chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SPONTANEOUS HEADACHE; This spontaneous report received from a health care professional concerned a 63 year old female. The patient's height, and weight were not reported.  The patient's past medical history included abdominal aortic aneurysm, ascending aortic aneurysm, atrial fibrillation, degenerative disc, heart issue, stroke, drug allergy, blood clot behind eye, smoker, and overweight, and other pre-existing medical conditions included patient had medical history of naturally throwing clots and short term memory. The patient was previously treated with promethazine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802029, and batch expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. Concomitant medications included apixaban for atrial fibrillation, hydrocodone, levothyroxine, and lisinopril.  On an unspecified date, the subject experienced spontaneous headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of spontaneous headache was not reported. This report was non-serious.
This spontaneous report as received from a registered nurse refers to a child who was a patient of unknown age and gender. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On 24-OCT-2017, the patient was vaccinated with PROQUAD (lot # N020008, expiry date: 13-JAN-2019) for prophylaxis. The vaccine was reconstituted with 0.6 ml of 0.4% sodium chloride diluent (Sanofi Pasteur) (lot # U1799AAB, expiry date: 01-JUL-2018) (product preparation error). No adverse effects were reported. No product quality complaint (PQC) was involved.
Minutes after vaccine developed tachycardia, shortness of breath, tingling and trembling hands. Tachycardia and a feeling of heart distress remains many days after the vaccine.
9 doses were administered post excursion; Product storage error; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses were administered post excursion), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) in a 73-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses were administered post excursion), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses were administered post excursion), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses were administered post excursion) and PRODUCT STORAGE ERROR (Product storage error).    No concomitant medications were reported. Storage condition at the time of the excursion was frozen. Temperature noted in that condition was -2 to -18 C. Excursion duration was for 2hrs. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2023: Live Significant follow-up received: New events added and narrative was updated
While waiting for 15 minutes after receiving vaccination, patient was walking around the store, and suddenly he said, he "blacked out." He fell sideways into the wall, and then fell backwards. He gained consciousness right after. Patient said, he "blacked out," and next thing he was on the ground. Patient was conscious and oriented to what had just happened. EMT was called, and vitals were taken. Vitals were all normal, and patient felt ok. Patient was not taken to the hospital.
I felt tired, ached and slight fever a few hours after third (booster) dose on 28 December 2021. The next day I was feeling very tired, had 101 F Fever with no appetite. On the night of 29 December 2021 I continued to be tired with fever and urinated frequently (due to Atrial Fibrillation?). The next morning on 30 December 2021 I felt better and went to the toilet for my ablutions. After that I went to the kitchen for a banana. While eating the banana in the kitchen I fainted and my wife had me transported to Hospital Emergency by Ambulance. I was told I came into hospital with active Atrial Fibrillation. FYI:  On 14 July 2021 antibody test SARS COV-2 IgG SP Quantitative > 2000 AU/mL,, On 21 October 2021 antibody test SARS COV-2 IgG SP Quantitative 3,862.30 AU/mL,, On  17 February 2022 antibody test SARS COV-2 IgG SP Quantitative = 56,962.20 AU/mL.  Could my fainting on 30 December 2021 be due to the very high levels of antibodies developing after the third (booster) vaccine dose? None of my medical providers can tell me and that is why I am asking.
OTHER THINGS (UNSPECIFIED); PAIN IN LEFT BREAST; LYMPH NODE ISSUES; TWO LUMPS ON MY NECK; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: homeless. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAY-2021, the patient experienced two lumps on my neck. On an unspecified date, the patient experienced other things (unspecified), pain in left breast, and lymph node issues. Laboratory data (dates unspecified) included: Laboratory test (NR: not provided) Lymph node issues, and Mammogram (NR: not provided) Found something (unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from two lumps on my neck, pain in left breast, and other things (unspecified), and the outcome of lymph node issues was not reported. This report was non-serious.
I noticed soreness in my spine and slight neck pain. By the next day the pain was worse in my back and concentrated in my lower back and neck. By the third day I could barely walk because of the pain in my lower back. There is also pain in my neck. I am taking Naprosyn now, so I don't know the ultimate outcome.
Initial and follow up information has been received from a Registered Nurse concerning a white female patient who on the afternoon of 10 Oct 206 was vaccinated IM with her first dose of Gardasil (yeast), lot #653650/0720F, and experienced flu-like symptoms and vomiting. No medical attention was sought. Within a day or two, the patient recovered. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 12/14/2006.  Initial and follow up information has been received from a Registered Nurse concerning a white female patient who on the afternoon of 10-OCT-2006 was vaccinated IM with her first dose of GARDASIL, lot #653650/0702F, and experienced flu-like symptoms and vomiting.  No medical attention was sought.  Within a day or two, the patient recovered.  Follow up information indicated that the patient received her second dose of GARDASIL and had no adverse experience.  Additional information is not expected.
Patient started feeling feverish the evening of the immunizations, then felt hot and cold alternating through the night. Patient then fainted briefly in the shower early the next morning. Patient felt lethargic through the day the day after the immunizations.
Patient complained of feeling dizzy after receiving 1st Pfizer Covid vaccine (Lot#ER8732 Exp. 3/28/21). Client was sitting in post vaccine waiting area approximately 15 mins when she alerted EMTs she was feeling dizzy. EMT alerted HCP. At arrival to client, client was leaning to the side of chair, pale, and diaphoretic. HCP  began assessment. Client alert and oriented x2, slow to respond. EMT took vitals: blood pressure 88/52, pulse 43, oxygen 95. Client stated being 22 weeks pregnant. No high risk pregnancy, had consulted provider prior regarding vaccine. No medication she takes at this time or history of allergies. Emergency responders called at 1146. HCP on phone with operator. 1149 oxygen 100, pulse 65. Client stated not wanting paramedics that she was starting to feel better. HCP informed client we are unable to cancel call. Vitals taken at 1154: blood pressure 108/64, pulse 74, oxygen 99. Per client dizziness had resolved. Alert and oriented x4. Last vitals at 1159: blood pressure 112/72, pulse 65, oxygen 98. Client advised to speak with provider prior to receiving second vaccine. Fire department arrived at 1154 and assumed care. At 1209 client signed against medical advise with paramedics. Client contacted husband to come pick her up. Client remained in waiting room and left facility with a steady gait at 1229.
Chills at 5 pm, rapid breathing followed by nasea arouns 10 pm, vomited once around midnight, naseau until morning, symptoms revealed in morning
Erythematous Malar rash. Desquamating rash on face, chest, extremities. Pruritic
caller states the pt woke up on 3/10/2021 w/ tender arm, headache, nauseated, dry-heaving, very weak, diarrhea, slight fever,  and chills.  Pt will go to the ER if her symptoms do not improve.
Pt developed papulovesicular lesions which developed into a rash along the T8 dermatome approximately Pt called back 2 days after ZOSTAVAX.
Started with headache within 24 hrs of/HA all over/ Throbbing and sharp; some sensitivity to light; sore in jaw; booster; This is a spontaneous report received from a non-contactable reporter(s) (Other healthcare professional: Nurse). The reporter is the parent.  A 17 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 09Dec2021 13:15 (Lot number: FE3594) at the age of 17 years as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing); "known allergies: environmental allergies" (unspecified if ongoing); "known allergies: seasonal allergies" (unspecified if ongoing); "Cramps" (unspecified if ongoing). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Concomitant medication(s) included: ADVIL [IBUPROFEN], 200 mg, as needed, orally, taken for muscle spasms; CETRIZINE, 10 mg, 1x/day, orally; SERTRALINE, 12.5 mg, 1x/day, orally. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8736, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 24Apr2021, when the patient was 16 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0183, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 15May2021, when the patient was 16 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 09Dec2021 13:15, outcome "unknown", described as "booster"; HEADACHE (medically significant) with onset 10Dec2021, outcome "not recovered", described as "Started with headache within 24 hrs of/HA all over/ Throbbing and sharp"; PHOTOSENSITIVITY REACTION (non-serious) with onset 10Dec2021, outcome "unknown", described as "some sensitivity to light"; PAIN IN JAW (non-serious) with onset 10Dec2021, outcome "unknown", described as "sore in jaw". The events "started with headache within 24 hrs of/ha all over/ throbbing and sharp", "some sensitivity to light" and "sore in jaw" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: computerised tomogram head: (Dec2021) unknown results.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a healthcare worker refers to a female patient of unknown age. On 25-APR-2013 the patient was vaccinated with PROQUAD (Merck) (Lot # not provided) (dose and route not reported). Other suspect therapies included VARIVAX (Merck) (Lot # not reported) (dose and route not reported). No concomitant therapy was reported. On 25-APR-2013, the patient was vaccinated with PROQUAD (Merck) and VARIVAX (Merck): no adverse effects reported at this time. Additional information is not expected.
Client was seen in the emergency room 1/8/2021 (9 days after vaccination) for sever redness at site of vaccination.  Seen and given medication.
Aproximately 28 hours after vaccination the patients Right forearm began to have hives on it.  The following morning approximately 42 hours after vaccination, the hives were on both forearms.  His arms began to blister.  Pt went to the ER approximately 48 hours after vaccination.  Pt complained of a swollen Uvula and the feeling of needing to continuously swallow. The Uvual was approximately twice the normal size.  Pt was administered IV Benadryl and reaction was reversed.  No allergies prior to this reaction were noted.
herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 58 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 10-JUL-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a healthcare provider for  herpes zoster. The outcome of herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).    Additional information has been requested.
local inject hypersensitivity react; 15x22cm temp 98.8 @ clinic; t101 @ home in AM 5MAY94; no other systemic problems;
Started sore at injection site progressed to red and warmth about 4-5 inches from injection site.
Gave shot, patient moved to other chair, gave brothers shot, then went to give mother's shot and patient clenched fists and feel out of chair. Became cold and clammy and eyes rolled back in head. Lowered head to ground and gave smelling salts. Patient woke and didn't remember what happened, sweaty and dizzy.
woke up at 1:30 AM on 7/30/2021 from a deep sleep with something I can only explain as the spins.  I had believe I had a fever because my husband gave me wet cold towels to try and cool my body and my body warmed them immediately.  I could not move or the spins would worsen, I couldn't even move my head to either side I had to keep laying down, if I tried to sit up it got worse.  After about 30 minutes I had to vomit so my husband got the trash can because I could not even attempt to get to the restroom. I began to vomit profusely. I needed something to hold me up so my husband helped me to the floor. We considered calling 911. I vomited intermittently for the next 4 hours. I could not sleep because a slight movement in my head would send me spinning. At about 5 AM I was able to slowly get to a chair in my room to try and sleep.  By 8 AM I could walk. Up until about 7 PM (on 7/30) I still felt nausea. I could only sip water or Gatorade, I have managed to eat some soup and crackers.
Neurological,  Mostly muscle twitching in left eye. Mild Chest pain and periods of low and/or rapid heart beat. High lack of energy compared to before injection. Possible depression?
Around 9pm was very tired with small headache. Went to bed at 10pm and laid there for an hour and a half with my head pounding and burning. I?ve never been able to feel a fever on myself?it was so high. I also had major chills the whole time. I?d get up and hydrate and took 2 Advil around 12:30pm as no sign of sleep was coming. I put ice packs on my hot head for an hour with no relief. Meanwhile my heart rate was steadily above 100 for the whole night until about 4am when my fever went down and I was able to sleep till 7am. I thought I was going to die it was so hot and painful and pounding. In the morning the fever is gone and I am extremely tired. Currently not recommending people get the vaccine.
16y/o (almost 17) daughter/patient received dose 1; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16y/o (almost 17) daughter/patient received dose 1) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16y/o (almost 17) daughter/patient received dose 1). On 31-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16y/o (almost 17) daughter/patient received dose 1) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication use was not reported.   Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow-up received on 16-APR-2021 report from pharmacist who administered the vaccine and includes patient and vaccine product information.
Redness and slight swelling, increasing to itchiness and tenderness.  Covered about a 1 1/2"  x 3" area. Hurt to lay on that side of arm.  Today there is still redness and some slight swelling, no tenderness...10/24/2009
I tested positive for COVID-19 on 12/24/2022. On 12/25/2022 I felt like I had a mild cold. On 12/26/2022 I had trouble breathing so I called my provider and she said to go to the emergency room. I also had wheezing and coughing. I went to a local medical center. Also, I got a nebulizer treatment, and it helped me out. Also, when I took EKG it came back abnormal but then they did blood work, and everything was fine. The provider prescribed PAXLOVID, but I did not take it.
I have a history of skin cancer and I went in for a skin check up on 3-18-2022 and the PA found a cancer spot on my forehead and biopsied it with basal cell result. It was removed on 3-29. They removed the stitches on 4-8. On 4-13, I went back in for another skin check and they found spots on my nose (basal cell) and a spot on my scalp (squamous cell). They operated on the spot on my nose on 4-25. They removed the spot on my scalp on 6-28, stitches removed 7-13. I feel the vaccine may have stimulated the growth of my cancer cells.
A 5 year old, male patient experienced injection site cellulitis, one day after receiving a number of vaccinations on 8/2/2005. The patient received the following injections: Daptacel lot number C2220AA intramuscularly in the upper left thigh, IPOL lot number Y0325 intramuscularly in the lower left thigh and MMR lot number 0033R subcutaneously in the right thigh. On 8/3/05, the patient presented with a hard, red, swollen, reaction of 1 1/2" in diameter. On 8/4/05, the patient was seen at the doctors office with a reaction of 4" where the Daptacel was given. It was diagnosed as cellulitis and treated with an antibiotic. The patient recovered from the adverse event. Follow up received on 9/28/2005 the patient experienced 4 episodes since 2000 of cough and wheeze that required office visit and treatment by medicines. It was never coincided with vaccine administration. There were never any other reactions to previous vaccines. Cultures were not done on reaction site. The patient had received the antibiotic for 10 days. The patient recovered from this adverse event. Data complete. Case is closed.
Large red local reaction and urticaria within 48 hrs of Dtap and HIB vaccines, right leg.
Administered the Moderna vaccine almost 20 hours after first puncture; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Administered the Moderna vaccine almost 20 hours after first puncture) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Administered the Moderna vaccine almost 20 hours after first puncture). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Administered the Moderna vaccine almost 20 hours after first puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.
Minor discomfort at shot area loss of energy for 24 hours.; Minor discomfort at shot area loss of energy for 24 hours.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 28Feb2021 08:15 (Batch/Lot number: unknown) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Stage 1 Hypertension" (unspecified if ongoing); "Type 2 diabetes" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; METFORMIN; ATENOLOL; ATORVASTATIN. The following information was reported: VACCINATION SITE DISCOMFORT (non-serious), ASTHENIA (non-serious), outcome "recovered" and all described as "Minor discomfort at shot area loss of energy for 24 hours.". Therapeutic measures were not taken as a result of vaccination site discomfort, asthenia.  Additional information: Minor discomfort at shot area loss of energy for 24 hours. Slept it off. He reported no known allergies and confirmed that he did not test covid positive after vaccination and also did not have covid prior to vaccination. It was also confirmed that no other vaccine was taken in four weeks.  No follow-up attempts are possible. No further information is expected.
04/15/2022  I have had a runny nose and it became worse. It developed into a sinus infection, upper respiratory infection and then bronchitis.  I had chills and body aches that only lasted a few days. I still have the cough and runny nose. I tested negative for COVID-19.
Mother of child reported a red, warm to the touch, area the size of an apple at the injection site.  Child did not have a fever. Today mom reports that there is a bruise at the injection site, red edematous area is gone.  Mom was told by M.D. to treat with Motrin, Benadryl and ice.