chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Insomnia/Sleeplessness; his brain won't shut off it keeps racing; This is a spontaneous report received from a 60-year-old male contactable consumer (patient). The patient reported for himself that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6202) via an unspecified route of administration on 05Mar2021 (at-60-year-old), as dose 1, single for COVID-19 immunization. The medical history was reported as none. The patient's concomitant medications were not reported. On 07Mar2021 the patient experienced Insomnia /Sleeplessness and his brain would not shut off it keeps racing. The patient wanted to know if it was normal to happen with the vaccine. He clarified it was the Pfizer COVID 19 vaccine. He went to the doctor regarding it yesterday, he could not sleep, his brain would not shut off it keeps racing. It was ongoing, it was getting better but it was lingering and sleep deprivation was never good. He says he was not going to say it is improved he would say it has persisted about the same. The patient had not recovered. Communication: The caller was provided the contact number and hours of operation of Monday through Sunday 8AM-8PM for COVID vaccine calls prior to attempted warm transfer to Medical Information. Due to high call volume caller elects to be placed in the hold queue to continue holding for an agent.  Follow-up attempts were completed. No further information was expected.
urticaria developed on 6-11-2021, seen in the ER 6-13-2021 and received Benadryl and pepcid
Patient developed red rash (hives) with raised wheals covering almost all of anterior chest and abdomen within 1 hour after receiving the vaccine. There has been no rash on back, legs, or arms. No reaction at the injection site. No other symptoms. Patient will take benadryl 25 mg orally three times daily (starting tonight) and use hydrocortisone 1% cream topically three times daily (starting tonight). Outcomes are yet to be determined. Will continue to monitor.
Information has been received from a medical assistant concerning a 25 year old female with a history of cervical cancer who in October 2007, was vaccinated intramuscularly with a first dose of GARDASIL. Eleven hours later she "got sick to her stomach and could not hold anything down for about 24-30 hours". The patient was planning on receiving the next dose of GARDASIL. There were no laboratory or diagnostic tests performed. The patient did not seek medical attention. Subsequently, the patient recovered. Additional information has been requested.
8/18/16 5:42 PM Patient called to say area was red (about the size of a lemon) and hard in the center, no fever - told her to apply ice, take ibuprofen and BENADRYL if itchy. Told her to call pharmacy if area doesn't start to get smaller or looks worse. May need to call MD if worse. 8/19/16 pm Patient came to pharmacy - entire upper part of arm is bright pink, there was darker red, raised bumpy area around injection site. Said she could feel a lump under skin. Patient told to see a doctor/urgent care/ER. 8/23/16 10:40 Am patient self treated. She said she's better - redness is gone, hardness gone, has brown spot remaining where it was large area of pink
This spontaneous report as received from a pharmacist refers to an approximately 69 year old female patient. Patient was not pregnant. Medical history and current conditions were not reported. On 03-OCT-2014, the patient was vaccinated with ZOSTAVAX vial, lot # K000327, expiry date 05-MAR-2015, via an unknown route (dose and frequency was not reported). Concomitant therapies included VYVANSE 30 milligram (mg), BUPROPION XL 150 mg, progesterol 100 mg and baby aspirin. On 04-OCT-2014, the patient experienced horrible headache, fever, injection site was little red, swelling and itching at the injection site and pain in her groin. The pharmacist reports that the patient reports that the swelling was of the size of "half od a large apple". Patient sought medical attention by calling the pharmacy and her dermatologist for advice. Treatment rendered for the events included CLARITIN, ZOVIR AX (only used once), and patient put ice on her arm. Lab tests were performed. The outcome of pain in her groin, fever, swelling at the injection site and horrible headache was reported as recovered on approximately in October 2014. The outcome of itching at the injection site was reported as not recovered. The outcome of injection site little red was reported as recovering. Causality assessment was not reported. Product quality complaint was not reported. Additional information has been requested.
Severe muscle and joint pain, fever (+1.7 degrees above typical 97.3 = 99.1), upset stomach, lethargic.
Tiny hive-like spots & redness noted by mom behind left ear 20 mins. after immunization.Tx w/ Epinephrine & Benadryl.Pt's pulse was 140;respirations 24.After Tx red spots begain fading;pt pleasant and alert.
This spontaneous report has been received from a pharmacist via a company representative reporting on a 45-year-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, and concomitant therapies were not reported. The pharmacist reported that on an unknown date, the patient was vaccinated with ZOSTAVAX 19400 "PFU" (Inappropriate schedule of drug administration) (dose, frequency, lot number and expiration date were not reported) intramuscularly (product use issue) for prophylaxis. Additional information has been requested.
Moderna COVID-19 vaccine administered to patient under 18 years old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna COVID-19 vaccine administered to patient under 18 years old) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna COVID-19 vaccine administered to patient under 18 years old). On 09-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna COVID-19 vaccine administered to patient under 18 years old) had resolved.        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.   No concomitant drugs provided.  No treatment drugs provided.
Patient received dose 1 on (14-Jul-2021), second dose received on (01-Sep-2021); This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on (14-Jul-2021), second dose received on (01-Sep-2021)) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 003C21A) for COVID-19 vaccination.     Patient was not tested positive or diagnosed for COVID-19.  Concurrent medical conditions included Drug allergy, Chronic kidney disease, COPD and Insomnia. Concomitant products included TRAZODONE for Insomnia, BUPRENORPHINE, SALBUTAMOL SULFATE (ALBUTEROL SULFATE), LISINOPRIL, GABAPENTIN and METHOCARBAMOL for an unknown indication.   On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 01-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 23-Jun-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on (14-Jul-2021), second dose received on (01-Sep-2021)). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on (14-Jul-2021), second dose received on (01-Sep-2021)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient did not seek any medical care. Treatment information was not provided.   This case was linked to MOD-2022-600713 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2022: Follow up received. Patient demographic added.
This spontaneous report as received from a registered nurse refers to a 5 year old female patient. The patient was vaccinated with a dose of VARIVAX (Merck) (Lot # not reported) on an unspecified date when patient was 4 years old. No other co-suspects were reported. No concomitant medications were reported. The nurse reported that on an unknown date, the patient experienced shingles-like rash on her right arm. The sought medical attention by an office visit. The outcome of shingles like rash on her right arm was unknown. Additional information has been requested.
9-28-09 Patient received vaccines. 10-03-09 Patient miscarried/spontaneous abortion at ER. She was 6 weeks pregnant.
No additional adverse events reported; administration of improperly stored PNEUMOVAX 23; administration error; Inofrmation has been received from a registered nurse and an office administrator reporting on a 58-year-old female patient. The patient concurrent conditions included diabetes type II, hyperlipidemia, and fatty liver. The patient's allergies included cough with lisinopril (manufacturer unknown) (captured in MARRS# 2105USA004965), adverse reaction with merformin, and nausea with atorvastatin calcium (LIPITOR) and rosuvastatin calcium (CRESTOR). There was no information about the patient's concomitant medication or historical conditions.   On 03-MAY-2021, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscular, lot # T035379, expiration date 31-MAY-2022 for prophylaxis (first dose). That same date, the patient was vaccinated with an improperly stored dose of diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, tetanus vaccine toxoid (ADACEL) intramuscular, lot # U6900AA, expiration date 18-NOV-2022 for an unknown indication (first dose). Both vaccines were administered in the right deltoid. The medication error occurred during the administration. No additional adverse events reported, and no prescription drug treatment was required. The vaccine after administered was placed into sharps.  On an unknown date, pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) underwent a temperature excursion of 34.5 Celsius degrees for 31 hours and 36 minutes. The refrigerator was out of the temperature range and the health professional/medical assistant did not acknowledge the temperature. The medical assistant gave the vaccines without any regard to the temperature. The patient was made aware of this afterwards. There was no previous temperature excursion. The call was not placed due to a digital data logger. After verifying that the remaining vaccines were not viable, they were removed from the fridge and shipped. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T035379; expirationdate: 31-MAY-2022; deviceage and unit: 0 ; operatorofdevice: Medical Assistant; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2105USA004965:
AT APPROXIMATELY 2:00PM, DEVELOPED TEMPERATURE (100.5), REMAINED ELEVATED AT 3:35PM SAME DAY.
Pt given Flu vaccine 12-1-10 1600. Wife called on 12-3-10 3:20. Pt c/o body aches, sweats/chills, nausea, abdominal cramps. In bed. F/u visit on 12-6-10 pt feels better today and soreness at site resolved.
I started getting symptoms of being unwell. The next day, I could barely get out of bed and was fatigued. I had a slight fever and a sore throat. I felt that way for 2 days. I took an at home COVID-19 test that was positive. I went to my doctor. I had to get my O2 levels checked. My results were bad and was told to go to the ER. While at the ER I had a chest x-ray and was told that I had no problems. I was was given a prescription for PAXLOVID. I took the full dose of PAXLOVID. For the next few days, I would have a headache and diarrhea. I tested positive for at least a week. My serious symptoms lasted for 3 days. Then I had minor symptoms after the 3 days. I also had follow up checks with my doctor.
Pt recv vax on 8/21/98; on 8/22/98 pt exp erythema/ swelling of LA w/ febrile response
Headache, upset stomach all day 4/20/21. Swollen and sore lymph nodes 4/21/21
I had a scratchy throat, shortness of breath, afternoon brain fog, body aches. I used a home COVID-19 test that came back positive, I called in to have a telehealth visit to discuss my symptoms. I was given a prescription of Paxlovid that I was able to start on January 3, 2023. It did take a while for my symptoms to subside maybe day three most symptoms were gone except the cough. I did not test negative until day twelve. On April 22, 2023, I had a weird earache in my left ear and I was tired. The next day the left side of my throat started to hurt like it did when I had COVID-19. I tested using a home COVID-19 test, it came back positive. I choose not to call the doctor this time as I am not experiencing shortness of breath.
Pt presented 3 days after vaccines given with sudden onset of LVE erythema and warmth. no fluctuance or edema no tenderness The patch was located on dorsal aspect of distal upper arm measuring approx 4x6 cm triangular shape found site of injection. localized tx if ice prn ibuprofen/Benadryl rec. but pt admits at f/u that she only used ice. All sx resolved 3 days.
During her 15 minute, post vaccination wait, the left side of her bottom lip began to swell. Then the swelling progressed to the right side of her bottom lip. She did not tell anyone at the clinic about this. Within the hour, she had also developed swelling under her tongue, around frenulum. Also had swelling under her top lip, where lip attaches to gum. Also had metallic taste in her mouth and throat was itchy.  These symptoms are the same exact symptoms she gets when she has an allergic reaction to cold substances that she eats/drinks (she has cold urticaria for which she carries an Epipen).  She notified me at approximately 2pm. She said lip swelling had decreased some by that time but other symptoms still present. I had her take 50mg of benadryl. That helped reduce symptoms further but they were still present. At urgent care, she was given decadron IM, told to use benadryl 50mg every 6 hours x 24 hours, and given RX for prednisone 50mg x 5 days. She already takes zyrtec daily.  Within an hour of the decadron injection, symptoms improved further. As of 1300 on June 10, symptoms are resolved.
SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total, for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on JAN-2022 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient recently experienced suspected covid-19 infection (dose number in series 2) and stated that she got it while helping a patient from a doctor's office. The patient had got over COVID-19, and it has been lingering. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection. This report was non-serious.
expired vaccine administered as booster dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine administered as booster dose) in a 67-year-old male 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine administered as booster dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine administered as booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported.   This case was linked to MOD-2021-361756 (Patient Link).
Vomiting, diarrhea, lethargy, loss of appetite, distended stomach.
SHINGRIX was mixed with Sterile water instead of the provided adjuvant-No adverse event to the patient.
No adverse event; They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.).    The beyond use date (BUD) of the vaccine was reported as on 12-May-2022. The patient received the vaccine at a pharmacy.  No concomitant medication reported. No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Follow-up document received on 24-Jan-2023 with no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
The vial was expired on 24-Mar-2022 and removed from freezer just prior to administration time on 04-Apr-2022 at 10:26; administered with an expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine) and PRODUCT STORAGE ERROR (The vial was expired on 24-Mar-2022 and removed from freezer just prior to administration time on 04-Apr-2022 at 10:26) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 032H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2022 at 10:26 AM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Apr-2022 at 10:26 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was expired on 24-Mar-2022 and removed from freezer just prior to administration time on 04-Apr-2022 at 10:26). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine) and PRODUCT STORAGE ERROR (The vial was expired on 24-Mar-2022 and removed from freezer just prior to administration time on 04-Apr-2022 at 10:26) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The vial  did not undergo any temperature excursions. All vials were removed from freezer just prior to administration times. No concomitant medications information was reported.   This case was linked to MOD-2022-570968, MOD-2022-571139, MOD-2022-570985 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2022: Follow-up received: Added lot number, administration date and time of vaccine.
Case number PHEH2015US020466, is an initial spontaneous report received from a pharmacist on 09 Oct 2015. This report refers to a 16 year old male patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUCELVAX (batch number: 173991) intramuscular on 09 Oct 2015. No adverse event was reported following the maladministration (inappropriate age at vaccine administered). No further information was provided.