chrisvoncsefalvay/vaers-outcomes huggingface dataset:
101.6 temperature; My arm hurts a little; Chills; Weakness; This is a spontaneous report from a contactable consumer (patient herself). A 55-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: Pfizer Eng 205), dose 1 via an unspecified route of administration, administered in Arm Left on 15Mar2021 at 13:30 (at the age of 55-years-old) as a DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included rash; known allergy from an unknown date and unknown if ongoing reported as, I had rashes with unknown cause but not from food. Patient reported that, I had Covid last year (2020). Other medical history was none. The patient's concomitant medications were not reported. No other vaccine was administered in four weeks of vaccination. Patient had covid prior vaccination and has not tested for covid post vaccination. On 15Mar2021 at 19:00, the patient experienced 101.6 temperature, my arm hurts a little, chills and weakness. Patient reported that, my arm hurts a little. The next day in the afternoon I had chills and feeling weak. About 7:00 pm has a 101.6 temperature. Patient said, I had Covid last year (2020) and still has antibodies present according to my last blood test. No treatment was received for the event. The patient underwent lab tests and procedures which included pyrexia that was 101.6 on an unspecified date and sars-cov-2 test that was positive on an unspecified date. Outcome of all the events were Resolving.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a nurse, referring to a female patient of unknown age. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported. On an unknown date in 2017, the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis (strength, dose, route, frequency, lot# and expiration date were not reported). On 08-FEB-2019, the patient was back for the second dose. No adverse effects were reported from the first or second dose.
Rash all over torso and chest-small red welts. Not itchy or painful.
3 days after receiving her vaccination she noted redness and tenderness at and around the injection site. This lasted approximately 3 days.
Client scheduled appointment for second dose 7 days after first dose and was given the vaccine at the second dose appointment. This was not caught during the screening process.
Five days after my first vaccination of covid 19 vaccine, I developed rash on my left trunk. It is now very itchy and painful. I put cortizone on the affected area to alleviate the pain and the itchiness to no avail.
Pt received Daptacel, Prevnar and Rotateq on 12/04/2006. Also his twin brother received at the same time. Did not have any SX. On 12/09/06 mom fed them at 5am and found them dead at 9:00 am.   6/29/07 Received Autopsy Report which reveals COD as Undetermined & contributing condition simultaneous death of twin brother.  Pathological Dx: I. Sudden unexpected infant death     A. Twin B infant male found unresponsive in crib on stomach     B. Vitreous electrolytes, abnormal, w/decreased Na & increased Cl, urea nitrogen, calcium, carbon dioxide     C. Brain congestion & edema, neuronal heterotopia & insular micro-dysgenesis, mild focal. II. Ancillary studies, other, non-contributory. III. Simultaneous death of twin brother IV.  Fractures, ribs, anterior & lateral, w/minimal hemorrhage.
Received vaccine at 4 pm and got instant Headache,  and got funny taste in mouth. Sore arm started at 5 pm. Lost taste and smell and couldn't sense hot or cold. Weak, shaky with severe joint and muscle pain. Middle of night, full nasel congestion began. In the morning  was able to taste cold and mouth does not feel funny any more.
Hard to breath, panic attack, dizziness , extreme body aches,  numb arms and legs, fever at 101
TOOK TWO DOSES IN A ROW; This spontaneous case report was received from a nurse (PVX2019-465) on 20-Feb-2019. The report describes a 32-year-old adult female consumer who "took two doses in a row". The consumer was receiving Vivotif for an unknown indication.   It was reported that the consumer took two doses in a row. The doses were taken on Monday (18-Feb-2019) and Tuesday (19-Feb-2019).  The action taken with Vivotif with respect to the event "took two doses in a row" was not applicable.  The clinical outcome of the event "took two doses in a row" was unknown.  Company's Comment: The causality of the event "took two doses in a row" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two doses in a row" was considered as not applicable.
Local reaction at site of injection for about 2.5 months. 10 days after shots, developed symptoms of high fever, irritability and decreased appetite lasting approximately 4 days.
developed a slight rash.  took PO benadryl in monitoring site.  Symptoms resolved.  Patient left without issue
Localized, well demarcated erythema of L shoulder w/induration. Spread laterally down arm - 10 cm x 11 cm. Lt. shoulder arthralgia and stiffness. Subjective patient fever.
I started having issues with breathing after first injection and my breathing got much worse after the second and now have a rash more problems. Blood pressure issues along with autoimmune diseases. I had 2 different types of rashes did a biopsy and found it was called lichen planus. Other rash was called chronic idiopathic urticaria. I also have Glossodyna a tongue disorder and also graphic tongue. I now have tremors and I don't know if its from all the medications they have me on now and muscle weakness, they are not sure but the the doctor said I am getting signs of dermatomyositis. My arms and hands were swollen for months and gained over 65 lbs due to the medications. I am having problems with my gastro bypass and heavy acid reflux. I do not think the vaccine was worth it and was required to go back to work.
Pfizer-BioNTech vaccination given on 2/26/21 and 3/19/21. Presented to ED on 3/27/21 with generalized body aches, shortness of breath, and cough. Was admitted to hospital for COPD exacerbation and COVID-19 infection without hypoxia.
Pt. c/o pain and swelling on vaccine site. Also, she spiked a high temperature at night. Rx IBUPROFEN 600 mg QID PO.
Received my first dose of Moderna Vaccine on 1/5/2021.  No symptoms until the morning of 1/11/2021 when I noticed an enlarged lymph node on the left side of my neck.  Was sore to touch.  1/13/2021 experienced redness and swelling on my left arm at the injection site.  The area is about the size of an orange.   No other symptoms at this time.
Dizziness and disequilibrium since vaccine. started feeling better on 14th during Office visit.
Pt woke up Thursday morning with severe hives covering all of her legs.  The rash was itchy and red.  10mg zyrtec given at 6:45AM.  Rash went away by 11am, and pt was given prednisone.  Benadryl and prednisone was given thursday night, and the hives reappeared all over the patient's arms on Friday, Nov 12th.  10mL of Zyrtec given and prednisone given.  Rash went away by noon that day.  On Saturday, Nov 13th, more hives appeared on the patient's chest area.  Zyrtec 10mL given.  Benadryl given at night.
Vomiting, diarrhea, body aches, cough, rashes on body like chicken pox
Information has been received from a claims examiner concerning a female who on 21-JUN-2013 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot # J000434 with expiration date 10-APR-2014) and had an unspecified adverse reaction. It is unknown if the patient sought medical attention. At the time of reporting, the outcome was unknown. Additional information is not expected.
Patient developed hives from their left arm to their trunk and legs within 24 hours. After speaking with provider it was deemed contraindicated for them to receive their second shot.
vertigo, mental confusion, severe h/a, feeling tired; 10JAN94 pain lt arm & leg, neck & lower back 1 hr p/inject; blurred vision; resolved p/24-48 hrs;
1st dose on 14Sep2021, 2nd on 07Sep2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 25-year-old male patient who received HAB (Twinrix) (batch number EP47E, expiry date 6th February 2023) 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.   Previously administered products included Twinrix (On 14th September 2021, the patient received 1st dose of Twinrix and lot number GG355, reporter did not have expiration date).   On 7th September 2022, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 7th September 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: 09-SEP-2022 Reporter's Comment: The reporter reported that, patient then forgot about coming in for next dose of Twinrix.  The second dose of Twinrix was not administered until 7th September 2022. The reporter consented to follow up. Additional Supportive Information: The patient received the 2nd dose of Twinrix later than the recommended schedule, which led to lengthening of vaccination schedule.
I received my 2nd Moderna vaccine at 10:00 am on 02/19/21, that night I just had chills. I woke up on 02/20/21 with body aches over my entire body. On 02/21/21 I woke up at 7:30 am felt ok and ate a bowl cereal. By 10:30 I started with stomach pains and diarrhea. I remained in bed all day 02/21/21 with severe chills and stomach pain. woke up 02/22/21 still having diarrhea and stomach pain. By tuesday 02/23/21 I felt a little better. This last until  02/26/2021. I finally felt much better and had a normal bowl movement by Sat 02/27/2021.
About a week after receiving the shots, patient had rapid painless large swelling of the left knee. He had not injured his knee. His knee has remained swollen with fluid and large for nearly a month.   I suspected the vaccine could be the cause and found a study.
Noted relatively transient, superficial wheals scattered on abdomen x 4 measures .5 to 1 cm on circular shape. Pruritis - BENADRYL 50mg orally.
Developed hives over entire body, with blisters.  Given Benadryl by Mom.  Fever of 104 degrees, given Tylenol.  Went to ER.
Pt claimed sx noticed when she woke up at 2am.  Complained of throat closing up, difficulty breathing, gi discomfort, and face swelling
~ 1300  notified that patient, was experiencing a scratchy and itchy throat. Patient had just prior received a J&J vaccine in her right deltoid. First BP attempt was unsuccessful. Anterior oropharynx and tongue had no swelling noted on exam. Pt having increased anxiety. Second attempt BP 180/120 HR ~110. No difficulty breathing, diaphoresis, pallor or urticaria noted. Oropharynx and tongue remained unchanged. Patient was clearing throat with increased frequency and breathing shallowly and fast. Anxiety present. No stridor noted, LS clear bilaterally, no urticaria noted. Notified pt that 911 was being called for evaluation. ~1306 BP 180/125 HR 110?s. Pt reporting increased difficulty breathing. I discussed the use of epinephrine and the risks with an elevated BP and HR. Pt stated ?do you want to use mine or yours.? Pt carries an epi pen for anaphylaxis from food allergies and has had to use it in the past. I asked the pt if she was sure she wanted epi and she stated ?yes?. No stridor noted, LS clear bilaterally, no urticaria noted, no diaphoresis, A&O, still clearing throat and taking shallow breaths. 0.3mg of epinephrine administered by RN via pt?s own pen in the left lateral thigh. EMS arrived ~ 3 minutes after administration of epinephrine. EMS evaluated patient and discharged her at the location. Patient remained at location for ~ 15 more minutes with RN at her side. She stated her throat was starting to feel better. Throat clearing decreased. Smiling and conversing with no distress noted. She walked out of the location in stable condition.
pneumonia; pneumonia; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team..  A 68-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as single dose (Batch/Lot number: unknown) for immunisation; pneumococcal vaccine polysacch 23v (PNEUMOVAX), as single dose (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), PNEUMONIA (hospitalization, medically significant), outcome "unknown" and all described as "pneumonia". A 68-year old female patient who had previously been vaccinated with Prevnar 13 and Pneumovax. About 5 months ago, the patient was hospitalized due to pneumonia and was in the hospital "quite a while" due to the pneumonia.   The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine towards the onset of pneumonia in this patient cannot be completely excluded.  Further information like confirmative pathological/serotype results are needed for full medical assessment.
about 80 hours after receiving the shot, I experienced severe diarrhea , starting at about 10 PM. I spend most of the night sitting on the toilet. No vomiting. Some abdominal cramping, and my nose was very runny, altho not stuffy. By morning the diarrhea had stopped, but I felt awful. Did not know if I was mainly dehydrated, exhausted from no sleep, or sick. Ate nothing that day, but drank a lot of fizzy water and herbal tea with a little honey. Following day feeling OK, and by third day, fine. The experience felt like a really bad stomach flu or food poisoning, but I haven't had either of those for over 15 years (and that was from Erythromycin prescribed by my dentist when I didn't realize I am allergic to it).
Rapid heart rate. 120 standing, 100 resting for first few days. Chest pain since second shot.
body aches; tired; This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 15th October 2021, the patient received the 1st dose of Shingles vaccine. In October 2021, less than a week after receiving Shingles vaccine, the patient experienced general body pain and tiredness. On an unknown date, the outcome of the general body pain and tiredness were unknown.   It was unknown if the reporter considered the general body pain and tiredness to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got shingles vaccine and experienced body aches and was tired. The patient was being told that the second one was worst and the patient was not looking forward to that. This case was linked with the case US2021AMR217039, reported by same reporter.
Severe back pain, unable to move or walk.  Could not use her breathing machine, pulmo-aid, was not able to do her breathing treatments with albuterol, so her emphysema got worse and she had to go to the hospital in December.  Then, in February she became ill with pneumonia, she had water in her lung because phlegm accumulated in her lung because she was not able to move. So, she had to go to the hospital again in February.
This spontaneous report as received from a healthcare professional refers to an unspecified number of patients of an unknown age and gender. Medical history and concurrent conditions were not reported. In approximately 2015 (reported as since 13-MAR-2015), the patient were vaccinated with doses of ROTATEQ lot# K015816 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. The healthcare professional informed that the total excursion time for this lot was 63 hours. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Severe abdominal pain and sore abdomen; Fever at 100.2; Nausea; Fatigue; Anorexia; Foggy head; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9262, Expiration Date: May2021), via an unspecified route of administration in left arm, on 21Jan2021 at 16:15 (04:15 PM), at a single dose, for COVID-19 immunization. The patient's medical history included coronary artery disease, hypertension (HTN), diabetes, and iron supplement. The patient's concomitant medications included cilostazol and chondroitin sulfate/ collagen (INTEGRA) as iron supplement. The patient previously took sulfamethoxazole/ trimethoprim (BACTRIM) and experienced allergies. The patient was not diagnosed with COVID-19 prior to vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a hospital facility. On 22Jan2021 at 04:00 PM (around 24 hours after shot), the patient experienced severe abdominal pain and sore abdomen for 12 hours; fever at 100.2; nausea for 24 hours; and fatigue, anorexia, and foggy head for 48 hours. OTC treatment was received for the events including calcium carbonate/ famotidine/ magnesium hydroxide (PEPCID COMPLETE), calcium carbonate (TUMS), and simeticone (PHAZYME). The patient had not been tested for COVID-19 post-vaccination. The patient recovered from "Severe abdominal pain and sore abdomen" on 23Jan2021 at 04:00 AM; "Fever at 100.2" in Jan2021; from "Nausea" on 23Jan2021 at 04:00 PM (16:00); and from the remaining events on 24Jan2021 at 04:00 PM (16:00).
Information has been received from a physician concerning a 15 year old female with no pertinent medical history who on 21-JUN-2007 was vaccinated intramuscularly with a 0.5 ml first dose of Gardasil. There was no concomitant medication. On 21-JUN-2007 the patient experienced dizziness for about 30 minutes. On 27-JUN-2007, she developed lymphadenopathy on the left side of her groin. It was reported that she had two swollen lymph nodes in her groin closer to her femur. The area is sore and tender. No fever was involved. The patient was seen in the doctor's office. A urinalysis and a blood test were performed, results not reported. The patient was prescribed DURICEF 500 mg. The patient's condition improved but thr nodes were still present in the left groin area. On 21-JUN-2007, the patient recovered from dizziness. At the time of this report, the physician confirmed that the patient was recovering from the lymphadenopathy.  Additional information is not expected.
Took unrefrigerated Vivotif; Spontaneous report received on 14JAN2020.  A pharmacist reported that a 50-year-old consumer who "took unrefrigerated Vivotif" (PT: Product storage error). The consumer was receiving Vivotif for immunisation. The consumer completed the course of unrefrigerated Vivotif. The pharmacist assumed that the consumer had started Vivotif approximately 8 days ago. She could not confirm the lot number of Vivotif and stated that the vaccine was likely left unrefrigerated since 17DEC2019. Moreover, she confirmed that the consumer took Vivotif every other day. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took unrefrigerated Vivotif (Incorrect product storage). Considering the nature of the event, the causality of incorrect product storage is assessed as not applicable to Vivotf.; Sender's Comments: A consumer took unrefrigerated Vivotif (Incorrect product storage). Considering the nature of the event, the causality of incorrect product storage is assessed as not applicable to Vivotf.
headache; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, intramuscular (left arm) on 18Dec2020 08:00 at a single dose for Covid-19 immunisation. Medical history included asthma, hypertension (HTN), and allergy to latex. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. After receiving the first dose, the patient experienced headache on 18Dec2020 12:00. No treatment was given for the event. The patient underwent lab tests which included nasal swab: negative on 16Dec2020 (Covid test name post vaccination: Binex). Outcome of the event was recovered.  Information on the lot/batch number has been requested.
Headache, Sedation, Myalgia, Arthralgia, chills and fatigue. pain and swelling at injection site. Narrative:
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 45 year old female of and unknown ethnicity. Initial information was processed along with the additional information received on 12-JAN-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: no alcohol use, and non-smoker. The patient experienced drug allergy when treated with hydrocodone bitartrate/paracetamol, and metronidazole.  The patient received covid-19 vaccine ad26.cov2.s (Dose number in series was 1) (suspension for injection, route of admin not reported, batch number: 1820095, expiry: 02-OCT-2021) dose was not reported, administered 1 in total at the right arm on 28-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-JAN-2022, the patient experienced suspected clinical vaccination failure, and suspected covid-19 infection (Dose number in series was 1).  The patient experienced symptoms like bad headache, cough, congestion, feeling cold and hot, pain, fatigue and loss of appetite (subsumed under suspected covid-19 infection). The Symptoms started on 02-JAN-2022, patient experienced different symptoms daily.  On 02-JAN-2022, She had cough and migraine that won't go away, sore throat, then chills, pain in different parts of her body, lost her apatite then she has fatigue.  The patient visited urgent Care on 02-JAN-2022 and took a rapid antigen test (via nasal swab) and results came back positive within 15 minutes. The patient was told to quarantine for 10 days. Laboratory data included: COVID-19 antigen test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20220116910 (booster dose series 2 case). This report was associated with product quality complaint: 90000211426; Sender's Comments: V0: 20220107394-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. 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
Face flushing about 30 minutes after vaccine followed by torso rash -- noticed on day after, which totally cleared by third day post-vaccine.
mom states pt woke up on 2nd day w/swollen arm & shoulder;was red & warm to touch;pt had no fever;reddness started near elbow & extended to neck;remained reddened for 2wk;called MD office & was told usual rxn to vax;not seen by MD;no tx;