chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   Co-suspect product included non-company product HUMIRA for Plaque psoriasis.   Concurrent medical conditions included Plaque psoriasis (Moderate to severe chronic plaque psoriasis).   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In July 2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had not resolved.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    No relevant concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication reported.   The reporter's causality for the event(s) of COVID-19 with HUMIRA(ADALIMUMAB) was no reasonable possibility.   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.   CC: This spontaneous case concerns a 34-year-old, female patient with a concurrent condition of chronic plaque psoriasis treated with adalimumab, who experienced an unexpected, non-serious AESI COVID-19 in association with a dose of mRNA-1273 vaccine. Exact onset latency of said event relative to vaccination cannot be determined with unknown event's onset date and vaccination date. Vaccination history included one dose of mRNA-1273 vaccine. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's underlying psoriatic arthritis and treatment with adalimumab could predispose the patient to various infectious diseases. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement.; Sender's Comments: This spontaneous case concerns a 34-year-old, female patient with a concurrent condition of chronic plaque psoriasis treated with adalimumab, who experienced an unexpected, non-serious AESI COVID-19 in association with a dose of mRNA-1273 vaccine. Exact onset latency of said event relative to vaccination cannot be determined with unknown event's onset date and vaccination date. Vaccination history included one dose of mRNA-1273 vaccine. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's underlying psoriatic arthritis and treatment with adalimumab could predispose the patient to various infectious diseases. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement.
ITCHY SCALP; EYES SWELL; FEET SWELL; RASH; GENERAL ACHE; CHILLS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced general ache. On APR-2021, the subject experienced chills. On 13-APR-2021, the subject experienced itchy scalp. On 13-APR-2021, the subject experienced eyes swell. On 13-APR-2021, the subject experienced feet swell. On 13-APR-2021, the subject experienced rash. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the itchy scalp, rash, eyes swell, feet swell, chills and general ache was not reported. This report was non-serious.
Fever; A spontaneous report was received from a healthcare professional concerning 98 patients who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the event the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, about 3 or 4 patients out of 98 experienced fever. It was also reported that those patients were fine next day.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   On an unknown date, the outcome of event fever was considered to be resolved.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event of fever, a causal relationship cannot be excluded.
6 year old client that we serviced was recently given a Pentacel vaccine. Since they were given the vaccine over the age indication with no reported adverse event; Initial information received on 08-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 years old and unknown gender patient who was recently given a DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] vaccine since they were given the vaccine over the age indication with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, 6 year old client that we serviced was recently given a pentacel vaccine. since they were given the vaccine over the age indication with no reported adverse event (product administered to patient of inappropriate age) (latency: same day)(Suspension for injection) (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunization). Information on the batch number was requested.   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.
pt states the next day she had a painful left arm.  She had a developed a red rash on her neck.  She noticed a red rash on upper part of her right chest area.  After she showered she noticed another red patch of bumps in other areas on her body.  It is now more like hives and itching.  The rash if from her scalp to her feet.  Pt will contact her PCP.
patient developed hives to arms, torso and legs following administration of vaccine, no other symptoms reported; Benadryl administered x2 (25mg @ 8:28 AM and 25mg @ 9:11 AM). Patient observed for 1.5 hours after start of reaction with no additional symptoms noted. Patient's mother aware, left in care of school nurse after observation period.
Child who was verbal became non-verbal total 180 degree in personality. Flapping, screaming, biting people, no sleeping for 2-4 days.
Patient's reaction(s) noted during COVID vaccine observation period: Pt states that after 17 minutes of receiving the Covid vaccine she developed feeling of lips tingling and tongue "prickly".  She denies SOB or dysnpea.    1533: 180/74, HR 59, O2 98% 1544: 144/67, HR 60, O2 99%; states that her lips and tongue have stopped tingling and feel back to baseline.    Actions Taken: Pt states that she is fine to drive home.    Disposition: Patient declined ED visit
Rash on face, arms and legs which later included swelling and purple extremities and lips.
I was really sick for 2 days after taking it; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced sickness (Verbatim: I was really sick for 2 days after taking it).  The outcome of the sickness was resolved (duration 2 days).   It was unknown if the reporter considered the sickness to be related to RSV vaccine.     It was unknown if the company considered the sickness to be related to RSV vaccine.   Additional Information: GSK receipt date: 28-SEP-2023 This case was reported the patient via interactive digital media. The patient reported that the shot was not for everyone as an adult.  The patient was really sick for 2 days after taking the vaccine. Follow-up not possible as no contact details provided.
Soreness, knot (local) slightly red size of 50 cent piece, pinkish and raised.
cardiac arrest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the parent.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC ARREST (medically significant), outcome "unknown". Clinical course: She also mentioned that the Pfizer vaccine didn't work and she said that her son who was forced to take the Pfizer vaccine got cardiac arrest.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient reported he requested Moderna as his booster of choice after a primary injection of Johnson & Johnson. Staff, with an additional staff witness, report that protocol was followed and the participant was asked at check-in and at point of injection which booster he preferred, to which he replied Johnson & Johnson.  However, after injection, participant approached staff and stated he got the wrong shot.
Bilateral knee pain occurred about 3 weeks after vaccine Psoriasis type patch of rash on left lower abdomen 2 1/2 " X 1" occurred a couple of days after vaccine  Also experienced Psoriasis type patch of rash on left thigh about 1"X 1 1/2 " about 2 days after 1st vaccine. Date of 1st vaccine 1/13/2021
This case was retrieved via a search of scientific literature on 11 November 2011. The reporter for this case is the same as in case numbers: 2011-11264, 2011-11265, 2011-11267, 2011-11272 and 2011-11371. Verbatim form the abstract: "Background: Tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine was not licensed for use in adults aged greater than or equal to 65 years due to lack of sufficient efficacy and safety data. Objective: To characterize reports to the Vaccine Adverse Event Reporting System (VAERS) among adults aged greater than equal to 65 years who received Tdap vaccine 'off label' to assess for potential vaccine safety concerns. Methods: We searched VAERS for reports of adverse events (AEs) in subjects aged greater than or equal to 65 years who received Tdap vaccine from 9/1/2005 to 9/08/2010. Medical records were requested for all reports cases as serious (death, hospitalization, prolonged hospitalization, permanent disability, life-threatening illness). Proportional reporting ratio (PRR) was used to assess for higher proportionate reporting for AEs after Tdap compared with Td reports in subjects aged greater than or equal to 65 years. Results: VAERS received 243 reports following Tdap administered to persons aged greater than or equal to 65 years. Eleven (4.5%) reports were serious, including two deaths. Most common AEs were local reactions in 100 (41.2%) reports. Seventy-eight (32.1%) reports contained coding terms that denoted inappropriate administration of vaccine. 'Cough' was the only term associated with disproportionately higher reporting after Tdap compared with Td. Six of seven Tdap reports containing the term 'cough' were non-serious. Clinical review of serious reports identified no unusual patterns of AEs. Conclusion: Our VAERS review of the 'off-label' use of Tdap vaccine in adults greater than or equal to 65 years did not find any safety concerns that warrant further study. These data will provide useful baseline information to assist CDC and FDA with monitoring efforts as permissive recommendations for Tdap in older persons are adopted." A 67-year-old female patient had received Tdap (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later was diagnosed with Bells Palsy. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: None.
Incorrect vaccines given to patient.  This error was due to a language barrier and improper double checking/understanding  of patient identifiers.   Follow up by provider at time of incident, a telephone call/discussion later that afternoon and again 2 days latter.  Mother reported no abnormal signs or symptoms.
Information has been received from a medical assistant referring to an unspecified number of unspecified patients. Information about concurrent condition, concomitant medication and medical history was not provided. On 29-OCT-2016, PNEUMOVAX 23 (lot# L013428, expiration date 03-FEB-2016; dose, frequency and route were unknown) were exposed to temperatures outside of the recommended range. The vaccines were exposure to 52.9 Fahrenheit for 15 hours. There was no previous temperature excursion reported. The incorrect storage of vaccines was not found by a digital data logger. Doses of the vaccine had been administered to unspecified patients on unspecified dates since 29-OCT-2016. The doses were not administered after the expiration date. No adverse experiences had been reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA014768.
RIGHT DELTOID WAS SWOLLEN, RED, HOT FOR 2 WKS AFTER VACCINE WAS GIVEN 10-27-2011. NO TREATMENT WAS GIVEN.
COVID-19; They are sick and not doing well; They are sick and not doing well; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (COVID-19), ILLNESS (They are sick and not doing well) and MALAISE (They are sick and not doing well) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.  No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19), ILLNESS (They are sick and not doing well) and MALAISE (They are sick and not doing well). At the time of the report, COVID-19 (COVID-19), ILLNESS (They are sick and not doing well) and MALAISE (They are sick and not doing well) outcome was unknown.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Patient received booster dose of Moderna. No treatment medications were reported.  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. This case was linked to US-MODERNATX, INC.-MOD-2022-623837 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2022-623837:mother case.
This patient seen for a general physical on October 27, 2020. There she was administered HPV vaccine #2 of 2 and her annual flu vaccine. She came back in November 6th with a chief complaint of fatigue and pallor and foul-smelling urine. She had a history of recurring urinary tract infections without typical symptoms (In other words she did not have urinary frequency or dysuria). She was afebrile. Mom noticed that she seemed pale and so we had a CBC which was unremarkable and she had a urine analysis which at that time showed large bilirubin In the urine however that fact was missed at the time of the evaluation because there were also a lot of other markers suggesting a urinary tract infection and she had a urine culture on a clean catch specimen which showed greater than 100,000 E.coli. She was started on cefdinir. She did have a UTI but I missed the fact that she had elevated (large) bilirubin on her urine thus I think her pallor was actually mild jaundice. She came back several days later when it became clear that rather than being pale she was actually jaundiced as the parents noticed that her eyes were yellow. We proceeded to undertake an evaluation of liver function and she clearly had acute hepatitis. Detailed laboratory evaluation eventually followed by a biopsy confirmed she had type I acute autoimmune hepatitis and she was hospitalized for further evaluation and management. What is interesting is that 1 year prior when she also received HPV vaccine and also had an influenza shot she had come in a couple of weeks later with a chief complaint of diarrhea and abdominal pain and at that time we did comprehensive metabolic panel which showed a mild elevation of liver enzymes, there was also a CBC and overall at that time my assessment was a viral enteritis with mild elevation of liver enzymes these elevations at that time were so mild that I did not feel they deemed follow-up as it is not uncommon to see slight elevations of liver enzymes during viral gastric infections. Thus both times that she received HPV and influenza vaccines she came in sick soon thereafter and both times we were able to demonstrate that there was some hepatic inflammation however with the second dose the inflammation was much more severe. My concern is that this patient may have had a vaccine triggered autoimmune hepatitis. She is now being treated with steroids and azathioprine and the long-term prognosis is unknown. Infectious etiologies have been ruled out and the overall picture is very clearly of autoimmune hepatitis. Whether this would have happened with or without the vaccine of course is unknown. There is at least one case report of a type II autoimmune hepatitis associated temporally with HPV vaccine published.
Starting day of vaccination  I have been having pain in deltoid muscle causing pain when I use my arm; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old patient of unknown gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the arm right on 27Feb2021 at 13:00 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included central respiratory depression, migraine, chronic pain, arm dry, reflux, non allergic rhinitis, cholesterol, back surgery^5, knee total replacement, and Rx L Tibia ORIF. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ATENOLOL; PROTONIC, AREDS2 and VITAMIN D3, all from an unknown date for an unknown indication and unknown if ongoing. The patient previously took EFFEXOR, STATINS. ACE INHIBITORS, and AMBIEN, and experienced drug allergy. On 27Feb2021 at 17:00, the patient experienced had been having pain in deltoid muscle causing pain when using arm. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of pain in muscle and included treatment with pain medications. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pain in muscle was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On 13-OCT-2014, an unspecified number of patients were vaccinated with improperly stored ROTATEQ lot # K001716, expiration date: 24-NOV-2015, oral (dose was not reported). No symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Patient expired 02/06/2021. COD as ruled by Coroner "Hypertensive and Atherosclerotic Cardiovascular Disease."
Information has been received from a registered nurse concerning a female consumer who on 25-MAR-2008 was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, on 27-MAR-2008 the patient experienced swelling, redness, warmth and pruritis at the injection site. Medical attention was sought, the patient called the office. It was unspecified if lab studies were performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.
Flu-like, fever, muscle pain, headache, fatigue, ear ache, swollen and painful arm at injection (swollen to baseball size), swollen and painful arm pit, insomnia, chills
04/22/2022 vaccination. 06/22/2022 I woke up feeling congested, solid consolidation in my chest. Short of breath and hard to walk to bathroom. The fever stayed below 103 but in the 100's. I contacted my physician. My family had to drive over from another city to deliver the medication which I took the next morning. I had a pulse ox, as well. I was prescribed PAXLOVID a half dose. That last dosage, I feel asleep so much I had to take the last dose the following day, on the 6th.
16 year old who received the Moderna COVID-19; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old who received the Moderna COVID-19) in a 16-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old who received the Moderna COVID-19). On 05-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old who received the Moderna COVID-19) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This report refers to a case of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE for mRNA1273 with no associated adverse events.; Sender's Comments: This report refers to a case of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE for mRNA1273 with no associated adverse events.
Hives (waist up) itching. Since Fri 7/8/11. Given ZYRTEC and advised to take BENADRYL at night. No respiratory issues.
Pt recvd 1st dose of Hep B vax on 9APR92 & on 10APR92 devel a middle ear infect & dizziness;
Breakthrough COVID case: Scratchy cough which became more productive with snot. The snot was a real thick consistency. Cough went through for about 8 days. Extreme fatigue. I still have fatigue. I still have snot. Not even a post nasal drip but I will cough up junk. I take Mucinex to help with that.