chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, chills, sweating, headache and movements reduced. On an unknown date, the outcome of the fever, chills, sweating, headache and movements reduced were unknown. It was unknown if the reporter considered the fever, chills, sweating, headache and movements reduced to be related to SHINGRIX. Additional information was reported as follows: The healthcare professional reported that, he experienced fever, chills, he could barely move and sweats when the fever broke down. The patient experienced 101 degrees. The events were updated after call review. This case was linked with case US2018GSK133629, reported by the same reporter for the same patient. Lab Comments: On an unknown date, the patient's body temperature was found to be 101 degree C.
tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report from a contactable consumer. A 28-years-old male patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EP7534) via an unspecified route of administration, administered in Arm Right on 22Mar2021 13:30 (Batch/Lot Number: EP7534) as single dose for covid-19 immunisation.  Medical history included asthma and food allergy. There were no concomitant medications. It was reported, on 08Apr2021, the patient experienced tested positive for covid-19. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 08Apr2021. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
c/o weakness, sweating reported to school nurse w/ BP 98/60, P32?;pt normally hypertensive-MD ?BP med 2 days prior;sent to ER via amb;seen & released by hosp;
This spontaneous report as received from a registered nurse refers to a 18 month old female patient. The patient did not have any pertinent medical history, drug reactions or allergies and concomitant medications. On 25-MAR-2016, the patent was vaccinated with a first dose of M-M-R II intramuscularly in the leg (lot # and expiry date were not reported). On 25-MAR-2016 in the evening, the nurse noted that the patient was not quite herself, was fussy and crying and was not able to put any weight on the leg (unspecified which leg) where the M-M-R II was administered. The patient was given TYLENOL the same evening and was able to bear weight on that leg by the next day. The nurse reported that the patient was not herself since the M-M-R II was administered and continued to cry and fuss. She was taken to a physician on 03-APR-2016, and she had fluid in one ear. No lab diagnostics studies were performed. The outcome of the event of not being able to bear weight on the leg was recovered on 26-MAR-2016. The outcome of the events of not being herself, being fussy and crying was reported as recovered at the time of this report. The outcome of the event of fluid in the ear was unknown. The relatedness between the events and the suspect therapy was not provided. Additional information has been requested.
Headaches, Arm Pain, Armpit Glands Sore/Swollen, Injection Site Red/Painful/Raised
It became red, swollen w/a big lump, achy. Then it went away. On 2/17 it came back again only covered a bigger area & was very itchy.  I was concerned that I got a 2d reaction a week after the first reaction. As of 12:50 a.m.  2/19 it is still reacting.
became very sick after vaccine; Cough; profound weakness; Marked SOB; Fever; joint pain; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (became very sick after vaccine), COUGH (Cough), ASTHENIA (profound weakness), DYSPNOEA (Marked SOB) and PYREXIA (Fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (RN diagnosed. Patient was very sick.) in March 2020.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (became very sick after vaccine), COUGH (Cough), ASTHENIA (profound weakness), DYSPNOEA (Marked SOB), PYREXIA (Fever) and ARTHRALGIA (joint pain). At the time of the report, ILLNESS (became very sick after vaccine), COUGH (Cough), ASTHENIA (profound weakness), DYSPNOEA (Marked SOB), PYREXIA (Fever) and ARTHRALGIA (joint pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood immunoglobulin G: > 2500 (High) norm range >0.8, patient consistently had spiked antibodies. On an unknown date, SARS-CoV-2 antibody test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.  Patient's cardiologist suggested not to take 2nd vaccine and to monitor antibodies and patient had done that for one year (every 3 months).   No treatment information was provided.
Received 4 vaccines on 2/3/14. Mom called Health Department on 2/4/14 to notify us patient has developed a head-to-toe rash on 2/4/14. Took pt to doctor on 2/6/14 et reported to have hives. Mom refused steroids for head-to-toe breakout. Mom reports child acted fine throughout et returned to normal 2/6/14. On 2/4/14 pt had rash on face. Has had since 10/2013 et doctors unable to diagnose. Going to dermatologist.
Pain radiating to left side of head and shoulder started morning after injection and worsening through day. It has continued three days and is still current. Treating with pain meds and rest.
Severe diarrhea and loose stools from rotavirus vaccine. It lasted until 7/25/2016. Saw at least 4 different doctors about symptoms and had tests done to see if something else was wrong. 2 doctors independently said that it was probably the vaccine since there was nothing else happening to her at that time. Her diarrhea episodes were about 8 times a day, when she previously only had one solid bowel movement a day.
dx with shingles; Sore throat; Very sore arm; Felt unwell; "Weird" headache; This spontaneous case was reported by a non-health professional and describes the occurrence of HERPES ZOSTER (dx with shingles), OROPHARYNGEAL PAIN (Sore throat), PAIN IN EXTREMITY (Very sore arm), MALAISE (Felt unwell) and HEADACHE ("Weird" headache) in a 70-year-old female patient 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 an unknown date, the patient experienced HERPES ZOSTER (dx with shingles), OROPHARYNGEAL PAIN (Sore throat), PAIN IN EXTREMITY (Very sore arm), MALAISE (Felt unwell) and HEADACHE ("Weird" headache). At the time of the report, HERPES ZOSTER (dx with shingles), OROPHARYNGEAL PAIN (Sore throat), PAIN IN EXTREMITY (Very sore arm), MALAISE (Felt unwell) and HEADACHE ("Weird" headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  Treatment medications were unknown.
Nasal congestion, sneezing, sore throat. Palatal petechiae, erythematous tonsils, upper cervical tenderness of lymphnodes.
Urticaria, half hour following administration of vaccines, .2 cc epinephrine, sq., left arm given by MD. Then 1.5 tsp Benedryl, to be followed every 6 hours.
My balance is off.  Did Epley Maneuver thinking Lightheadedness might be caused by misplaced ear crystals.  Also some tingling on the tip of left fingers Today is Thursday 16 Sep 2021
Fast heart beat; Felt like it hit a nerve; Burning feeling in arm/burning moved up her face; Started feeling so sick; Whole left side of face from ear to head was numb; Was not able to sleep; Headache; Felt tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TACHYCARDIA (Fast heart beat), INJECTION SITE NERVE DAMAGE (Felt like it hit a nerve), BURNING SENSATION (Burning feeling in arm/burning moved up her face), MALAISE (Started feeling so sick) and HYPOAESTHESIA (Whole left side of face from ear to head was numb) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039k20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced TACHYCARDIA (Fast heart beat), INJECTION SITE NERVE DAMAGE (Felt like it hit a nerve), BURNING SENSATION (Burning feeling in arm/burning moved up her face), MALAISE (Started feeling so sick), HYPOAESTHESIA (Whole left side of face from ear to head was numb), INSOMNIA (Was not able to sleep), HEADACHE (Headache) and FATIGUE (Felt tired). At the time of the report, TACHYCARDIA (Fast heart beat), INJECTION SITE NERVE DAMAGE (Felt like it hit a nerve), BURNING SENSATION (Burning feeling in arm/burning moved up her face), MALAISE (Started feeling so sick), HYPOAESTHESIA (Whole left side of face from ear to head was numb), INSOMNIA (Was not able to sleep), HEADACHE (Headache) and FATIGUE (Felt tired) outcome was unknown.            Treatment and concomitant medications were not provided by reporter.   Reporter did not allow further contact
This spontaneous report as received from a pharmacist refers to a 65 year old female patient. No pertinent medical history and drug reactions were reported. On 18-JAN-2014, the patient was vaccinated with ZOSTAVAX lot # J011218, single dose, subcutaneous. No concomitant medication was administered. On 20-JAN-2014, the patient developed a red welt at the injection site. On 21-JAN-2014, the area of reaction became very painful. The symptoms were now improving without requiring medical treatment. No lab diagnostic tests were performed. Patient's present status was reported as recovering. The patient sought medical attention, called pharmacy. No product quality complaint (PQC) was reported. This is case 1 of 3. Additional information has been requested.
Nursing preparing a MENVEO inj for a patient noticed that the box of 5/5 and one extra vial of the liquid component (MenCYW-135) that should have been used for reconstitution for the lyophilized portion (MenA conj component). Suspect a plain diluent was used for reconstitution. 2 potential patients and one is missing the liquid component.
Rash at immunization site left leg per family began 8/2/11. Area red and indurated with cluster of very small vesicles. Seen at office 8/17/11.
3 vaccines administered. 2 min. post vaccination, patient experienced a syncopal episode lasting a few seconds. Patient reported feeling fine. Upon standing, patient experienced a 2nd episode. We laid patient down. Patient had loss of colors in lips/face. Orthostatic BP 97/68 mmHg w/Pulse of 62. EMS arrived and took over. Patient did not eat prior to receiving vaccinations; little to no fluids as well. Patient was monitored for 1 hour by EMS. Patient's father brought her food and she began to feel better. She left at approximately 2:40 P.M. Patient's annual physical with primary physician showed nothing remarkable.
headache; sore throat; pulse stayed up from 120 - 140 bpm; didn't sleep other than that first night except for about 2 hours at a time.; felt like I was about to get a cold, but then it went away; immediately felt sleepy; couldn't function and wasn't feeling well; tired /fatigue; This is a spontaneous report from a non-contactable Nurse.   A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 22Dec2020 at single dose for COVID-19 immunization. Relevant medical history included high blood pressure. Concomitant medications included vitamin B. Patient informed that since an unspecified date in Dec2020 after receiving vaccine she immediately felt sleepy, she asked other's that I work with if they felt sleepy. (None reported feeling sleepy). Patient went back to work and took Vitamin B and Coca Cola. She went to sleep 8 pm that evening and stayed asleep all night, and woke up at 6:-6:30 am. On 23Dec2020 she called out of work because so tired. I went to work the next day (Thursday, 24Dec2020) and couldn't function, she wasn't feeling well but stayed for her entire shift.  She woke up the next day with a sore throat. From Wednesday (23Dec2020) her pulse stayed up from 120-140 bpm. The pulse went back to normal on the following Wednesday, it took a week for it to get back to normal. She didn't sleep other than that first night except for about 2 hours at a time. Patient felt like she was about to get a cold, but then it went away. She took her soup and didn't go to work for a week. Patient returned to work on Monday the 28Dec2020. All of her symptoms (fatigue, headache, sore throat) subsided on Wednesday 30Dec2020.  Patient also reported  that a  Co-worker told her that the day after the vaccine said she had chills, not feeling well. Her friend said she will call to report and did not want to provide any demographic information on her behalf. Another Nurse - felt congested and worried. (Yesterday), also no demographic information provided. The Provider (he participated in the clinical trial and had the placebo) received the vaccine the same day as she and he will be calling also. He had body aches and headache.  No follow up attempts are possible; Information on lot/batch cannot be obtained. No further information is expected.
COVID-19; COVID-19; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Oct2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 37 years, in left arm for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 25Jan2021 as dose 1, single (Lot number: 028L20A), in left arm, on 23Feb2021 as dose 2, single (Lot number: 030M20A), in left arm and on 03Sep2022 as dose 4 (booster), single (Lot number: AS7140C), in left arm for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing); "History of blood pressure issues on and off" (unspecified if ongoing); "Known allergies: Sulfa antibiotics" (unspecified if ongoing); "Known allergies: mild food allergy to jalepeno peppers" (unspecified if ongoing); "Known allergies: lactose intolerant" (unspecified if ongoing). There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 28Oct2021, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Oct2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Oct2022) Positive, notes: rapid antigen test - x2; (10Oct2022) Negative, notes: Negative PCR; (12Oct2022) Negative, notes: Negative Rapid antigen; (13Oct2022) Negative, notes: Negative Rapid antigen; (20Oct2022) Positive, notes: Positive rapid antigen. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: It was reported that patient tested positive (rapid antigen test - x2) for COVID-19 on 10Oct2022. Started Pavloxid on 11Oct2022. Final dose on 15Oct2022. Negative PCR on 10Oct2022, negative rapid antigen on 12Oct2022 and 13Oct2022. Symptom free 13Oct2022. Re-developed symptoms on 20Oct2022. Positive rapid antigen test on 20Oct2022.
Patient states around 5 or 6 this evening she started noticed some itching in the back of her scalp.  She took 1 Benadryl, then she got home she took a second Benadryl.  At that time she started feeling her throat was closing up and came to the emergency room.  She did not have nausea until she arrived in the emergency room.  She endorses some wheezing and throat discomfort.  ED Course and Disposition:  Patient was given her first dose of IM epi at about 730 this evening.  Approximately 15 minutes later patient began vomiting and was given 4 mg of IV Zofran. approximately an hour later patient began feeling like her throat was closing up again.  She was transferred over to the critical care bay for second round of epinephrine.  She is been monitored in the critical care bay for 4 hours without requiring a third dose of epinephrine.  Her blood pressure has remained stable throughout.  She had no further emesis.  We will plan to admit to observation for monitoring overnight  Patient began feeling like her throat was closing up again. Patient transferred to the critical care bay for closer observation and second round epi You were seen today for allergic reaction. You were administered epinephrine, steroids in the ED. You can take Benadryl for itching. Admission was recommended but was declined at this time. If you have worsening swelling, increased shortness of breath or any symptoms you find concerning please turn the ED. If you feel like you mouth, tongue, throat is swelling up and you are having difficulty breathing you can administer the EpiPen and call emergency services.   comirnaty
Home Health nurse called office stating pt received vaccine x2 days ago and now site is swollen, hot, tender to touch, spreading from injection site. Pt afebrile. Pt advised to go to Urgent Care.
24-36 hours after second Moderna covid vaccine, patient began experiencing greying-out of the left superior quadrant of his vision in both eyes. He presented to care by 4 days after his vaccine date and was found to have right sided occipital lobe ischemic stroke.
Initial pain at injection site, flu-like symptoms ~16 hours post-vaccine (chills, fever of ~101, exhaustion, body aches, nausea). Resolved ~25hours post-vaccine when acetaminophen was taken at 24 hours post-vaccine. Severe lower back pain began ~22 hours post vaccine and has not resolved. Swollen lymph node under right  arm showed up ~36 hours post-vaccine accompanied by pain in the area.
No additional AE.; Caller stated a patient who received the complete series previously was administered a fourth dose.; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.  On unknown dates, the patient was vaccinated with first, second and third doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (doses, routes of administration, anatomical locations, lot numbers and expiration dates were not reported) for prophylaxis.  On 28-NOV-2022, the patient was vaccinated with a fourth dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe, dose of 0.5 mL, lot number: U038662, expiration date: 10-AUG-2024 (route of administration and anatomical location were not reported) for prophylaxis (extra dose administered). No additional adverse event was reported (no adverse event).
The day of injection and the following day (1/7-1/8) my arm was sore. Day 6 (1/13) I started getting pain in my left axilla/clavicle. Ibuprofen/tylenol didn't really help. Day 7 (1/14), still sore, but the injection site was red, swollen, warm to touch, and itchy.  Took benadryl. Day 8 (1/15) less itchy, but more red. Still a little swollen and warm to touch.
The patient is a 82y.o. female presenting to the ED with chief complaint "fall."  Patient states that just prior to arrival she was at home when she fell.  She states she is not exactly sure what caused her to fall but she has been feeling unsteady and experiencing back pain since an EMG that was done around the holiday time.  She reports that she is experiencing pain in her left hip/leg and has been unable to walk since the fall.  She is unsure if she hit her head.  She takes 81 mg aspirin daily but no other blood thinners.  EMS administered 50mcg of fentanyl and 4mg of Zofran.  Patient denies any other injuries and has no other complaints at this time. ? Fall Yes ? COVID-19 virus infection   ? Closed displaced subtrochanteric fracture of left femur, initial encounter (CMS/HCC)
Severe muscle pain in her hands and her arm and was very painful in her neck. When the pain started we saw the doctor and they said she had PMR and they put her on phenazone. When she was off pentanone the pain came back. She got fatigue and it's still going.
pt shook all over, arms & lips turned blue-face turned red & blotchy-by the time got to ER pt was OK-happened @ home;
About 14 hours after the second vaccine dose, I awoke with chills shaking my body even though I didn't feel cold.   I got out of bed and became nauseous and lightheaded. Later that morning I was no longer nauseous but was very tired.  I slept most of the day for two days. After two days I was still tired and had a headache.  My temperature was 101 (that was the first time I took it). I was still tired and my head was buzzy for several weeks.    FYI I had no symptoms after the first dose.
Morbilliform rash and itch; no itch, though pt was on Allegra at time of rash development
TD vaccine given 07/29/2005, Patient had pain and swelling of right arm at site occuring 08/07/2005.
Patient was informed prior to dosage that it would be "You'll be getting 5cc's of the Morderna vaccine. "Which led him to research the amount that should be visible according to the verbal presentation given by the personel at the vaccine site. Patient describes seeing the needle measuring marks and stated it "...was near emtpy, and in no way shape or form could it be confused with 1.9in the converted amount of 5cc's."     Unknown employee in white labcoat
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in May2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 4 (booster), single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (11Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: No Known allergies, No other medication received in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Loss of taste/smell, sore throat, chills. Positive swab for Covid 12/29/20