chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rashes on back and on skin below eyebrows and around outside of eye resulting in burning and itching. Also, crescent-shaped inflammation below cuticles on hands. Very sensitive to anything sharp or hot water. Some dry, flaky areas on forehead and lips. Sore in left nostril that won't heal. Redness around outside of nose. Using Desonide Ointment 0.05% on face and Clobetasol Propionate Ointment on back and hands. Facial redness seems to be lessening. Rashes on back appear to be healing. No change on hands yet.
No additional AE reported; temperature excursion and administered to patient; This spontaneous report was received from a medical assistant referring to a 12-month-old male patient. Information of the patient's pertinent medical history, concomitant therapy, concurrent condition and drug reactions/allergies was not reported.  On 16-FEB-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot# W006412, expiration date upon internal review was established as 23-FEB-2024, dose and strength were not reported) intramuscularly in right thigh for prophylaxis at a private doctor's office/hospital, after a temperature excursion. Total time in the range of -14 degree Celsius to -10 degree Celsius was 1 hour. Total combined excursion time was 1 hour (product storage error). This adverse event was previously reported to manufacturer. No additional adverse events were provided (no adverse event).  This is one of several reports reported by the same reporter.; Sender's Comments:  US-009507513-2304USA007931: US-009507513-2303USA002114:
I have developed Parosmia (self-diagnosed) in the last months and some mild fatigue. I did not immediately associate it with the COVID vaccine but have recently read some medical publications (I am a medical professional) reporting this as a rare side effect. I can't really pinpoint the exact date when this started but it has been within the last year or so and it is getting WORSE! There doesn't appear to be any other obvious cause because my medications and medical condition have been unchanged for several years. I have never contracted COVID and have had no minor illnesses for some long time (certainly none in more than a year or two).
Patient reports she received her COVID-19 booster yesterday afternoon, and was feeling well until the evening.  She states around 11 PM she began feeling leg cramps bilaterally and was having moderate difficulty ambulating.  She went to bed, and this morning awoke feeling significantly fatigued and unwell.  She admits associated headache and tingling in feet.  She denies fever, chills, appetite change, sore throat, chest pain, dyspnea, cough, abdominal pain, nausea, vomiting, diarrhea.  She attempted to use the restroom, however found she was unable to stand from the toilet afterwards.  She used her emergency alert button to notify EMS.  Patient reports she has had prior COVID vaccination/boosters without any resultant symptoms afterwards.  Patient uses 4 wheeled walker for ambulation at baseline, however when EMS arrived she required significant assistance to be transferred into ambulance due to weakness
Day 0-headache  Day 1- fever, chills, headache, joint pain Day 3- diffuse rash over trunk and over injection site on left arm
Pounding headache on right side of the head; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Pounding headache on right side of the head) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Dec-2021, the patient experienced HEADACHE (Pounding headache on right side of the head). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) in December 2021 for Adverse event, at a dose of 1 dosage form and SUMATRIPTAN in December 2021 for Adverse event, at a dose of 1 dosage form. At the time of the report, HEADACHE (Pounding headache on right side of the head) outcome was unknown.            She received the booster vaccine on 11 Dec 2021 that was administered on the left arm. After receiving the vaccine, she was experiencing pounding heading on the right side of the head. Daughter stated that she tried Tylenol which did not helped. Reached out to her HCP and HCP prescribed her medicine called Sumatriptan.  No concomitant drug were reported.
This is a spontaneous case, initially received on 02-Jan-2018, reported by other health professional (nurse), concerning a 32-year-old adult female patient. This report was linked to case 201800029. The patient's medical history and concomitant medications were not reported. It was reported that, FLUCELVAX QIV vaccine reached 58-degree F and was out of range for about 5 hours (explicitly coded as incorrect product storage). On 02-Jan-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195236 and expiry date: 30 -May-2018) which underwent temperature excursion (58-degree F and was out of range for about 5 hours) (explicitly coded as drug administration error). The reporter stated that, the patient did not experience any adverse effect after the vaccination. The reporter assessed this case as non-serious. Follow up received on 07-Feb-2018: The patient's date of birth and age (32-year-old) were updated. The narrative was amended accordingly.
COUGHING; BODY ACHES AND PAIN; COULDN'T LAY STILL; CHILLS; FEELING BAD / FEELING CRAPPY; This spontaneous report received from a patient via a company representative concerned a female of unspecified age.. 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: Unk) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers  No concomitant medications were reported. On 14-MAR-2021, the subject experienced feeling bad / feeling crappy. On an unspecified date, the subject experienced coughing, body aches and pain, couldn't lay still, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling bad / feeling crappy, body aches and pain, chills, coughing and couldn't lay still was not reported. This report was non-serious.
Received Tdap 1-31-12 (Tues.) Called employee health 2-2-12 (Thurs.) complained of fever, headache, muscle aches. Swelling & pain at injection site. Nose bleed. Nausea.
Pt received Pfizer x2.  Pt tested COVID + on 9/23/21 and admitted to hospital for COVID on 9/26/2021. Pt receiving remdesivir, baricitinib and dexamethasone.
6/14/02-11:30 pm Vomiting x 2 T-102 degrees, 6/15/02- temperature-all day- 102 Advil. 6/16/02-Temp 101-went down, 6/16/02, evening-normal, 6/17/02, rash on legs, raised red, called MD am, 6/19/02- Cough croupy-MD prescribed tussi, 6/20/02-rash over body,  Told to call MD.
I felt slightly light headed; I felt a slight disorientation; a very heavy feeling in the center of my chest; hip joint pain sever enough; This is a spontaneous report from a contactable consumer reported for himself. A 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: PFREH9899), via an unspecified route of administration at left arm on 29Dec2020 16:00 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included ongoing Chronic hip joint pain. Concomitant medication included celecoxib at 100mg once daily. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Dec2020 at 16:30, after patient left the observation tent, while walking to his car, He felt slightly lightheaded. Upon reaching his car he felt a slight disorientation and a very heavy feeling in the center of his chest. These symptoms lasted until he reached home which was about a 15 min drive. Once at home he experienced hip joint pain sever enough that he had to stop being mobile. All symptoms disappeared within 1-2 hours except for the heaviness in the center of his chest. This lasted for about another hour. After that no more issues. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on 29Dec2020.
Vaccines received in the morning. Was admitted to the hospital that evening with 104+ degree fever. Admitted. Pneumonia from CNS suppression. Administered intravenous penicillin. Allergic reaction, swelling in face, burst tear ducts. Child presented with social developmental delays, chronic food allergies, auto-immune disorders, eczema, sever anxiety, milld autism spectrum disorder. Diagnosis came later in life. Most chronic ailments began to be resolved in patients early 30's.
Five days after injection of Adacel, c/o itching at site, red and hard area about the size of 50 cent piece. Advised to use Benadryl, cold compresses and Tylenol prn.
EXPIRED VACCINE USED; This spontaneous report received from a pharmacist concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: 21-SEP-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-SEP-2021, the patient experienced expired vaccine used. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine used was not reported. This report was non-serious.
Rapidly ascending muscle weakness requiring intubation & hospitalization in ICU. Guillain Barre suspected.
CDC recommends using single-use vials of normal saline to dilute to each vial of the Pfizer vaccine.  Staff member incorrectly used 100 ml bottles of normal saline to reconstitute multiple vials of vaccine each day.  Staff member used a new bottle per day, however, and used the correct amount of normal saline to dilute each vial (1.8 ml per vial). We have since corrected this error and also notified local health authorities.  Patient has not reported any adverse events to health clinic where error occurred.
Received my bivalent covid booster on 9/23/22 (2nd total booster.  First covid booster was 10/28/21.  All have been pfizer vaccines.  No known history of covid-19 infection) and a flu shot on the same day.   That evening (9/23/22) I had expected side effects which included mylagias, fatigue, and some chills.  Those subsided the next day (9/24/22) however I subsequently developed a very painful sore throat 8/10 in severity.  It is located more superior in the oropharynx than what I typically experience and seems to approach the posterior aspect of the hard palate.  There is also a fullness of my ears.  Lastly, I am experiencing severe xerostomia which I have never had before.   I tested myself twice for covid-19 infection on subsequent days but this was negative.  I have no other infectious symptoms such as n/v, diarrhea, mylagias, arthralgia, fever, cough, sinus pain,  or congestion. No significant erythema or exudates noted on exam.  I have been taking advil 600mg BID with minimal relief,  The symptoms continue to persist (9/27/22) but do not appear to be getting worse. Given that I do not have any other infectious symptoms and that this was so closely temporally related to my vaccine, I worry that this constellation of symptoms may be secondary to covid bivakent vs flu shot vs conbo covid + flu.
Pt reports memory loss of events after about 30 minutes post vaccination with shingles vaccine.  Pt reports her last recollection was at the end of driveway from hospital grounds.  Patient's husband reports that his wife called him on her cell phone and said that she could not find her way home.  Pt husband reports that his wife was not cognitive enough to follow directions until they were able to find her after about 2 hours.  Patient was found on a gravel road in their home vacinity.  Husband reports that his wife complained of a "bad" headache and eye sensitivity to light.  EMS arrived and patient was taken to hospital.  Husband reported that patient was combative when EMS tried to take her in.  Labs and CT of head were taken at hospital.  Patient was kept overnight for observation.  Patient was given oral potassium for slight hypokalemia and observed overnight.  Patient reports after the vaccination and prior to time of memory loss, she denies any onset of known symptoms.  Patient's husband reports that patient has a long time history of "severe" migraine headaches.
"A nurse reported that a 4 month old infant, post vax, developed loose, watery stools which resolved within 7 days." Follow up #1-additional reporter address info was provided from telephone contact on 6/1/01. No further info is anticipated for this report. Case is closed.
Erythema, tenderness, edema (R) deltoid at site of BEXSERO injection.
6:13 pm - 9 pm   Extreme shooting pain, right shoulder, clavicle and neck causing my arm to jerk and sometimes my body spasmed. Pain was intermittent, coming and going but taking my breath away. I called CVS about aspirin and took 5 Baby Bayer aspirins. Pain went away at around 9 pm. Never returned. NO  other adverse effects  Surprising result is diminished pain in knees! When it gets cold, rainy, my knees have been extremely painful so I'd have to lift myself up from sitting but since then the pain is at 1 to 2 on the scale rather than 10 ! It sounds strange but it has happened and that's why I felt I needed to report this.  Rainy days this week with no debilitating pain and I waited to report this for a week since the pain usually began days before.
seizure like activity; Initial information received on 10-Oct-2022 regarding an unsolicited valid serious case received from a healthcare professional.  This case involves a 16-year-old patient (unknown gender), who experienced seizure like activity after receiving vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Oct-2022, the patient received 0.5ml total dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE (strength, formulation, route: unknown) (lot number: U7249AA and expiry date: 11-Mar-2024) in unknown administration site for Immunization.  On 07-Oct-2022, on the same day, the patient developed a serious event of seizure like activity (Seizure like phenomena) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE.   It was reported, Office has since removed all MENQUADFI with that particular LOT# from refrigerator and has ordered more. No additional patient information at the time of call.   Action taken with MENINGOCOCCAL VACCINE (MENQUADFI) was not applicable.  It was not reported if the patient received a corrective treatment for the event (seizure like activity).  At time of reporting, the outcome was Unknown for the event seizure like activity.  Seriousness Criteria: Medically significant for seizure like activity.; Sender's Comments: Sanofi company comment dated on 14-Oct-2022: This case involves a 16 years old and unknown gender patient who experienced seizure like activity while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  The time to onset is compatible with the role of the product. However, information regarding medical history, past medical treatment, vaccinations, condition at the time of vaccination and laboratory data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine will be assessed completely after receiving follow up information.
Right arm hurting; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right arm hurting) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018b21a) for COVID-19 vaccination.     No reported medical history.  Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), HYDROXYZINE and PARACETAMOL (TYLENOL) for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (Right arm hurting) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Right arm hurting) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications included: sleeping pill.  No treatment information was provided.
Light headed and dizzy, funny taste(metallic taste),pins/needles in tonsil area, nausea/vomiting
Diarrhea; This is a spontaneous report from a contactable consumer (patient).  A 56-year-old female patient received first dose of bnt162b2 (BNT162B2, lot number EJ1686) , via an unspecified route of administration on 13Jan2021 09:30 at single dose on left arm for covid-19 immunization .  Medical history included breast cancer (hence tamoxifen) , prediabetic.  Concomitant medication included tamoxifen for breast cancer, calcium, vitamin d nos.  The patient experienced diarrhea on 13Jan2021 11:30. The patient stated that, "started diarrhea within 2 hours after the vaccination, stopped 10 hrs later.  I had a toast with peanut butter and hot water 1 hr before the shot (which is something I eat every morning) I skipped lunch and dinner. Just drank water until the diarrhea stopped around 10pm. I had the same thing next morning without issue." No treatment was received. 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 not been tested for COVID-19. No allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Case assessed as non-serious. The outcome of the event was resolved on 13Jan2021 22:00.
This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant mediations and drug reactions or allergies were not provided. On 09-OCT-2017 and 19-NOV-2017, the patient was vaccinated with the first and the second GARDASIL 9 (dosage, route, lot # and expiration date were not reported) for prophylaxis. The patient would like to receive the third dose now. No adverse symptoms reported. No further information was provided.
4 to 5 hrs after vaccination pt felt warm & itching at site of injection left arm. Swelled up & raised. Painful knot - feverish - seen day after - 11/11/11 noted cellulitis at site - treated with KEFLEX - pt better after 2 days - lasted total 5 days.
Arm sore; Felt like had cold; body was so  cold; Body was shaking so bad; Swelling a lot; Felt like she had covid but much worse; Chest and rib hurt when she breathed; Back hurt when she breathed; Fever really high; Felt like tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore), NASOPHARYNGITIS (Felt like had cold), FEELING COLD (body was so  cold), TREMOR (Body was shaking so bad) and SWELLING (Swelling a lot) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in 2020.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm sore), NASOPHARYNGITIS (Felt like had cold), FEELING COLD (body was so  cold), TREMOR (Body was shaking so bad), SWELLING (Swelling a lot), FEELING ABNORMAL (Felt like she had covid but much worse), DYSPNOEA (Chest and rib hurt when she breathed), BACK PAIN (Back hurt when she breathed), PYREXIA (Fever really high) and FATIGUE (Felt like tired). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK, bid. At the time of the report, PAIN IN EXTREMITY (Arm sore), NASOPHARYNGITIS (Felt like had cold), FEELING COLD (body was so  cold), TREMOR (Body was shaking so bad), SWELLING (Swelling a lot), FEELING ABNORMAL (Felt like she had covid but much worse), DYSPNOEA (Chest and rib hurt when she breathed), BACK PAIN (Back hurt when she breathed), PYREXIA (Fever really high) and FATIGUE (Felt like tired) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included thyroid medicine. The patient reported that she felt much better and mentioned that it was her worse night in all her life, she was about to go to the hospital. The patient does not  want to receive the second dose.
Pt developed diffuse rash throughout entire body several hours after the vaccine. Pt took Benadryl and the rash resolved the following morning.
pt recvd vax; exp n; no vomiting; felt this way on way home p/ shot;nothing taste good;intermittent HA;for 2 wks had rectal hives(but has had this for 40 yrs)
Pain in my legs, lower back, left bicep, and head; Pain in my legs, lower back, left bicep, and head; Pain in my legs, lower back, left bicep, and head; Pain in my legs, lower back, left bicep, and head; Drowsiness; Difficulty concentrating; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD0809) via an unspecified route of administration in the left arm on 02Nov2021 at 17:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD0809) via an unspecified route of administration in the left arm on 12Oct2021 at 17:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. On 03Nov2021 at 12:00, the patient experienced pain in his legs, lower back, left bicep and head, drowsiness and difficulty concentrating. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain in my legs, lower back, left bicep and head, drowsiness and difficulty concentrating was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
I tested positive for Covid on a home test. Upon calling, I was prescribed Paxlovid. My symptoms were sore throat, headache, and runny nose.
Information has been received from a nurse practitioner (N.P.) concerning a 12 year old female patient with no relevant medical history or drug allergy who in 1997 was vaccinated with a dose of RECOMBIVAX HB (lot # not reported). There is no concomitant medication. It was reported that the patient developed benign lymphadenopathy 12 years ago (in 1997) after receiving the vaccine. The patient sought medical attention at the physician's office. On an unspecified date, the patient recovered from the benign lymphadenopathy. Additional information has been requested.