chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hair hurts; deep cough; left arm sore to the touch, left arm hurts when lifts up; feels like someone whipped her good; can't get warm; body aches; headache; fever; nausea; headache worst than before; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (hair hurts), COUGH (deep cough), PAIN IN EXTREMITY (left arm sore to the touch, left arm hurts when lifts up), FEELING ABNORMAL (feels like someone whipped her good) and FEELING COLD (can't get warm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02SBZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL for an unknown indication.    On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 05-Apr-2021, the patient experienced PAIN (hair hurts), COUGH (deep cough), PAIN IN EXTREMITY (left arm sore to the touch, left arm hurts when lifts up), FEELING ABNORMAL (feels like someone whipped her good), FEELING COLD (can't get warm), MYALGIA (body aches), HEADACHE (headache), PYREXIA (fever), NAUSEA (nausea) and HEADACHE (headache worst than before). At the time of the report, PAIN (hair hurts), COUGH (deep cough), PAIN IN EXTREMITY (left arm sore to the touch, left arm hurts when lifts up), FEELING ABNORMAL (feels like someone whipped her good), FEELING COLD (can't get warm), MYALGIA (body aches), HEADACHE (headache), PYREXIA (fever), NAUSEA (nausea) and HEADACHE (headache worst than before) outcome was unknown.            No treatment information was provided.
Started to have shortness of breath 6 hours after vaccination.  Woke up multiple times during the night having trouble breathing.  At 11:30 the next morning went to Urgent Care because it felt as if my throat was closing.
Headaches, onset one week from vaccine. Dizziness onset 2 days from second dose vaccine
I had my first Shingrix vaccine on May 1  2020.  Approx 8 to  10 days later I broke out in a rash across my chest.  My physician diagnosed eczema and said it wasn't related to vaccine.  On August 11 I had my second Shingrix vacvine and 9 days later my right hand has erupted with an ecxema rash.  I don't  think that this is coincidence.   Knowing that I have an autoimmune gastritis and that eczema is an autoimmune dermatitis and that many people have more than one autoimmune disease,  I felt it important to report this reaction, especially since it is not mentioned in the literature given ro patients.
Besides common post injection complaints of flu like symptoms. . .I am experiencing a scalded looking red rash 7in down my arm below injection site and 4 in wide.  Hot and painful.  Discomfort radiates to lymph nodes in right arm pit.
Pt has a red swollen area around the injection site that is tender for the Zostavax. She also said she bled a lot at the time of injection for the Adacel.
conquer that infection; conquer that infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 49-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "immunocompromised" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 2021, outcome "unknown" and all described as "conquer that infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2021) Positive, notes: Delta variant at the end of 2021. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient's spouse recently reached out to a local Pfizer representative to inquire about the availability of Paxlovid, and received a response explaining that Paxlovid is not yet registered here in (Address with held). It was reported that the patient was immunocompromised and, after catching the Delta variant at the end of 2021, ended up spending 2 months in the hospital on a ventilator, in a medically induced coma. He managed to conquer that infection and came back home in Feb. However, any re-infection could have been proved critical or even mortal, despite being Pfizer vaccinated. The reporter asked If her husband was to be re-infected with any new covid variants, he would greatly benefit from having the Paxlovid medication readily available. Therefore, She would like to make a crucial, personal request. Could the Pfizer team please grant permission for a family member to purchase a treatment pack of Paxlovid from a pharmacy for her husband (in case of re-infection), and can be brought with them to (Address with held).  The information on the batch/lot number for BNT162B2 has been requested and will be submitted if and when received.
I started developing symptoms of COVID-19 on 10/11/2022. Tested positive for COVID-19 on 10/12/2022. I had a pounding headache; coughing; sore throat; fever of 101.0; chills; coughing; fatigue; and some abdominal pain.
family came in to receive flu shots but the children received ADACEL instead with no AE; Initial information received on 21-Oct-2021 regarding an unsolicited valid non-serious case received from an other health professional.   This case involves a 5-year-old male patient whom it was reported "family came in to receive flu shots [INFLUENZA VACCINE] but the children received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead (wrong product administered)".   The patient medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 21-Oct-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [lot U7055BA and expiry date: 03-Jun-2023] via an unknown route in the right arm for prophylactic vaccination.  It was a case of actual medication error due to wrong product administered [Latency: on the same day].  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.
Systemic: Pain that radiated up the neck of the patient from the injection site, followed by numbness of the arm under the injection site, both of which completely resolved within minutes of injection.-Mild
pt had shot and went to sit for observation period.  when period was almost over mom noticed pt looked asleep and just not right.  she tried shaking him and he seemed groggy and unoriented. called for nurse and we checked him then took him to ER. symptoms seemed most consistent with vagal syncope so epinephrine was not administered.
Provider hospital summary "Patient is a 70 year old female who presented to the ED for falls at home and weakness. She was diagnosed with COVID on arrival. She was not hypoxic past her baseline and was given regeneron. She was also diagnosed with bacteremia and fungemia thought to possibly be due to recent midline placement. Infectious disease was consulted and recommended IV vancomycin which the patient completed over the course of her stay and IV eraxis which she will continue until 12/18/21. She will need an eye exam and will be set up with ophthalmology outpatient due to diagnosis of fungemia. She will need repeat blood cultures in 1-2 weeks after completion of eraxis and will follow up with infectious disease outpatient. "
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. Relevant medical history and concomitant medication was not provided. On 28-OCT-2013 the patients were vaccinated with ROTATEQ lot number J003465. Dose, route and frequency were not provided. On 28-OCT-2013, the patients were vaccinated with ROTATEQ stored as high as 47F for up to 44 hours. No adverse effects were reported. This case was linked to MARRS case numbers 1311USA008054, 1311USA007704, 1311USA007705, 1311USA007695, 1311USA007696, 1311USA007699, 1311USA007700, 1311USA007701, 1311USA007702, 1311USA007703, 1311USA007698, 1311USA007697, 1311USA008058, 1311USA008059, 1311USA008060, 1311USA008055, 1311USA000906, 1311USA008061, 1311USA008056 (same reporter link). Additional information has been requested.
patients  doctor called saying patient had an allergic reaction to the shot, since the pneumovax 23 was given in error (patient was supposed to get prevnar 13, as they had pneumovax23 back in 2011.) Md said the allergic reaction was due to getting the same shot twice , and the reaction involved a sore arm, with redness at the injection site
Initial report received from a pharmacist on 15 Jan 2010: This patient was vaccinated with 0.5 ml of FLUVIRIN vaccine (batch number: 104045P1) intramuscularly on an unknown date. It was reported that the vaccine was stored at temperatures as low as 34F and 35F. No adverse effect was reported. No seriousness criteria was provided.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 09-AUG-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K016154 with exp. 24-SEP-2016), (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Chest pains. Headache(severe) Lethargy. Dizziness.
About 24 hours after vaccine at 3am I woke up shivering, fever of 100.3. I took Motrin and fell back asleep. I woke up at 8am, my temperature was 101.7. The fever continued throughout the day and I treated it with Motrin.  On Friday 7/15 I continued to feel fatigued and had full body aches. I got tested for covid work 2 rapids and a PCR. Both were negative.  Saturday 7/16 I woke up and noticed hives on my arms and upper chest. But my fever, fatigue and aches resolved.  Sunday 7/19 I have hives throughout my entire body (except my face).
Information has been received from a female consumer who on an unknown date was vaccinated with a dose of VAQTA. Subsequently the patient experienced arm soreness after receiving VAQTA. It is unknown if the consumer sought medical attention. At the time of the report, the outcome of the patient was unknown. The consumer also reported that she had experienced arm soreness after receiving RECOMBIVAX (WAES # 0911USA04201). Additional information has been requested.
redness at site; pain at site; Arm felt so"painful could not lift".; Arm felt so"painful could not lift".; received the 1st dose of Shingrix on November 2019.; rash; flu like symptoms; bad headache; This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 1st November 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 2nd November 2019, 1 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced influenza-like symptoms and headache. On 4th November 2019, the patient experienced rash. On an unknown date, the patient experienced injection site erythema, injection site pain, mobility decreased, pain in arm and incomplete course of vaccination. On an unknown date, the outcome of the influenza-like symptoms, headache, rash, injection site erythema, injection site pain, mobility decreased, pain in arm and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the influenza-like symptoms, headache, rash, injection site erythema, injection site pain, mobility decreased and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and woke up with flu like symptoms, bad headache, rash started on day 3, redness at site and pain at site.  The arm felt so painful could not lift.  The patient did not receive 2nd dose yet, which led to incomplete course of vaccination. No additional information was provided. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020178062:same reporter
This is a 74-year-old female who was discharged from the hospital on September 13, 2021, with COVID pneumonia.  She states she has been home.  She has been coughing, having these coughing attacks, productive.  She denies any fevers, chills, nausea, vomiting, abdominal pain, diarrhea, but she feels very fatigued.  She went to her primary care doctor and did a CT of the chest, which showed consolidation involving the lingula and left lower lobe, suggestive of pneumonia.  COVID cannot be excluded.  Slight increase in size of the right middle lobe nodule, which now measures 4 mm in transverse diameter compared to 3 mm on the patient's prior CT scan performed in 2019.  The patient is being admitted for further evaluation.
I started to experience pressure in neck, head, and chest. Then my heart began to race very really fast. These symptoms lasted for about 7 minutes. Then my heart rate slowly declined. I went to the doctor on August 31st about this. They gave me an EKG, which slowed a short PR interval. They gave me a stress test.
Severe migraines that have been happening at least twice a week and last 2-3 days. Migraine medicine (Relpax) and prevention medication (Topamax) is not helping. I have been extremely tired and having memory loss as well.
very very painful arm and shoulder, cannot move arm on its own, muscle in arm is throbbing and very very painful, unable to lift or do anything will left arm
This case was reported by a pharmacist via call center representative and described the occurrence of hives in a female patient who received SHINGRIX for prophylaxis. Previously experienced adverse reactions included anaphylaxis and allergic reaction (experienced a lot after numerous other unspecified vaccines). On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced hives. On an unknown date, the outcome of the hives was unknown. It was unknown if the reporter considered the hives to be related to SHINGRIX. Additional details were provided as follows: The reporting pharmacist got this information from another registered pharmacist who administered the SHINGRIX to the patient. The age at vaccination was not reported. The healthcare professional was looking for information on one dose efficacy with SHINGRIX. The reporter did not speak to the patient, so did not have any other details. The reporter would have other pharmacist to call back with details of the adverse event.
Weirdly despite a right arm injection - left arm ache and left thigh muscle spasms started a few hours afterwards. At 7pm heavy sweat and slight fever. During course of evening nausea, neck, shoulders and lower jaw severe ache by morning. Small sores (the little bubble kind) similiar to mild food allergy broke out on inside bottom lip only and passed only when soreness left lower jaw near late afternoon. Felt better by 5pm. Slight muscle aches in left arm, shoulders & tiredness remained through following day April 2. As of today, 4/12 - I'm having the heavy flow menstral cycle of a freaking teenager. Not fun. I'm accustomed to a very light period at my age not the uteras ripping heavy flow of those first 20 years. Hoping this is a one time deal.
Initial unsolicited report received from a consumer on 22-May-2017. This case involves 44 year-old female patient who was vaccinated with dose of ADACEL (Batch number, expiration date, dose, dose in series, were not reported) intramuscularly in right deltoid on 12-May-2017. Medical history was reported that pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was allergic to iodine. No Illness at the time of vaccination. Any other vaccinations within four weeks of vaccinations were not reported. On 12-May-2017, four to five hours following vaccination patient developed throat swelling, hives widespread over the body which were red, itchy and blotchy, right arm became very sore and she had difficulty with ROM. On an unknown date following vaccination patient nausea, diarrhea, and she feels exhausted. Patient still had soreness in the right arm, the muscle is tender to touch, hives are coming and going and are red, itchy and blotchy. On 12-May-2017, patient required emergency room and doctor visit. Laboratory investigations were not reported. Corrective treatment included BENADRYL, CORTIZONE, PREDNISONE and antibiotics. Outcome of all the events were not recovered. Documents held by sender: none.
Patient stated she developed 3 blisters on her upper right lip on 10-1-16. Also, her right cheek felt like it has bugs crawling on it. (Her words).
ITCHY, NO RESPIRATORY DISTRESS/ STRIDOR NOTED. BENADRYL 50MG PO GIVEN X 1 @ 1045 PT WAITED 15 MIN PRIOR TO DISCHARGE. NO FURTHER COMPLAINTS FROM PATIENT.
11/15/2022 could not get out of bed... later on, when I had the ability to get out of the room.. I went to my dining room.. my legs collapsed in the living room. I was able to recover enough to get back to my room. My arm was still sore from the shot. Lasted 3 days sore arm.  I have had various vaccines taken before and I've never had this problem before.
Visible lip smelling under lower lip margin 1.5 cm x .25 cm.  Pt. also c/o tongue tingling. Pt. had no other symptoms.  VS stable and lungs were clear.  No other swelling.  Responded well to benadryl orally with reduced lip swelling within 20 minutes.  Sent home with instructions to RTC for any increase in sx. and to continue benadryl through the night. Allergy to COVID 19 vaccine Moderna added.
Onset: 10 days after COVID-19 Moderna booster vaccination. Duration: 4 months post injection. Stayed for about an hour w/Benadryl 25mg. Characteristics: Can feel it flaring-up. Often flares-up at night/evening/when sun goes down, after she eats. Timing: randomly occurring. Makes it better: Benadryl works at the moment. Did not help: topical antihistamine; arnica gel.
adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (adverse reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (adverse reaction). At the time of the report, ADVERSE REACTION (adverse reaction) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    No relevant concomitant medications were reported.  No treatment information was provided.
One week after receiving vaccine (yesterday), my upper arm below site of injection is swollen/ hard and had a rash that is tear shaped, about 4 inches long and 3 inches wide at the bottom. It appears to start just below the site of injection.
Redness, swelling of entire deltoid muscle and surrounding area and fever, tiredness, headache, malaise, chills.
About two weeks after the second shot on March 30th, I experienced my lichen planus outbreak. I had been in remission for approximately 2 years prior to that. It started as a small rash on my rt forearm, then spread to my left. In June it turned into an allergic rash going from my knuckles up to my elbows (not sure if that was due to me using hydrocortisone to treat the lichen planus).
hives; full body itching; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) and PRURITUS (full body itching) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 URTICARIA (hives) and PRURITUS (full body itching). At the time of the report, URTICARIA (hives) and PRURITUS (full body itching) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No Concomitant medications were reported. No Treatment information was reported.
Patient experienced an episode of syncope almost immediately after her first dose of Pfizer covid vaccine.  She was unresponsive for approximately 20-30 seconds.  Her vaccinator held the patient steady until help was available.  When the patient came to, her pupils were not of equal size, left being larger than right. Cap refill was about 5 seconds.  She felt hazy/dizzy and was clammy.  First pulse readings were 39-45 bpm.   Vitals recorded 1545  BP 73/40, P 48, O sat 99 1558 BP 91/55, P 58, O sat 96 1607 BP 106/62, P 68, O sat 98 BP 111/70, P 57, O sat 100  At the time of dismissal, patient reported that she felt fully recovered.  She was accompanied by her father who was her mode of transportation. It was recommended that she be scheduled for an appointment with her PCP for baseline/well visit as she had not been in some time.
Patient experienced inflammation at the injection site, as well as swollen arm down to hand, and face. Redness also. Contact administering nurse for further information
Patient came in for 5-yo WCC. It was determined that patient would need the Varicella and MMR vaccines. These were ordered and drawn up and administered. When attempting to enter the NDC and LOT numbers it was noticed that the wrong order was put in for the MMR. What had ultimately been determined was that the PROQUAD and Varicella was given instead of just single MMR and Varicella.  These were both recorded in patient's chart. State was called to make sure of any potential adverse reactions and any instructions needed from them. VIS was given to mom. Dr. was informed. Mother called to let her know what the mistake and what to look for. Reassured mom that we did not expect any reaction since he had had already received the first dose and was already exposed. Asked her to keep an eye out for any swelling, redness, fever, unusual behaviors. She understood. Business coordinator notified to have one the varicella vaccine charge be removed and only charge for the PROQUAD. Will call in a week to see how patient is doing to be sure no reactions occurred.
lt shoulder tender to touch over deltoid & active/passive ROM, tender axillae;dx inflammation lt deltoid secondary to flu shot;
severe headache, severe dizziness, body aches, fever, enlarge lymph nodes in right arm.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included intervertebral disc disorder. In August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm and swelling arm. On an unknown date, the outcome of the pain in arm and swelling arm were recovered/resolved. It was unknown if the reporter considered the pain in arm and swelling arm to be related to SHINGRIX. Additional details were provided as follows: The patient experienced a huge arm for 10 days that was hurting and swollen. For tolerance of 2nd dose refer case US2019027627.
51 YEAR OLD FEMALE COMPLAINED OF MALAISE. ONSITE EMS AND PHYSICIAN RESPONED. BP 122/76  HR 76  O2 95% ON ROOM AIR. SHE REFUSED ADDITIONAL EVALUATION AND CARE.