chrisvoncsefalvay/vaers-outcomes huggingface dataset:
soreness around injection site; This is a spontaneous report from a contactable Other Health Professional reporting for herself. This is one of two report from same reporter. A 26-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL8982; Expiry date: unknown) as a single dose for COVID-19 immunization on 13Jan2021 at 09:45 in the left arm. The patient past medical history and concomitant medications was not reported. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient was not tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Approximately in 2021, after first dose the patient developed soreness around injection site. The patient reported that the clinical outcome for soreness around injection site was recovering. The patient did not receive any treatment for adverse event.  Follow-up attempts are completed. No further information is expected.
Pt had Johnson & Johnson vaccine on 06/14/2021 and came to supermarket to get Pfizer 1st dose on 07/17/2021.  Pt came back for 2nd dose Pfizer on 8/7/2021, upon query of only 1st and last name (DOB left open), the patient name was found twice in the registry with the same address and differ month/date of birth, but same year. Upon asking the patient, he confirms having had the Johnson & Johnson vaccine prior to the Pfizer vaccine. I explained to him that it was not advised to get another COVID vaccine after completing the JJ vaccine and he verbally communicated that he understood.
This spontaneous report was received from a pharmacist and a control nurse via a company representative and refers to a 68 years old non-pregnant female patient. The patient's pertinent medical history, and concurrent conditions were not reported. The patient's historical drugs included PREVNAR 13. Concomitant therapies included LEXAPRO, metoprolol XL, nitroglycerin SL, atorvastatin, MURO 128 OPHTHALMIC SOLUTION and XIIDRA. On 16-JAN-2018 (also reported as 19-JAN-2018), the patient was vaccinated with PNEUMOVAX 23 (dose and route of administration were not reported, lot # N019348 and expiration date: 08-FEB-2019) for routine vaccination. On 18-JAN-2018 (reported as 48 hours post vaccination with PNEUMOVAX 23), the patient experienced a problem with cellulitis; the signs were reported as redness, swelling, pain and heat. The patient sought medical attention but, it was unknown if laboratory diagnostic tests were performed. As treatment for the event, the patient received KEFLEX. At the time of this report, the patient was recovering from the event cellulitis. The reporting nurse request a lot check to determine contamination and offered to send a sample it would help with the investigation. The nurse stated that the vaccine was quarantined. Additionally, the clinic had many sites but the reactions only occurred in one site. The causality between cellulitis and PNEUMOVAX 23 was not reported. Upon internal review cellulitis was determined to be medically significant. This is one of three reports from the same reporter. Sender's Comments: US-009507513-1801USA007997: US-009507513-1801USA008061.
Patient complained of feeling dizzy and became syncopal. Patient was lowered to the ground and regained consciousness quickly. Gave patient juice while laying in stretcher. Became dizzy again while sitting up. Evaluated by EMS. BP 124/60 and HR 65. Declined transport and released home.
Vomiting,  muscle aches,  fatigue,  chills, temperature,  hot flashes,  bone pain, headache,  the runs,
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On an unknown date after 07-OCT-2016, the patient was vaccinated with improperly stored VARIVAX (lot # L020001, expiration date 02-JUN-2017, 0.5 ml, subcutaneous) for prophylaxis. No adverse effects were reported. The excursion temperature included higher than 5 Fahrenheit degree but lower than 14 Fahrenheit degree for 8 hours and 30 minutes and higher than 14 Fahrenheit degree but lower than 46 Fahrenheit degree for 30 minutes. There was no previous excursion. Data logger was involved. No product quality complaint was involved. This is one of several reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1701USA003754:
Body aches chills neck pain rapid heart beat nausea fatigue dehydration brain fog worst headache of my life guises heavy menstrual cycle
Bruising of chest; Fall; Injury; Chest pain; Vaccination site pain/sore arm; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Bruising of chest), FALL (Fall), INJURY (Injury), CHEST PAIN (Chest pain) and VACCINATION SITE PAIN (Vaccination site pain/sore arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis.    The patient's past medical history included Knee replacement (In November 2019, the patient experienced RIGHT KNEE REPLACED.) in November 2021 and Knee replacement (In July 2021, the patient experienced LEFT KNEE REPLACED.) in July 2021. Concurrent medical conditions included Rheumatoid arthritis.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain/sore arm). On an unknown date, the patient experienced CONTUSION (Bruising of chest), FALL (Fall), INJURY (Injury) and CHEST PAIN (Chest pain). At the time of the report, CONTUSION (Bruising of chest), FALL (Fall), CHEST PAIN (Chest pain) and VACCINATION SITE PAIN (Vaccination site pain/sore arm) outcome was unknown and INJURY (Injury) was resolving.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medication information was  provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2022: Live significant Follow up
Bell?s Palsy. Diagnosed 13 days post Moderna vaccine injection #1.
The pt developed a fever of 104.6F, the night of the shots, 12/10/01. On office visit on 12/11/01, erythema was noted at both thigh areas with heat on left thigh 2cm area with 3cm induration on right leg of 1 1/2cm area with 2cm induration.
Information has been received from a physician concerning a 23 year old female with a history of papanicolaou smear abnormal in January 2006 but was not tested for HPV at that time. On 13-NOV-2006, the patient was vaccinated with the first dose of GARDASIL. On 15-JAN-2007, the patient was vaccinated with the second dose of GARDASIL (lot number was reported as 1426S, which is a available lot number of dexamethasone acetate). On 12-JUL-2007, the patient was vaccinated with the third dose of GARDASIL (lot # 658100/0525U). Concomitant therapy included ORTHO TRI-CYCLEN. On 16-JAN-2009 the patient experienced abnormal PAP smear that was positive for high risk HPV. The specific type of HPV she had was unknown. The patient was scheduled to have a colposcopy. Additional information has been requested.
09-08-14 - Sent to ER from MD office - treated and released. 09-09-14 - Went to PCP - had ambulance transport - increased HR/severe pain - respiration. 9/6/14 Overnight - sick all weekend nausea, sleepy - slight site discomfort.
Presents with cardiomyopathy, eosinophilia --cardiac bx done pt is postive for eosinophilia.  MRI suggest acute cardiac inflammation with possibility of apical clot and endomyocardial biopsy suggestive of acute eosionophilic myocarditis. Smear for parasites negative.  quantaferon gold negative.  Currently in the CICU unit
1. sore left arm, started about 6-7 hours after injection lasted for 2-2 1/2 days 2. low grade fever, started 18 hours after lasted 2 days 3. chills, started 18 hours after lasted 2 days
Pt vax w/MMRII on 4JUL90 dev T of 104 & sore throat, she fainted & dev a macular rash on both thighs; She exp weakness & pain.F/U 12MAR91:  SXS INCLUDED T 104, SORE THROAT, MAC RASH, FAINTED, WBC 21,000 W/ LEFT SHIFT, ANA +, ESR 83, HCT 30.
death shortness of breath N17.9 - AKI (acute kidney injury)  K92.2 - Gastrointestinal hemorrhage, unspecified gastrointestinal hemorrhage type
Pt was seen in clinic for  IPV #3, Hib #4, MMR#1, Varicella#1. Following immunizations (within 2 hours). child broke out in welp-like lesions that did not go above neck. Pt was given Benadryl liquid and improved. PCP of child notified.
I felt faint and  dizzy, as though I was about to faint. I was unable to think clearly. After arriving at the ER, my symptoms graduated to achy muscles, pounding headache, neck aching, odd throat sensation, etc.
Small red area at injection site on left arm; not raised. Additional red not raised area 2 inches below injection site measuring 1 cm x 5 cm (left arm). Whole left arm is tender and aches.
Passed out several times; he got up to go to the bathroom and on his way back to bed he got dizzy; fell down on the floor; sweating; belly pain; Initial information received on 27-Aug-2020 regarding an unsolicited valid serious case from a consumer/non-healthcare professional.  This case involves a 74-years-old male patient who experienced sweating (hyperhidrosis), he got up to go to the bathroom and on his way back to bed he got dizzy (dizziness) and fell down to the floor (fall) due to which he passed out several times (loss of consciousness) and belly pain (abdominal pain), while he received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history included sinus infection (sinusitis) in 2019 for which doctor had gave him antibiotics, and he got dizzy (dizziness) and passed out (loss of consciousness).  The patient's past medical treatment, concomitant medication, vaccination and family history were not provided.  The patient had ongoing medical history of Type 2 Diabetes Mellitus.  On 26-Aug-2020 at 3:00 to 4:00 PM, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number, expiry date not reported) via an intramuscular route at an unknown administration site for prophylactic vaccination.  On 27-Aug-2020 at 3:00 to 4:00 AM, the patient experienced sweating (hyperhidrosis), he got up to go to the bathroom and on his way back to bed he got dizzy (dizziness) and fell down to the floor (fall) due to which he passed out several times (loss of consciousness) (few hours) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. These events were assessed as medically significant.  On 27-Aug-2020 at 3:00 to 4:00 AM, the patient developed a non-serious belly pain (abdominal pain) (few hours) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.   He does not check his blood sugar because he said it is managed well. It normally runs about 140.  It was not reported if the patient received any corrective treatment.  The events outcome was not reported.  Information on the batch number was requested.; Sender's Comments: This case involves a 74-years-old male patient who experienced hyperhidrosis, dizziness and fall which was associated with loss of consciousness and also experienced abdominal pain, same day after vaccination with FLUZONE HIGH DOSE. The time to onset is compatible. Medical history, previous exposure to any vaccine, concomitant medication, precise final diagnosis and lab data ruling out alternative etiologies would be needed for complete assessment of the case. Based upon the reported information, role the vaccine cannot be assessed.
Thurs 11/6 woke up with swelling & soreness @ site of injection.  Low grade fever 11/6 & 11/7.  Severe body aches Friday 11/7 - particularly in face & legs felt weak.  Arm continued to feel sore & was red & swollen.  Monday 11/10 arm warm to touch below site of injection, red & hive- like appearance.  No itchiness.  Con't to be sore.  PHN suggested seeing Medical provider.  Pt. saw nurse practitioner - given antibiotic (BACTRIM) due to infection at site.  PHN will follow up in 10 days.
My left are never stopped hurting and it has progressively gotten worse I can barely lift my arm up and I?m in constant pain.
I21.4 ACUTE NON ST ELEVATION MI 4/24/2023 CHEST PAIN I21.4 ACUTE NON ST ELEVATION MI 4/24/2023 ABNL CARDIOVASCULAR STRESS TEST
had a strange feeling; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (had a strange feeling) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced FEELING ABNORMAL (had a strange feeling). On 10-Feb-2021, FEELING ABNORMAL (had a strange feeling) had resolved.            No concomitant medication was reported. Treatment medication was not provided.
Tachycardia and flushing immediately after shot given, followed by fullness (slight swelling) in mouth, prickly feeling to tongue.
Client sitting while vaccinated reported dizziness immediate/seconds post injection followed by stiffening/mild jerking of her body for less than 10 seconds, followed by seconds of syncope. Entire episode less than 1 minute. Ammonia inhalant used and was effective. Client taken to lie down left side, fluids given by mouth. Client remained for approx 20 min and left ambulatory with parent. Advised parent to inform physician of event prior to further vaccinations. If further incident after office hours go to emergency room. Follow up with this clinic during office hours to report any further incident.
After nurse administered all vaccines at 10:53 on 08/19/19 , pt. c/o dizziness & nausea, found pt's face & lips turn  pale, pt is alert, O x3, instructed pt. to put head down, check BP 66/40, P 42, R 18 at 10:55 am. BP 73/32, P 44, R 18 at 11:00 am. Nurse with other RN used wheelchair to transfer & assisted pt. to lie on the bed with both legs elevated at 11:02 am. Nurse stayed with pt. & assessed pt. Pt can answered questions, awake  & responsive. Check BP 110/62, P 56, R 18 at 11:09 am. Pt said that he had no more nausea & dizziness. Assisted pt. to sit up. Checked BP 89/55, P61, R 18 at 11:17 am. Pt left with father without acute distress noted.
Second vaccine given at 1627. 1700 pt. Stating having tingling lips and feeling shaky. Taken to sit in observation area to sit and VSS BP178/92, HR 92, sat 98%. Benadryl, 25mg PO given with water. VSS 1705 BP191/88, HR 90 and sat 94%. 1710 162/91, 90, 99%, 1715 158/91,93,96%Patient put on cart with knees up and cont. To complain of dizziness and left neck stiffness. 1720 166/83,85HR,99% 1725  154/83, HR85, 99% 1728  157/91, HR 86, 98% 1732  156/94, HR 86, 99% 1737  175/87, HR 86, 99% Took patient into wheelchair, complaining of head spinning 1741  184/72, HR 90, 97% 1747 155/87, HR 90, 98% 1751  187/91, HR 95, 95% Patient was going to attempt to go to car, but continued with dizziness; EMS called.  1756  182/84, HR 97, 99% EMS arrived at 1800; took down history  1800 182/91, HR 99, 99% Patient transferred to cart and taken to hospital. Patient alert/oriented x3, anxious for the entire encounter.
Patient received these vaccines in error. Nurse mixed up patients and gave wrong injection to patient. No adverse reaction.
Vasovagal response of passing out.  Persisting nausea and vomiting for 24 hours. Diarrhea for 6 hours Constipation for 4 days Taste was diminished for 7 days Feelings similar to motion sickness for 3 days
Pt was given vaccine that had exceeded the allowed 10 weeks in the refrigerator. Pt or parents informed us of any adverse reaction and the parents were informed of the vaccine error
Site: Pain at Injection Site-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Weakness-Mild, Additional Details: patient reported signs of feeling faint and lips turning white. temp was stable at 96.7 and breathing was normal. Parents refused 911 so I instructed them to seek medical attention immediately. Parents drove to hospital themselves. Called parents later in the evening and mom said daughter was doing ok and was told  px reacted to pain of getting the vaccine and not the actual vaccine and she should continue vaccines series on 8/10/21. All vitals wore normal and she's being monitored at hospital
Pt received FluBlok (ages 18 and up) instead of FluZone (ages 6 months and up)
pt recvd vax; skin eruption on rt arm; achy joints, h/a, fatigue; stomach pain;skin eruption on lt upper quadrant of abdo;denies fever;sxs occured w/in 12-15 hrs after vax & subsided after 24 hrs of onset;
Per patients husband, patient's arm started to hurt after the Shingrix shot given 10/8/19.  This was the 2nd dose in the series.  The first shot did not cause pain.  However, the 2nd dose has given her a sore arm.  The pharmacists are thoroughly trained to make sure both patient and pharmacist are seated for ALL vaccinations to be sure to administer vaccine into the deltoid muscle.
I had an appointment with my cardiologist on July 26, 2021. In the office they did an EKG, and the cardiology nurse noted A-fib and that I needed to go to the hospital immediately. I ended up at the hospital and had no symptoms. I was in for 3-4 days. They did an echocardiogram which was okay. They did blood tests and nothing came positive. They also did a monitor and there was no repeat of a-fib. They had me do an at home monitor for 5 weeks and there was no reoccurrence of a-fib. At the hospital they sent me home with Eliquis, they told me to stop taking ibuprofen and I started taking Tylenol. There are no other changes now other than taking the Eliquis.  My sister and I had gone on a road trip right before this event, and part of that required climbing and hiking. At some point, I did get dehydrated and that may have had something to do with it. But I'm not sure. I was surprised when we got back. That trip was the weekend before the cardiologist appointment.
This spontaneous report as received from a consumer (patient's mother) refers to a 19-year old non-pregnant female patient. Patient had no pertinent medical history, drug reactions or allergies. Information regarding patient's concurrent conditions and past therapies were not reported. On 14-DEC-2017 the patient was vaccinated with first dose of GARDASIL 9 one injection via intramuscular route for human papilloma virus (HPV) prevention whose lot and expiry date were reported as unknown. The patient's concomitant medications included unspecified birth control pills. On 14-DEC-2017 reported as "immediately after vaccination" the patient started feeling dizzy and out of sorts (malaise). It was reported that patient's injection site was sore right after receiving the vaccination. No lab diagnostics or studies were performed and no medical attention was sought. The patient received an unspecified treatment for the adverse events. On 04-JAN-2018 reported as three weeks after vaccination, the patient's soreness was subsided. On an unspecified date, the patient's dizziness and malaise got subsided. The reporter stated that patient has not yet received the second dose in the HPV vaccination series that was due in February. The reporter did not provide the causal relationship with GARDASIL 9 vaccination. There was no product quality complaint (PQC) involved.
Fever lasting more than 3 days. Cough lasting more than 3 days.  Irritated eyes lasting more than 3 days. Rash.
A few minutes after receiving his vaccine, patient fainted and went down to floor. He was immediately responsive and sat up. I provided him a cold compress to his neck. A few moments later, he started to slump and appear to fall asleep. He was again immediately responsive. We moved him onto the floor and called paramedics. They arrived, checked his vitals and cleared him. He left with his father.
Left knee pain and stiffness about 12 hours after injection. Resolved by next day. No other obvious cause.
Patient reports to the pharmacy on 5/25/21 and says that as of 3 or 4 days (she can't remember) she has bruising on both arms and bleeding from nose. She attributes this reaction to the vaccine she received on 4/30/21  but also says she suffers from low platelets and anemia. She was urged to go immediately to the hospital and second dose was postponed until further evaluation.
specialist ordered titers for pneumonia and the results showed reduced immunity; This is a spontaneous report from a contactable pharmacist. A 9-years-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose (9 weeks, 4 months, 6 months and 12 months) for immunisation. The patient medical history and concomitant medications were not reported. The 9 year old female vaccinated previously with Prevnar 13 at 9 weeks, 4 months, 6 months and 12 months. Patient was seeing allergy specialist and specialist ordered titers for pneumonia and the results showed reduced immunity. Allergy specialist sent prescription for Prevnar13. The outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
COVID-19 TEST POSITIVE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age and race, ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient received covid-19 vaccine ad26.cov2.s (dose number in series: 1), (suspension for injection, route of admin not reported, batch number: and expiry: unknown) dose was not reported, 1 total, administered for prophylactic vaccination and it was unknown whether patient had any adverse events (dose number in series: 1 - manufacturer unspecified). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2), (suspension for injection, route of admin not reported, batch number: and expiry: unknown) dose was not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient tested positive for coronavirus disease (covid-19), (test was unspecified), (dose number in series: 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was unknown. This report was non-serious. This report was associated with product quality complaint: 90000207648.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Starting about 1 day after receiving the vaccine, patient reported pain in shoulder area that has not improved as of 11-2-19. According to the patient he is unable to move lift his left arm fully without pain. He will continue to apply ice to the area, and take Benadryl and acetaminophen as needed. He was instructed to follow up with the pharmacy and his PCP in the next several days with updates on the pain.