chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 14-OCT-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 336 hours, the lowest recorded temperature was 20F (-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.
11 days after initial vaccination: vaccination site became warm swollen and red. Physically felt lightheaded/dizzy with near syncope episode and heart palpitations. Took Zyrtec, Benadryl and went to emergency room.
Per the EUA, cases of COVID-19 vaccination that result in hospitalization or death are to be reported. This patient received Moderna on 3/4 and 2/4. Patient is admitted for left pontine acute infarction ?
Initial unsolicited report received from a nurse on 09 October 2015. This case involves a patient (gender and age was not reported) who was vaccinated with a dose of INFLUENZA VACCINE (Flu shot) (batch number, expiry date, dose, dose in series, route and site of administration were not reported) administered on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date following the vaccination, the patient had experienced adverse event (not specified) from the flu shot. Laboratory data and corrective treatment was not reported. The outcome of event was not reported. List of documents held by sender: none.
Patient admitted to Hospital with acute hypoxic respiratory failure secondary to viral pneumonia from COVID-19 and exacerbation of COPD.  Worsening of symptoms prompted Average Volume-Assured Pressure Support.  Ventilation did not seem an option d/t HX of severe inflammatory interstitial lung disease.
Swelling of the left arm with progression down the arm, with well demarcated dollar sized erythema on the right.
I got the second dose of the vaccine and I felt bad the next day. I had headaches, neckaches, terrible fatigue, body aches. I had not improved after six days and I went to the doctor. My doctor did a Covid-19 test, and it was positive. I think I actually had the Covid-19 at the same time as getting the second dose. My Covid-19 test indicated that I had had the Covid-19 within the last 7-10 days. I am still unable to work after 12 weeks and still taking a lot of pain medication and I have severe fatigue. I still have really bad headaches and neck aches. I had brain fog which has gotten a little better. My doctor believes that the combination of having the vaccine at the same time as the disease may have made the effects worse.
Groggy and scrambled brain.  Achy..  Hearing non-existent pounding sounds.
Seven year old patient received  Quadracel/No AE; Initial information was received on 03-Jun-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a seven-year-old male patient who received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (product administered to patient of inappropriate age).  Medical history, medical treatment, vaccination and family history were not provided.  The patient received MMR and VARICELLA VACCINE as concomitant medications.  On 01-Jun-2020, the patient received a 0.5 mL fifth dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [lot C5688AA, expiry date: 26-Nov-2021] via an intramuscular route at the left leg for prophylactic vaccination.  It was a case of actual medication error due to inappropriate age at vaccine administration.   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.
VACCINE WAS GIVEN BEYOND USE DATE. VACCINE WAS RECEIVED IN REFRIGERATOR ON 01/11/2022 AND KEPT IN APPROPRIATE TEMPERATURE (2-8 CELSIUS). VACCINE WAS ADMINISTERED TO PATIENT 16 DAYS PAST THE 30 DAY TIME IN REFRIGERATOR.
arm was really sore after 1st dose; discomfort from head and neck down to shoulder; discomfort from head and neck down to shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was really sore after 1st dose), HEAD DISCOMFORT (discomfort from head and neck down to shoulder) and MUSCULOSKELETAL DISCOMFORT (discomfort from head and neck down to shoulder) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination.     No medication history was provided.  Concomitant products included METFORMIN for an unknown indication.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2. On 27-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm was really sore after 1st dose), HEAD DISCOMFORT (discomfort from head and neck down to shoulder) and MUSCULOSKELETAL DISCOMFORT (discomfort from head and neck down to shoulder). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Symptomatic treatment, at an unspecified dose and frequency. On 27-Apr-2021, HEAD DISCOMFORT (discomfort from head and neck down to shoulder) and MUSCULOSKELETAL DISCOMFORT (discomfort from head and neck down to shoulder) had resolved. On 08-May-2021, PAIN IN EXTREMITY (arm was really sore after 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Rash around injection site and about 4-5 inches away from injection site, noticed about a week after immunization. Not itchy or painful, I just noticed in the mirror.
still feeling sick; This is a spontaneous report from a contactable consumer or other non hcp. A 16-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number and Expiration Date was not reported), via an unspecified route of administration on an unspecified date for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Previously patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Reporter stated he received his second dose of Pfizer COVID vaccine 2 weeks ago and still feeling sick from it. He did not know if it was supposed to be like that and wanted to know if that was normal. The outcome of event was unknown.   No follow-up attempts are needed. No further information is expected.
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Severe, Additional Details: Per wife had a vasovagal response, attempted method to provide circulation to the head but patient was barely responsive and had to call EMT
woke up this morning throwing up (nauseous); got really hot all over her entire body; had chills through the night off and on; tired; getting sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Sep2021 (Lot number: 3014589) at the age of 75 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "blood pressure" (unspecified if ongoing), notes: she had the symptoms before. Concomitant medication(s) included: AMLODIPINE BENAZEPRIL taken for blood pressure measurement. Vaccination history included: Bnt162b2 (Dose: 1, Lot number EN6202), administration date: 26Feb2021, when the patient was 74 years old, for Covid-19 Immunization; Bnt162b2 (Dose:2), administration date: 20Mar2021, when the patient was 74 years old, for Covid-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 30Sep2021, outcome "recovered with sequelae" (01Oct2021), described as "had chills through the night off and on"; FATIGUE (non-serious) with onset 30Sep2021, outcome "recovering", described as "tired"; NAUSEA (non-serious) with onset 01Oct2021, outcome "recovered" (01Oct2021), described as "woke up this morning throwing up (nauseous)"; FEELING HOT (non-serious) with onset 01Oct2021, outcome "recovered" (01Oct2021), described as "got really hot all over her entire body"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "getting sick".  Additional Information: Patient is 75 years, 11 months. Patient wanted to report how she ended up getting sick. Stated that she got really hot all over entire body. Stated that she had chills through the night on and off and felt nauseous. Stated that she woke up this morning and ended up throwing up. Stated that she took her blood pressure pill that she decided not to retake and then threw up. Stated that she had taken Amlopidine Benazapril. Stated that she had the symptoms before and took it because it controls her blood pressure. Stated that she took the anti-Covid shot yesterday. Clarified that it is the Covid 19 shot. Stated that this is her third shot. Stated that from 12:30am until 5am or 6am that she felt really hot all over her entire body. Stated that 1.5 hours later that she was able to eat. Stated that she started taking it years ago. Stated that it is 5/20mg. Stated that the lot could be 3014S8A for the third shot. Stated that the lot for the first shot was EN6202 on 26Feb2021. Stated that the lot for the second shot on 20Mar2021 is for Pfizer BioTech is not listed.  No follow-up attempts are possible. No further information is expected.
Narrative:  COVID infection following COVID vaccine series 04/06 Janssen, dose #1 12/30 COVID swab, result: detected 12/30 pt cc: sore throat and congestion exposure: unknown 12:30 CXR impression: No acute cardiopulmonary disease.
I just did not feel right, I didn't feel sick, but I cannot explain it. I took a test because my husband had tested positive. I used a home COVID-19 test that came back positive. I called my doctor's office once to discuss that I was positive, they called in a prescription of Paxlovid, that I started taking that night. I took the five-day course of the Paxlovid, I was taking a shower and noticed I was so exhausted that could not get out of the shower. I called my doctor's office to let them know my concerns. They advised me to take vitamin c 500mg, get plenty of rest and contact them if it got worse. It took two weeks before I could do more than just sit in the chair. It lingered a bit longer, but it has finally left.
Around 2  o'clock in the morning I woke up. In excruciating pain all through out my body, coughing, wheezing, sweating and cold at same time, headache, fever. Could not get comfortable no matter what I did . My breathing was becoming more and more labored.  Felt miserable for about 1 week to 1o days.
Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. In or around February 2007, the patient was vaccinated with ZOSTAVAX (lot number, dosage, and route of administration not provided), for its intended purpose, the prevention of shingles. Shortly after, the patient suffered vision loss and within one month vision was completely lost in his left eye. In or around May 2007, the patient presented to his physician for this injury and was diagnosed with retinal necrosis. The patient's physician diagnosed the patient's vision loss as being related to receiving the ZOSTAVAX vaccine. As a direct and proximate result of ZOSTAVAX the patient's symptoms have resulted in physical limitations, and experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result, the patient sustained severe and permanent personal injuries. The patient suffered serious, 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. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of ZOSTAVAX vaccine. Upon internal review, vision loss, complete vision loss left eye and retinal necrosis were determined significant medical event. Vision loss, complete vision loss left eye and retinal necrosis were considered disabling. Additional information has been requested.
Injection arm red, swollen and hot to touch. Appears like a cellulitis infection. Treated with Keflex 500mg qid x 10 days Benadryl 25mg q 6 hrs.
scratching; his injection site on the left arm had a wheal; some rashes on his left arm; the rashes are still there and is now up to his face; developed scabs that are now bleeding; This is a spontaneous report from a Pfizer. A contactable consumer (patient) reported that a 77-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration in left arm on 14Apr2021 as 2ND DOSE, SINGLE for covid-19 immunization. The patient previously received first dose of BNT162B2 (Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration (at the age of 77 years) in right arm on 23Mar2021 for covid-19 immunization and experienced his injection site on his right arm also had a wheal. Patient had no allergies to anything. Patient consulted with his regular dermatologist on 27Apr2021 and doctor noticed that he was scratching. On an unspecified date in Apr2021, patient experienced his injection site on the left arm had a wheal and there had been some rashes on his left arm; rashes are still there and is now up to his face. They are not healing and he had developed scabs that are now bleeding. Therapeutic measures were taken, prescribed a cream for 2 weeks as a result of scratching, his injection site on the left arm had a wheal, some rashes on his left arm; the rashes are still there and is now up to his face with cream for 2 weeks. The events assessed as non-serious. The clinical outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Experienced sore throat in between doses; Mild cold symptoms; little bit of a cough; Runny nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 39 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Sep2021 (Lot number: FD8448) at the age of 38 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 05Oct2021, outcome "unknown", described as "Experienced sore throat in between doses"; NASOPHARYNGITIS (non-serious) with onset 05Oct2021, outcome "unknown", described as "Mild cold symptoms"; COUGH (non-serious) with onset 05Oct2021, outcome "unknown", described as "little bit of a cough"; RHINORRHOEA (non-serious) with onset 05Oct2021, outcome "unknown", described as "Runny nose". Therapeutic measures were not taken as a result of oropharyngeal pain, nasopharyngitis, cough, rhinorrhoea.  Additional information: The report was related to a study or program. Number and expiry date were reported as unknown. No investigation assessment. He wanted to know if he can take the second dose of the COVID-19 vaccine. He had no fever but didn't know if it was okay to get the shot or if he should wait till symptoms go away.  No follow-up attempts are possible. No further information is expected.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination. No Medical History information was reported. On 10-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 10-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported. This case was linked to MOD-2022-448109 (Patient Link).
59 Years old  Male presenting with respiratory infection symptoms x 1 days, chills, body aches, fever. The patient got his COVID vaccine on 5/22 and started having symptoms yesterday.
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Redness and itching at injection site on right deltoid-Mild, Systemic: Headache-Mild, Additional Details: Pt had received 2 doses of Pfizer previously and wanted Moderna as her Covid booster. Within 30 seconds of receiving the vaccine patient c/o itching in her right arm at injection site and redness.  There was a pea size area of inflammation at site also. Patient given Benadrl. All symptoms were improved within 3 minutes.
A mass in her right arm relating to a flu shot she received three weeks ago. Large mass on right arm in the deltoid region approximately the size of an egg. Pt denies that it is painful to touch.She states it is painful on certain movements.
Nausea, sore throat, fever/chills, legs felt numb, head like "balloons" Tx with SOLUCORTEF, DEPOMEDROL, ANAPROX, TAGAMOL followed by MEDROL DOSE PACK on 10/22/08
Injection site is warm; Injection site is red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site is warm) and VACCINATION SITE ERYTHEMA (Injection site is red) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Injection site is warm) and VACCINATION SITE ERYTHEMA (Injection site is red). At the time of the report, VACCINATION SITE WARMTH (Injection site is warm) and VACCINATION SITE ERYTHEMA (Injection site is red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant was provided. Patient treatment information was not provided.
Approximately 12 hrs post-injection with H1N1 min. Experienced fitful sleep and injection site tenderness. Approx. 30 hrs post-injection, reports head is "foggy" ("not normal"), throat is sore and injection site is itchy.
she lost her voice; could hardly breath; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot number was not reported), via an unspecified route of administration on 24Mar2021 (at the age of 57-year-old) as dose 1, single for COVID-19 immunization. The patient medical history included allergies (patient has a history of allergies). The patient concomitant medications were not reported. The patient reported that she lost her voice, could hardly breath on an unspecified date in 2021. Within about 30 mins after receiving the vaccine patient felt like she was having a reaction (patient stated she has a history of allergies), she lost her voice and "could hardly breath." Patient was admitted to the ER and given an EpiPen and steroids for treatment. Patient wants to know how much protection will she have since she has only received one dose and will not be getting the second. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I was 26 weeks and 4 days pregnant when I received the Moderna booster vaccine. Two and a half days later, I experienced a premature rupture of membranes (my water broke prematurely). I was admitted into the hospital where I remained on bed rest for 10 days. On December 8, 2021, when I reached 28 weeks and 4 days pregnant, my child was born. My original due date was February 28, 2022.  My child was born extremely prematurely weighing 2 lbs 11oz. He remains in the neonatal intensive care unit.
Information has been received from a physician concerning a female who was vaccinated with Gardasil. Subsequently the patient experienced renal failure. The physician was in a hospital facility when a nurse approached him and stated that a family member of hers had received Gardasil and went into renal failure. No further information was provided and the physician can not be contacted. Additional information has been requested.
Child was administered DTAP Right thigh intramuscular on 05/01/2003 and by nighttime, child had redness, warm to touch, swelling at site (7 x 8cm) child was seen 05/06/2003.
erryth. 7.2 x 8.7 cm  central palar area 3.5 x 5.8  Keflex 250 mg 3/4 tsp. TID x 10d - warm compressors
Vaccinated 2/9/04. Developed rash consistent with varicella 2/23/04. Documented in physician office 2/25/04. No treatment necessary.
RECEIVED ONLY 2.5 ML OF THE JANSSEN COVID-19 VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 30 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, and expiry: 14-DEC-2021) dose was not reported, administered on 14-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-NOV-2021, the patient experienced received only 2.5 ml of the janssen covid-19 vaccine. On 14-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received only 2.5ml of the janssen covid-19 vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211219686, 20211219701, 20211219807 and 20211219871.
4:57pm c/o head spinning a little and heart racing.  Skin W/D. no resp. distress.  HR 88, B/P 146/96, 5:10pm Stated feel better, advised if s/s returned, pull over and call 911.