chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vomiting and pale after dose.  Patient reported a history of vomiting in past immunizations.  Gave patient water and monitored for 30 min.  He was able to feel better and left the store feeling better.
Left Axillary lymphadenopathy; Also mild tinnitus and sense of muffled hearing; Achiness
Fever and chills; This is a spontaneous report from a contactable consumer or other non hcp.   A 70-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 26Jan2021 (Batch/Lot Number: E19262) as 2ND DOSE, SINGLE for covid-19 immunization. The patient medical history and concomitant medication was not reported. On 06Feb2021, After the second dose the patient experienced fever of almost 104 degrees and chills, they do not know the reason for it. He did not feel sick before. He had not been in contact with anyone with COVID. The fever, to be exact, was 103.5 all night. It broke early the next morning after taking Tylenol. He has not had it since then. they both went to get tested for COVID. They both had a rapid COVID test, and they were both negative. Their daughter was saying that maybe he had a delayed reaction to the vaccine. The patient experienced fever and chills on 06Feb2021 with outcome of recovered.  The patient lab tests included body temperature: 103.5(Almost 104 degrees/The fever, to be exact, was 103.5 all night) on 06Feb2021 and Sars-cov-2 test: negative on 08Feb2021. The event outcome is recovered on 07Feb2021.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected
The Yellow Fever vaccine was reconstituted with the incorrect diluent (sterile water) and administered to the patient.
Pt reports onset of upper neck pain and sever H/A at approximately 0100 10-30-09. H/A continued until Saturday evening 10-31-09. Saturday evening pt reports had onset of numbness in bilat legs lasting till 11-1-09 at 1900. Denies tingling in legs. States was able to ambulate with leg numbness.
08/04/2021: Admitted to ER with positive COVID test, shortness of breath, body aches, fever, and hypoxia on room air that began 3 days prior to admittance. Patient found to have AKI, Pneumonia, hyponatremia, hypertension, transaminitis, and acute respiratory failure with, tachypnea.  08/05/2021: AKI & hyponatremia resolved, hypertension controlled. Patient cough and 02 sat chief concern. 08/06/2021: Admitted to ICU for respiratory distress secondary to COVID induced pneumonia and placed on BiPAP.  08/07/2021-08/09/2021: Patient continued on BiPAP and remained stable with close monitoring.  08/10/2021: Patient taken off BiPAP and continued on high flow oxygen via nasal cannul. Showing signs of improvement. 08/11/2021: Oxygen requirements showed drastic improvement, still has elevated inflammatory markers. Moved out of ICU. 08/12/2021: Continued improvement, slowly working off of oxygen and antibiotics. 08/13/2021: Further improved and discharged on oxygen.
patient was given a dose of PENTACEL today and the vaccine expired on 31Jan2023,with no reported adverse event; Initial information received  on 03-Mar-2023 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 4 months old female patient who was given a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] today and the vaccine expired on 31jan2023,with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Prophylactic vaccination.  On 03-Mar-2023, the patient received dose 2 at 0.5ml total of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE Suspension for injection (strength: standard) (lot number: UJ658AAA, expiry date: 31-Jan-2023) via unknown route in unknown administration site for Immunization and on the same day, patient was given a dose of pentacel today and the vaccine expired on 31jan2023,with no reported adverse event (expired product administered).  It was reported, reporter stated that she is the manager in the office. Caller states that she is calling about PENTACEL and the expiration date. Caller asking if the company has any information regarding this.  No further information provided by the reporter.   Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL (VERO)) was not applicable.  At time of reporting, the outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Diarrhea; brain fog; Fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), FEELING ABNORMAL (brain fog) and FATIGUE (Fatigue) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea), FEELING ABNORMAL (brain fog) and FATIGUE (Fatigue). At the time of the report, DIARRHOEA (Diarrhea), FEELING ABNORMAL (brain fog) and FATIGUE (Fatigue) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Treatment information was unknown.   Reporter did not allow further contact
This spontaneous report as received from a pharmacist refers to unspecified patients of unknown age and gender. No information about medical history, concurrent conditions was reported for the patient. The patients were vaccinated with improperly stored ZOSTAVAX (dose, route unspecified) on 19-MAY-2015, 02-JUN-2015, 04-JUN-2015, 05-JUN-2015 and 08-JUN-2015. No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information has been requested.
Swollen, slightly painful armpit on right arm. Same arm as the injection site in shoulder.
felt bad; had bad chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt bad) and CHILLS (had bad chills) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (felt bad) and CHILLS (had bad chills). At the time of the report, FEELING ABNORMAL (felt bad) and CHILLS (had bad chills) had resolved.            No concomitant medications was provided.  No treatment medications was provided.  The patient have not yet had the booster but qualified and the patient was considering it.   Reporter did not allow further contact
7 days post inject pt devel rash disapating w/no casual treatment; resp benign;
Routine shots for tots clinic held on site, administered Tdap, Menactra, and Hepatitis A vaccine per VFC guidelines and ACIP recommendations without any problems. Patient standing after receiving immunizations and within 10 minutes noticed pallor color to face and eyes rolling to back of head. Assisted patient to floor, lying flat with knees bent, cool compress to forehead and back of neck. Vital signs: BP 100/70 Pulse 74 Resp. 22 Patient alert and orientated x3. After 15 minutes, assisted to sitting position in chair. Vital signs: BP 98/68 Resp. 22 Pulse 74 Patient offered no complaints. Skin dry, pink, and warm. Patient escorted to car and released in c/o of guardian. Advised to take child to get something to eat. Aware report will be submitted.
Patient developed a local reaction on 4/16. On 4/23 the patient had a hard lump and bruising at injection site. On 4/26 patient was noted to have a pea-size left inguinal node and a 1 cm slightly tender mass on left thigh which was a hematoma or possible early abscess.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 13-NOV-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015432, expiration date 15-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Patient presented to the clinic 2/2/23 with redness, swelling, and warmth around the injection site, Denied a fever. NP started patient on Bactrim DS 1 tab BID x 7 days. Patient came back on 2/6/23 for a recheck and arm looked a lot better with no swelling redness or warmth noted.
Under left armpit swelling; Under left armpit pinching pain; This is a spontaneous report from a contactable consumer, the patient. An adult non-pregnant female patient of unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 08Mar2021 at 10:15 as a single dose for COVID-19 immunisation. Medical history included hemorrhoids. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included vitamin d nos (reported as generic: VITAMIN D) and ascorbic acid, betacarotene, biotin, calcium carbonate, calcium pantothenate, chromic chloride, colecalciferol, cupric oxide, cyanocobalamin, dl-alpha tocopheryl acetate, ferrous fumarate, folic acid, magnesium oxide, manganese sulfate, nicotinamide, phytomenadione, pyridoxine hydrochloride, retinol acetate, riboflavin, sodium selenate, thiamine mononitrate, zinc oxide (ONE A DAY WOMEN'S) for unknown indications from unknown dates and unknown if ongoing.  On 09Mar2021 at 19:00, the patient experienced under left arm pit swelling and pinching pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events under left arm pit swelling and pinching pain was not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.
Admitted on 09/24/2021 with complaints of cough.  Patient was found to have COVID-19 pneumonia.  Patient had multiple imaging studies done including multiple chest x-rays, CT angiogram chest PE protocol, and EKG. During hospitalization course, patient was treated with dexamethasone and remdesivir.  He was also treated with inhalers and supplemental  oxygen.  Patient improved nicely and significantly during his hospitalization course.  On day of discharge, patient had no complaints.  He denied any headaches, dizziness, nausea, vomiting, fevers, chills, shortness of breath, chest pain, or abdominal pain. Patient had home oxygen evaluation by Respiratory and did not require any oxygen at rest or with  ambulation.  All risks and benefits of discharge were outlined and patient was agreeable.  Patient was seen and evaluated by Infectious Disease during his hospitalization course
This case was reported by a consumer via call center representative and described the occurrence of incomplete dose administered in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete dose administered, occupational exposure to product and exposure via skin contact. On an unknown date, the outcome of the incomplete dose administered, occupational exposure to product and exposure via skin contact were unknown. Additional details were provided as follows: The age at vaccination was not reported. The reporter was a patient. Caller states her first dose of the Shingrix vaccine leaked out a lot wetting on her arm, which led to incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact.   Caller had since received her second dose and states that went fine. Caller inquiring if she should have a third dose to compensate for the first dose that leaked out.  There was no pain or reaction after the injection. The reporter consented to follow up. No additional details were provided by the reporter.
Pt was vaccinated on 06/27/1997 and on 01/24/05 came down with a rash diagnosed as chicken pox, reason for reporting is because several other pt's has chicken pox that were vaccinated.
Previously manageable tinnitus is now amplified several times & extremely difficult to deal with. Constant 24-7, bilateral, high pitched tone.
At approximately 9pm the day of the vaccination I developed a very aggressive and pounding headache, I went to sleep at about 11pm. The headache progressed throughout the night and I could feel that I had a fever. At 5:45 the following morning I got up and checked my temperature. It was came back as 101.2°F. I took 2 tablets of 200mg ibuprofen and the headache and fever subsided in about an hour and my temperature was within normal range. For several hours I felt fine, however in the early afternoon my body felt extremely fatigued and the headache was returning and I had a few bouts of chills.  At 4:30pm  this afternoon (the day after vaccination), I took my temperature again and it was 100.4°F.  I took 2 more 200mg tablets of ibuprofen and took a nap. Approximately 90 minutes later, I rechecked my temperature and yielded a 100.1°F fever and still had a mild headache.  As of right now, at 9:30pm the day after vaccination, I no longer have a headache nor a noticable fever, just minor fatigue.
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 22-FEB-2018, the patient was vaccinated with ROTATEQ (strength, dose and frequency were not reported) (lot # M005619, expiry date: 29-OCT-2018) orally for prophylaxis (product storage error). The vaccine was stored at 34 degrees Fahrenheit (F) for 12 hours. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. No additional information provided. There was no product quality complaint (PQC) reported. This is one of the 6 reports received from the same reporter. Lot number [M005619] is an invalid lot number for ROTATEQ. Sender's Comments: US-009507513-1803USA003815: US-009507513-1803USA003594: US-009507513-1803USA003817: US-009507513-1803USA003813: US-009507513-1803USA003814.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No concomitant conditions, medical history, allergy/drug reactions or concomitant medications were reported. On 24-MAR-2016, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L018501, expiry: 22-JUN-2017 (dosing details and route of administration were not reported). No adverse effect was reported. It was reported that the vaccines were exposed to a temperature of 1.4 C for a time frame of 2 hours 41 minutes. No previous temperature excursion was reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested
Pain, redness, itching, body aches, chills. Pt went to ED and received abx Doxycycline Monohydrate and Benadryl.
elevated blood pressure, numbness and tingling in left arm, chest pain,  started on rivaroxaban
HEMATOMA BELOW INJECTION SITE; SORE ARM; VIAL WAS SHAKEN BY VACCINE PROVIDER; LOWER BACK PAIN; FATIGUE; MUSCULAR PAIN; This spontaneous report received from a patient concerned a 49 year old male. 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: UNKNOWN) dose was not reported, administered on 06-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On AUG-2021, the patient experienced lower back pain. On AUG-2021, the patient experienced fatigue. On AUG-2021, the patient experienced muscular pain. On 06-AUG-2021, the patient experienced vial was shaken by vaccine provider. On 06-AUG-2021, the patient experienced sore arm. On 10-AUG-2021, the patient experienced hematoma below injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vial was shaken by vaccine provider, fatigue, lower back pain, muscular pain, hematoma below injection site and sore arm was not reported. This report was non-serious.
Narrative:  a71yo male with PMH of Tobacco Use, DJD, Vitamin D deficiency, Cervical Spondylosis without Myelopathy, GERD. Cough, Rectal Bleeding, Low Back Pain, General Weakness, Hypertension, Hyperlipidemia, Asymptomatic Carotid Artery Stenosis, Chronic gingivitis, BPH, Osteoarthritis, Pain of LT Shoulder Joint and ED. Per vaccine administering staff RN documentation; He received Pneumovax 0.5ml IM in left shoulder on September 16, 2021 and 10 to 15 minutes post vaccination, had itching at the injection site. The physician in charge was notified, oral Benadryl 25mg was ordered, administered and was tolerated well
Received Moderna as first dose and Pfizer as second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Received Moderna as first dose and Pfizer as second dose) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21-2A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Received Moderna as first dose and Pfizer as second dose). On 10-Sep-2021, INTERCHANGE OF VACCINE PRODUCTS (Received Moderna as first dose and Pfizer as second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitants medications were reported.   No treatments medications were  reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: follow up received and contain no new information
she developed shingles on the opposite arm of the vaccine arm; she is in a lot of nerve pain.; This is a spontaneous report from a contactable consumer via medical information. A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number : EK9231; expiry date : Apr2021) via an unspecified route of administration, in Arm Right on 05Jan2021 10:00 as single dose for protect against covid. The patient medical history and concomitant medications. The patient previously took mortin and had allergy ongoing, influenza vaccine (Flu shot) and had pain (She got a Flu shot 3 years ago in her left arm and the pain didn't go away for 9 months. States that for the next 2 years she got her flu shot in the right arm). Patient had the 1st dose on 05Jan2021, and was due next Friday for her 2nd dose, but she has come down with shingles on her opposite arm on 11Jan2021. She doesn't know if it has anything to do with the vaccine. Has it been reported before, and can she get the 2nd dose. Shingles was reported as worsened. She has shingles on the left arm, hand, wrist, and fingers; she was in a lot of nerve pain in Jan2021. The pain started 6 days after she got the vaccine; pain and tingling. Then 2-3 days later, she noticed some red marks by her elbow. She went to a clinic and was diagnosed with Shingles and was started on Valacyclovir 1gm tablet, 1 tablet 3 times daily for 7 days. The next day she called the doctor, and had a tele-visit and the doctor was able to see some lesions. She told the doctor how much pain she was in, so the doctor prescribed Gabapentin 100mg. She was told to start off with 1 daily at night to help with sleep because she wasn't sleeping because the pain was so bad, then after 5 days she can take 1 twice daily as needed. States that it hasn't been 5 days yet, so she was still only taking it once at night, and she was able to sleep over 4 hours at a time, which was great. She wishes she could jump ahead and start taking it twice a day already because she was in pain all day long, but she was following the directions. States that the pharmacist said she could take Tylenol in between, so that was what she is doing. States that she was getting more lesions, but they are faint and are mostly on the palms of her hands and in between her fingers. The outcome of the event Shingles was recovered 11Jan2021; for Nerve pain was unknown.
3X3 CM INDURATION MEDIAL TO THE INJECTION SITE. ERYTHEMA AND TENDERNESS. THE DAY AFTER THE SHOT NOTICED ARM PAIN THAT WAS MORE THAN TYPICALLY EXPERIENCED AFTER FLU SHOT.
Information has been received from a certified medical assistant referring to a female patient of unknown age. There was no medical history or drug reaction/allergies reported. On 21-JUN-2016, the patient was vaccinated with the first dose of ROTATEQ (oral, dose and lot# were unknown). No concomitant therapy was reported. After receiving the vaccine (unspecified date in June 2016), the patient vomited. The outcome of the event was unknown. Causality was not provided. Additional information has been requested.
Systemic: Abdominal Pain-Medium, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Fever-Medium, Systemic: Hypotension-Severe, Systemic: Nausea-Medium, Systemic: Weakness-Medium, Additional Details: PATIENT'S FAMILY REPORTED THAT PATIENT FAINTED 3-5 MINUTES AFTER THE TWO IMMUNIZATIONS. WHEN PHARMACY  SAW THE PATIENT, SHE WAS AWAKE WITH IMPAIRED RESPONSIVENESS TO QUESTIONS. PATIENT ALSO HAD PALENESS IN HER FACE. EMERGENCY LINE CALLED IMMEDIATELY AND ARRIVED TO TAKE HER TO NEARBY HOSPITAL (NAME OF HOSPITAL UNKNOWN). RESPONDERS REPORTED NORMAL BLOOD GLUCOSE IN PATIENT BUT LOW BLOOD PRESSURE (APPROX 70/55).