lowgrade fever of around 99-100 degrees; This spontaneous case was reported by a patient and describes the occurrence of BACK PAIN (lower back pain), PAIN (body aches) and PYREXIA (Lowgrade fever of around 99-100 degrees) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B212A and 040B27A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced BACK PAIN (lower back pain), PAIN (body aches) and PYREXIA (Lowgrade fever of around 99-100 degrees). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at a dose of 1 dosage form. On 16-May-2021, PAIN (body aches) and PYREXIA (Lowgrade fever of around 99-100 degrees) had resolved. At the time of the report, BACK PAIN (lower back pain) had not resolved.            Patient used arthritic cream for his back as corrective.   No concomitant medications were reported.