chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned an 82 year old male of an unspecified ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-Hodgkin lymphoma (compromised immune system due to a rare blood cancer). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, route of admin not reported, batch number: 1708609 and expiry: UNKNOWN) dose was not reported, 1 total, primary dose administered in right arm on 23-MAR-2021 for covid-19 prophylaxis. On an unspecified date in NOV-2021 following vaccination with primary dose of covid-19 vaccine ad26.cov2.s, the patient had covid-19 with symptoms of coughing and tested positive for COVID-19 virus test on 08-NOV-2021 (confirmed covid-19 infection and confirmed clinical vaccination failure) (Dose number in series: 1). It was also reported that patient was home quarantined for 5 days (Date unspecified). On an unspecified date and month in 2021, the patient experienced COPD (Chronic obstructive pulmonary disease) (Dose number in series: 1) and had received treatment with Doxycycline. The outcome of the confirmed clinical vaccination failure, confirmed covid-19 infection and COPD were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 2) (suspension for injection, route of admin not reported, batch number: 213D21A and expiry: UNKNOWN) dose was not reported, 1 total, first booster administered in right arm on 07-DEC-2021 for covid-19 prophylaxis. Age at time of vaccination 82 years old. No concomitant medications were reported. On an unspecified date in FEB-2022 following vaccination with covid-19 vaccine ad26.cov2.s (first booster), the patient experienced diarrhea and viral infection, and tested positive for COVID-19 virus test which was confirmed covid-19 infection and confirmed clinical vaccination failure (Dose number in series: 2). Laboratory data included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000256360. This case, involving the same patient is linked to 20211208454 (Dose number in series 1) and 20221046895 (Dose number in series 3).; Sender's Comments: V0: 20221045009-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.
Client received shot of NS instead of Covid  19 vaccination. Client notified of mistake and given option to return to clinic and be re vaccinated.
Administered expired vaccine to the patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration) in a 65-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Date the vial was initially stored in the refrigerator was unknown. The vial did not undergo any temperature excursions. Vaccine manufacture date of expiry reported was 07-Apr-2022.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non-significant follow up information receive on 08-Jun-2022. reporter details was updated.
Pfizer COVID19 Vaccine EUA  Admitted acute from specialty clinic for respiratory distress and anemia. Negative for COVID per rapid test.
Fever of 100 degrees; The "little" pain in his arm.; That night he could not sleep; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 41-years-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 06May2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. On 6May2021 and reports that that night he could not sleep properly because of the "little" pain in his arm and stated that this morning (07May2021) has a fever of 100 degrees. Caller would like to know if it is normal to have a fever after the first dose of the vaccine. The patient underwent lab tests and procedures which included body temperature: 100 degrees on 07May2021 and covid-19: negative on 30Apr2021. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Body aches like flu, slight headache, no fever. Then stiffness primarily in the knee but also in arm and shoulder extending up to neck.
All the fingers on my left hand, of the arm that got the shot) began popping constantly after the first vaccine and have continued to do so every since the first shot. It seems to have negatively impacted the joints of the fingers only on that hand. This is impacting my playing the piano, and I regularly play piano for church services. To date there has been no improvement. My fingers have been doing this continuously since my first shot on March 11.
I felt light headed, sore arm, head ache and fever at first and that evening. Then woke up the next morning  I felt fine but had swelling  to the face more swelling to the left side then the right with a heavy feeling to my left side of my face along with pain to the eye.  I feel very lethargic and very tired I could not go to work. I feel to bad to work.
blood in their stools; This case was reported by a physician via call center representative and described the occurrence of blood in stool in a 4-month-old male patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Concurrent medical conditions included breast feeding.   On 17th February 2020, the patient received the 2nd dose of Rotarix lyophilized formulation (oral). On 19th February 2020, 2 days after receiving Rotarix lyophilized formulation, the patient experienced blood in stool (serious criteria GSK medically significant). On an unknown date, the outcome of the blood in stool was unknown.   It was unknown if the reporter considered the blood in stool to be related to Rotarix lyophilized formulation.  Additional details were provided as follows: The patient received the  dose of the Rotarix vaccine and two days after receiving the vaccine, the patient had blood in their stools without any other additional symptoms.  The patient was exclusively breastfed. The follow up consent was granted.
Diagnosed with CIDP - treatment is ongoing.  Symptoms of extreme leg tiredness and fatigue started toward the end of August 2020.  Late November unable to feel sharp poke during physicall assessment.
Myopericarditis. Patient cared for by doctor involved in ? pertaining to myocarditis status post smallpox vaccine.
This is an instance of breakthrough COVID)-19 after which death occurred.   The individual was vaccinated with the Moderna product on 12/26/2020, 01/23/2021, and 11/03/2021. THey tested positive for COVID-19 on 03/03/2022 and were admitted to hospital the same day. They died on 03/09/2022.
Narrative:  Dose 1 Moderna: Days 2 & 3--Slight diarrhea with some chills. Left arm soreness. Tired, headache and diarrhea. After 1 week, fsore throat, headache, diarrhea, flu symptoms, chest congestion. No symptoms after three weeks.
I took the first shot on 4/9/21 and had muscle ache and pain, but it went away as stated. I took the second dose on 5/7/21 and have had pain and cramping since.  On 5/7/2021 I was working in my yard and noticed the cramping in my legs so bad I sat down to rest because of the pain. I didn't get the fever just didn't feel good and had cramps in my legs. As the week progressed I starting noticing numbness in my arms and occasionally the legs. The numbness ended after 2-3 weeks but the cramps have never stopped in the legs. My arms have days I do not notice cramping but I find myself shaking and stretching my hands now to relieve what I would describe as pressure in my forearms. I've stopped working out and went back to working out. My Dr. told me to return to my exercise routine because I had stopped walking all together. When I lay down I can feel the cramps the worst in my legs. At times it feels like something is crawling through my calves, and I've seen the calve muscles moving. It looks gross and matched where the pain was. Thankfully I've only see it a couple of times, but I stopped looking because it is really sad to watch.   I still mountain bike and work out. I went on a 16 mile ride in the mountains and when I got home and didn't notice the difference in my calves I schedule an appointment with my Dr. They are always in pain so it didn't make a difference. I did get really bad cramping in my thighs during the ride which would be expected.  I believe my forearms have almost returned to normal, minus the occasional shaking and stretching I find myself doing. It doesn't matter if I work out, don't work out, run, walk, etc. my calves feel like they are ruined and will always suffer from cramping and the sensation of something crawling through them.   It is usually both legs but the forearms can be either side, and the forearms have gotten better. My calves feel like they are going to cause me pain the rest of my life at this point. Thankfully I just keep going because it helps with the mental health.   I wanted to report this because I'm scared to death to take a booster. I don't want anymore pain in me calves and feel like it could cripple me. I'll tell my Dr I see on 10/25/2021 I've reported this so they know.
This spontaneous report was received from a pharmacist refers to a 79 year old male patient. No medical history or drug allergies was reported. On 30-MAY-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiry not reported). Concomitant therapies included simvastatin. On 10-JUN-2013, the patient was diagnosed by his eye physician with "shingles" in the patient's right eye. On 11-Jun-2013, the pharmacist called back to report that the physician determined the adverse event was not related to ZOSTAVAX and it was a herpes simplex infection, dendritic keratitis simplex. Patient received treatment with acyclovir and Zirgan. Patient sought medical attention (saw eye physician). The outcome of herpes simplex infection, dendritic keratitis herpes simplex was reported as not recovered. The reporter considered herpes simplex infection, dendritic keratitis herpes simplex to be not related to ZOSTAVAX. Additional information has been requested.
I have some pain in my neck; This is a spontaneous report from a contactable consumer via the Medical Information Team. A female patient of an unspecified age received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported by the patient that she has some pain in her neck unrelated to the vaccine. She is due to receive her steroid shot. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
pt adm to hosp p/emesis & syncope @ home;recv flu vax 2PM on 23OCT97;c/o not feeling well @ home around 7PM; 1 day hosp stay & d/c to home;
herpes zoster; worsening left back and flank pain; worsening left back and flank pain; This case was reported by a other health professional via call center representative and described the occurrence of herpes zoster in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th August 2022, the patient received the 1st dose of Shingrix. On 18th August 2022, 7 days after receiving Shingrix, the patient experienced herpes zoster, back pain and flank pain. On an unknown date, the outcome of the herpes zoster, back pain and flank pain were unknown.   It was unknown if the reporter considered the herpes zoster, back pain and flank pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 26-AUG-2022 Reporter's Comments: The rporter reported that he/she had a patient that received his first dose of Shingrix. The patient noticed worsening left back and flank pain around 18th Aug 2022 The patient was diagnosed with herpes zoster when he presented for evaluation on 25th Aug 2022 The patient never previously had a case of shingles in the past.  The reporter wanted to know the immunization had precipitated his case of shingles.
Vial was initally stored in refrigrator of 08-jul-2022 and was adminstered on 08-Aug-2022; No adverse event; Patient administered vaccine after 30-day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-jul-2022 and was adminstered on 08-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 3-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 08-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-jul-2022 and was adminstered on 08-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-jul-2022 and was adminstered on 08-Aug-2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date) and PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-jul-2022 and was adminstered on 08-Aug-2022).    No concomitant medication was reported.  On 08-Jul-2022, the vials were initially stored in the refrigerator.  Vial did not undergo any temperature excursions.  The healthcare professional was not aware of any symptoms for any patient after the vaccine was given.  No treatment medication was reported.
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed/Sweating-Mild, Systemic: Weakness-Mild, Additional Details: FOLLOWED UP WITH PATIENT AT 6:30P ON 05/02/2021. DAD SAID PATIENT IS DOING OK NOW. HE EATS AND TALK NORMALLY.
she had been feeling dizzy "like if she had been drinking" and lightheaded,  and today this symptoms are more intense than yesterday; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (she had been feeling dizzy "like if she had been drinking" and lightheaded,  and today this symptoms are more intense than yesterday) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004m20a) for COVID-19 vaccination.     Concomitant products included CLONAZEPAM for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced DIZZINESS (she had been feeling dizzy "like if she had been drinking" and lightheaded,  and today this symptoms are more intense than yesterday). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, DIZZINESS (she had been feeling dizzy "like if she had been drinking" and lightheaded,  and today this symptoms are more intense than yesterday) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
8 days later I developed a rash on the injection site (swollen, red and very itchy) it seemed to be getting better on Saturday 1/9/21 and Sunday 1/10/21, but today Monday around 1:00pm it started to get irritated and very itchy again (it kind of looks like hives today)
Severe urticaria and Angioedema extending all over the arms, legs, waist, torso, face, and head.  Chills, severe pain reactions in foot, sensitivity to heat and cold. swelling of hands, feet, arms and legs.  Shortness of breath.
Red blotches appeared on abdomen about a week after vaccination, started hardening about a week later. Went to urgent care, which referred me to dermatologist, because they could not diagnose the condition.
The patient received the second dose of the moderna vaccine 21 days after the first dose due to scheduling error.
LARGE RED SPOT-WARM TO THE TOUCH  AT INJECTION SITE 06/17/22-06/20/22
PATINET HUSBAND REPORTED TO PHARMACIST THAT SHE HAD ALLERGIC REACTION/RASH TO ALL OVER THE BODY.
Large red rash at spot of injection.  Hot to the touch.  Lump in muscle
Pt broke out in hives in the evening after her second covid vaccine. She applied hydrocortisone cream to  the hives.
Day 10 post vacc - patient reported double vision and blurred vision.  Pt. reported that she had a 1 week plus history of vertigo which resolved with use of a scopalomine patch.  Pt. has had headache but no mental status changes.  Pt. admitted to hospital.
Engerix-B pediatric administered to adult; Engerix-B pediatric administered to adult; This case was reported by a nurse via call center representative and described the occurrence of underdose in a patient who received HBV (Engerix B 10 mcg) for prophylaxis.   On an unknown date, the patient received Engerix B 10 mcg 10 ug. On an unknown date, unknown after receiving Engerix B 10 mcg, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 01-NOV-2022 Reporter's Comment: The reporter was a nurse. The reporter reported that during an audit they found that the Engerix-B pediatric doses were administered to the 5 or 6 adult patients. The vaccine administration facility was the same as the primary reporter. The reporter consented to follow up.  Additional Supportive Information: The adult patients was administered a pediatric dose of Engerix-B, which led to underdose and adult use of a child product. This case had been linked with US2022158132 by same reporter for different patient. Note: The reporter did not know the exact number of patients was 5 or 6 so conservatively this case was processed as master case.; Sender's Comments:  US-GSK-US2022158132:Same reporter
Interstitial cystitis flared up with immense pain in all pelvic region. Flare has continued for 7 months with urgency, burning and pain.  My menstrual cycle has been off with coming more frequently, severe cramping and spotting in between. Have also had burning sensations on skin of leg and arm happens randomly.
7/2/04 0100- Face flushed and hot; sick feeling 0130- Mild facial swelling with red blotches on face; felt "goose egg" in throat 0300- Went to ER; given Claritin, Prednisone and Pepcid. Sent home with prescription for Claritin and Prednisone 0800- Went home and took Benadryl 2000- Flushing of face resumed 7/3/04 0800- Got prescriptions filled and took. 7/4/04- Symptoms stopped
Pt became light headed and dizzy. 911 called. EMS arrived first set of VS normal by EMS, second set BP low, EMS taking hospital when pt became unresponsive, Epi-pen given by EMS and transported to hospital.  Follow up call on Apr 5 found pt was hospitalized and discharged Apr 5th.
Patient is a 32yo male with no significant PMH who presented to the Emergency Department on 5/7 with several hour history of crushing substernal nonexertional chest pain and was found to have acute myocardial injury with normal EKG, concerning for NSTEMI. He was given sublingual nitro (which improved his pain), started on heparin drip and loading doses of DAPT, then admitted to the Cardiology service for ACS rule out. Initial troponin was 0.426 and EKG demonstrated normal sinus rhythm without ischemic changes. Due to rising troponin (peak 1.34), he was taken to cath lab for LHC, which was negative for obstructive CAD or thrombus. His troponin downtrended to 0.929 (then stopped trending). Chest pain resolved on the evening of presentation after administration of nitroglycerin and morphine without recurrence during the duration of his stay. Leading differential for acute myocardial injury is myocarditis rather than NSTEMI given clean LHC, but due to potential for ischemic event not detected by LHC, DAPT will be continued until further evaluation with Cardiac MRI. He has pending viral panels and serologies to work-up cause of possible myocarditis, and scheduled to undergo cardiac MRI on 5/11 in the morning. Given patient has remained chest pain free, he is safe for discharge to limited duty (no strenuous physical exertion) and follow-up tomorrow morning for cardiac MRI and follow-up in Cardiology clinic to be scheduled pending results of MRI.
November 20, 2007: Received Zostavax vaccine from Pharmacy.  Vaccine shot given same date at doctor's office by his nurse. On or about May 25, 2008, noticed red blotches on upper left side of chest and front and back of her neck.  On May 28, 2008 M.D. confirmed diagnosis: Shingles and provided Rx for seven days.  Scabs fell off within next 45 days.  Redness of skin (caused by scabs) now not noticeable.
Fever 100.6F, joint ache, myalgia, fatigue, chills.
Received Moderna vaccines on 2/4, 3/5/21 COVID-19 positive by PCR on  1/3/22 admitted to hospital 1/10-1/14/22 for complete AV Block, COVID-19 pneumonia.
Pt received Varicella vaccine 10/05/2005 SC on Left arm. Pts mother noticed area was red on 10/06/2005, area increased redness on 10/07/2005. On exam area was red, raised and warm to touch, Child complained of itching in the localized area. Area measured 5.4 x 3 cm induration. Child was examined by Dr.
Once PNEUMOVAX 23 inj. 25/0.5 was administered that is when the problem began. First started with blood clot, bumps in arm, pain and immobility of arm. On 7/1/15 Pneumonia shot was administered in my local pharmacy with referral from my doctor. Same day left developed blood clot. Excruciating pain developed and immobility to use arm occurred.
immediately after getting shot patient reposted a hot chest, described as a hot flash. She remained seated and then described tingly, weak limbs, I did ask her if she was nervous, she does have anxiety and was nervous about getting the vaccine.  patient left store after 20 mins feeling better.