chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 27Feb2021 at 13:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient had no known allergies to medications, food or other products. 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 four weeks prior to the vaccination. On 04Mar2021 the patient experienced rash which progressively spread all over and gotten worse over time. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included treatment with testing and steroid therapy from an unknown date. The clinical outcome of the event rash was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Information has been received from a physician referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with M-M-R II (lot # L026550, expiration date: 16-JUL-2017, route and dose were unknown) that were improperly stored (55 Fahrenheit for 1 month). No adverse effects were reported. There was no previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
No additional AE/no PQC.; PROQUAD dose that was administered to a patient over the age of 13; This spontaneous report has been received from a nurse and refers to a 28-year-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included sterile diluent (STERILE DILUENT) (manufacturer unknown).   On 23-AUG-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, at a dose of 0.5 milliliter (product administered to patient of inappropriate age) (lot number X007358 has been determined to be valid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), with an expiration date established as 09-AUG-2024), administered for prophylaxis (strength, and route of administration were not provided). No adverse events were reported for this patient.
Headache, Sedation, NauseaVomiting, Insomnia, Abdominal pain, Unable to concentrate,  Narrative: Received shot 1/20/21 and worked rest of the day, experienced atypical insomnia that night. Had nausea and headache the morning of 1/21/21. Also difficult concentrating and felt "fuzzy". Worsening nausea and abdominal pain as the day went on. Nausea and headache continued into 1/22/21. Felt fatigued through 1/24/21. No known prior COVID infection.   Other Relevant History:
Patient was given the flu shot for the second time. The facility had a prior clinic with us in October for flu. They filled out a consent form and gave it to the staff and told them the patient needs a flu shot.  They did not tell the employee  who administered the vaccine that patient had already received this in October already.  After the employee had given the vaccine the staff told her the patient had already received this vaccine. Staff was told to watch for any symptoms or additional side effects by Employee.
chill; muscle pain; Fever 103-104°F; This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 54-year-old male patient who received Herpes zoster (Shingrix) (batch number 3454N, expiry date 23rd August 2022) for prophylaxis.   On 3rd November 2020, the patient received the 1st dose of Shingrix. On 4th November 2020, 1 days after receiving Shingrix, the patient experienced chills, muscle pain and fever. On an unknown date, the outcome of the chills, muscle pain and fever were not recovered/not resolved.   It was unknown if the reporter considered the chills, muscle pain and fever to be related to Shingrix.  Additional details were provided as follows: The patient was administrated the first dose of Shingrix and the day after the administration of the vaccine the patient experienced fever of 103-104 degrees F, chills and muscle pain. The patient was having the symptoms till the time of reporting. The reporter consented to follow up.
Shivering; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 60-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th December 2019, the patient received Shingrix. On 6th December 2019, 1 days after receiving Shingrix, the patient experienced shivering. On an unknown date, the outcome of the shivering was unknown.   It was unknown if the reporter considered the shivering to be related to Shingrix.  Additional details were received as follows: Yesterday in the afternoon from the date of reporting the patient received a dose of Shingrix. In the past 30 minutes from the date of reporting the patient started shivering.
Patient received Pfizer COVID vaccine on 3/10/21 (lot # EN6208), 4/15/21 (lot # EW0153), and 1/22/22 (lot # FJ1614). On 2/27/22, patient admitted to our inpatient facility with benzodiazepine withdrawal, schizoaffective disorder and bipolar affective disorder, and positive COVID test. As of today (3/3/22), patient is still admitted in the med/surg unit for the benzodiazepine withdrawal. No respiratory symptoms noted.
3 days p/vax pt devel an inj site rxn characterized by redness, swelling, soreness, & warmth;
pain in her shoulder (75 percent of motion)/ in her left shoulder/ pain in left arm as 3/10; pain in her shoulder (75 percent of motion)/ in her left shoulder; not being able to lift much weight; This spontaneous report was received from an administrator who was reporting on 35-year-old female patient. She has no pertinent medical history, no known drug reactions or allergies, she was not in pregnant and had no concomitant therapies. Her concurrent conditions were not reported.   On 10-JUL-2020, the patient was vaccinated with her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 milliliter administered intramuscularly in the left deltoid (strength was not provided; lot number R030453 was confirmed to be valid, expiration date 23-JUL-2021 was confirmed) for HPV prevention. On 09-SEP-2020, she received second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) also intramuscularly in the left deltoid (strength, exact dose, lot number and expiration date were not reported) for the same indication.  On 15-SEP-2020, after second dose of the vaccine, she reported pain in her shoulder (75 percent range of motion), on an unknown date in 2020 she also complain that she is not able to lift much weight. She sought medical attention and on examination, the patient had full range of motion but the doctor is ruling it vaccine related injury. It was recommended that the patient use warm compresses and oral acetaminophen (TYLENOL) or ibuprofen for pain management, but she preferred to use "ARNICA" (it was unknown if it was topical or oral "ARNICA"). On 12-OCT-2020 the patient was brought in for examination, she continued to complain on 75 percent range of motion with left arm and not being able to lift much weight. Patient pain rating was 3 of 10 with movement. Health business partner reported that there was no inflammation or discharge noted at left deltoid injection site. On 16-OCT-2020, the patient was feeling much better, and recovered from the above-mentioned events.   The reporter did not provide a causal assessment between the events of pain in shoulder, 75 percent range of motion and being not able to lift much weight and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R030453; expirationdate: 23-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Fever of 101f for 11 days along with body ache,; First dose she had a fever of 101f for 11 days along with body ache, site of injection pain, and mild nausea; Site of injection pain; Mild nausea; This is a spontaneous report from a contactable healthcare professional. A 71-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number was not reported) via intramuscular route of administration in the left arm on 12Mar2021 14:00 (at the age of 71-years-old) as dose 1, single for COVID-19 immunization. The patient medical history included hypothyroidism, arteriosclerosis, arthritis, migraine and ischemic brain disease from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient had no known allergies. The event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date, the patient experienced fever of 101f for 11 days along with body ache, site of injection pain and mild nausea. No therapeutic measures were taken as a result of these events. The clinical outcome of the event fever was recovered on an unspecified date and rest events outcome was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) :-PFIZER INC-2021391438 similar report from same reporter
Psychosis; Psychiatric Symptoms; This case was reported by a physician via call center representative and described the occurrence of psychosis in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced psychosis and psychiatric symptom. On an unknown date, the outcome of the psychosis and psychiatric symptom were unknown.   It was unknown if the reporter considered the psychosis and psychiatric symptom to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experienced psychosis or psychiatric symptoms. The reporter did not consent to follow up. The physician declined to give any additional details and declined to respond to a letter from Safety.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 08-AUG-2011, the patient was inoculated with ZOSTAVAX at a hospital as recommended for routine adult health maintenance and for the prevention of shingles (dose, lot, and route # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 27-AUG-2014, the patient was treated by a physician for the onset of a vesicular rash which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
FEVER 104 SUSTAINED. BODY ACHE, FATIGUE, INVOLUNTARY LEG MUSCLE CONTRACTIONS, JOINT PAIN, HEADACHE, INABILITY TO WALK AND REMAIN STANDING.
Almost immediately patient described feelings of dizziness and nausea. Within 5 minutes she was in the bathroom vomiting. After 20-30 minutes of rest in the breakroom she was still feeling ill and had to go home for the day and could not resume work. She reports not being able to eat for most of the day. No further treatment was needed and she was able to come back to work the next day, still feeling weak but able to complete her tasks.
Patient was admitted to Hospital 2/15/22 with chest pain, fever, EKG changes and elevated C reactive protein. A coronary angiography showed normal coronary arteries with mild pericardial effusion. Suspicion was acute myopericarditis confirmed by MRI that showed edema with subepicardial non ischemic pattern in wall of left ventricle.  Patient was discharged approximately 2/26/22 and allowed to fly home 3/8/22 with follow up at home.  He is now doing well with no cardiac issues
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red injection site that's getting bigger) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (no medical history provided). On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (red injection site that's getting bigger). At the time of the report, VACCINATION SITE ERYTHEMA (red injection site that's getting bigger) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. No concomitant medication and treatment provided.
Patient awoke to chills, shaking, muscle aches, trembling, coughing, headache. Fever of 102.1 F and nausea. Patient went to ED.
weakness; chills; nausea; temp was 101.3/fever; swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231), via an unspecified route of administration on left arm on 18Jan2021 19:45 at a single dose for COVID-19 immunization. The patient had no medical history. The patient had no known allergies. The patient received other vaccines within 4 weeks prior to the COVID vaccine including Whooping cough vaccine (Pertussis vaccine) on 11Dec2020 (dose number 1, left arm). On 19Jan2021 19:30, the patient had weakness, chills, nausea and his temperature (temp) was 101.3. He came home Wednesday from work at the 44th hour and had all symptoms "accept" (as reported) for swollen lymph nodes. Patient's fever broke 6 hours later at 22:00 (as reported) Wednesday night (on 20Jan2021, also reported as 50 hours after the injection), he slept all night comfortably, woke up with no issues and temp was 96.1 (21Jan2021). At the time of the report the patient felt fine. There was no treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event fever was recovered on 20Jan2021 and other events recovered in Jan2021.
Patient developed pruritic, erythemic rashes, 10 on left arm and 2 on right arm. Also received Typhoid shot on the same day, 27 Jan 2006.  Denies pain on Typhoid shot site but anthrax site on left arm is a little tender to touch. Patient denies any systemic symptoms.
Seizure like activity for 3 weeks off and on following immunizations. Eyes rolled back a to side banged head not cooperative. Had from 1-9 times ad day during this period.
Symptoms: Rash & arm swelling and redness Treatment : DIPHENHYDRAMINE 25 MG PRN
L shoulder started itching, then traveled to chest, abd, anterior thighs. Given  benadyrl 25 mg with no response, then second dose of benadyrl 25 mg. Symptoms mainly resolved with second dose, minimal itching. Pt observed for 30 minutes.
I had dry, scaly patches on both of my areolas that appeared. It was like an itchy rash. Then I got a dry, scaly patch around my left eye, but it was not as itchy. Both patches was sensitive skin. I did two two telehealth visits. The patches were both diagnosed as eczema. I never had that before. They provided me with steroid cream for both. I used the cream, but then the rash kept coming back so I stopped using the cream. I started using vitamin E oil which helped clear it up. The rashes has been gone for a while now.
Awakened at 2 am 5/1/21 with acute onset of chest pain, SOB, and diaphoresis.  No cardiac history; no history of similar episode.  Reported that, following his second dose of COVID vaccine, he was ill for 1 day with vomiting.  Chest pain continued upon arrival to ER 5/1/21 about 7 am.   EKG indicated STEMI.  Adm with Acute ST elevation myocardial infarction.
pt recv vax 11APR97 & had tonic clonic movements of upper limbs & rolling over of eyes on 15APR97;16APR97 3 episodes in 24hr lasting few seconds;pt had CT scan of head showed cortical atrophy;fever on 11APR97;warm to touch, low grade
RASH ON ARM, WHEEZING, PAIN IN FOOT (SPASM), SHIVERING, ACHES, AND TINGLING BACK. LEFT MESSAGE WITH DR. PATIENT CONTACTING DR AS WELL.
Information has been received from a physician concerning a 9 year old female who on 10/27/98 was vaccinated with a dose of varicella virus vaccine live. On 10/17/03 the patient developed a severe case of chicken pox. Subsequently, the patient recovered. Unspecified medical attention was sought. There was no product quality complaint. The physician also indicated that three other children experienced chicken pox after being vaccinated with a dose of varicella virus vaccine live. Additional information has been requested.
Blood pressure was 203; Pulse was 113; ear ringing; A spontaneous report was received from a Healthcare Professional concerning a 69-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events blood pressure was 203, her pulse was 113, ear ringing.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 3 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 015M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 4 Feb 2021, the patient experienced the events blood pressure was 203. her pulse was 113, ear ringing.  Treatment details included She doubled the dose of lisinopril 5mg  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events, blood pressure was 203, On an unknown date the outcome of events, her pulse was 113, On an unknown date the outcome of events, ear ringing was not reported.
Child called office 1:41 pm 4/26/10 stating arm red and showed to pharmacist 4/25/10. Mom did not respond to call back from office. Recalled office at 5 pm and told to take to Peds. Seen at Peds (see notes) - Has not called to schedule f/up visit yet.
A report was received from a health care professional on 11/24/03 concerning a 69 year old female vaccinee who was inadvertently administered frozen Fluvirin vaccine on an unreported date. On an known date, the vaccinee inadvertently received Fluvirin, which had been left adjacent to a freezer compartment and was subsequently frozen. The vaccinee will be advised to receive Fluvirin again in 3 weeks time. It was not reported if the vaccinee had experienced any adverse reaction. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
PATIENT RECEIVED VACCINATION ON 03/19/2021 AND ANOTHER ON 04/09/2021 WITH ONLY 21 LAG DAYS BETWEEN VACCINATIONS.
Symptoms started with frequent urination night of receiving vaccine(got up at least 4-5 times in the middle of the night to pee, felt like I couldnt get it all out.), cramping in the bladder area, blood in the urine(pink urine).   Little cramping but not urinating blood for now Drank a lot of water and went away  This more than likely unrelated.  The next step you would need to take is to go to your primary care physician to get checked, if you have any updates on this please give us a call.
At 15 minutes I felt flushed and a tightness in my throat. I was moved to private observation with nurse for an additional 30 minutes. After the additional 30 minutes, I started feeling better. I was released to go home.
Tachycardia started approximately 1 hour after injection. My general resting heart rate is between 60-65 bpm and over past two days my heart rate has spiked for several minutes at a time to 80-90 bpm even when sitting or asleep. It will generally go back down for long stretches of time and increase again for no apparent reason. Have not seen doctor.
The patient developed dyspnea on exertion 4 hours after getting the vaccine. He did not notify us at the time. His home weights are stable and no increase in peripheral edema. He is still having symptoms but is improving. I recommended that he come in to be evaluated but he just wants to watch it for now.
red splotches to posterior torso within 5-6 minutes after administration of vaccine. Patient denies pain, c/o itching.  T 99.3, 52.5 lbs, HR 92, BP 106/64. Treated with 29 mg Benadryl IM LDT and observed for 30 minutes. No s/s of deterioration during observation period. VS after 30 minutes: T98.7 F, BO 100/62, R24, HR 93. No redness on posterior torso. Pt discharged home with instructions to go to ER for any S/S of detioration of condition.
I think my Dr gave my child the wrong vaccine. I don't believe them.; This spontaneous case was reported by a patient and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (I think my Dr gave my child the wrong vaccine. I don't believe them.) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 26-Jul-2022, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (I think my Dr gave my child the wrong vaccine. I don't believe them.). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (I think my Dr gave my child the wrong vaccine. I don't believe them.) outcome was unknown.            Concomitant medication was not provided.  It was unknown patient ever had COVID positive test or diagnosis.It was unknown other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  It was reported that they think doctor gave his/her child the wrong vaccine and they don't believe them. It was unknown that AE cause patient to seek medical care. The patient experienced a similar event in the past and symptoms improved was unknown.  Treatment information was not provided.
It was reported that a female patient received a yellow fever vaccination on 3-Nov-2000. Reportedly that same day, the patient developed a local reaction followed by hives at the injection site, which became generalized. Patient self-medicated with Chlor-Trimeton.  Patient went to emergency room for evaluation, no treatment administered since patient already took an antihistamine. The emergency room physician gave patient Benadryl capsules to take if needed. Hives were subsiding at emergency room visit.