chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Caller states she is fully vaccinated against Covid-19 and received the first two doses of Pfizer's Covid-19 vaccine, but now she has Covid-19; Caller states she is fully vaccinated against Covid-19 and received the first two doses of Pfizer's Covid-19 vaccine, but now she has Covid-19; 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 BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: NIFEDIPINE taken for hypertension. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Caller states she is fully vaccinated against Covid-19 and received the first two doses of Pfizer's Covid-19 vaccine, but now she has Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical course: Caller stated she was fully vaccinated against Covid-19 and received the first two doses of Pfizer's Covid-19 vaccine, but now she had Covid-19 and had been prescribed Paxlovid. Caller stated she was breastfeeding and also took nifedipine for high blood pressure. Caller asking if Paxlovid interacts with nifedipine. Caller denied having started taking Paxlovid. Caller asking if she can take Paxlovid while breastfeeding.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201374878 mother/baby case;
Approx. 3 days after started with pain in both legs - I went to chiropractor for 3 visits - it got worse. Then I lost strength completely in both legs and both arms totally. I got a friend to bring me to emergency room at hospital where I spent the first 3 days in I.C.U. They administered I.V.'s of medicine for that time - then I spent 6 1/2 days in therapy. Came home and had 9 wks. of home therapy and nursing. 50% to 60% recovery legs are no longer same.
Collapsed at front desk possibly unconsciousness x2-3 sec.  BP 80/60 P-91.  Pale.  Occurred within 5 minutes of vaccine.
Chills; Fatigue; Not feeling well; Swollen lymph node; This case was reported by a nurse via call center representative and described the occurrence of chills in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included gabapentin.   In August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced chills, fatigue, feeling unwell and enlargement of lymph nodes. On an unknown date, the outcome of the chills, fatigue, feeling unwell and enlargement of lymph nodes were recovered/resolved.   It was unknown if the reporter considered the chills, fatigue, feeling unwell and enlargement of lymph nodes to be related to Shingrix.  Additional details were provided as follows: The reporter was a registered nurse and also the patient. Approximately 2 months before the date of reporting, the patient received Shingrix in an unknown deltoid. After receiving the vaccine, patient developed chills, fatigue, and a swollen lymph node under the injection arm.  The patient states that she did not feel well after receiving the vaccine.  The patient's symptoms resolved within 1 week. The reporter did not consent to follow-up. The reporter did not provide any additional information.
1 of 5 pts who exp an inject site react w/in 24 hrs p/vax; react was the size of a quarter, hard, raised & warm to touch; afebrile; No treatment initiated;
Pt states "Large lemon sized welt". "Extreme itchiness." "Swollen, red, painful." (Observed this personally).
SEVERE Body pain -  just like when I had COVID in October (sick 9 days)   Fever: 103.2.     Broke last night.   When I had COVID it was 103.2 for 3 days Very light head Exhaustion skull pain
got drowsy, leg hurting, wouldn't stand w/in 15 min of vax;10-15 min later perked-up & was fine w/nothing more
Information has been received from a pharmacist referring to unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored GARDASIL (lot number, dose and route were unknown). No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information is not expected because the reporter did not want to be contacted.
High fever. Severe coldness, 5 blankets didn't help, terrible shivering. Headache, nausea. Very tired. These symptoms lasted all day & night. Today (5-30) still have headache & tiredness.
Nose bleeding from left nostril starting on Thursday (one day after 2nd shot of vaccine). Would not stop bleeding/clot on its own. Went to emergency room three times in a 5 day span. Had nose cauterized twice and did not stop it beyond a few hours. Had nostril packed. Bled from the other nostril. Packed again. Cauterized again six days after initial bleeding started. Right now - two days after the third cauterization it has finally stopped for the time being.
shingles; pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain) and HERPES ZOSTER (shingles) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced PAIN (pain). On an unknown date, the patient experienced HERPES ZOSTER (shingles). At the time of the report, PAIN (pain) had not resolved and HERPES ZOSTER (shingles) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   after receiving the 1st dose on 9Feb2021 patient got shingles and  He was prescribed an antiviral by an urgent care doctor at that time. no concomitant medications were reported.   This case was linked to MOD-2021-349818 (Patient Link).
very red eyes with mucus; nasal discharge; tighening of throat; very red eyes with mucus; Initial information regarding an unsolicited valid non-serious case was received from a consumer via The Agency (Reference number- 00418470) and transmitted to Sanofi on 06-Jan-2021.  The case involved a 67 year old male patient who had allergic reactions, nasal discharge (rhinorrhoea), very red eyes with mucus (ocular hyperaemia and eye discharge) and tightening of throat (throat tightness), while he received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Relevant medical history, past medical treatment, vaccination details, concomitant medications and family history were not provided.  Concomitant medications included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL).  On 01-Sep-2020, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported) via unknown route in unknown administration site prophylactic vaccination.  On 01-Sep-2020, the patient developed non-serious allergic reactions, nasal discharge (rhinorrhoea), very red eyes with mucus (ocular hyperaemia and eye discharge) and tightening of throat (throat tightness), 2 hours following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Relevant laboratory test was not reported.   Around 6pm, he called his doctor, who prescribed Benadryl. He took the antihistamine about 7PM and went to bed. He stated that he had never taken a flu vaccine before.  On 01-Sep-2020, the patient had recovered from all the reported events within 3 or 4 hours of taking the Benadryl.  There would be no information available on batch number for this case.
Fever/exhaustion after 1 day; rash/peeling of skin after 1 month
painful outbreak of shingles; Information has been received from a lawyer regarding a case in litigation referring to a male patient (pt) of unknown age. Information about concurrent condition, medical history and concomitant medication was not reported. On or around 26-SEP-2017, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) at the direction of his primary physician for routine health maintenance and its intended purpose: the prevention of shingles (herpes zoster). Subsequent to the zoster vaccine live (ZOSTAVAX) being administered, in 2017 (reported as within a week), the pt developed a painful outbreak of shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not presenting prior to using the product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the product, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. All damage proximately caused by the aforementioned characteristics of the zoster vaccine live (ZOSTAVAX) product that rendered the product unreasonably dangerous, arose from the reasonably anticipated use of the product by the the pt. The outcome of the event was not recovered. The causality assessment was considered as related by the lawyer.  The lawyer considered the event painful outbreak of shingles to be disability.
Nausea, vomiting, fever, severe left arm pain with redness and swelling at injectionsite, muscle aches, body aches  headache. Inability to function for 48 hours.
Initial Onset (Sunday, 10/7, 8:00 PM) - fatigue, headache. Day 1 (Monday, 10/8, 7:00 AM) - fatigue, headache, dry cough, mild respiratory difficulty. Day 1 (Monday, 10/8, 7:00 PM) - fatigue, headache, dry cough, mild respiratory difficulty, fever, chills. Day 2 (Tuesday, 10/9, all day) - fatigue, headache, dry cough, mild respiratory difficulty, fever, chills. Day 2 (Tuesday, 10/9, 11:00 PM) - all symptoms as before, but alternating chills and fever symptoms intensify Day 3 (Wednesday, 10/10, 8:00 AM) - all symptoms still present but have begun to abate in severity. Treatment throughout: two Tylenol or Aspirin no more frequent than every four hours; fever and chills treated with adding or removing additional blankets or garments.
This spontaneous report as received from a 70 years old female patient with high cholesterol refers to herself. She did not have drug reactions/allergies. The patient was vaccinated with ZOSTAVAX (lot number not provided) on 10-JAN-2010. No other co-suspects were reported, Concomitant medications included ZOCOR and simvastatin (manufacture unknown). Approximately in October 2011 the patient experienced shingles "14 months ago" lasting 3 weeks, outbreak happened on her hands and arms. On 08-DEC-2012 the patient experienced rash on her abdomen area going to her breast. Unspecified treatment was given for adverse event. The outcome of adverse events was unknown. The patient did not seek medical attention. Additional information is not expected.
Pt experience almost immediate pain in the shoulder and subsequently in the arm. There is an irregularly depigmented area under the injection site approximately 3 X 5 cm.
she became sick; headache; chills; sweating; nausea; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (she became sick), HEADACHE (headache), CHILLS (chills), HYPERHIDROSIS (sweating) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced ILLNESS (she became sick), HEADACHE (headache), CHILLS (chills), HYPERHIDROSIS (sweating) and NAUSEA (nausea). At the time of the report, ILLNESS (she became sick), HEADACHE (headache), CHILLS (chills), HYPERHIDROSIS (sweating) and NAUSEA (nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   ? No treatment information was provided.
Reporter indicated that 5 employees have not converted; some employees recvd 2 courses (6 doses) of Engeix-B; some employees recvd 1 course (3 doses) of Engerix-B & 1 course of Recombivax-HB (3 doses);
no AE; expired dose of VAQTA was administered to a patient; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 18-APR-2022, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) 1 dose, lot #T035720, expiration date: 15-APR-2022 (expired product administered)(route of administration and injection site were not provided) for prophylaxis. Dose was properly stored up through time of administration. No other adverse events reported (No adverse event).
Day 8 after receiving vaccine - a large, sore red spot that itches at vaccination site
The child developed a fever of 102 degrees by Friday, March 28 at 4:00 p.m., she had no appetite, she seemed extremely sleepy and kept pulling at her ear.  By Saturday morning, at 11:00 A.M. her neck was observed to be swollen--the first time this has ever happened to this child.  At the time this report is being filed, this previously healthy child has no appetite, is whimpering as if in severe pain and is being taken to the hospital emergency room again.
Patient stated that later that day he began to feel tired and chills. Later that night he felt his shoulder swelling with severe pain. The swelling moved all the way down his arm and swelled like a balloon. This lasted 6 days until 6/13 when nearly all of the swelling was resolved. He couldn't sleep at all during the height of the incident and said it was some of the worst pain he has ever experienced.
Scalp irritation; Psoriasis flare-up; Fatigue; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of SKIN IRRITATION (Scalp irritation), PYREXIA (Low grade fever), PSORIASIS (Psoriasis flare-up) and FATIGUE (Fatigue) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriatic plaque.    No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In February 2021, the patient experienced PYREXIA (Low grade fever) and FATIGUE (Fatigue). On an unknown date, the patient experienced SKIN IRRITATION (Scalp irritation) and PSORIASIS (Psoriasis flare-up). At the time of the report, SKIN IRRITATION (Scalp irritation), PYREXIA (Low grade fever) and FATIGUE (Fatigue) outcome was unknown and PSORIASIS (Psoriasis flare-up) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: Low Grade Fever.         The patient had occasionally dry scalp. He took first Moderna shot and had a low grade fever and fatigue. He did not agree to have physician contacted.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No treatment and concomitant information provided
Reporter indicated that 28 pts recvd the Engerix-B series; 8 pts have tested neg (3 pts tested pos p/1st booster dose, 1 pt borderline p/1st booster dose; retested p/a 6 wk period;
Redness, swelling, itching around injection site - Raised red patch size, hot to the touch compared to surrounding skin, increased from 2 in diameter on 26-Jan to 6 in diameter over 4 days.  Bruising at extreme edges of red patch (approx 4 in from injection site).  Hard painful lump at injection site approx 1 in by 0.5 in.  30-Jan redness has started to fade, size of erythema no longer increasing in area.  Itching present but subsiding.
The patient did not suffer any ADRs. However, they erroneously received their second dose of the series intramuscularly instead of the ordered route of subcutaneous. Guidance states that this still counts as an effective dose so the patient was not re-immunized.  On review, the information in our records was confusing because the subcutaneous administration instructions contains the word "deltoid". We are removing this confusing word to avoid other causes of intra-deltoid administration.
Sick; Weak; Really Tired; A spontaneous report was received from a consumer concerning a 70-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events really tired / fatigue, sick / illness and weak / asthenia.  The patient's medical history included diabetes. No relevant concomitant medications were reported.  On 9 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced the events, really tired, sick and weak.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, really tired, sick and weak was unknown.
Redness, warmth, swelling to (L) deltoid. Treatment: BENADRYL, steroids f/u if no improvement.
Information has been received from a physician concerning a 2 month old male who on 10-OCT-2007, was vaccinated with a first oral dose of ROTATEQ vaccine live (human-bovine) (lot#657517/0877U. It was reported that the patients mother had called the physician and informed him that the baby had developed persistent green diarrhea and was screaming as a result of the diarrhea. On 13-OCT-2007, the mother phoned the on-call physician and proceeded to an emergency department. It was reported that no diagnostic studies or labs were preformed. On 15-OCT-2007, the mother called the physicians office for follow and she reported that the patient was recovering. A product quality complaint was not reported. No further information was available. Additional information has been requested.
On 01/07/2021, adverse event started happening the next day on Jan 8, 2021 in the morning tired, fatigue, I wake up with a headache. The headache comes and goes. I am taking Tylenol every time I get a headache. I get exhaustion so bad that I have to take nap for couple of hours. I get tired easily which I never had before. Its affecting my daily activities. I can't do anything. I still have it now I am to going back and forth with the doctor with exams. Heart palpation I was getting for almost every day.
She was initially referred to clinic for reports of chest "closing in", trouble breathing and lightheadedness almost immediately following receipt of flu vaccine on 11/3/2015 (manuf SKB Lot#497KX) at reserve bldg. She advised she was 5 months pregnant at the time. She advised the staff had her sit, relax and gave her some TYLENOL and monitored for 30 minutes with resolution of all symptoms. She denied having any HA, weakness, wheezing, difficulty swallowing, rash, or other systemic reactions. She did state the building is currently being remediate for mold (2016). She reported she does have PMH of passing out as a child (age 5-10) "a lot" especially if hot and rarely does it today. She returned on 11/1/2016 reporting concerns following receipt FLUARIX vaccination (day 11 after vaccination). She reported immediately as vaccine being injected 10/21/16 she could feel a sensation of the vaccine being pushed throughout her body. She went to the lobby to wait and began to feel throat itchy and was having difficulty swallowing. Staff checked on her at 15 min and she was brought back to nurses station where monitored without worsening of symptoms, no vs done, no exam done, no c/o of shortness of breath, angloedema, chest pain, anxiety, fever, headache, myalgia/arthralgia, et al. She advised 20 min later the sensation of throat closure resolved and she was released home where she took a BENADRYL for continued itching. The itching fully resolved 2 hours after onset and she went to sleep with the BENADRYL. Upon awakening, all symptoms had resolved and they have not returned. She did eat a bagel with cream cheese on 10/21 but has had since w/o issues. She does eat eggs but they must be fully cooked (preference).
When I laid down for bed my tongue felt weird on my left side.  I looked in the mirror and the left side of my face was swollen around the cheek.  I have a little soreness around the jaw.  My left are was sore to the touch and slight stiff where I cannot raise my arm all the way.  I took 2 Benadryl tablets.
I got COVID - 19 a few months following my vaccination. I got a prescription of Paxlovid but I didn't take it because my case wasn't that severe. My physician explained the side effects and recommend I hold off on taking it.
The patient start to present itching, redness at injection site, and inflammation. The patient wants to take Benadryl because she indicates that she has experience before with other medication and the Benadryl works fine to block the symptoms. I observed the patient for 30 minutes, the patient start to fell better. The paramedics come to the pharmacy and evaluate the patient, then the patient fell normal and go home.
On 1/11/2020, 11 days after vaccination, a large rash/hive/blotch developed at the injection site and under. It measured approximately 5-6? long and 3-4? wide.  Arm discomfort characterized by mild tingly sensation, almost felt like it was cold, but it was actually slightly warm to the touch.   Other symptoms: About 10 minutes after vaccination became very hot/flushed. Nurse decided to monitor me for 30 minutes. Severe headache day after vaccination Nauseous day after vaccination  Extremely sore arm for about a week