chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 54 year old male. Initial information was processed along with the additional information received on 08-JUL-2022. 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 not reported, batch number: 204B21A and expiry: unknown) dose was not reported, 1 total, administered on 13-DEC-2021 for prophylactic vaccination. 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: 211A21A expiry: Unknown) dose was not reported, 1 total administered to left arm on 13-MAR-2022 for prophylactic vaccination.  Age at time of vaccination 54 years old. No concomitant medications were reported.  The patient was tested positive for Covid after 7 weeks (/MAY/2022) following booster vaccination and it was third time the patient tested positive which was coded as confirmed covid-19 infection (dose number in series 2) and confirmed clinical vaccination failure (dose number in series 2). The first time the patient was tested positive, where the test was received at his work place and then patient had a real test at the doctors office. The patient was sick for 5 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220714463. This report was associated with a product quality complaint: 90000241155 and 90000241159.; Sender's Comments: V0:20220712200-COVID-19 VACCINE Ad26.COV2.S-  confirmed clinical vaccination failure . The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Baby born, weight 7 pounds 9 ounces, Baby was perfect and healthy. 17 August OB appt - 18 August was admitted in hospital, 19 was slow labor 170/103 BP, started Magnesium drip and Albuterol, had section. Had infection and stayed in the hospital and discharged on 24-25 August - was in pain and BP 198/133 went in ambulance back to hospital and put on same drips again for 24 hrs and discharged on 27 August. 28 August BP was high again, vision was looking like a kaleidoscope more on the right and went to ER and was not admitted. August 2021 Preeclampsia and then severe, hospitalization and discharged and went to the hospital.
This spontaneous report was received from a physician regarding a male patient. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. The mother of the patient was a female. On an unspecified date, the mother of the patient was vaccinated with the first two doses of GARDASIL 9 (frequency, route, anatomical location, lot # and expiration date were not provided) for prophylaxis. On 06-JUL-2018, the mother of the patient was vaccinated with third dose of GARDASIL 9 intramuscularly, lot # R000301 with expiration date 29-AUG-2020 (frequency and anatomical location were not provided) for prophylaxis. On 13-JUL-2018, the mother of the patient returned for intrauterine device (IUD) placement and the nurse discovered that the mother of the patient was pregnant (foetal exposure during pregnancy). The mother of the patient's last menstrual period was on 10-JUN-2018. The estimated date of delivery (EDD) was on 17-MAR-2019. On an unknown date, the mother of the patient had motor vehicle accident (MVA) (road traffic accident) and developed brain aneurysm from MVA and the mother of the patient underwent to clipping of brain aneurysm (intra-cerebral aneurysm operation). On 19-OCT-2018, the mother of the patient underwent Ultrasound examination and the result showed fetal abnormality, Ureterovesical junction (UVJ) abnormality and renal concerns at normal measurements. The quad screen and Prenatal panel test were performed, and the result showed as Trisomy 18 was at risk of 1/65. On 27-DEC-2018, the mother of the patient was vaccinated with another suspect product diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (strength 0.5 ml), (dose, lot number, expiry date not provided) for prophylaxis. Other therapy taken by the mother of the patient included prenatal vitamin. On an unknown date, the patient experienced hydronephrosis. The outcome of the events was unknown. The causality assessment was not provided by the reporter. Upon internal review, the events hydronephrosis and ureterovesical (UVJ) junction abnormality were determined to be medically significant. This case has been cross linked to 1808USA003635 (mother case).; Sender's Comments:  US-009507513-1808USA003635:
2/12/07 Given Td and Hep B developed redness, pain, and heat in RA IM the site 4", 12/17/07 called advice nurse line for recommendations, 12/18/07 went to Urgent Care for treatment. (Antibiotics given).
10/28/18 Arm red, warm to touch, aching, nausea. Went to see MD 10/31/2018. Dr. - seen 10/31/2018.
Initial report received on 04 January 2012 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 2-year-old subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance System electronic database. The subject's vaccine history included 3 doses of PENTACEL; dose 1 received on 16 July 2009 (lot number C3299AA), dose 2 received on 17 September 2009 (lot number C3430AA), dose 3 received on 24 November 2009 (lot number C3470AA), and a dose of DAPTACEL; lot number C3380AA received on 26 August 2010 (route and site of administration not reported). The subject developed cold-like symptoms on 24 November 2011, approximately 15 months after the last dose. On 03 December 2011, the subject developed a paroxysmal cough with a whoop and posttussive vomiting. The subject also experienced apnea and sleep disturbance. Laboratory testing included negative PCR on 22 December 2011. However, the case was epidemiologically linked to a laboratory confirmed case. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin for 5 days starting on 22 December 2011. The subject was not hospitalized. At the time of final contact on 23 December 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 22 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Patient came to ED with abnormal labs (Scr and BUN) and was found to have a UTI and pneumonia due to Covid.  Patient admitted to hospital.
pt recv vax 23APR97 & Sunday had broke out in sweats;also breaking out in a rash, joint pain & fever;
might have gotten one dose within the last one year with no adverse event; Initial information received on 03-Nov-2020 regarding an unsolicited valid non-serious case received from the other health professional via phone at call center (reference number: US-SANOFI-00344458).  This case involved a 36-year old female patient who might have gotten one dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (ADACEL) within the last one year with no adverse event (Extra dose administered).  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 03-Nov-2020, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: C5757AA, expiry date: 21-Jul-2022) via intramuscular route in the left deltoid for prophylactic vaccination.  On 03-Nov-2020, on the same day of vaccine administration, it was reported that patient might have gotten one dose within the last one year with no adverse event (Extra dose administered). Patient thought that patient might have received a DTaP vaccine within the last 1 year. Patient was given Adacel today and then mentioned that she might have gotten one within the last 1 year.  It was an potential medication error due to the extra dose administered.   At the time of reporting, the patient had no adverse event.  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 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.
Patient called today at 1pm on 1/7/18 stating that last night she started having swollen lips. She took BENADRYL and this morning it is still bad. I advised patient to seek medical attention immediately.
Body aches; Not doing well; Difficulty getting out of bed; Difficulty doing anything; Headache; 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 PAIN (Body aches), MALAISE (Not doing well), SOMNOLENCE (Difficulty getting out of bed), LAZINESS (Difficulty doing anything) and HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ALPRAZOLAM (XANAX) for an unknown indication.   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 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 PAIN (Body aches), MALAISE (Not doing well), SOMNOLENCE (Difficulty getting out of bed), LAZINESS (Difficulty doing anything), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, PAIN (Body aches), MALAISE (Not doing well), SOMNOLENCE (Difficulty getting out of bed), LAZINESS (Difficulty doing anything), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.            Concomitant medication included muscle relaxers. Treatment medication not reported. Action taken with mRNA-1273 was not applicable.   Reporter did not allow further contact
Increase in temperature; Moderate left arm pain; Slight headache; Very fatigued; Feel very sick; This is a spontaneous report from a contactable other healthcare professional, the patient. A 62-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Apr2021 at 14:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 (Prior to the vaccination, the patient was diagnosed with COVID-19). The patient had no known allergies. Concomitant medications included paracetamol (TYLENOL), acetylsalicylic acid (ASPIRIN) and azithromycin (Z-PAK), all for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 28Apr2021 at 06:00, the patient experienced increase in temperature, moderate left arm pain, slight headache, very fatigued and felt very sick. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events increase in temperature, moderate left arm pain, slight headache, very fatigued and felt very sick was not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Delayed reaction to vaccine. On day 8  developed an very itchy, red, hot, slightly raised, inflamed area on left upper arm where injection was given approximately 6" x 5" in size. I still have it 2 days later.  Called doctor's office  to see if I should get my second shot but have not heard back yet.
Fever 4-5 days after MMR injection. Rashes 10-15 days after MMR injection. Fussiness, loss of communication x15 days with resolvement.
UrticariaPruritus Erythema at injection site, Induration at injection site, swelling at injection site for 3-5 days after injection. now return with numbness and tingling to the finger  tips Narrative: Employee reported to EOH provider that she has skin erythema, swelling, itching at the injection site that developed after the injection. Skin is hard and swollen. Symptoms were present for 3-5 days then resolved. They have since returned and now with numbness and tingling to the finger tips.
Sudden onset, 48 hours after vaccination,  of severe and increasing pain in left ankle and foot, radiating up to left buttock. Pain crescendoed for 8 to 12 hours, not relieved by Tylenol, pèrcocet, high dose advil, ice. Severe difficulty walking due to pain in ankle and foot. Gradually eased after 12 hours, but has become chronic and waxing and waning over the past 10 days.
Pt recvd DTP/OPV/HIB & mom reported 3SEP91 that mouth white, limp, slept 7.5 hrs p/1st DTP, "looked dead"; fine by 24 hrs; Reportedly called MD's office & was reassured;
Pt seen in ER 4/1/17 at 20:51 for C/O "cough, congestion x 1 week, fever starting tonight, 101 at home TYLENOL given. Skin problem: vaccines received on Friday redness/swelling to right leg." Given Ibuprofen in ER. "Moderate local immunization reaction." Pt seen in clinic 4/4/17 at 15:40 for 2cm X 2cm firm area at injection site on right thigh. Note: Vaccines were documented as PEDIARIX, Varicella >Left thigh, MMR -right thigh, IPV - Right arm, However when patient returned on 4/4/17 for follow-up she had the following, 2-injection sites - right thigh, 1 injection site - Left thigh, 1- injection site- Right arm. We believe the MA that gave and documented the vaccines reversed the thigh given. DTaP component of PEDIARIX most likely cause of reaction.
Information has been received from a registered nurse concerning a 61 year old female consumer with type 2 diabetes mellitus, sulfonamide and shellfish allergies who developed shingles in a cervical dermatome distribution on 08-APR-2008 after being exposed to her mother who was vaccinated with zoster vaccine live (Oka/Merck) on 05-APR-2008. Concomitant therapy included LEXAPRO, quinapril HCl, GLUCOPHAGE, sitagliptin phosphate (MSD) and potassium acetate. It was noted that the first lesion erupted on 08-APR-2008. On 12-APR-2008 the patient sought medical attention at an immediate care facility because of neck pain and a second vesicular lesion. There were no lab studies performed. The patient was treated with VALTREX, and given a prescription of hydrocodone bitartrate for pain. The patient was referred by the immediate care physician to her primary care provider for follow-up. At the time of the report the patient was recovering. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/24/2008. Follow up information was from the physcian who thought shingles was a reactivation of a latent disease and there was no relationship between patient's symptoms and relative's vaccination and she also thought that it was not significant. No further information is expected.
On 08/31/2021- 1st breakout of shingles. Prescribed the antiviral Valacyclovir HCL 500 mg tablets, 2 tablets, 3 x day for 1 week.  It was a very mild outbreak and I recovered in 3 or 4 days.  About a week after my 3rd Dose, Pfizer-I noticed the symptoms, 10/06/2021 a general not feeling good and then the rash. It was raised, itchy bumps.  On 10/07/2021- I went to see my doctor and he diagnosed it as shingles and prescribed another week worth of antiviral. The same one, Valacyclovir HCL 500 mg tablets, 2 tablets, 3 x day for 1 week. I recovered in 3 or 4 days. On 10/25/2021- I had the same symptoms as 10/06/2021- malaise, raised, itchy bumps. I was diagnosed again with Shingles. This time they did not treat it with antiviral. I recovered on my own after 5 or 6 days.  I am fully vaccinated with the original Shingles vaccine in 2009. Then I had the Shingrix, 1st dose in June and the 2nd dose beginning of Dec 2018.
Constant shoot chills/sensation cin neck and back of head. Shaking sensation when laying down, inability to sleep more than 2 hours due to aforementioned sensations.
The vaccine was injected too high in left arm. I know this because I am a retired pharmacist and when I removed the bandage noticed injection was near the shoulder and not in the mid deltoid area. The left arm/shoulder began to feel sore in the evening and was very sore the next day. Was unable to lift arm or move without pain. Over the next several days the severe pain decreased, but I continue to have pain in the arm, especially the bicep area. Range of motion is limited. Severe pain when trying to lift my arm from resting position while in bed. Severe pain when rotating arm inward. Pain occurs with certain movements.
Mom reported "that night after shots at about 6 pm, he developed a severe cough, which made him vomit; his sister also had this same cough and she did not get any shots." the kids were seen by a doctor for this cough on 4/18/12 and md order Mucinex. Mom gave a dose after returning home. First dose at about 3:30 pm. Then about 45 minutes after the first dose of Mucinex, "he could not walk, sit up, his head turned sharply to the left, he toppled over and was lying on the floor, his body was very straight and he was screaming the whole time, his head remained turned to the left, and his body was jerking against me when I held him." "After this, he seem dizzy and could not walk for about 25 minutes, I called the pediatrician and she told me to call poison control and to not give anymore Mucinex, poison control said they have never heard of this type of reaction to Mucinex." "He went to bed early and slept, we have had no further symptoms, except the cough is still there, I am taking him back to the pediatrician now".
pain,redness, soreness, swelling, headache, muscle aches, fever, shivering, fatigue
edema and redness at injection site, seen on 10/9/2009 and gevin keflex, and told to continue Bendryal
Vaccine was given on 4/1/21. Symptoms started 4/2/21 in the afternoon. Symptoms were described as teeth/gums hurting. At 12:30 am on 4/3/21 his mouth was very swollen and he couldn't talk. Also he had trouble breathing. He went to the ER and was given IV solu-medrol. Patient was sent home 30-40 minutes later with the instructions to take Benadryl PO. In the morning they purchased some benadryl and gave it PO every 4-6 hours all day Saturday, 4/3/21. On Sunday, 4/4/21 at about 5:30 am his gums and lips were swollen again. He made another trip to the ER and was given solu-medrol IV again and PO methylprednisolone for 5 days. At this visit, they also gave lasix IV due to extra fluid around his heart. He was told by the ER provider that he developed congestive heart failure due to the vaccine.  Patient followed up with his primary care provider on 4/8/21 and was told that his symptoms of congestive heart failure had resolved. Patient also reported his  symptoms of swollen gums and mouth had resolved at this time.
Administered both vaccines on 10/14/22 - second in the series of both (no problems noted with the first dose administered to the patient in the series). Vasovagal syncope noted approximately 20 minutes after vaccines administered. Patient was sent to hospital to be assessed; not admitted. Follow-up call patient had no problems to report on 10/19/22.
injection site redness and soreness, severe migraine headache, severe myalgia (even the tendons in my hands and feet hurt), arthralgia, chills, rigors, swollen lymph nodes lasted two and a half days, mostly spent in bed
One week after receiving the Shingrix vaccine, patient presented to the ED and was left-sided facial paralysis. He was diagnosed with Bell's palsy and given a 1 week course of prednisone and valacyclovir. It is now 13 days since the onset of symptoms and the patient has not had much improvement. At visit with PCP 11 days after onset of symtpoms he was given an additional course of prednisone.
Hair and clothes wet with diaphoresis the night of injection, woke up with nausea, vomiting. Temperature ranged 99.5-101.3, l check my temp daily. Sweating, chills, headache, body aches and fatigue. The symptoms began to decline approximately 24H after vaccine but headache, mild nausea and extreme fatigue continued.  I felt so bad that I missed 2 days of work and got a COVID test to be safe, as I am a nurse, results were negative and employer was made aware of reaction.
Employee noticed 3x3 inch area around injection site with multiple hives, red and itchy when she woke up at noon. Employee did not take any medication or do any treatment. The 3x3 inch area resolved by 23:00 the same day, leaving a 1x1 inch red, itchy induration at injection site.
Retinal vein occlusion; This is a spontaneous report from a contactable consumer (patient) reported that a 24-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration, administered in arm left on 18Mar2021 13:00 as a single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history was reported as none. The patient had no known allergies. The patient had no covid-19 prior vaccination. The patient was not covid-19 tested post vaccination. There were concomitant medications. The patient received oral contraceptives in two weeks. The patient had no other vaccines in four weeks. On 25Mar2021, the patient experienced retinal vein occlusion. The patient received Avastin injection as treatment for the event. The event was resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. The outcome of the event was not recovered.  It was reported that the patient also received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported) via an unspecified route of administration, administered in arm left on 15Apr2021 as a single dose for covid-19 immunisation.  Information on the lot/batch number has been requested.
Pt. complained of achy pain in back and neck on day following vaccine.  No headache, no fever, no sore throat, no weakness, no numbness. +/- dizzy only on awakening. Exam negative except for mild paraspinous. Muscle tenderness in lumbar region both. DTR 1-2t/=B, MS B/S throughout.