chrisvoncsefalvay/vaers-outcomes huggingface dataset:
When this patient was seeing former doctor, she received one PREVNAR vaccine. Prior to the vaccine, she was already smiling and interactive. For 2 days after the vaccine, the parents reported she stopped smiling and interacting, as if "no one was there". She then recovered and they have declined the vaccine since.
day p/vax pt devel raised red rash, like hives on head, forehead, back, stomach, neck, chest , buttocks & genital area.
Fatigue; Muscle ache; This case was reported by a nurse via sales rep and described the occurrence of fatigue in a female patient who received Herpes zoster (Shingrix) (batch number T44C7, expiry date 26th February 2022) for prophylaxis.   On 14th February 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced fatigue and myalgia. On an unknown date, the outcome of the fatigue and myalgia were recovered/resolved.   It was unknown if the reporter considered the fatigue and myalgia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that the patient experienced muscle ache and fatigue for several days. The patient received 2nd dose on 15th July 2020 (batch number: T44C7, expiry date: 26th February 2022). The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR135104:same reporter US-GLAXOSMITHKLINE-US2020AMR135190:same reporter US-GLAXOSMITHKLINE-US2020AMR137983:same reporter
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 28-FEB-2019 (reported as yesterday), the patient was vaccinated with second dose of GARDASIL 9 (lot, expiry date, dose and route of administration were not reported) one month early in a two dose regiment for prophylaxis. No adverse effects were reported. No product quality complaint was filed.
Spoke with the patient's mother, who reports patient had the following side effects after receiving the Pfizer vaccine on 9/8/21. Symptoms occurred while at home: - "Throat swelling" (she did not call EMS or seek medical attention. Mom gave her Benadryl and symptom improved) - Tongue itchiness - Lower lip swelling and itchiness - small itchy bumps on her chin - "diarrhea" (frequent passage of loose stool) - tactile fever - abdominal pain The mother gave patient OTC Benadryl and symptoms improved. Pt scheduled to see a Provider for follow-up care. .
near syncope, dizziness; near syncope, dizziness; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PRESYNCOPE (near syncope, dizziness) and DIZZINESS (near syncope, dizziness) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced PRESYNCOPE (near syncope, dizziness) and DIZZINESS (near syncope, dizziness). At the time of the report, PRESYNCOPE (near syncope, dizziness) and DIZZINESS (near syncope, dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PRESYNCOPE (near syncope, dizziness) and DIZZINESS (near syncope, dizziness) to be not applicable.    Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
SWOLLEN LEGS AND FEET; ACHES AND PAIN IN NECK; LEGS FELTS TIGHT; FEET FELTS TIGHT; ACHES AND PAIN IN HIPS; ACHES AND PAIN IN ARMS; EXHAUSTED DAY AND NIGHT; This spontaneous report received from a patient via a company representative concerned a 60 year old female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported. On APR-2021, the subject experienced swollen legs and feet. On APR-2021, the subject experienced aches and pains in neck. On APR-2021, the subject experienced legs feel tight. On APR-2021, the subject experienced feet feels tight. On APR-2021, the subject experienced aches and pains in hips. On APR-2021, the subject experienced aches and pains in arms. On APR-2021, the subject experienced exhausted day and night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the exhausted day and night, aches and pains in hips, swollen legs and feet, aches and pains in arms, aches and pains in neck, legs feel tight and feet feels tight was not reported. This report was non-serious.
Covid positive on 21-JAN-2022; 21Jan2022: Covid positive; pain at the injection site; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid positive on 21-JAN-2022) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INJECTION SITE PAIN (pain at the injection site). On 21-Jan-2022, the patient experienced COVID-19 (Covid positive on 21-JAN-2022) (seriousness criterion hospitalization) and DRUG INEFFECTIVE (21Jan2022: Covid positive). At the time of the report, COVID-19 (Covid positive on 21-JAN-2022) and INJECTION SITE PAIN (pain at the injection site) had resolved and DRUG INEFFECTIVE (21Jan2022: Covid positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2022, SARS-CoV-2 test: (Positive) Positive.         No concomitant medication was reported.     Patient received treatment of Monoclonal antibody infusion on 28-Jan-2022.  Company Comment: This is a spontaneous case concerning a female patient of an unknown age with no medical history reported, who experienced the unexpected serious (hospitalization) adverse event of special interest COVID-19, supported by a positive SARS-CoV-2 test, which occurred approximately 12 months and 1 week after receiving the first dose of mRNA-1273 vaccine and approximately 11 months and 1 week after receiving the second dose of mRNA-1273 vaccine. Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 26 days. Additionally, Drug ineffective was also reported. Patient was given a Monoclonal antibody infusion and reported that the event COVID-19 had resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-611900, MOD-2022-611797 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a female patient of an unknown age with no medical history reported, who experienced the unexpected serious (hospitalization) adverse event of special interest COVID-19, supported by a positive SARS-CoV-2 test, which occurred approximately 12 months and 1 week after receiving the first dose of mRNA-1273 vaccine and approximately 11 months and 1 week after receiving the second dose of mRNA-1273 vaccine. Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 26 days. Additionally, Drug ineffective was also reported. Patient was given a Monoclonal antibody infusion and reported that the event COVID-19 had resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.
patient described feeling lightheaded, near syncope, 'almost passed out' 15 minutes after vaccine administration
8/14/21 hx of SLE on chronic steroids, adrenal insufficiency, HTN, Sjogren's, DM, fibromyalgia, avascular necrosis of hips, RA, TIA vs seizures. Presented for left rib pain, shortness of breath and worsening cough
I woke up March 20,2021 and both of my Parotid glands were swollen. I went to UTC and they could not find any sign of infection and I did not have pain or a fever. They told me to follow up with my Primary Care doctor and get some blood work done. I saw my doctor March 22 and he examined me and ordered blood work. I did not feel well the week before my glands swelled and he felt it was just a viral syndrome that will run it course. All of my blood work was normal but my glands are still swollen as of today. I am beginning to wonder if it is a side effect from the vaccine.
A booster clinic was set up with Pharmacy and Facility to ensure that residents were receiving the boosters. All paperwork had been done and consents signed. This resident was given a booster even though staff told pharmacist there was no consent. Family was notified of the adverse event. They had declined to let her have the booster even though she had had the initial vaccines.
Information has been received from a physician via a field representative referring to a patient of unknown age. On an unknown date the patient was vaccinated with ROTATEQ (strength, dosage and lot# not reported) orally. On an unknown date the patient was diagnosed with ROTATEQ. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Fever; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (Fever) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Myasthenia gravis. Concomitant products included PREDNISONE for Myasthenia gravis.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment medications were not provided.   This case was linked to MOD-2021-339089 (Patient Link).
Approximately 4 hours post vax, this child presented to the ER irritable and fussy, projectile vomiting 3 times at home and having no interest in breast feeding. Skin pale and clammy. Family history of reaction to DPT in family. Possible allergic reaction in child. Was given Benadryl 65 mg, Tylenol 40 mg, post was feeding with irritability. Sent home with Atarax - every 6 hours as needed and check mental satus and report any changes.
This spontaneous report as received from a physician via company representative refers to a non-pregnant female patient of unknown age. The patient's pertinent medical history included she had asplenia. No previous drug reactions or allergies were reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dosing details were not reported), intramuscularly. No information was reported regarding concomitant medications. On an unknown date while on PNEUMOVAX 23 the patient experienced swelling of her whole left arm. The patient received treatment for the event, sought medical attention by visiting the doctor. The outcome of the event was reported as recovered. The reporter did not provide the causality assessment between the event and the suspect therapy. There was no product quality complaint involved. Additional information has been requested.
Given half of adult dose to substitute for pediatric dose; Given half of adult dose to substitute for pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of wrong technique in product usage process in a 1-year-old male patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced wrong technique in product usage process and adult product administered to child. On an unknown date, the outcome of the wrong technique in product usage process and adult product administered to child 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: The reporter stated that, the Havrix adult dose was halved and given to the pediatric patient, which led wrong technique in product usage process and adult product administered to child. The reporter asked if this dose was valid dose and how to proceed further. No other information was provided. The reporter consented to follow up. This case is linked with US2021090128, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021090128:Same reporter. Patient 2 of 2.
Vision loss in cornea transplanted eye, treated with steroid drops, anti rejection drops, antibiotic drop.  Still being treated. Nose bleeds, went to ER on 10/20/2022 but nose bleeds started in Sept.  Still have bad nose bleeds about every 3 weeks
Left upper arm 4cm redness, mild pain, itch Advil 100mg 2tsp Q 8 hours PRN Benadryl 1 tsp TID PRN.
at approximately 9:50 patient received 0.4CC of air. Error was discovered immediately, and patient was informed and correct dose was then administered
C/o diarrhea, tiredness, crabbiness for about 4 days.
There was no adverse event. Wrong vaccine was given: a monovalent dose was given after it was recommended to stop vaccination with the monovalent vaccine and prior to new dosage recommendation for bivalent vaccine.
Redness and Rash on face; on forehead and cheeks. Patient applied Benadryl cream on rash starting Monday July 5th. At times rash is itchy, patient uses Benadryl for itchiness. Rash started on Monday July 5th.
pt recv vax 22FEB96 & 2 hrs later pt became edgy & jittery;23FEB95 pt's face became flushed;devel a mildly pruritic rash under lt axilla on the underside of lt arm;pt felt out of sorts;pt devel a virus;pt presented to MD;poss allerg rxn
This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 12-NOV-2014 the patient was vaccinated with the second dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored. There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
I experienced slight nausea the night I received the vaccine. The following morning was miserable. I had a fever of 101 all day long, a headache, my body was aching from head to toe, extreme lethargy, and occasional bouts of extreme nausea as well as throwing up twice. As of the following day (March 18), almost two days since receiving the shot, I feel pretty much completely normal again aside from a slight headache and some pain at the injection site still. I experienced some pretty bad side effects that only really lasted a day.
stated that she was with her daughter and husband, nonstop and unable to quarantine including close face to face contact with both; This is a spontaneous report from a contactable Nurse (Patient). A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 12Jan2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. The patient previously took historical vaccine first dose of BNT162B2 for Covid-19 immunisation. It was reported that patient husband started to show very mild symptoms of covid on 04Feb2021, but he never got tested. The patient daughter had symptoms of fever and headache on 15Feb2021 and tested positive that day for covid. The patient stated that she was with her daughter and husband, nonstop and unable to quarantine including close face to face contact with both on an unknown date in Feb2021. On 18Feb2021, patient was tested for COVID-19 and resulted in negative. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Next day. 12/31/20 - severe muscle pain myalgia, could not ambulate well 1/1/21 - chills  severe shaking chills N/V & diarrhea severe shivering, freezing causing difficulty breathing lasted 1/2 hour
Extremely sharp head pains and nausea started Tuesday (4 days after receiving the Vaccine) at 0245 AM. Thursday night around 0930 PM I noticed the swollen lymph nodes in the shower. After further investigation I noticed there were three almond sized swollen nodes (largest and most painful was in the left Clavicle and the other two were in the jugular area. Unfortunately after palpitations the nodes became extremely agitated and pain radiated from the neck down into the fingers in the left arm. On Friday (19 Mar I went to the clinic where I was tested for COVID and was negative) Over the weekend approximately 10-15 more Nodes became enlarged, followed by blurred vision in right eye and more intense headaches. 22 March I was sent to the ER for Lab work (testing white blood cell count) and an ultrasound of the lymph nodes .
Diarrhea, vomiting, cold sweats (worst at 5 hrs after vaccine, lingered 24hrs after vaccine)
Took first two doses of Vivotif on consecutive days; Spontaneous report received on 31JAN2020.  A 44-year-old adult female consumer (weight: 135 pounds/61.24 kg and height: 167.64) who "took first two doses of Vivotif on consecutive days by mistake" (PT: Inappropriate schedule of product administered). She was receiving Vivotif (typhoid live oral TY21A) capsule (lot number: 3003306 and expiry date: OCT2020) as typhoid vaccination. The consumer took first and second dose of Vivotif on 29JAN2020 and 30JAN2020 respectively. Action taken with Vivotif with respect to the reported event was not applicable. The outcome was unknown.  The patient's medical history included allergies (unspecified) and hepatitis B.  Concomitant medications included birth control pills, levothyroxine, loratadine, quetiapine, Flonase (fluticasone) for allergies. The consumer was also taking shots for hepatitis B and was in the middle of regimen, at the time of report.  Company Comment: A consumer took first two doses of Vivotif on consecutive days by mistake (Inappropriate schedule of product administered) instead of taking them on every other day. Considering the nature of the event, the causality is assessed as not applicable with Vivotif.; Sender's Comments: A consumer took first two doses of Vivotif on consecutive days by mistake (Inappropriate schedule of product administered) instead of taking them on every other day. Considering the nature of the event, the causality is assessed as not applicable with Vivotif.
Day after shot  severe fatigue, loss of balance, dropping things[. Hand Tremors, headaches, dizzyness, raspy voice,  shoulder pain, shortness of breath.
triggered his asthma to get worse; pain in his neck; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 35-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunization. Medical history included asthma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. It was reported by the patient that he received the Pfizer COVID 19 vaccine back in early February and on an unspecified date in 2021 he thought it was triggered his asthma to get worse and he has been having to use a nebulizer and he also had a pain in his neck. Consumer does not currently have a doctor. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pain at injection site, extreme back and body aches, headache, dizziness, low grade fever. Ibuprofen & Acetaminophen  As of 4:00pm on following day of injection, reactive symptoms still occurring...
Adacel (Tdap) is a new vaccination intended for adults under 65, which should replace Td for tetanus booster and will increase immunity to Pertussis. Daptacel (DTaP) is one of many brand names of the vaccine which is intended for infant use. The component antigens are the same, but the relative amounts are much greater for the infant vaccination. The nomenclature DTaP and Tdap is confusing and a potential source of error, which is further compounded by the similarity in the brand names. We have identified instances where adults and one adolescent have received inappropriate infant vaccine.
Pain started at elbow and shot down to the wrist and hand. Worsened with time.  Could not lift anything, had to wear a sling to avoid movement and pain has not fully gone away until now. It's lessened, but I have to avoid doing many things with my left arm now. Diagnosed with Compression of right radial nerve, left lateral epicondylitis, left ulnar nerve irritation  on Friday April 23, 2021.
This spontaneous report was received from a physician, via company representatives and refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On 02-NOV-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, "10PK-0.5ml SD-PFS LLok wTip" which had the lot # K009874 with expiration date 19-MAR-2016, (dosage number and route of administration were not reported). Nonetheless, no adverse effects were reported and no product quality complaint was involved. On an unspecified dates, the vaccine experienced two temperature excursions of 48 hours each. For one excursion the lowest recorded temperature was 34 F (1.111111111 Celsius) and for the other excursion the lowest recorded temperature was 32 F. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of several reports received from the same reporter. Additional information has been requested.
Monday- 3 days later patient notice little red light small pink rashes on his chest area, down on his abdomen and on both ankles. Patient states it itches once in a while. Client will take Benadryl if rashes get worse or check with PCP.