chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vial was first moved to refrigeration was on 08-Apr-2022, date of administration was on 09-May-2022 (booster's fridge shelf life of 30 days ran out on 08-May-2022); Administered a booster dose, the booster's fridge shelf life of 30 days ran out on 08-May-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered a booster dose, the booster's fridge shelf life of 30 days ran out on 08-May-2022) and PRODUCT STORAGE ERROR (The vial was first moved to refrigeration was on 08-Apr-2022, date of administration was on 09-May-2022 (booster's fridge shelf life of 30 days ran out on 08-May-2022)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered a booster dose, the booster's fridge shelf life of 30 days ran out on 08-May-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was first moved to refrigeration was on 08-Apr-2022, date of administration was on 09-May-2022 (booster's fridge shelf life of 30 days ran out on 08-May-2022)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered a booster dose, the booster's fridge shelf life of 30 days ran out on 08-May-2022) and PRODUCT STORAGE ERROR (The vial was first moved to refrigeration was on 08-Apr-2022, date of administration was on 09-May-2022 (booster's fridge shelf life of 30 days ran out on 08-May-2022)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2022: Upon live follow-up, date of administration and lot number of suspect product as well when the vial was first moved to refrigeration were added.
This patient had two febrile seizures on 03/29/01. One at 1:30 AM and one at 5:30 AM. He was seen on 03/29/01 for otitis media.
On 10/06/2021 the client presented to the clinic for her 2nd dose of Covid vaccine. Upon assessment of the patient's record the nurse realized the patient was under the age of 18 when she received her 1st dose of Moderna vaccine on 09/08/2021. Patient reports a sore arm at the injection site, but no other side effects. Nursing manager advised that the patient and her parent be made aware of the situation. The patient and parent verbalized understanding that under the EUA for Moderna the patient should not have received Moderna vaccine due to her being under 18. The patient and her parent were given the information necessary to make a decision regarding the 2nd dose of the vaccine. The patient and her parent voiced their concerns of the risk of Covid versus the risk of receiving a 2nd dose of vaccine.  A 2nd dose of vaccine was administered in the LA, the patient was observed for the 15 minutes per guidelines and no adverse effects were noted.
Chills, aches, fever, swelling and redness of injection site, headache.
This spontaneous report as received from a Certified Medical Assistant refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. In approximately December 2014 reported as about two months ago, the patient was vaccinated with a dose of ZOSTAVAX. On an unknown date, the patient was diagnosed with herpes zoster. The outcome of herpes zoster was unknown. Relatedness between the therapy with ZOSTAVAX and the herpes zoster was not reported. Additional information has been requested.
p/vax pt felt like passing out;arms weak especially rt forearm;stomach cramps w/diarrhea;n/v;bad h/a;pt not totally recovered 1/15/99;dx general malaise, adverse drug rxn;
Evening after administration of PPSV23 the patient stated she had pain, bruising, and a rash all over her left arm. She stated she could not move her arm until the following day.
Patient mother states patient had been febrile, her arm where injection was given is painful, a satellite appearing blister/red lesion has appeared a few cm down from injection site.
Rapid HR and high BP. Lasted about 5-10 minutes approximately 3-4 minutes after vaccine was administered. Strange lump/feeling /taste in the back of throat. Like a tang. Lymph nodes in throat swelling, build up of mucus and bad taste once secreted. Right ear plugged and sinuses plugged. Lots of sinus pressure and headache.  Felt very out of it. My feet were elevated immediately and blood pressure and heart rate monitored. Left approximately 30 minutes later, my head was foggy did not feel ?normal? until approximately 9:15pm . I had taken 1/2 a Benadryl when I left the clinic (in my car) and another once I got home. I live 30 minutes from the doctors office.
positive for covid 19; This is a spontaneous report from a Pfizer-sponsored program. A contactable physician reported that a male patient (unknown age) received the first dose of at single dose for COVID-19 IMMUNISATION. Relevant history and concomitant drugs were unknown.  Physician stated four days after receiving the first dose of the COVID vaccine the patient tested positive for COVID-19. He was hospitalized and treated with plasma. Doctor was wondering how long his patient had to wait before receiving the second dose.  Outcome of event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, the event COVID-19 most likely represents an intercurrent infection as it is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, as appropriate.
first Shingrix vaccine 3 years ago, but has not received the second Shingrix vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received at unknown arm 3 years ago prior to the reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: first Shingrix vaccine 3 years ago, but has not received the second Shingrix vaccine). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 07-SEP-2023 The reporter was a patient's friend. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Headache, Myalgia, Arthralgia, Fever, Dose 2: tired, fog, body aches, fever, chills and headache.
Headache, body ache, dizzy, nausea.  Left upper arm at the injection site is swollen, red and painful.
COVID Vaccine Breakthrough Case  Pfizer Dose 1 2/12/21 (en6201) Pfizer Dose 2 3/8/21 (EN6203) COVID Positive 11/1/2021  11/1/21: 91-year-old lady presented to the emergency room following a fall at home.  A friend helped her from the ground.  Reports that she has been very, very weak in the recent days, feeling weak and fatigued.  She reports a mechanical fall today and was brought to the emergency room by the EMS.  In the emergency room was noted to have a temperature of 100.8.  Denies shortness of breath and chest pain.  11/17/21: Patient is 91-year-old female with past medical history of asthma, essential tremors, CKD stage 3, type 2 diabetes, hypothyroidism, hyperlipidemia.  She was brought to the emergency room on 11/01/2021 after fall at home. Later, she was found to COVID-19.  Her oxygen requirement has been increasing progressively since.  Currently she is being managed for acute hypoxic respiratory failure secondary to COVID-19 pneumonia Rule out superimposed bacterial pneumonia and right pneumothorax.  Patient was seen examined by the bedside.  Her friends by the bedside. Overnight events were noted.  Earlier this morning, patient has been removing her OptiFlow. She informed staff and her friends were by the bedside that she wants to be comfortable. I called and talked to patient's daughter and POA who is in agreement with palceing patient on comfort care. Pt  passed away at 18:47 PM on 11/17/2021. CPR was not initiated as patient  was on comfort care with a DNR code status. Family members notified. Time of death was called at 18:47 PM on 11/17/2021
Atrial flutter; This is a spontaneous report from a contactable consumer (patient). A 67-years-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 17Mar2021 at 02:45 hours as dose 2, single (at the age of 67-years-old) for covid-19 immunisation. Medical history included hypertension and caffeine allergy (both from an unknown date and unknown if ongoing). Concomitant medication(s) and other medications the patient received within 2 weeks of vaccination included amlodipine; atorvastatin calcium (Lipitor); cetirizine hydrochloride (Zyrtec); lansoprazole (Prevacid); famotidine (Pepcid). Historical vaccine included BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 17Feb2021 at 01:45 hours as dose 1, single (at the age of 67-years-old) for covid-19 immunisation. Patient was not diagnosed with COVID-19, prior to vaccination. Patient had not been tested for COVID-19, since the vaccination. On 18Mar2021, at 08:00 hours, patient had atrial flutter. Patient had a doctor or other healthcare professional office/clinic and emergency room/department or urgent care visit. Patient received Cardizem, Xarelto and further heart testing for the event, as treatment. The outcome of the event was recovering.  Information about lot/batch number has been requested.
Swollen eyelids; red eyelids; dry itchy eyes; dry itchy eyes; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 68-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6203), via an unspecified route of administration, administered in arm left on 06Mar2021 at 16:00 as dose 1, single for COVID-19 immunization. Medical history included samter's triad and coronary artery disease from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient previously took prednisone and ceclor and experienced known allergies. The patient did not receive any other vaccine in four weeks. Patient does not have covid prior vaccination and has not been tested for covid post vaccination. The facility type vaccine was reported as other while the facility type vaccine other was reported as fire house. On 07Mar2021 at 01:00, the patient experienced swollen eyelids, red eyelids, dry itchy eyes. The treatment was not received for all the events. The clinical outcome for all the events was reported as not recovered.  No follow-up attempts are possible. No further information is expected.
pt was seen in office for well child exam & updating immun; pt was found to be in good hlth by MD x/for eye infect; pt appeared normal that noc; following AM pt was found dead in bed;
Rash Hives patient prescribed Hydrocortisone 2.5% cream Prednisone 10mg, Hydroxyzine 25g and Famotidine 20g on 9/7/2020
The Patient received a Fluzone HD flu shot on 9/2/2020.  The patient came in on 9/5/2020, and said she noticed a rash and a bump when she removed her band aid on 9/3/2020.  She said she reached out to her nurse practitioner and she advised her to notify the pharmacy. The patient still had a rash on 9/5/2020, but it was diminishing.  The patient was concerned that the shot was given SC instead of IM.  I let her know that we use a 1 inch needle, and that it was administered intramuscularly.  She said she could hear a noise at the end of the shot.  I let her know there is usually an air noise one the syringe is empty.  She asked if she needed another vaccine, and I assured her it was administered IM and she definitely got the vaccine.  I told her I would document her reaction, research of there have been any other reports of this reaction with this year's vaccine  and complete a VAERS form.
Patient had a syncope episode lasting approximately 2 minutes.  Patient was pale and diapheretic
This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient. A 58-year-old female patient received BNT162b2 (Pfizer-BioNTech COVID-19), on 04Apr2022 at 18:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Symptoms of menopause" (unspecified if ongoing); Concomitant medication(s) included: ESTROGEN taken for menopause, cardiac disorder; PROGESTERONE taken for menopause, cardiac disorder. Start date: about 7 years ago or when she was about 51 or 52 years old. Indication as Reported: Symptoms of menopause and possible protection of heart health. Vaccination history included: Bnt162b2 (First dose, administered to her left arm), for Covid-19 immunization, reaction(s): "None"; Bnt162b2 (Second dose, administered to her left arm.), for Covid-19 immunization, reaction(s): "None"; Bnt162b2 (Third dose, administered to her left arm.), for Covid-19 immunization, reaction(s): "None". Regarding dates of doses 1-3 she (patient) explained that their vaccine cards were due to expire on 14Apr2022 which was 9 months from the date of the Third dose/first booster; so that would be approximate timeline of third dose at least. The patient had not received any other vaccine within 4 weeks. Patient no had Family Medical History Relevant to AE(s). The following information was reported: EAR DISCOMFORT (non-serious) with onset 05Apr2022 (onset time by the end of the evening), outcome "not recovered", described as "Fourth dose: Feeling of fullness in right ear, like there is something in the ear"; On 06Apr2022 this worsened, feeling strongly the feeling of fullness in right hear. It sounds very similar to a kind of overreaction of the tissues and inflammation. EAR PAIN (non-serious) with onset 05Apr2022 (onset time was overnight), outcome "unknown", described as "Fourth dose: Pain in right ear"; DEAFNESS (medically significant) with onset time morning of 06Apr2022, outcome "not recovered", described as "Fourth dose: Hearing loss"; TINNITUS (non-serious) with onset time morning of 06Apr2022, outcome "not recovered", described as "Fourth dose: Tinnitus". The patient underwent the following laboratory tests and procedures: Weight: About 131-132. Therapeutic measures were not taken as a result of deafness, tinnitus, ear discomfort, ear pain. Reporter verified that there has been no testing, treatment or medical interventions performed relative to these events, and she has not been seen by any healthcare professional. Report is not related to a study or programme. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient came in on 5/1/21 for a 2nd dose of Pfizer vaccine. On consent form for 2nd dose, date of birth was 5/9/05. Since he was under 16, patient was NOT given a 2nd dose, and was advised to wait until he is at least 16 years old. His first shot was given on 4/10/21 at the School Clinic. Consent form from first vaccine has his birthday as 4/9/05. Consent form for first dose showed the month crossed off and a new month was written (April). Confirmed with patient that his birthday is 5/9/05.
Left arm started to hurt minutes after the injection, radiating down toward elbow and my arm started to go numb, especially the pinkie and ring finger.  Difficult to hold my phone while waiting, I dropped it, then started to get dizzy.  Called a volunteer over, who summoned another lady.  They told me they were going to move me to another area, and attempted to help me there, but I fainted about 3 steps out.  When they were lying me down on the floor, I came to and was oriented at that point.  BP was somewhat low initially, but increased as I lay there,  and oxygen levels increased from 94 to 99 before I left facility.
Information has been received from a female nursing assistant who was vaccinated with the first dose of Gardasil vaccine in her deltoid. Subsequently, the patient's arm became red and sore for a few days. No lab diagnostic studies were preformed. Subsequently, she recovered. Additional information has been requested.
Pt had swollen and painful arm, and even until now, her arm is still sore and a little bit swollen. No fever, no other complaint otherwise.
PATIENT HAS EXPERIENCED NUMBNESS ON THE LEFT ARM THAT PROCEEDS FROM HIS HANDS TO HIS NECK AS WELL AS PAIN SINCE THE VACCINATION. HIS NECK IS ALSO HURTS TO TURN.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 32-year-old female patient who received FLUARIX QUADRIVALENT. On 19th September 2014, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 19th September 2014, several hours after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain. The patient was treated with Anti-Inflammatory. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to FLUARIX QUADRIVALENT. Additional details provided were as follows: This case was not reported previously to anyone. This case was reported by the patient herself. The healthcare professional reported that, last year after she received a dose of FLUARIX QUADRIVALENT she started experiencing pain from the same evening. For 6 months she experienced a deep soreness and pain in the deltoid where the vaccine was given. When her arm was lifted up she would feel the pain and when her arm was put behind her back she would experience pain radiating through her arm to her shoulder blade. She did not seek medical attention for this, but she was treated with over the counter anti-inflammatory medications. The patient would like to be followed up with through mail regarding this. She may have additional information to add (lot number and expiration date).
HPI: 56 y.o. male with no pmhx c/o generalized bruising for 2 days, noticed small blood tinged spots generalized. Gradual onset, severe on severity, no alleviating or aggravating factors. Patient denies fevers, chills, N/V/D, abdominal pain. In ER: Platelet <1. Platelet transfusion in ER. Admitted for Thrombocytopenia/ITP
Patients wife presented at the pharmacy stating that after the booster shot, patient was driving and passed out and hit two other cars.  He was being transported to the hospital at the moment.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not provided.  Treatment medicines was not provided.   This case was linked to MOD-2021-220974.
2 inch red circle around the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (2 inch red circle around the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (2 inch red circle around the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (2 inch red circle around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's concomitant medication included several unspecified medicines for blood pressure.  Patient did not take any treatment for the symptoms.
This spontaneous report was received form a consumer and refers to her husband. The report was received via Pfizer. The patient's age, medical history and concurrent conditions were not reported. On an unknown date (reported as "a couple of years ago"), the patient was vaccinated with unspecified shingles shot (manufacturer unknown) (dose, lot #, expiration date and route of administration were not provided). Concomitant therapies were not reported. On an unknown date, the patient developed shingles despite the vaccination. The shingles were described as "not as bad as he would have" by his physician. The patient was taking LYRICA for about 3 months (unspecified start date, approximately in April 2016) for shingles pain. The outcome of the event was unknown. The relatedness between the events and suspect vaccine was not reported. Additional information had been requested.
My arm did become sore; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received first dose and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration, administered in left arm on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient experienced really weird side effects after first dose of vaccination, patient arm become sore. The second shot was really bad, got a huge red blotch on her arm It was a big welt that look like a cloud, It became swollen and hot and 2 weeks later, patient arm is still really hurting but not red, hot or swollen". The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
2/23 Armpit-elbow swelling, red, hot - TX W/cold compress. Excessive thirst. 2/24 Hives on neck and chest. Swelling armpit - forearm, red hot - TX W/BENADRYL, increased HR, increased BP, syncope. Went to ER.
Given adult (12+) formulation instead of 5 to 11-year-old formulation.
p/vax pt devel rash over body on 10/16/99 vomited x 2;rash lasted 3 days;pt was not seen by provider, no meds were given by family;
red 2" diameter, warm to touch, hard knot at injection site, began on 11/15/2008.  Patient did not take any OTC meds