chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; DIFFICULTY FALLING ASLEEP; This spontaneous report received from a patient concerned a 55 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805029 expiry: Unknown) dose was not reported, 1 total, administered on 10-MAR-2021 in left arm for prophylactic vaccination.  On 01-MAR-2022, patient had confirmed clinical vaccination failure (dose number in series 1). The patient received additional non-company suspect vaccine included: mrna 1273 (Moderna, ELASOMERAN) (form of admin, and route of admin were not reported, batch number: 084J21A expiry: Unknown) dose was not reported, administered on 16-FEB-2022 in left arm for prophylactic vaccination. No concomitant medications were reported.  On 01-MAR-2022, the patient experienced stuffy nose and sneezing (confirmed covid-19 infection) and had difficulty falling asleep (dose number in series 2). Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s, and mrna 1273 was not applicable. The patient recovered from confirmed covid-19 infection, and difficulty falling asleep on 03-MAR-2022, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0: 20220324974-COVID-19 VACCINE AD26.COV2.S-confirmed 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.
Information has been received from a physician concerning a 5 month old male who was vaccinated PO with the second 2.0 ml dose of Rotateq.  Concomitant vaccinations administered that same day were "other vaccines" (names unknown).  In 2008 "10-12 days" after vaccination, the patient experienced "full-blown" rotavirus and dehydration and was hospitalized (length of hospitalization unspecified).  Lab diagnostic studies included a positive test for rotavirus.  Subsequently, the patient recovered.  There was no product quality complaint.  Additional information has been requested.
23 years old received a dose of pediatrix Engerix-B; 23 years old received a dose of pediatrix Engerix-B; This case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 23-year-old female patient who received HBV (Engerix B pediatric) (batch number 722KC, expiry date 6th April 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th May 2021, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 11th May 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced adult use of a child product and underdose. On an unknown date, the outcome of the adult use of a child product and underdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Medical assistant reported that a 23 years old patient received a dose of pediatrix Engerix-B, which led to adult use of child product and underdose. The reporter consent to follow up.
Pt c/o flushing/sweating and dizziness after vaccination. Vitals: 128/79, 70, 16 Pt given juice and crackers. Pt stable and released from the vaccination site.
Blanching macular rash to face, abdomen, chest, and arms 10 days after receiving Proquad vaccine.
pt inadvertently recv 2 doses of Pnu-Imune 23 30 days apart;pt devel pneumonia;addtl info recv 12MAY97;reporter stated thought that pt vax could have an untoward effect;however it is not the case;
Sicker that I have ever been in my entire 49yrs! Fever, tremors, vomiting, diarreah, vertigo (all at once).
Received MCV4 IM left Deltoid and TDAP IM (R) Deltoid. At 1125 on 8/5/16. At 1800, patient noticed swelling at injection sites when removed bandaids; warmth, induration. No meds taken to relieve pain/selling. RTC 8/7/16 at 1644 R Deltoid erythema induration 6/5 cm X 7cm Left Deltoid 8cmX7.5cm. Tx with Ibuprofen; cool pack, monitor for adverse effects or increase in size/pain.
Sore slightly raised red patch 1/2x1/8" inside mouth (inside cheek), right side, appeared 2d post-vax
Abscess at injection site. Lump with no cellulitis or pain. Site drained and prescribed Cephalexin 250mg/5ml Two milliliters three times daily for ten days.
Pt's mother notice a red rash on DTaP site. PT C/O itching on TDaP side. Mother also noticed a small rash on varicella side with no itching. Mother gave TYLENOL 2ml for pain. Pt was seen today by provider and prescribed BENADRYL 125mg oral/chewable tablet. 1 tab every 6 hours. Mother states that she never had a reaction before.
I am sensitive to the vaccine and was out of work for three days just not feeling good. I had a fever, fatigued and body aches. I tested in COVID-19 in 01/2023. I was too far into being sick and unable to get a prescription. I was monitored at the emergency room due to having difficulty breathing. I had test ran and at that time I was diagnosed with an aortic aneurysm. As of today, I feel better from COVID-19 with no lingering symptoms. I am taking medication for my heart.
Bells Palsy dx pt 12/9/2014. Vaccine influenza 12/12/2014.
EXFOLIATIVE ERYTHRODERMA - required hospitalization due to dehydration. Treated with steroids for over 2 wks.  6/17/09 Medical record received DOS 6/1/09. Assessment: Exfoliating erythroderma, dehydration. Patient presents with pruritic, raised, macular rash over entire body except for hands and feet. Irritable. Rash is scaly and began to desquamate. Excoriations. Pain. Not sleeping well. Decreased food and fluid intake and fewer wet diapers.  To admit to hospital.  6/22/09 ICD-9 Codes received DOS 6/1/09: 69589, 27651
Information has been received from a physician concerning a male who in November 2007, was vaccinated with ZOSTAVAX vaccine (Oka/Merck) (lot number, injection site and route not reported). In August 2008, the patient developed mild zoster. The physician drew a serum. It was unknown whether the patient sought any medical attention. Additional information has been requested. Follow up information was received which indicated that no adverse effect and no action was needed. Additional information is not expected.
fever 38+  chills; cough; fatigue; muscle or body aches; headache;   loss of taste smell congestion or runny nose
Massive swelling in armpit area. Arm was sore the day after the shot but the swelling in armpit did not Come until 2 days later. Very uncomfortable. Very sore.
Less than 24 hours after injection developed color, induration at DTaP site left deltoid.
Vaccine was administered on 1/19/23, which was after the Beyond Use Date (1/6/23). Individual was notified of the need to repeat the dose.
LEFT SIDE FACIAL PARALYSIS INCLUDING EYE; This spontaneous report received from a consumer concerned a 55 year old white and not Hispanic or Latino male. The patient's height, and weight were not reported. The patient had no medical problems before the vaccine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown), dose was not reported, 1 total, administered on 28-MAY-2021 to left arm as prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included unspecified blood pressure medication, an unspecified diuretic, aluminium hydroxide/magnesium hydroxide (Maalox) for stomach issue, and vitamin b nos.  On 29-MAY-2021, Saturday around midnight the patient experienced left side facial drooping. On 30-MAY-2021, the patient was hospitalized. The patient did not have a stroke, but was on medication now with facial paralysis, taking multiple medications including unspecified steroids. The patient was getting blood work every 10 days now and was seeing a neurologist for the paralysis. It was also reported that the patient could not see out of left eye due to drooping but seemed to be looking better after a week with steroids. On an unspecified date in 2021, Laboratory data included: Blood test (NR: not provided) Not reported.  The patient was hospitalized for 1 day and was discharged on 31-May-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left side facial paralysis including eye. This report was serious (Hospitalization Caused/Prolonged).; Sender's Comments: V0:20210608311 -COVID-19 VACCINE AD26.COV2.S-Left side facial paralysis including eye. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Initial and follow up information has been received from a registered nurse, via a company representative (initial information), concerning a 69 year old male patient, with no known medical allergies, who on 10/06/2005 was vaccinated intramuscularly with a dose of Pneumococcal 23v polysaccharide vaccine (lot 649989/0579P)> it was reported that at the time of vaccination, the patient had acute bronchitis. It was previously reported that on 10/06/2005 the patient developed severe inflammation at his injection site. On 11/1/2005 the patient returned to the clinic complaining of an abscess at the injection site. It was approximately a half dollar size and redness surrounding it. The patient was treated with an intervenous antibiotic, ceftriaxone sodium (Rocephin), one gram daily three times, and cephalexin (Keflex), 500 every 8 hours, #20. Subsequently, on 11/17/2005, the patient recovered. The patients experiences were considered an other important medical event (OMIC). Additional information is not expected.
Dropped a vial out of refrigerator 3 to 4 feet.; It may have shaken when it hit the ground; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Dropped a vial out of refrigerator 3 to 4 feet.) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (It may have shaken when it hit the ground) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034c21a) 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 PRODUCT STORAGE ERROR (Dropped a vial out of refrigerator 3 to 4 feet.) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (It may have shaken when it hit the ground). At the time of the report, PRODUCT STORAGE ERROR (Dropped a vial out of refrigerator 3 to 4 feet.) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (It may have shaken when it hit the ground) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.
States got Flu shot and 8-10 hours later started itching & red spots & in arm (6-8 hours later) had hives, severe itching and pain all over especially in legs.
-Elevated resting heart rate from a normal of 64-67 to 90+ for hours.  -Elevated blood pressure.  Normal is ~120/76.  My blood pressure was consistently 150+/95 for hours.  -Sweating and anxiety.
From initial information received on 20Apr04 from a physician regarding an adverse event occurring, it was reported that a female pt (age not reported) received her first dose of Imovax rabies pre-exposure series, lot number W14192, route and site of administration not reported, on an unspecified date. An unspecified time later, the pt experienced arthralgias, migraine headaches and enlarged mass in her chest wall. A work up for breast mass revealed an enlarged lymph node. Reportedly, the pt refused to receive the second dose of the vaccine. She is to follow up per recommendations. It is unk whether the pt recovered from these events. From additional information received on 23Apr04 from the pt, it was reported that she received the Imovax Rabies vaccine at 4:15PM on 20Apr04. Approx a half and hour later, the pt developed hives and a headache. She took Benadryl and ibuprofen at 4:50PM. The hives slowly went away over two hours. She did not experience any difficulty breathing, but did state that her arm is still sore and she still has a headache. The pt has not recovered from these adverse events. The pt had previously experienced hives after receiving Imovax Rabies (lot not reported) in Oct and Nov of 2003. She received three doses and experienced hives after each dose. The hives reportedly got worse after each vaccination. From additional information received on 24May04, it was reported the pt received Imovax Rabies vaccines on 05Oct03, 22Oct03 and on 12Nov03. The reaction was reported to the health dept in Apr 04. The pt did not contact the health dept at the time symptoms occurred. Reportedly the pt recovered from these events. No further information is anticipated, this case is considered closed.
I woke up this morning not feeling great; I don't feel well; Joint pain; Muscle pain; Fever; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# FL3247 or EL3247) via an unspecified route of administration on 21Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no problems in the evening of 21Jan2021. The patient woke up this morning on 22Jan2021 and was not feeling great. The patient had some muscle pain, little more intense during the day, joint pain and muscle pain and now the patient had a fever. The patient had thermometer and it said 101.2. The outcome of events was unknown.  Information on Lot/batch number has been requested.
Patient was administered high dose flu shot at approx 0943 on 10/5/10. Triage RN received a call at 1542 from spouse stating that patient was in bed with temp of 102 could not stop shaking, cool to touch, red face/head and could not get warm, no cough. Patient instructed to drink fluids, take TYLENOL and go to ED if temp increased to 104. Follow up call made on 10/6/10 at 0950 patient stated he was back to normal-reported 6-7 hours of discomfort, 2 hours of which he had chills and rest of time hot.
Yesterday am (6/9) awoke with swelling and redness on left arm, just below shoulder to elbow area, to ice and give Ibuprofen.
administered adjuvant without active component; administered adjuvant without active component; This case was reported by a physician via sales rep and described the occurrence of inappropriate preparation of medication in a 61-year-old male patient who received Herpes zoster (Shingrix) 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 inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient was administered the Shingrix adjuvant without the active component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The Shingrix vaccine batch number, expiration date were unknown The reporter consented to follow up. This case is linked with case US2022051810, US2022051804 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022051804:Same reporter. US-GLAXOSMITHKLINE-US2022051810:Same reporter.
Tested Positive for the Covid Virus; Fever 103.5 along with other symptoms; This is a spontaneous report from a contactable nurse reported that a female patient of an unspecified age received bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for Covid-19 immunization. The patient medical history was unknown. The patient's concomitant medications were unknown. it was reported that, patient was vaccinated with the first Pfizer Covid Vaccine and wanted to let you know 10 days later had Fever 103.5 along with other symptoms. Tested Positive for the Covid Virus. Outcome of the events were unknown.       Information on the batch/lot number has been requested.
Information obtained from mother.  Pt. c/o a lump on left shoulder near the neck about 1 weeks after 1st covid vaccination.  It is about 1/2" in size, oval in shape.  It is tender but not painful.  The lump has not changed in size.  He has not sought care because of having no insurance.  Mom was given names of local clinics for uninsured.
Redness, swelling, warmth around the injection site. Patient noticed >24 hours post injection. Spread across deltoid and down arm toward bicep. Mildly pruritic. Has remained inflamed, pruritic and uncomfortable to this time (~66 hours post vacination). Not interfering with activities of daily living.
Sore lower back; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Sore lower back) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced BACK PAIN (Sore lower back). At the time of the report, BACK PAIN (Sore lower back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
Red Rash resembling goosebumps from ankle to mid calf.  Very itchy. Warm to touch. Used creams to help with itching.  The only thing that seemed to offer relief was one Zyrtec every 24 hours along with very hot bath in the evening.  Lasted 10 days.  You can still see dots on legs.
Pt was given Flublok vaccine that is meant for individuals 18 years of age and older. Pt is 16 years of age.
Shingles, maybe eye infection too? I got grit in my eye while working on my car 5 days after my first Pfizer shot. In the following days I began to be bothered by my eye and possible infection. A doctor video call 9 days after my Pfizer shot suggested antibiotics for my eye (Cephalexin). My girlfriend thought possibly shingles and suggested I ask doctor. 2nd doctor video visit, 11 days after Pfizer shot, doctor agreed Shingles likely - began antiviral Valacyclovir that evening for 7 day prescription . Continued with my 7 day prescription of Cephalexin as well. I had a relatively light bout of Shingles but the scaring and nerve tingling is still present two months later. I had face breakouts for about a month.
Has a question about a possible interaction with Naproxen and the COVID vaccine; her muscles and joint pain are worse /her pain was worse; Injection site pain; Legs, back, shoulders, and pretty much everything hurts; stronger muscle and bone pain; stronger muscle and bone pain; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9267), via an unspecified route of administration on 10Feb2021 12:36 (at the age of 73-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included diabetes, arthritis, blood pressure. Concomitant medication(s) included metformin 500 mg twice a day taken for diabetes mellitus, start and stop date were not reported; lisinopril 10 mg once a day taken for blood pressure, start and stop date were not reported. The patient experienced stronger muscle and bone pain after the injection on 10Feb2021. She was due for her second dose on 03Mar2021. She had started taking Naproxen 500 mg twice daily and was wondering if there was a possible interaction with the vaccine. If so, when should she stop taking the medicine and when should she resume after receiving the second dose. She had read some place that Naproxen, an NSAID, might reduce the effectiveness of the COVID Vaccine. She was in such pain after the COVID Vaccine. Right afterwards her muscles and joint pain were worse. She needed to take Naproxen. Wanted to know how long she can be on Naproxen before her second dose. Her back and legs were in pain. She thought she could use heat pads. Tylenol does not work at all for muscle pain. She wanted to know if that was detrimental to the vaccine. She reported that injection site was not hurting after two days. Injection site was painful starting 11Feb2021 and she could lift her arm. After two days it subsided. The rest of her was not good. Her legs, back, shoulders, and pretty much everything hurts. Pain was terrible on 11Feb2021. She could not say she never had back pain before the COVID vaccine because she has arthritis. Her arthritis was under control. For some reason after the COVID Vaccine, her pain was worse. Started the Wednesday after the COVID vaccine and has continued. She said she has regular arthritis and not rheumatoid arthritis. The patient willingly took Naproxen. She stated asking her doctor for Prednisone would probably be worse. Stated sometimes doctors prescribed Prednisone and then has to be tapered off. Definitely read that Prednisone has an interaction and lowers the effectiveness of the COVID vaccine. She confirmed that she has not been prescribed Prednisone. The patient received treatment for stronger muscle and bone pain. The outcome of event vaccination site pain was recovering, stronger muscle and bone pain and for all other events was unknown.  No follow-up attempts are possible. No further information is expected.
Client had a Trumenba at his doctor's office. Came here to get the second Men B . Gave Bexsero.  This clinic does not carry Trumenba but this nurse aware that manufacturer needs to stay the same. Oversight when looking at the Record.  There was no adverse event at this time. Explained error to the mother.
Varicella Information has been received from a physician concerning a 11 year old male who in 1997 was vaccinated with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck). The physician reported that in 2005 the patient subsequently developed chickenpox characterized by about 120 lesions. Unspecified medical attention was sought. At the time of this report, the patient still appeared to have "a few lesion" or scars but the physician noted that the patient was not contagious
I had body aches, chill, fever, SOB, and cough. I also had lost taste and smell. These lasted for about a month and half. On Dec 21st, I tested positive for COVID-19.