chrisvoncsefalvay/vaers-outcomes huggingface dataset:
he is experiencing beating headaches; numbness in his mouth; his shoulders started hurting when he does work or exercise like basketball; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 47-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "having surgery in his face" (unspecified if ongoing), notes: having surgery in his face 6 years ago. The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "he is experiencing beating headaches"; HYPOAESTHESIA ORAL (non-serious), outcome "unknown", described as "numbness in his mouth"; ARTHRALGIA (non-serious), outcome "unknown", described as "his shoulders started hurting when he does work or exercise like basketball". Additional information: Seriousness was reported as No. Patient was reporting that after getting the Pfizer covid vaccine he was experiencing beating headaches and numbness in his mouth, he also mentioned later on that his shoulders started hurting when he did work or exercise like basketball. His friend told him that patients who took the vaccine have experienced getting heart attacks/blood clots/strokes and that the vaccine was being used for other things such as medical for autism, alzheimers, and/or memory loss. Patient asked if him having surgery in his face 6 years ago and taking the vaccine caused him to experience this. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
low grade fever - 99.4 to 100.1; dry cough; nasal congestion; a little bit achy; achy mouth - jaw aching; sore arm; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE PAIN (sore arm), PYREXIA (low grade fever - 99.4 to 100.1), COUGH (dry cough), NASAL CONGESTION (nasal congestion) and PAIN (a little bit achy) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Allergic to cats, Hay fever (hay fever to certain plants.) and Mastectomy. Concurrent medical conditions included Drug allergy (codeine).    On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 13-Feb-2021, the patient experienced PYREXIA (low grade fever - 99.4 to 100.1), COUGH (dry cough), NASAL CONGESTION (nasal congestion), PAIN (a little bit achy) and PAIN IN JAW (achy mouth - jaw aching). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (sore arm), PYREXIA (low grade fever - 99.4 to 100.1), COUGH (dry cough), NASAL CONGESTION (nasal congestion), PAIN (a little bit achy) and PAIN IN JAW (achy mouth - jaw aching) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 99.4 to 100.1 99.4 to 100.1. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.
10JUN94 elevated temp of 103, high pitched crying, semi-comatose, eye rolling up, sz, pulse 140, APAP suppository, Atarax;
This spontaneous report was received from a pharmacist via a company representative and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 18-SEP-2016, the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, route of administration, lot# and expiration date were not reported). The reporter stated the patient came back in to the pharmacy on the next day 09-SEP-2016, with complaint of injection site reaction, and stated the entire backside of her arm was red and painful (unspecified which arm). The reporter did not state that redness was a rash, therefore breakthrough varicella could not be ruled out and VZV packet was requested. No treatment was given to the patient for the adverse events. The outcomes of the events were unknown. The causality between the events and ZOSTAVAX was not reported. Additional information has been requested.
Little pain in my arm/arm soreness; Slight Fever; It has been about 7 months since I received my first dose of the Moderna COVID-19 vaccine (only received one dose thus far); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Little pain in my arm/arm soreness), PYREXIA (Slight Fever) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (It has been about 7 months since I received my first dose of the Moderna COVID-19 vaccine (only received one dose thus far)) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced PAIN IN EXTREMITY (Little pain in my arm/arm soreness), PYREXIA (Slight Fever) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (It has been about 7 months since I received my first dose of the Moderna COVID-19 vaccine (only received one dose thus far)). In 2021, PYREXIA (Slight Fever) had resolved. At the time of the report, PAIN IN EXTREMITY (Little pain in my arm/arm soreness) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (It has been about 7 months since I received my first dose of the Moderna COVID-19 vaccine (only received one dose thus far)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  Treatment medications were not reported.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter was infection control manager.  Concomitant medication of the patient was not reported.  Date the vial was placed in the refrigerator was 31-May-2021. There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.  The patient did not experience any adverse event.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-491837 (Patient Link).
Headaches, sinus congestion. I was prescribed a Prednisone steroid and an antibiotic at a local medical facility. The medication did not provide much relief. Later, I was told to take Zyrtec and Flonase. I am scheduled to get a CAT scan on 03/03/2022. I am still dealing with these symptoms.
A syringe collar broke when a staff member was vaccinating a patient with a vaccine, slicing the staff members finger.; A syringe collar broke when a staff member was vaccinating a patient with a vaccine, slicing the staff members finger.; This spontaneous case from the  was received on 29-Sep-2020 from other non-health professional via Product Technical Complaint (PTC) group and concerned a staff member of unknown age and gender.  The patient's medical history and concomitant medications were not reported.   On an unknown date, when a staff member was vaccinating a patient with Afluria Quadrivalent (influenza vaccine), a syringe collar broke and sliced the staff member's finger (explicitly coded as 'Syringe broke'). The device associated with Afluria Quadrivalent was Luer Lok syringe. The batch number reported was P100230205.  The outcome of event 'laceration of finger' was not reported.  The reporter did not provide a causality assessment to Afluria Quadrivalent.  This case has been entered onto manufacturing quality assurance tracking database and allocated reference number 1067172.  An investigation into batch P100230205 revealed that the most probable root cause of broken finger flange on was due to packaging equipment at the fill/finish facility. Shipping of the product was also a possible root cause for the event, as it could not be completely ruled out. Since the packaging line was the most likely root cause, the root cause had been assigned as 'Equipment Malfunction' and the complaint was justified. It was concluded that there was no requirement for any market action based on all information received, as there was no patient safety risk and the overall defect rate for broken finger flanges is 1 Defect/Million Syringes distributed. No additional actions were required for Afluria PFS Drug Product or for batch P100230205.  Additional information was received on 10-Nov-2020 from manufacturing quality assurance department: Quality Assurance Investigation Results were provided. Batch number was added. Narrative was amended accordingly.  Company comment: A syringe collar broke when a staff member was vaccinating a patient with Afluria Quadrivalent, slicing the staff members finger. Laceration was a result of syringe issue making causality unrelated to the product, while device issue was assessed as unrelated per company conventions. The causality for the events of 'laceration of finger' and 'syringe broken' were assessed as related to device Luer Lok syringe.; Sender's Comments: A syringe collar broke when a staff member was vaccinating a patient with Afluria Quadrivalent, slicing the staff members finger. Laceration was a result of syringe issue making causality unrelated to the product, while device issue was assessed as unrelated per company conventions. The causality for the events of 'laceration of finger' and 'syringe broken' were assessed as related to device Luer Lok syringe.
Myalgia fatigue Narrative:  Only available details:  "symptoms: fatigue, body aches."
Information has been received from a lawyer concerning a minor female patient who on 01/22/2002 was vaccinated with an unspecified vaccine. Subsequently, the patient experienced an unspecified injury. Additional information was received concerning hepatitis B virus vaccine rHBsAg(yeast)(MSD) lot #'s 638570/1700K and 640327/0754L, but it was not indicated if the patient received lot no. 638570/1700K or 640327/0754L. Additonal information was not provided.
9 1/2cm erythema & swelling surrounding inj site;warm to touch & tender;
Nov 19 morning - Talking to husband when suddenly had to stop as could not catch my breath. Symptoms went away after a couple of minute.  Nov 20 - noted that I could feel my heart beating.  It is not extra fast but harder.  This worsened and I presented to Emergency on evening of Nov 24.    Nov 29 - Holter monitor Nov 30 - Stress test. Dec 7 - Phone consult with cardiologist who did my stress test and he said that I had PAC (premature atrial contractions).   Dec 8 - in-office meeting with family physician. Current - still experiencing palpitations.
1st covid dose - unable to left the left arm for three days with pain , swelling , tenderness  2nd covid dose-  red rash at left arm injection site litttle by little started with  left arm pain, loss of the left arm movement
After the shot I experienced severe brain fog. I could not drive, or even direct a person to my house. Then for the past 10 days I have experienced very strong and horrible night mares. I have also experienced several more episodes of extreme brain fog.
Pt developed extreme pain, swelling, redness and warmth approx 1 hr after her injection. Discomfort made pt very distressed.
Pt recv vax on 4/23/99; 2 hr post vax pt exp body shakes & chills x 1 hr, flu-like sx (fever &body aches) x 3 days
07/12/22-07/21/22 I had upper respiratory infection. After the vaccine it ended up being that I needed to go and get checked out at the clinic because I was having migraines and they were every day. I had a CT scan and this was in August 2021 and they didn't see anything and said the migraines would subside and that some people reported having migraines or headaches after getting the vaccine and after that I didn't go back and I managed the headaches until I didn't have them anymore which took a month and a half in total. Then I got COVID-19 on 12/26/21 and tested positive on 12/28/22. Symptoms included vertigo, chest and muscle soreness, aches and pains, fatigue, diarrhea, and I was sick until 01/10/22. I had vertigo and shortness of breath and then everything else came after that like the diarrhea, muscle pains, fatigue, coughing, and headache. I was exposed again on 07/13/22 and symptoms was runny nose and I thought it was allergies but by Friday I felt like sinus symptoms were going on and on Saturday I thought I was tired from traveling and was dehydrated and I got itchy and thought I was having allergic reaction. Later that night I had vertigo and felt like throat was closing on me so I went to the ER and they said I didn't have strep and I went to the clinic and asked them to test me for COVID-19 and it was positive. They gave me epinephrine and I was so tired that I came home from the clinic and my symptoms became symptoms of COVID-19 allergies, post nasal drip, sinus congestion, sore throat, and vertigo, and by Tuesday I had diarrhea and that lasted until Thursday or Friday and then I had no appetite, was very fatigued, and had chest congestion.
Right upper thigh swelling anteriorly; scattered erythematous, blanchable placques; tender to touch- within 24 hours of receiving vaccine. On 11/11/09 - mom reports patient's symptoms are improving.
Patient received vaccine at the improper age.  Child not quite 5 years old  Patient's mother/guardian reported incorrect date of birth.  Unaware of patient harm.  Parent intentionally reported and recorded her son's age on consent form incorrectly.   I phoned the mother on 11/15/2021 at 1730 to report the vaccine error.  I inquired about her son's age and advised that I verified in the system that her son was born not on the date that she reported on the vaccine consent form.  The mother stated "well I do not trust the state immunization reporting system, because I was born and I was unable to be located in the system.  I then asked her had she delivered her son at a certain Hospital and she confirmed "yes".  I then advised her that in her son's medical record the date of delivery report was listed differently.  She then hung-up up the phone.  When I attempt to call her back, thinking we had gotten disconnected there was not answer.  I did leave my name and contact number on her voicemail.
Cough; Chills; Fever; Headache; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 79-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6201, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 20Feb2021 (age at vaccination was 79 years) as dose 2, single for COVID-19 immunization. The patient did not have any medical history. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9265, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 30Jan2021 (age at vaccination was 79 years) as dose 1, single for COVID-19 immunization. The caller stated that she wanted to report that she had a reaction to the second dose of the Pfizer COVID vaccine received on Saturday, 20Feb2021. On 20Feb2021, the patient experienced cough, chills, fever and headache. The caller stated she was in an out of the place in less than half an hour, they were very organized, stated she went home and started having a cough later on in the day, also experienced chills, temperature and headache, stated it was like the flu. Stated she took Tylenol and went to bed. Was able to get up the next day and got on couch. Chills progressed during the day, by 6 pm she was underneath blankets. The caller stated the symptoms were gone by Monday, 22Feb2021. The outcome of the events was resolved on 22Feb2021.   Follow-up attempts are completed. No further information is expected.
Cough, couldn't swallow, labored breathing, chills, fever, vomiting, body aches.
Patient c/o nausea and shaky. Patient reports that nausea started first. On call provider was notified of reaction and patient was brought to treatment room.  Patient was given 4mg ODT Zofran.
No side effects or adverse event.  Patient is 16 years of age; reporting vaccine error.
other severe autoimmune injuries; postural orthostatic tachycardia syndrome ("POTS"); Information has been received from a lawyer, regarding a case in litigation and concerning a female patient (pt) of an unknown age. No other information concerning the pt's medical history, concurrent conditions or concomitant medications was provided. On 30-SEP-2016, the pt was vaccinated with quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On that day, the pt was injured "injured by a quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) injection which led her to develop postural orthostatic tachycardia syndrome ("POTS"), among other severe autoimmune injuries. The outcome of the events was unknown. The lawyer considered the events of POTS and autoimmune disorder to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).  Upon internal review, the event of autoimmune disorder was determined to be medically significant.
Since 21 January she has complained of recurrent episodes of generalized itching and rashes described as raised, red, itchy whelts which can occur anywhere on her body, especially at sites of pressure or where her skin is scraped or scratched. Lesions last less than 24 hours, affect her palms and soles, and resolve without post-inflammatory changes. She denies laryngeal, pulmonary, GI, neurologic, and cardiovascular symptoms with these episodes. Episodes not associated with heat, exercise, sweating, cold, foods, medications, NSAIDs, IV contrast, latex exposure, known infections, or insect bites/stings. She received her Moderna COVID-19 vaccine booster dose on 13 January, 8 days prior to onset of symptoms. Her symptoms led her to present to the ER on two occasions (28 January and 5 February) where she was treated with antihistamines at her first visits and an oral corticosteroid at her second visit. She has used oral antihistamines with benefit and a course of oral corticosteroids without benefit. He denies constitutional symptoms. UCT score today is 16 (1, 2, 0, 3, 3, 2, 2, 3). No history of adverse reactions to prior vaccines.
Information regarding PREVNAR was received from a healthcare professional regarding a 20-month-old male patient who experienced severe pneumonia with a positive blood culture for S. Pneumoniae and renal failure. The patient received the fourth dose on 15-Apr-2009. The patient also received the first dose of VARIVAX (Merck & Co Inc) and the first dose of MMR (Sanofi Pasteur) on 15-Apr-2009. Additional suspect medication included PREVNAR. The patient experienced severe pneumonia with a positive blood culture for S. Pneumoniae and renal failure and on 05-Jan-2010. Additional lab results were not provided. VARIVAX and MMR were considered additional suspect vaccines for renal failure. The outcome of the events is unknown. The events either caused or prolonged hospitalization and were considered life threatening. No additional information was available at the time of this report.
Within 1 hour of immunization, patient developed vomiting and diffuse urticaria with fussiness. She was taken to the Emergency Department and IM epinephrine and IM diphenhydramine were administered approximately 1 hour after symptom onset. All symptoms resolved within 30 minutes. Patient observed for several hours without return of symptoms.
LOSS OF ABILITY TO TASTE FOOD AND METALLIC TASTE; EXCESSIVE SWEATING AT NIGHT; CHILLS; PAIN ON HER LEFT ARM; FATIGUE; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient had no known drug allergies. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced excessive sweating at night. On 31-MAR-2021, the subject experienced chills. On 31-MAR-2021, the subject experienced pain on her left arm. On 31-MAR-2021, the subject experienced fatigue. On 02-APR-2021, the subject experienced loss of ability to taste food and metallic taste. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from excessive sweating at night, chills, and fatigue on 02-APR-2021, was recovering from pain on her left arm, and had not recovered from loss of ability to taste food and metallic taste. This report was non-serious.
p/vax pt devel T101; itching rash; Dx: chickenpox; was put on acyclovir; was on short term steroids; pt has Crohn's disease; did not tell nurse before or p/shots
at 7:00pm got hives all over body (arms, stomach, face, neck inside mouth, took Benadryl hives on body went down, the hives inside mouth went away by morning next day.
third dose; First dose 6/4/2018, second dose 2/13/2019; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) (batch number E3z7E, expiry date unknown) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix vaccine (1st dose received on 4th June 2018).   On 26th July 2021, the patient received the 3rd dose of Shingrix. On 13th February 2019, the patient received the 2nd dose of Shingrix. On 13th February 2019, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 26th July 2021, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered and drug dose administration interval too long were unknown.  Additional details were reported as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix vaccine later than recommended time frame, which led to lengthening of vaccine schedule. The patient also received the 3rd dose Shingrix, which led to extra dose administered. The pharmacist unable to provide patient details. The reporter consented to follow up.