chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It was also reported that with previous vaccines he had arm pain only; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (It was also reported that with previous vaccines he had arm pain only) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products TREPROSTINIL tablet for Secondary pulmonary arterial hypertension and TREPROSTINIL DIOLAMIN (ORENITRAM) for Secondary pulmonary arterial hypertension.    Concurrent medical conditions included Secondary pulmonary arterial hypertension. Concomitant products included TADALAFIL and AMBRISENTAN (LETAIRIS) for an unknown indication.   On 12-Mar-2021, the patient started TREPROSTINIL (Oral) 4.75 mg. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) .25 mg. On an unknown date, TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to 2.5 mg, TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to 1 mg and TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to 4.75 mg. In 2021, the patient experienced PAIN IN EXTREMITY (It was also reported that with previous vaccines he had arm pain only). At the time of the report, PAIN IN EXTREMITY (It was also reported that with previous vaccines he had arm pain only) outcome was unknown.            Orenitram 0.25 mg, 2.5 mg and 1 mg and the current dose was reported as 4.75 mg  Orenitram (TREPROSTINIL DIETHANOLAMINE) Extende (Continued)-Lot number (2102022),Expiry date-20-APR-2023.  Orenitram (TREPROSTINIL DIETHANOLAMINE) Extended-Lot number (2102020),Expiry date-20-NOV-2022.  No treatment medicines were reported.   This case was linked to MOD-2021-436681, MOD-2021-436609 (Patient Link).
sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt. rec'd VARIVAX vaccine at well check-up. Left office and returned shortly after. Eating breakfast c/o feeling ill, itching and difficulty swallowing. Pulse 88 B/P 102/66, O2 sat 94%. Given BENADRYL 50mg po at 9:47am. Cont'd difficulty swallowing, lip edema. 9:52am EPI PEN 0.3mg IM administered. 9:55 reported improvement. Left by squad and transported to local ER for further evaluation.
This was Oct. 9. I got very sick. Sore throat, fever, laryngitis. I was sick a month. My ear is still stopped up, and I am still hoarse -and I don't get sick. Haven't had a flu in 15 years or so.
A non serious spontaneous report of inadvertent administration of expired FLUMIST was received from a nurse concerning a patient of unknown age in a pediatrician's office. This case is submitted in accordance with MedImmune's post marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. There was no adverse event associated with this medication error at the time of the report, nor when contact was made with the site approximately two weeks later; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. 10/07/08 Follow-up received 07-Oct-2008: No adverse events had been reported. Follow-up information received on 20-Mar-2009 included Product Complaint Investigation results.
LIVER IS FAILING; This spontaneous report received from a consumer via a company representative through social media concerned a male of unspecified age. 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, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. It was reported that, on an unspecified date, the patient was hospitalized and was kept in the intensive care unit (ICU), after receiving covid-19 vaccine ad26.cov2.s. His liver was failing, according to the doctors. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of liver is failing was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210450603-covid-19 vaccine ad26.cov2.s-Liver is failing. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
black out-resulted in fall necessitating stitches on face-occurred p/last shot 36hr later;swelling in both hands, wrists & forearms occurred 36hr p/last host;migrating rash over 6wk period;tx antihistamines;
very painful cramping; Very heavy menstrual flow/large quantity clotting; Very heavy menstrual flow/large quantity clotting; This is a spontaneous report from a contactable other hcp (patient). A 42-year-old (non-pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: En6206) via an unspecified route of administration, administered in arm left on 09Mar2021 14:15 (at the age of 42-year-old) as dose 1, single and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Er8734) via an unspecified route of administration, administered in arm left on 30Mar2021 at dose 2, single for Covid-19 immunization. Medical history included Graves' disease from an unknown date and unknown if ongoing, total thyroidectomy from 2010 to an unknown date, known allergies: Pineapples. Patient did not have other vaccine in four weeks. Patient did not have covid prior vaccination. Patient was not tested for covid post vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID 150); collagen (COLLAGEN); multivitamins [vitamins nos] (MULTIVITAMINS [VITAMINS NOS]) all taken for an unspecified indication, start and stop date were not reported (Other medications in two weeks). On 03Apr2021 07:00 the patient experienced very painful cramping, very heavy menstrual flow/large quantity clotting. Patient did not receive treatment for the adverse events. Outcome of the events was resolved on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.
Erythema, edema, heat at site of immunization.  Edema has increased since date of injection, right arm deltoid.  Approximately 50mm diameter of circular swelling around injection site.
Immediately after MCV injection, patient passed out and had seizure-like posturing for approximately 5 minutes. He was able to sit up but immediately passed out again. After 25 minutes, he was not able to return to "normal" and an ambulance was called.
Itchy red arm on 2/2/21. Had chills, nausea, headache and abdominal pain about 5 days after vaccine.
Information has been received on 1/8/02 from a registered pharmacist concerning a 20 year old female who "as a child" was vaccinated with a dose of MMR II. On 1/8/02 it was reported that the pt had a recent rubella titer and it did not show seroconversion. The pt sought unspecified medical attention. Additional info has been requested.
Patient experience sensation of swelling of throat and wheezing within 5 minutes of vaccine administration.  Has NOT experienced similar reaction with the seasonal vaccine.  The sensation of throat swelling resolved within one hour of vaccination and the wheezing resolved by bedtime.  No intervention was necessary, however, patient did take her regularly scheduled cetirizine that evening.
Body wasn't regulating temperature; unsettled stomach; Overall tired and fatigue; Aching; Feeling unwell; Aching in legs; arm soreness was in the right arm, which was the injection arm; This is a spontaneous report from a contactable consumer (Patient). A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: C13248), via an unspecified route of administration, administered in Arm Right on 13Feb2021 (at the age of 74-years old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hypertension , ventricular tachycardia, blood cholesterol abnormal. Concomitant medication included lisinopril (LISINOPRIL) taken for hypertension, atenolol (ATENOLOL) taken for ventricular tachycardia, simvastatin (SIMVASTATIN) taken for blood cholesterol abnormal. Patient received her first dose of Pfizer-Biontech Covid-19 vaccine 13Feb2021 and reports AEs starting on 19Feb2021. Her symptoms include unsettled stomach, overall tired and fatigued, aching, body just wasn't regulating its temperature She was hot and then cold, no fever reported, started feeling unwell, aching in legs, and just unwell. It has been on and off over the weekend. arm soreness was in the right arm, which was the injection arm. Patient was feeling a little better on Saturday, but still kind of off. Yesterday she was feeling kind of off. It is hard to tell how she is feeling today because she just got up. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
R09.02 HYPOXIA 3/3/2022 CKD STAGE 3A (GFR 45-59) R09.02 HYPOXIA 3/3/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA R09.02 HYPOXIA 3/3/2022 ATRIAL FIBRILLATION, PERSISTENT R09.02 HYPOXIA 3/3/2022 SYSTOLIC HEART FAILURE, CHRONIC
Treatment of COVID-19; Treatment of COVID-19; Tested positive again after Paxlovid.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Feb2022 as dose 1, single (Lot number: 6022904), in left arm, on 17Mar2022 as dose 2, single (Lot number: 6022904), in left arm and in 2022 as dose 3 (booster), single (Lot number: EW0202) at the age of 47 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DISEASE RECURRENCE (medically significant) with onset Aug2022, outcome "unknown", described as "Tested positive again after Paxlovid."; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19, disease recurrence. Clinical course: The patient received Paxlovid treatment from 15Aug2022 to 19Aug2022.
covid 19 vaccine event ..   Client received a covid 19 Janssen vaccine and shortly following complained of breathing issues.  Client reported her chest felt "Tight" and she felt like her blood pressure was "High"  Client also reported that she takes blood pressure medication daily and was advised by the Dr. present to take another 12.5mg of her HCTZ.  Initial Blood pressure was 178/115 and the second in 5 minutes was 174/109.  Pulse 100 both times.  oxygen saturation 99-100%  EMS responded and client was discharged home by Dr following improvement in chest tightness and breathing.  Advised to seek emergency services if needed following discharge.
Ended up in hospital with stroke like symptoms, now have cranial nerves III, IV, and VI damaged with ongoing neurological problems
fever/He ran a temperature; a big knot came up under his arm; feeling really bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 41-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "fever/He ran a temperature"; AXILLARY MASS (non-serious), outcome "recovered", described as "a big knot came up under his arm"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "feeling really bad".  Additional information: The patient had side effects when he got the first shot, that was fever and feeling really bad and a big knot came up under his arm, right arm. The second dose he experiencing face burning. Didn't get the booster shot. Then later on 2 weeks or a Month after the second dose his face started burning, like it's on fire and it won't stop. She said this has been going on for 3 months and this is ongoing. She said that done alright and then his face started burning. She said the knot and the fever went away after a while then his face started burning and never stopped. There were no additional vaccines administered on same date of the Pfizer Suspect If applicable. No AE(s) required a visit to Emergency Room and Physician Office. There were no Prior Vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine. The patient had no medical history, Family Medical History Relevant to AE(s). There were no relevant tests.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
significant arm pain at site; This is a spontaneous report from a contactable Other HCP.  An 82-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Jan2021 at single dose in arm for COVID-19 immunisation at the age of 82-year-old. Medical history and concomitant medications were unknown. The patient complained of significant arm pain at site the at evening on 20Jan2021. Thus far, no other notable symptoms. The outcome of the event was unknown. Information on Lot/bath number has been requested.
This spontaneous report as received from a health professional refers to a 66 year old female patient with anxiety, diabetes, irritable bowel syndrome, macular degeneration and osteopenia. On 06-NOV-2013, the patient received her second dose of PNEUMOVAX 23 (lot # J010654, expiration date 17-OCT-2014, 0.5 ml, intramuscular). Concomitant therapy was not reported. In November 2013, the patient became tired and achy, had a fever of 101F and a 6 centimeter by 8 centimeter erythematous, slightly raised, warm area at the injection site. On 08-NOV-2013, the patient went to see the nurse practitioner and was told to use ice and naproxen to treat these adverse symptoms. The outcome of the events was unknown. Additional information has been requested.
Day 1.  Dead arm.  Couldn?t lift arm from hanging down to any height.  Felt like an impingement for 3.5 months.  Sharp stabbing pain in shoulder area, moving from injection site to front,  side and top.  This slowly subsided at the 3.5 month mark. This was repeated in arm #2.  This vaccine was given on 3/14/2021.  My right shoulder is still quite painful. Had the same symptoms in both arms. My left shoulder  is now 90% pain free.
The morning following vaccine administration client's (L) arm was, "itching, red, and had rash with bumps". Symptoms persisted 3 to 4 days, at which time, client applied topical hydrocortisone to affected area & began taking PO BENADRYL.
Patient was working as a nurse following the administration of the shot and began to feel dizzy, nauseated and short of breath.  Hands were visibly shaking. He could not stand or walk on his own. Patient's temperature was taken and presented with a low grade fever.
Frozen shoulder in left arm was relatively painless until receiving pfizer vaccine shot #1 upon which time my entire right arm became inflamed and has not recovered almost six weeks later.
Headache, Myalgia, Arthralgia, Fever, c/o rigors,arm sore at injection site,told to follow up with primary care physician if he doesn't recover Narrative:
Headache Chills Narrative: Reports onset of headache and chills on  5/13/2021 the day after vaccination.
Initial information received on 01-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 61 years old male patient who received vaccine FLUZONE QUADRIVALENT. The patient's past medical history and family history were not provided. The patient did not receive any concomitant medication. On 01-Oct-2018, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6310NA, expiry date 30 Jun 2019 via IV route in unknown administration site. It was an actual medication error due to inappropriate route of vaccination. It was reported that inpatient was administered FLUZONE QUADRIVALENT 0.5mL IV prior to his discharge from hospital today. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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. List of documents held by sender- none.
<18 years old received the 1st dose of the moderna covid-19 vaccine; A spontaneous report was received from a healthcare professional concerning a 17-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No concomitant medications were reported.  On 09 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-20A) intramuscularly for prophylaxis of COVID-19 infection.   On 12 Jan 2021, the reporter stated that after a vaccination drive thru they had a surplus vaccine of the vaccination site so they called in people to vaccinate. A family (mother, father and son) were vaccinated but the son was below 18 years of age and this wasn't confirmed before vaccination so he received the 1st dose of the Moderna covid-19 vaccine on 09 Jan 2021. No adverse events reported and no treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.  The event, <18 years old received the 1st dose of the moderna covid-19 vaccine, was considered resolved on 09 Jan 2021.; Reporter's Comments: This case concerns a 17 year old male who received fist dose of mRNA-1273 (Lot number: 025J20-20A) intramuscularly for prophylaxis of COVID-19 infection. There were no reported adverse events associated with this event of  product administered to patient of inappropriate age.
PER PATIENT REPORT, PAIN A WEEK LATER MY LEG WAS ACHING. I USED ICY HOT,  MASSAGER. STARTED SWELLING, WENT TO WALK IN. THEY DID AN ULTRASOUND AND SAID I HAD A BLOOD CLOT IN MY LEG AND IT WAS TRAVELING TO MY LUNGS. THERE WERE A COUPLE SPECKS ON LUNG PER XRAY.
Pt recvd vax on 17AUG92 & on 22AUG92 devel aching muscles & joints, especially in hips & knees; skin was tender to the touch; had nausea, dizziness, intermittent weakness, fever, chills but no vomiting or rash;
5ml syringes that had been provided by local Authority were used to draw up diluent for mixing the 5-11 year old Pfizer COVID-19 vaccine vial on 12/21/21.  Diluent drawn up and injected into the vaccine vial was 1.6ml rather than 1.3ml.  Diluent was measured on the 5ml syringes incorrectly:  Counting each mark as 0.1 rather than 0.2ml.  This resulted in the vial being mixed with 0.3ml extra diluent.  Vial had a bonus dose (so 11 doses total).  Patient was given a vaccine dose at 90% of the correct concentration.  Error has been reported to Pfizer.  Families are currently being contacted by letter and by phone to be alerted of the error and offered a re-dose if they would like this.  No adverse effects to patients have been reported.
~10 mins post vaccine became diaphoretic, described a buzzing in his ears, and was not aware of where he was, talking throughout, no LOC,  BP stable 100's/60's,  sats 98-99%, no respiratory distress, vomited a moderate amount and immediately felt better. Seen by PCP on site immediately following episode.
Infanrix to 62 year-old patient; This case was reported by a physician via call center representative and described the occurrence of adult use of a child product in a 62-year-old male patient who received DTPa (Infanrix) (batch number LS444, expiry date 16th September 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th September 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 17th September 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced adult use of a child product. On an unknown date, the outcome of the adult use of a child product 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: 28-SEP-2022 Reporter's Comment: The reporter reported for information about the administration of Infanrix to a 62 years old patient. The reporter asked how to proceed with this patient. The reporter consented to follow up. Additional supportive information: A 62 years old patient received infanrix vaccine, which led to adult use of a child product.
Persistent and severe ear pain in left ear. Pain reported as 8/10. No other symptoms reported. No ringing or tinnitus
5 minutes after the vaccination was given, patient developed soft swelling periorbital area, mostly under the eye.  No other symptoms. Swelling decreased after 1/2 hour. No other adverse effects.
Swelling of both ankles, purple/red color on heals. Extreme pain in left ankle/ achillies tenden/ lower leg. Began December 08- Present. Can not stand or put pressure on left foot without pain. Gardasil Dose #1 9/20/07 Lot# 1060U Site RA
Felt fatigued a couple hours after shot; arm was sore for about 36 hours after vaccine. About a week later - a quarter size lump in my arm. The next day, it had grown to be 3 inches in diameter and it was red and swollen. and I called the doctor at that point. Doctor said it should be fine but then it got a little itchy and it went away about five days. I get migraines anyway but I started having migraines  - had a migraine for about two weeks solid- from the time I had the first shot, I am still fighting them. Got put on another medicine for migraines but I think it was after my second shot. It was for high blood pressure - the vaccine may have increased the blood pressure - thinking that the blood pressure and migraines are connected. Was still getting headaches (increased) before the second dose but everything else had resolved.
Red, itchy rash on upper body and arms. Recommended treatment of BENADRYL & call 911 of sx progress.