chrisvoncsefalvay/vaers-outcomes huggingface dataset:
because the needle was not secured to the syringe 0.1-0.2mL of the dose leaked from the syringe; 0.1-0.2mL of the dose leaked from the syringe; A spontaneous report was received from a nurse concerning a 44-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and not a complete dose administered.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 06 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025G20-2A, Exp. date: 25 Feb 2021) intramuscularly in the left arm for prophylaxis of COVID-19 infection. The nurse reported that while administering, the needle was not secured to the syringe and believes 0.1-0.2mL of the dose leaked from the syringe. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, not a complete dose administered, was considered resolved on 06 Jan 2021.; Reporter's Comments: Company comment: This report refers to a case of 44- year-old female patient who experienced event of some dose 0.1-0.2mL of the dose leaked from the syringe for mRNA-1273, lot # 025G20-2A, Exp. date: 25 Feb 2021. There were no reported AEs associated with this case of dose leaked from the syringe.
Vertigo; 101 F oral temperature; nausea; generalized weakness; rigors/ chills; generalized muscle aches; This is a spontaneous report from a non-contactable Nurse (patient). A 27 years old male patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 27 years old on 21Jan2021 09:00 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced Vertigo, 101 F oral temperature, nausea, generalized weakness, chills, rigors, generalized muscle aches. Patient did not have covid prior vaccination and did not have covid tested post vaccination. The outcomes of events were unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Very red rash with some swelling and turned into watery blisters. I used hydrocortisone, went away after a week. Rash started on the right arm and then moved to my back.
Localized skin bruising, with large area of redness, swelling, warmth covering over lateral upper extremity.
Red, swollen, hot to touch, soreness at injection site. Place was not visible morning after shot but developed during the day and increased in size to about 2.5 inches in diameter.
pt recv vax 22JAN97 & approx 5PM states pt lt arm swollen & hurts from inj site to lt elbow;denies fever, redness, red streaks;instructed to call family MD to be seen;seen by MD evening as f/u phone call;
FATIGUE,CHILLS,SOB,GAIT DISTURBANCE Narrative:
Pt came in to office with a hive below the injection site of right arm. Not cellulitic. Was seen by doctor and given BENADRYL only for relief. Should not limit future vaccines.
After the second dosage my husband complained of pain in the shoulder which i assumed was normal because of what we were told by people after they received their dosage. On 09/07/2021 my husband wasn't able to walk unassisted and by the end of September he couldn't walk at all, couldn't control his bowels, couldn't swallow any food, drink or medication.
Began on the 21st of December, sores on the tip of the tongue and progressed to canker like sores on the inside of the bottom and top lips , burning sensation that covered the facial area. Doctor instructed to keep taking Valtrex and prescribed a Z pack , I was already taking the Valtrex with little to worsening effect BUT after administering the Z pack condition quickly deminished and went completely away within 2 days.
Body feels hot; Chills; shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), FEELING HOT (Body feels hot) and CHILLS (Chills) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Medical history was not reported.  Concomitant products included ACETYLSALICYLIC ACID (ASPRIN) for an unknown indication.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced DYSPNOEA (shortness of breath) and CHILLS (Chills). On an unknown date, the patient experienced FEELING HOT (Body feels hot). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (shortness of breath), FEELING HOT (Body feels hot) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, Influenza: negative (Negative) Negative. On 15-Apr-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This spontaneous report as received from a registered nurse refers to an unknown and gender age patient. Pertinent medical history, drug reactions or allergies were not reported. On 21-JUN-2013, the patient was vaccinated with an improperly store dose of VARIVAX (Merck), (dose was not reported), lot # H009635, expiration date: 09-MAY-2014. Concomitant medication was not reported. The reporter stated that VARIVAX (Merck) was improperly stored from 03-JUN-2013 to 21-JUN-2013, and the total amount of time that the doses were above the recommended storage range of -15 Celsius (C) was 187.5 hours. Though most the temperatures recorded in that time period were below -10C, there were three occasions where a highest temperature of 0C was recorded. The three temperature excursions were: 1). 88.5 hours to as warm as 0C, 2). 7.5 hours to as warm as -6C, and 3). 88.5 hours to as warm as -8C. No adverse effect had been observed or reported. This is one of four cases linked to the same reporter (MARRS # 1310USA008540, 1310USA010120 and 1310USA010122). Additional information has been requested.
The morning after getting the vaccine I woke up with a bad headache and my whole body in pain. I especially felt pain right below my ribs, my hips, and my neck. I also became congested which lasted the entire day.
Wednesday evening, I had a severe headache and took some Tylenol, Thursday day, I had some streaks going down my left eye. And it looked like there was a dot in front of my vision straight on. And I couldn't get rid of it, and it stayed there. I still had a severe headache, and I took Tylenol every day since the vaccine that week, I had a fever of 101.4. And I called the doctor and I had shadows on the left side of my peripheral vision and still had the dot. So, I went to go see doctor and he had dilated both my eyes. My doctor said he didn't think it was related to the vaccine, but he could see the dot and the floaters in my left eye. And I'm supposed to go see him again on Dec. 21. And I asked what I do with this, and he said my brain would get used to the vision, but I still have the dot and peripheral haze. I still have headaches, it's not severe but just dull pain on the left side. And my vision is fine, it's just around the peripheral, there shadows. Also, in that eye I did have a cataract removed from that left eye two years ago.
Fever; sore arm; This is a spontaneous report from a contactable consumer from Pfizer-sponsored Program.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced fever and a sore arm. The patient outcome of the events was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.
Metallic taste on 11/24 07:30, then Loss of taste (front part of tongue) after 8:00. Went to got a pcr test got negative result
patient called pharmacy 8/21/21 after receiving pfizer covid 19 vaccine 8/18/21. Patient reported swelling of eyes and angioedema. Patient reported receiving steroid shot from a medical facility.
After second shot: unsteadiness, tingling sensation in fingers 3 weeks after shot. After third shot: optic neuritis, 4 days after shot. Blind spot in eye. The medical records received on 1/28/04 states clouding vision, fatigue, headache, ischemic neuroopathy and anxiety. The medical record received on 2/24/04 states visual acuity diminished and visual field defect.   Follow up on 07/28/04 states: "Pt has not recovered from adverse events. There is a permanent partial loss of vision in one eye. I believe the symptoms began after the second shot: dizziness, tingling in fingers, fierce headaches in temples, fatigue, sensitivity to light." As per annual follow report permanent blindness in portion of left eye.
Local reaction right deltoid after receiving vaccine (IPV) complained of redness, warmth, swelling.
Pneumonia vaccine given, arm got red. Fever of 101 F. Fever began 24 hours after shot. Fever gone within 12 hours. Legs felt weak. Arm hurt.
Approx. 2 1/2 hrs post flu shot experienced sore throat, nasal congestion, SOB, periorbital edema, 98% O2 sat., weakness, fatigue, mild edema oropharynx . Tx: BENADRYL, SOLU-MEDROL, PEPCID initially. Sent home with ATARAX and Prednisone. Admit ER at 1828. Disch. 2025.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history: asthma; "Known allergies: Shellfish" (unspecified if ongoing), notes: Known allergies: shellfish. Concomitant medication(s) included: FLONASE [FLUTICASONE PROPIONATE], start date: 03Jan2022, stop date: 09Apr2022. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer). The following information was reported: NASAL CONGESTION (non-serious) with onset 24Apr2022, outcome "not recovered", described as "Congestion"; COUGH (non-serious) with onset 24Apr2022, outcome "not recovered"; FATIGUE (non-serious) with onset 24Apr2022, outcome "not recovered"; HEADACHE (non-serious) with onset 24Apr2022, outcome "not recovered"; NAUSEA (non-serious) with onset 24Apr2022, outcome "not recovered"; DRUG INEFFECTIVE (medically significant) with onset 24Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 24Apr2022, outcome "not recovered" and all described as "Relapse of Covid-19 symptoms and positive Covid-19 test after two negative tests two days apart"; DIARRHOEA (non-serious) with onset 24Apr2022, outcome "not recovered", described as "diarrhea"; DIZZINESS (non-serious) with onset 24Apr2022, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: 'positive Covid-19 test after two negative tests two days apart'; Negative, notes: two negative tests. Therapeutic measures were not taken as a result of Covid-19, nasal congestion, headache, cough, fatigue, nausea, diarrhoea, dizziness. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Got shingles after my first vaccine 5 years ago/Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-APR-2022 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient got shingles after his/her first vaccine 5 years ago. The patient stated that, shingles were horrible. The patient had feared to get them ever again. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Left thigh, red, hard, hot area - increased in size past 24 hours, painful, fever. Started on ABX TMP/SMZ.
Rash on trunk - fine, red, itchy - 8 hrs post vaccine administration. This is the first flu shot (ever) for this patient.
This literature marketed report was received from the authors in a published literature article title as stated above, concerning a 68 years old male patient with dyspnea, hyperlipidemia, prostate enlargement and hypothyroidism. On an unknown date, the patient started therapy with BCG live (manufacturer unknown) (dose, route, lot# and the expiration date were not reported) for prophylaxis. On an unknown date (reported as 1 year ago), the patient underwent a Quantiferon Gold test with a positive result (Mycobacterium tuberculosis(TB) antigen response 0.91, reference range in <0.35) (vaccination failure), but he had not received treatment for this. At the time of reporting the outcome of vaccination failure and mycobacterium tuberculosis complex test positive was unknown. A copy of the published article is attached as further documentation of the patient's experience.
It was reported that a 7 year old male patient received a Typhim VI vaccination. Reportedly sometime after the vaccination the patient experienced increased bilirubin and scleral jaundice. No specifics were provided. Further info requested. From additional correspondence received on 10/20/00, it was reported, "Child was in Guatemala when ill. The family reported the patient recovered - has since moved." From additional correspondence received on 04/17/01, it was reported, no further information is available regsarding this patient or this case. This case is closed.
Complete blackout of an entire day. No memory from late Saturday until some time on Monday. At some point during this period I must have hit the back of my head as woke in a fog on Monday with some dry blood caked in my hair.
Swollen lymph nodes in neck, I was told this would go away in a few days and a year later they are still swollen. Feels like a hard marble in my neck
an expired flu vaccine was administered, with no reported adverse event; Initial information was received on 05-Nov-2021 regarding an unsolicited valid non-serious case received from a consume/ non-healthcare professional via Regulatory Authority (Global Medical Information- 00845345).  This case involves a patient of (unknown demographics) who was vaccinated with an expired dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (Expired product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other concomitant vaccines were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot number UJ477AA and expiry date 30-Jun-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  It was reported an office administer, stated an expired FLU VACCINE was administered and she would like to know what should be done. AE reported. Caller stated she DOES NOT KNOW THE NAME OF THE VACCINE; she will call back with the name of the flu vaccine.  It was a case of an actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event reported.  Event outcome was unknown.  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.
Onset w/irritability on 19NOV w/fever 20NOV x 48 hrs; temp not taken but felt warm; On 23NOV temp spiked (felt hot); 24NOV rash on neck & progressed to stomach;
redness at injection site; injection site pain/Injection site tenderness; pain; difficulty in moving her shoulder; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, less than 2 months after receiving Bexsero, the patient experienced pain in arm, shoulder discomfort, injection site erythema and injection site pain. On an unknown date, the outcome of the pain in arm, shoulder discomfort, injection site erythema and injection site pain were unknown.   It was unknown if the reporter considered the pain in arm, shoulder discomfort, injection site erythema and injection site pain to be related to Bexsero.  Additional details were provided as follows: The patient received Bexsero vaccine a month ago and experienced pain in her arm and difficulty in moving her shoulder that lasted for about two weeks and experienced pain to touch and redness at injection site for a couple of days. The reporter did not consent to follow up. Provided information on dosing scheduled and side effects from PI.
This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unspecified dates, the patients received improperly stored doses of VAQTA lot # M003011 with expiration date 15-NOV-2017 and lot # L015460 with expiration date 20-JUL-2017 (dose and route of administration were not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Mom reports that patient developed a red, raised area below injection site about 31 hours after receiving the flu vaccine. The area was very itchy. Mom gave Zyrtec and the area returned to normal about 30 minutes later. Patient has not experienced a reaction to other vaccines and has no known allergies.
Nurse calling to report VARIVAX was administered to patient while it had a temperature excursion; Patient is asymptomatic. No additional AE.; This spontaneous report was received from a Registered Nurse (R.N.) referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection (1 dose; lot # W025274, expiration date 10-AUG-2024; strength and route were not reported) for prophylaxis while the vaccine had a temperature excursion (product storage error).   The excursion temperature was 24.4 Fahrenheit (F) with time frame of 5 hours 51 minutes 0 seconds. There was no previous temperature excursion. The patient was asymptomatic. No additional AE (no adverse event).
Started with a mild cough that got progressively more severe.  Sore throat after cough worsened.  Runny nose.  Had fever that lasted 3 days and reached as high as 101 degrees.  Aches and pains.
AFTER INJECTING IN PATIENTS RIGHT DELTOID AREA TH  FIRST INFLUENZA INJECTION -(NEEDLE FROM LOT#4155460) MALFUNCTIONED & ALL INFLUENZA LIQUID SPIRTED OUT AT THE NEEDLE/SYRINGE HUB. SO PATIENT WAS INJECTED A 2ND TIME WHICH WAS UNEVENTFUL & THE FULL DOSE WAS GIVEN. NO PROBLEMS WITH SKIN INTREGRITY NOTED A BOTH INJECTION SITES.
diagnosed with pneumonia; This is a spontaneous report from a contactable consumer via Pfizer Sponsored Program.  A 73-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Jan2021 at single dose for COVID-19 immunisation at the age of 73-year-old. Lot number was EL1284. There was no medical history nor concomitant medications. The patient experienced pneumonia on 18Jan2021. Pneumonia was diagnosed at check up on 25Jan2021. They were not thinking patient got the pneumonia after the vaccine, they did not know if he had the pneumonia already or not at the time of vaccination. The outcome of the event was unknown.
Headache,  Diarrhea, NauseaVomiting, Fatigue, Quesy stomach Narrative:
first day of injection was sore muscle from injection suite lasted about 3 days just ache and soreness. Jan 20 developed the red raised circle rash at site. about 5 cm.  on the 23rd i woke with a rash on the right side of face and neck to my shoulder and across chest. I had a throat swelling sensation and took two doses of  Benadryl one at 6:30 and the other at12:30 and that got better.
Narrative: Pt received his first dose of the covid-19 vaccine on 2/2/21. Pt called  in on 2/9/21 and per note "Pt states that he is experiencing body aches, no appetite   & extreme fatigue after having his first Covid vaccine on 2/2. Pt states that he just  feels bad & asks the provider if there is anything he can do about how he is  feeling. Reports staying up at night because of the body aches." Pt reported to ED  on 2/10/21 with similar complaints and was treated with ondansetron, ibuprofen,  acetaminophen, and guaifenesin. Pt reported that he felt much better and that  symptoms have resolved on 2/11/21.
Day after shot, client developed fever, neck pain, chills,muscle rigidity. Taken to hospital. Spinal tap done,revealing viral meningitis. Client admitted. Remains in hospital at time of report. Viral infection
anaphylaxis; my tongue blew up; had trouble breathing; pain in my chest; ears were blocked; 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 female patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), as dose number unknown (booster), single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "sulfites, artificial color, and preservatives." (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Pfizer covid vaccine, for COVID-19 immunization. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "recovered", described as "anaphylaxis"; SWOLLEN TONGUE (non-serious), outcome "unknown", described as "my tongue blew up"; DYSPNOEA (non-serious), outcome "unknown", described as "had trouble breathing"; CHEST PAIN (non-serious), outcome "unknown", described as "pain in my chest"; EAR DISCOMFORT (non-serious), outcome "unknown", described as "ears were blocked". The patient had anaphylaxis the night after she took Prevnar 20. That subsided. And at night, her tongue blew up and she had trouble breathing in with some pain in her chest and her ears were blocked. She've taken the Pfizer COVID vaccine with no problem with that. She was allergic to sulfites and some artificial color and preservatives. She was asking what is in Prevnar 20, if there was aluminum in Prevnar 20 and what was the aluminum used for.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht crm197 protein), pneumococcal 20-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received.