chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 75 year old female who on 31-Oct-2006 was vaccinated with the second dose of pneumococcal 23v polysaccharide vaccine (lot#651357/0391F), IM left arm. Concomitant therapy included simvastatin, alendronate sodium, ezetimibe (+) simvastatin, HCTZ/triamterence (MAXZIDE), lisinopril and ergocalciferol (DRISOL). The patient was initially vaccinated with pneumococcal 23v polysaccharide vaccine 9 years ago (in approximately 1997). On 31-Oct-2006, the patient experienced large painful local reaction with pruritis that extending from her deltoid to hand and forearm almost circumferential. Later in the evening while talking on the phone to one of her children (also reported as talking to her physician's office) she fainted. The patient was brought to the emergency room and was admitted for overnight observation. While hospitalized the patient was diagnosed with hypertension, hyperlipidemia and osteoporosis. The physician reported that there was no evidence for an acute myocardial event. The reaction appeared to be severe and local with no systemic effects. The syncopal episode was thought to be on a vagal basis due to the pain. The patient was stable the following morning and the reaction appeared to no longer be progressing. On 01-Nov-2006, the patient was discharged in improved condition (also reported as recovered) for close office follow-up. The patient was instructed to use cool compresses to the right arm 20 minutes on, 20 minutes off as often as possible. The event were considered to be other important medical events (OMIC). Additional information has been requested.
is sick with a fever; is sick with a fever/101F at night; He has been having body aches, feer, full body aches; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 46-years-old male patient received first dose of vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: unknown), via an unspecified route of administration as a single dose on 28Mar2021 for covid 19 immunization. The medical history included: the patient was infected with covid 19 on an unspecified date in Jan2021. The patient's concomitant medications were not reported. The patient enquired that he received first dose on 28Mar2021, and his second dose was due today (initially said 20Mar); is it okay to get it past 21 days. The caller reported that he was supposed to receive his second dose today, but he was sick with a fever on an unspecified date in 2021. He has been having body aches, feer, full body aches and 101F at night but takes NyQuil at night and then wakes up without a fever. He had Covid in January and this current illness is much worse. The outcome of the event fever was reported as recovered on an unspecified date in 2021 and other events were reported as unknown.  No follow-up attempts are needed. No further information is expected.
Had a hive about  3 inches wide that lasted 10 or more days. Doctor prescribes over the counter medications: oral Benadryl 75mg and topical hydrocortisone cream.
My level of taste buds has decreased it's not the normal taste bud; maybe I am sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 13Apr2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: TONGUE DISORDER (non-serious) with onset Apr2021, outcome "unknown", described as "My level of taste buds has decreased it's not the normal taste bud; maybe I am sick".  Additional information: It was reported that dates for level of taste buds have decreased it's not the normal taste bud; maybe patient was sick. Reporter seriousness for level of taste buds has decreased it's not the normal taste bud. The reason for no lot number was unspecified Vaccine: Complainant hung up abruptly/transfer incomplete patient stated, got Pfizer vaccine on the 13th of this month and for about a week and half level of taste buds has decreased it's not the normal taste bud, wanted to know it is one of the side effects or is it because of maybe patient sick or something else. Patient was informed about the Pfizer Medical Information and provided with the number and requested to dial the option 3. Further probing could not be done as consumer hung up the call abruptly. Hence, limited information available over the call.  No follow-up attempts are needed. No further information is expected.
Deep cough.  Mild sore throat with mucus.  Deep, somewhat hoarse voice.  Weakness.
Congestion; fatigue; cough with mild wheezing; cough with mild wheezing; 2 times severe sharp quick headache; hives at my jawline; sore arm at injection site; This is a spontaneous report from a contactable other HCP (patient).  A 54-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 04Mar2021 11:30 (Batch/Lot number was not reported), age at vaccination of 54-years-old, as single dose,for covid-19 immunisation.  Medical history included lyme disease from an unknown date and unknown if ongoing, autoimmune thyroiditis from an unknown date and unknown if ongoing, psoriasis from an unknown date and unknown if ongoing , psoriatic arthropathy from an unknown date and unknown if ongoing, asthma from an unknown date and unknown if ongoing, rubber sensitivity from an unknown date and unknown if ongoing, arthropod sting from an unknown date and unknown if ongoing, dust allergy from an unknown date and unknown if ongoing, mycotic allergy from an unknown date and unknown if ongoing, seasonal allergy from an unknown date and unknown if ongoing. The patient was not pregnant and was not pregnant at the time of vaccination. Concomitant medications included apremilast (OTEZLA) taken for an unspecified indication, start and stop date were not reported; vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) taken for an unspecified indication, start and stop date were not reported; colecalciferol (VIT D3) taken for an unspecified indication, start and stop date were not reported; zinc (ZINC) taken for an unspecified indication, start and stop date were not reported; bifidobacterium lactis (PROBIOTIC [BIFIDOBACTERIUM LACTIS]) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced congestion, fatigue, cough with mild wheezing, 2 times severe sharp quick headache, hives at jawline, sore arm at injection site on 05Mar2021. No treatments were given for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Facility type vaccine: Workplace clinic. The patient recovered from all events on an unspecified date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
2 x 4 cm  erythematous, tender region (L) thigh.  Recommended  applying cool compress  to reaction site & giving 5mL Benadryl   PO 3 times daily.
Diarrhea came two days after for four days. Sore arm. Head felt numb-ish, tingly on right side and sore shoulder/arm. Then, small bumps on head and headache. Then, five days or later large bumps formed on head. Top of head, then moved to right side of head, lymph nodes and right side of neck swelling. Very severe head ache 7 days later. Emergency call to doctor and doctor visit. Bumps moving and forming in different areas side of vaccine. Face swelling. Throat swelling...all on right side.
Pt. received H1N1 vaccine Monday Nov. 16th. Mother called Friday Nov. 20th stating pt's arm was very red, swollen, itching the next day. Pt. developed rash on arm and neck and one side of her face was red. Also c/o HA and stomach ache. Mother has been giving child Benadryl. Rash gone but still has a HA and stomach ache. Pt. ret to MD.
Passed out on 4/8 @ 8am  Was at home.  On going headache for reminder of 4/8
I experienced a bit of soreness to my left arm, my arm felt a little bit warm to touch. I also felt tired and some fever on the second day.   The pain went away in 3-4 days.
AT APPROXIMATELY 1:22 ON 3/15/2021 PATIENT STATED HER THROAT WAS BEGINNING TO FEEL LIKE IT WAS CLOSING. MONITORS AT VACCINE POD ASKED FOR NURSE ASSISTANCE. PATIENT STATES SHE HAS HER EPI PEN WITH HER. SHE SELF ADMINISTERED EPI PEN THROUGH RIGHT PANT LEG AT 1:24, 911 CALLED. BLOOD PRESSURE 138/99 HEART RATE 110. PATIENT STATES HER THROAT IS "FEELING BETTER" AT 1:26. EMT ON SITE AT 1:31 AND THEY RESUME CARE OF PATIENT. SHE AGREES TO BE TAKEN TO HOSPITAL BY AMBULANCE FOR EVALUATION. PATIENT LEFT VIA AMBULANCE AT 1:45.
9/20 sneezing, mild headache, stiffness. 9/21 muscle aches, vomiting, diarrhea, fever, fainting, loss of blood pressure. 9/22 dizziness, indigestion.
Vaccinated Thursday 9/26, Friday 9/27 noted swelling and itching at injection site - with increasing area of redness. Sat area was hard, warm, spreading and blistering.
Moderna Covid 19 Vaccine EUA. I have 3 inch circle rash at injection site.  It  itches.
frozen (thawed out) FLUZONE QUADRIVALENT was given to a patient which was left for the day by nurse and stated their refrigerator was not out of range/ No Ae; Initial information was received on 10-Sep-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 48 years old female patient who received frozen (thawed out) vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] which was left for the day by nurse and stated their refrigerator was not out of range (product storage error) on 10-Sep-2020.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   On 10-Sep-2020, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ452AB and expiry date 30-Jun-2021) via intramuscular route in an unknown administration site Prophylactic vaccination.  Case details: Reporter stated that there was the only one in the bubble wrap that was delivered that was frozen and the nurse has left for the day. Stated that their refrigerator was not out of range. Dose was given yesterday to non-pregnant female and no other vaccines given during that visit that day.   It is a case of actual medication error due to product storage error temperature too low.  At the time of report, no adverse event was reported.  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 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.
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 05-NOV-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (Vls 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the PNEUMOVAX had a temperature excursion for 804 hours, the lowest recorded temperature was 20 degrees F (-6.667 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
Sore arm from both; Bad chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm from both), CHILLS (Bad chills) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PREDNISONE for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced CHILLS (Bad chills) and PYREXIA (Fever). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm from both). The patient was treated with PARACETAMOL (TYLENOL) for Fever chills, at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) for Fever chills, at an unspecified dose and frequency. On 08-Apr-2021, CHILLS (Bad chills) and PYREXIA (Fever) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm from both) had resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine)  was Not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-073607 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073607:1st dose case
Started  off with scratchy throat low grade fever the next day with a bad cough over the next course of 5 days runny nose & fatigue.
A company representative reported that a female child received an injection of Prevnar and subsequently developed a rash. No further information is available.
pt recvd vax & devel rash, itching, hives, swelling of throat & eyes & neck pain; took DPH;
This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received first dose of BNT162B2 (BNT162B2, Solution for injection, Batch/Lot Number: ER8731) via an unspecified route of administration at arm right (upper) (at the age of 63-year-old) on 09Jun2021 as single dose for COVID-19 immunization. The patient medical history includes COVID-19 (indication because the caller had COVID-19 before prior to ever receiving the first dose Pfizer Covid vaccine and doesn't want to get Covid again). The patient's concomitant medications were not reported. On 09Jun2201, it was stated that the injection site was turning red began within two hours of getting home after receiving the first dose. The events were ongoing and it had worsened. On 10Jun2021 around 18:00, the patient began to experience having really bad swelling on the arm and the arm was really tender and had severe pain. The patient also stated the swelling on the arm had worsened. The outcome of the events was not recovered. Follow-up attempts are needed. Further information is expected.
Two weeks after first shot I developed swelling in the site with a rash and tenderness. It has lasted so far for three days. Still red and itchy. I have been using Benadryl cream and cold packs on it.
Sore arm; This is spontaneous report received from a non-contactable other health care professional. A patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sore arm. Felt like someone punched me pretty hard. That went away after about twenty-four hours. The outcome of events was recovered. Causality: Related  No follow-up attempts are possible; information about lot/batch number cannot be obtained
cold sores; This non-serious case was reported by a consumer and described the occurrence of cold sores in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cold sores (had gotten a cold sore at least once or twice a year for many years ). Concomitant products included levothyroxine sodium (Levoxyl) and amlodipine.   On 04-JAN-2020, the patient received Shingrix. On 10-JAN-2020, 6 days after receiving Shingrix, the patient experienced cold sores (Verbatim: cold sores). The outcome of the cold sores was not resolved.   It was unknown if the reporter considered the cold sores to be related to Shingrix.     It was unknown if the company considered the cold sores to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-May-2023 The patient had gotten a cold sore at least once or twice a year for many years but noticed she did not get any since she received the Shingrix vaccine. Recently, she got two cold sores and wondered if the side effects of getting the Shingrix vaccination were wearing off.  She thought there might be some cross immunity with herpes simplex after getting the Shingrix vaccination.  She saw a study where a couple of other women reported the same thing. Might be this should be studied because it would seem that it could be lucrative for the company if it could be shown that the vaccination suppresses outbreaks of cold sores (cessation of cold sores)  These symptoms were not treated. The reporter did not consent to follow up.
The first and second intradermal attempts did not result in a wheel. No physical adverse event occured. The third attempt was administered as a subcutaneous dose using .5 mL of the JYNNEOS vaccine, and was successful.
3 days after receiving shot 1 on 7 April 2021, I developed severe shortness of breath while doing trivial tasks. On April 13th, 2021, I went to my PCM for a scheduled appointment and told him how I was feeling. He listened to my heart and lungs and suspected I was in Afib. He confirmed his  suspicions by conducting a 12 lead EKG. I was then referred to an Electrophysiologist who conducted a full work up to include stress test and  CT scan with contrast. All normal. Electrophysiologist felt was an isolated incident as I had never had any heart issues prior. Worked for 25 years where my health was monitored regularly including yearly heart work ups once I turned 40 with no heart issues ever recorded. On 27 April 2021 received shot 2. On 30 April 2021 I went into Afib again with Tachycardia. Heart rate exceeded 200 BPM. Ended up in the ER of a local Hospital where I spent the weekend. Heart converted through medication to sinus rhythm on that Sunday. Decision was made to conduct cardiac ablation after continued repeated episodes of Afib with Tachycardia when treatment with Propophenon did not control. Was ablated in August of 2021 and continued treatment for the following year with Flecanide twice daily. After medication withdrawal in November of 2022 the Afib returned. Underwent 2nd Ablation in January of 2023 and it was discovered heart was continuing to make new pathways versus previous ablation reconnections. Treatment is continuing with Flecanide and Diltiazem but still having frequent episodes of Afib, severe atrial flutter, and Tachycardia.
2nd shot 3/22/21 pfizer dizziness starting 3/31/21  still dizzy every morning when first getting out of bed. better as the day goes on.
Information has been received from a Registered Nurse (R.N) concerning a 23 year old female patient who on 08-AUG-2008 was vaccinated with the first dose of GARDASIL (lot # 660391/0063X; expiration date on 19-OCT-2010). Concomitant therapy included PROTONIX and YASMIN. On 14-AUG-2008 the patient developed a 5 to 7 mm lump just below the injection site with obvious pain. It was reported that on 13-FEB-2009 received the third dose of GARDASIL with no adverse effects. The nurse stated that the patient only had adverse events with the first dose of GARDASIL. At the time of reporting the patient had recovered. Follow up information was received from a Registered Nurse (R.N) concerning a 23 year old female medical assistant with no known drug allergies/drug reactions who on 08-AUG-2008 was vaccinated with the first dose of GARDASIL (Lot # 660391/0063X) intramuscularly into her left deltoid. There was no illnesses at time of vaccination. It was reported that on 14-AUG-2008 the patient felt increased discomfort, a lump was felt near the injection site. The left upper arm was slightly lower than usual injection site. There was a 5mm - 7mm palpable area. On 25-AUG-2008, the patient had an office visit for evaluation. There were no laboratory diagnostic tests performed. There was local care. On an unspecified date the patient recovered. In October 2008 and in February 2009 the patient was vaccinated with the second and third doses of GARDASIL (lot numbers not reported) (respectively), there were no adverse reactions following these injections. No further information is available.
Uveitis; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a elderly patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 05-JUN-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster-related conditions (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). On an unknown date, reported as subsequent to the vaccination, the patient was treated for uveitis. The outcome of uveitis was not reported. The reporter considered uveitis to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, uveitis was determined to be medically significant events.
In January 2022 I had a stroke which affected my right side- In January 2023 I had another stroke affecting my right side.
tremors, abd, legs 3min p/vax;c/o visual disturbance & severe frontal head pain;LVN laid pt down gave lime juice;PB 110/60, P80, 02 sate 86-97;pale, shaky;
Nurse whom gave her the bivalent Covid-19 Moderna booster reported that she had flu like symptoms after receiving the Moderna bivalent vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Nurse whom gave her the bivalent Covid-19 Moderna booster reported that she had flu like symptoms after receiving the Moderna bivalent vaccine.) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Nurse whom gave her the bivalent Covid-19 Moderna booster reported that she had flu like symptoms after receiving the Moderna bivalent vaccine.). At the time of the report, INFLUENZA LIKE ILLNESS (Nurse whom gave her the bivalent Covid-19 Moderna booster reported that she had flu like symptoms after receiving the Moderna bivalent vaccine.) outcome was unknown.            No concomitant medications were reported.  No treatment details were reported.   Reporter did not allow further contact