chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received the second vaccine dose while being pregnant; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Patient received the second vaccine dose while being pregnant) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was in July 2020 and the estimated date of delivery was 12-Apr-2021. On 11-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Patient received the second vaccine dose while being pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. The delivery occurred  on 15-Apr-2021, which was reported as Normal Pregnancy Outcome. For neonate 1, The outcome was reported as Term Birth w/o Complications. On 11-Feb-2021, EXPOSURE DURING PREGNANCY (Patient received the second vaccine dose while being pregnant) had resolved. Not Provided          No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-101811 (Patient Link).
1 1/2 days after immunization I developed strong headache, flushed  and feverish feeling .  Checked my temperature and it was 97.5 which is normal for me.   My blood pressure was 165/62.   Ever since then I have daily, prolonged headaches and high blood pressure, generally 155 to 170/60.   All summer long  prior to this time my blood pressure was under control at  a systolic pressure of 130 or less. r I believe the flu shot  triggered my out of control  blood pressure condition.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium
Next day  8/17/2021 she was feeling achy, had a headache, slight  fever, cold like symptoms.  8/19/2021 she was gurgling in her sleep. I had trouble waking her. I learned later that was probably a seizure.  8/20/2021 She was sweating, clammy, confused and disoriented at school. She went into the wrong class and started convulsing.
Swelling, redness about 3 inches in diameter around injection, with redness spreading down upper arm toward elbow.
Right hand and arm painful and swollen, hives on torso, both legs, and left side of neck
Fever; Muscle Pain; Headache; Severe chills; In bed for three days; This case was reported by a nurse and described the occurrence of fever in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, bedridden, muscle pain, headache and chills. On an unknown date, the outcome of the fever, muscle pain, headache and chills were unknown and the outcome of the bedridden was recovered/resolved.   It was unknown if the reporter considered the fever, bedridden, muscle pain, headache and chills to be related to Shingrix.  Additional case details were reported as follows: The patient was a runner and very healthy. The age at vaccination was not reported. This vaccine has had patient in bed for three days with fever, muscle pain, headache, and severe chills.  It was reported that something was wrong with this vaccine. It scares patient to think of what she put in her body. The warnings on the side effects should be much stronger. The patient would never recommend this vaccine to anyone professionally or personally. The reporter consent to follow up. This is 1 of the 2 cases reported by the same reporter.
On June 28. The pt had a stroke, infarction in his brain and bleeding in his brain. He was hospitalized for 4 weeks. He was paralized on the left side.
Being winded; Heart rate has dramatically increased during any type of exercise (125 plus); Rapid breathing; This is a spontaneous report received from a contactable consumer, the patient. A 79 years old male patient received second dose of BNT162b2 (PFIZER BIONTECH COVID 19 mRNA VACCINE; Lot number: EN6200] via an unspecified route of administration in left arm on 19Feb2021 at 08:00 (at the age of 79 years old), as a single dose, for COVID-19 immunisation. The patient medical history included allergy to Zocin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID 19 vaccine. No concomitant medication was reported. The patient previously took first dose of BNT162b2 (PFIZER BIONTECH COVID 19 mRNA VACCINE; Lot number: El9262] via an unspecified route of administration in left arm on 29Jan2021 at 08:00 (at the age of 79 years old), as a single dose, for COVID-19 immunisation. On 28Feb2021, the patient noticed that his heart rate had dramatically increased during any type of exercise. The patients resting pulse was 74 and he was exercising on a treadmill for weeks before the second shot. The patient experienced being winded after a very short time on the treadmill with his heart rate reaching 125 plus after a very short time. This was out of patient target range and he stopped before getting to that heart rate that patient knew that something was definitely wrong. The patient also got rapid breathing when the heart rate increased. The clinical outcome of events heart rate increased, being winded and rapid breathing was not recovered. No follow up attempts are needed. No further information is expected.
It started on Saturday with a fever in mid afternoon. I had aches and my nose ran for a couple of days. On the second day I got the PAXLOVID. I took that and I began to feel better. I was very tired and slept a lot. After that I began to feel back to normal. After about 5 days I knew I would be fine. The fatigue and post nasal drip hung on for several days. I am now able to bike, walk and swim.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 12/23/20Lot#EK9231 2nd dose 01/09/2021,lot#EL3248 Diagnosed covid positive:08/15/21 Symptom onset:08/14/21 Exposure:Home Symptoms:Cough, fatigue,sore throat,runny nose,headache.
89 y/o male, PMHx of hypothyroidism, HTN, dementia, admitted for weakness and 3 days of diarrhea on 1/28/21. Pt tested positive for Covid on 1/27/21 but was not found to be hypoxic. Pt was found to be clinically dry on exam, metabolic acidosis. Received fluids throughout evening. Symptoms resolved. Pt was discharged on 1/30/21.
Soreness in my arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 -old female patient received bnt162b2 (BNT162B2), administration date 20Apr2021 (Batch/Lot number: unknown) at the age of 28 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "mono" (unspecified if ongoing). Concomitant medication(s) included: NIKKI taken for contraception. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Soreness in my arm". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient called office on 4/9/21 approximately 1430 complaining of chest pain.  Patient states that she had some mild chest pain after her first COVID-19 vaccine in March, which lasted 30 minutes, then went away and she was fine.  She states that 30 minutes after the vaccine today, approximately 1100, she began having chest pain in the middle part of her chest.  She also states she has had shortness of breath, more than her normal.  The chest pain has continued for several hours and not let up, worse when up and moving around, as well as the shortness of breath. Denies any other symptom.  Patient states she also does have anxiety, which she attributed the chest pain after the first vaccine to.  Advised patient that she should call the squad to get to the ER asap. Pt. agrees.
6 month old received Flublok Quadrivalent, no AE; Initial information received on 15-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 6 months old male patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV]. [Product administered to patient of inappropriate age].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Nov-2019, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1959 via intramuscular route in the right thigh.  It was a case of actual medication error due to Inappropriate age at vaccine administration.  At the time of the 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
got the worst case of Flu; Initial information received on 31-Dec-2021 regarding an unsolicited valid non-serious case was received from the patient via social media.  This case involves an unknown age and unknown gender patient who got the worst case of flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   In 1996, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, form, dosage, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious event "got the worst case of flu" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It is reported "The last Flu shot, 1996. Separation from employment and mysteriously I got the worst case of Flu I've ever had in my life! Never had another one and have not had the Flu again".  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (got the worst case of Flu).  At time of reporting, the outcome was Unknown for the event "got the worst case of flu".
I had a sore throat followed by a cough and a headache. I took over the count medications MUCINEX. After contacting the doctor, I was told to take over the counter medications. My symptoms got worse. My headache was more severe. It peaked on the 19th of October. The cough also worsened. I still have a cough which is less severe, but I am still recovering.
got them twice once after had the shot/ suspected vaccination failure; got them twice once after had the shot; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male 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: 08-JUN-2022 Reporter's comment: This case was reported by a consumer via interactive digital media. The patient was the reporter's husband. The patient got them twice once after he had the shot. 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. Follow up would not possible, as no contact details were available. Note: narraative is not clear if the patient experienced shingles twice after vaccination or only once after vaccination and 1 episode before vaccination.
102 F fever, chills, flushing, nausea, severe headache, body aches Started around 5 am day after the shot and is still ongoing (manageable with ibuprofen)
Vaccine reaction on (L) arm 3 1/2 in. "x 3 1/2 inch. Advised parent to use cold water. TYLENOL
Info has been received from a 50 year old female pt with no past medical history who on 09/28/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Concomitant therapy included sodium levothyroxine (SYNTHROID), pravastatin sodium (PRAVACHOL) and meloxicam (MOBIC). Subsequently, the pt stated that the injected arm "felt sore and then swollen for a few days after vaccination." The pt sought unspecified medical attention. Additional info has been requested.
Approximately 4 hours after receiving HPV vaccine developed fever and sore throat and nausea.  Did not take temperature-no vomiting.  Did not take any OTC medicine (TYLENOL, PEPTO-BISMAL, etc.).  Symptoms lasted about 24 hours.
Patient complained of pain at injection site and that the injection was given too high on the arm.  The discomfort occurred immediately upon the injection with discomfort lasting approximately 2 days.  No further symptoms were noted.  The patient did not seek medical care, but she did call to report symptoms that occurred at time of injection to this provider on 11/18/2021.  The report was made for informational purposes as she reports no residual symptoms or complaints.
vaccine was expired, no temperature excursion occurred and Moderna determined the vial "maintained the activity necessary to protect against the SARS CoV-2 virus a the time of administration".   Patient reported no adverse reactions.
muscle spasm; sore arm; sore back; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), BACK PAIN (sore back) and MUSCLE SPASMS (muscle spasm ) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LISINOPRIL, PROPRANOLOL HYDROCHLORIDE (PROPANOLOL BOEHRINGER), AMLODIPINE and METFORMIN for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and BACK PAIN (sore back). On 04-Apr-2021, the patient experienced MUSCLE SPASMS (muscle spasm ). On 03-Apr-2021, PAIN IN EXTREMITY (sore arm) and BACK PAIN (sore back) had resolved. At the time of the report, MUSCLE SPASMS (muscle spasm ) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details not included.
Cold; Headache; Shaking inside; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), HEADACHE (Headache) and NERVOUSNESS (Shaking inside) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced NASOPHARYNGITIS (Cold), HEADACHE (Headache) and NERVOUSNESS (Shaking inside). At the time of the report, NASOPHARYNGITIS (Cold), HEADACHE (Headache) and NERVOUSNESS (Shaking inside) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
approx 1yr p/vax pt exp chickenpox w/over 75 lesions. no further info avail
Rigors, fever (101), headache, myalgias, (day 1 through  day 3 so far), vomiting and diarrhea (day 3)
The patient is a 77-year-old male with T2DM (not on medications), gout, and HTN who received the first dose of the Pfizer COVID-19 vaccine on 2/14. On 2/17 (three days after vaccination), he sought care in the emergency department for chest pain that worsened when he was supine and shortness of breath.   EKG in the emergency room showed STEMI and troponin levels were normal. He was transferred to a different facility for cardiac catheterization. Cath showed mild circumflex disease and a stent was placed. He was diagnosed with pericarditis at that time (elevated inflammatory markers ESR/CRP). He was discharged home post cath on Plavix/ASA.   He had an echocardiogram at his PCP?s office on 2/25, results still pending (as of 3/10).  2/25 ? televist with cardiologist who concurred with pericarditis, maybe mild coronary artery disease (follow-up scheduled 3/11).  3/3 chest pain symptom improved further, no cough, improved shortness of breath.      Medications at home: statin, previously colchine for gout, likely BP medication (PCP will send records)  Allergies: None known.  Vaccine Indication: Age >75
Immediately felt pain in my upper shoulder that ran to my cheek  day of vaccine I was fine next day experienced extreme sleep and headache . Next morning developed a rash all over my body. Day 3 still itching headaches and weakness
Swollen lymph nodes and pain on side of body where vaccine was administered. Appeared 8 days after the vaccine. Sore in area of swollen lymph nodes.
Initial unsolicited report received from Pharmacist (also consumer) on 02-Apr-2018. This case involves female patient who was vaccinated with 0.1 ml third dose of IMOVAX (Batch number, expiration date, site not reported) intramuscularly on 29-Mar-2018. The patient's medical history and concomitant medications were not reported. On 30-Mar-2018, one day following the vaccination, the patient began to have vomiting which continued into Saturday, 31-Mar-2018. On an unknown date, following vaccination patient was lethargic continued to feel lethargic to the point where she was unable to be up out of bed except to use bathroom and had no appetite, did not feel like eating. It was also reported that will be returning to own physician for evaluation and treatment as needed on 03-Apr-2018. Lab data was not reported. Corrective treatment was not reported. On an unknown date patient got recovered from vomiting. Outcome of the other events were not recovered. List of documents held by sender: none.
scratchy voice; hives that were red itchy; dry arm; arm was swollen; spot at the injection site; hives; redness that covered the whole forearm; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (scratchy voice), RASH PRURITIC (hives that were red itchy), DRY SKIN (dry arm), PERIPHERAL SWELLING (arm was swollen) and VACCINATION SITE DISCOLOURATION (spot at the injection site) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013l20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history not provided.  Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC), PRAMIPEXOLE and OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced DYSPHONIA (scratchy voice), RASH PRURITIC (hives that were red itchy), DRY SKIN (dry arm), PERIPHERAL SWELLING (arm was swollen), VACCINATION SITE DISCOLOURATION (spot at the injection site), URTICARIA (hives) and RASH (redness that covered the whole forearm). At the time of the report, DYSPHONIA (scratchy voice), RASH PRURITIC (hives that were red itchy), DRY SKIN (dry arm), PERIPHERAL SWELLING (arm was swollen), VACCINATION SITE DISCOLOURATION (spot at the injection site), URTICARIA (hives) and RASH (redness that covered the whole forearm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Chicken pox disease. 3 year old pt mom called, pt has chicken pox 20+ spots on 06/25/02 and fever.
patient was given the two doses in January 2021.  first dose on 1/4/21, second on 1/25/21.  Starting at an unknown date, the patient started having undetected minor stroke activity.  Stoke activity got worse and worse and was noted on April 9th, but there was evicdence of activity prior to that date upon examination.  changes in handwriting noted after first dose with changes again after second.  Patient experienced minor undetected stroke activity in Feb-March, being diagnosed after a significant stroke issue on April 9.  Diagnozed with TIA at that time. patient now has permanent loss of function related to legs, continence and cognitive function.
extremely ill starting on the 18mar2021; joint stiffness; mild cough; sore throat; unbearable itching like crazy at injection site; extreme shivering; Temperature 99.8; intense headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (extremely ill starting on the 18mar2021), JOINT STIFFNESS (joint stiffness), COUGH (mild cough), OROPHARYNGEAL PAIN (sore throat) and INJECTION SITE PRURITUS (unbearable itching like crazy at injection site) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced ILLNESS (extremely ill starting on the 18mar2021), JOINT STIFFNESS (joint stiffness), COUGH (mild cough), OROPHARYNGEAL PAIN (sore throat), INJECTION SITE PRURITUS (unbearable itching like crazy at injection site), CHILLS (extreme shivering), PYREXIA (Temperature 99.8) and HEADACHE (intense headache). At the time of the report, ILLNESS (extremely ill starting on the 18mar2021), JOINT STIFFNESS (joint stiffness), COUGH (mild cough), OROPHARYNGEAL PAIN (sore throat), INJECTION SITE PRURITUS (unbearable itching like crazy at injection site), CHILLS (extreme shivering), PYREXIA (Temperature 99.8) and HEADACHE (intense headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Body temperature: 99.8 High. On 19-Mar-2021, SARS-CoV-2 test: negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported. No treatment medications were reported.
I had my first Moderna vaccine on February 13, and about 20 minutes later my tongue began to feel like novocaine wearing off. This lasted about two hours, and then I had no further reactions . My second shot was on March 13, and the same thing happened., tongue tingling, lasting 2 hours, then no further problems. On March 29 I woke up with lesions under my tongue, and a brief time of having difficulty moving my tongue. During the day my tongue felt strange and the lesions hurt. Since the 29th the lesions have disappeared, and each day my tongue improved.  Today, April 23, I would describe my tongue as feeling like I have burned it on something hot, uncomfortable but not painful.