chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reports on 10/3/12 was experienced temple soreness, hypotension, heart palpitations, icy cold/warm feeling, body achiness of entire body and chest/back/shoulder and legs were achy and weak.
Information has been received from a physician concerning a 26 month old male patient, with no known drug reactions/allergies and no pertinent medical history, who on 02-APR-2009 was vaccinated with PNUEMOVAX (Lot #657525/0554U), intramusculary in the right thigh. Concomitant suspect therapy included PEDVAXHIB (manufacturer unknown) (right thigh) and hepatitis B virus (left thigh), given on 02-APR-2009. Other concomitant therapy included POLIOVIRUS vaccine (left thigh), given on 02-APR-2009.  The patient's parents called because the child had a fever and vomited. The right leg was swollen and the child could not walk. The patient was supposed to get PREVNAR but instead received PNEUMOVAX. The parents would be seen the physician. At the time of the report, the patient had not recovered. The parents would be seen the physician. Follow up information has been received from a physician concerning a 26 month old male with no pertinent medical history reported and no illness at the time of vaccination who on 02-APR-2009 at 2:30pm was vaccinated intramuscularly in the right thigh with a first dose of PNEUMOVAX (Lot # 657525/0554U). The physician reported that on 02-APR-2009 at 6:00pm the patient experienced thigh pain and fever. Subsequently, the patient recovered from these events on 03-APR-2009.  Additional information is not expected.
the platelet level was 101,000; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the second dose of bnt162b2, via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2, via an unspecified route of administration on 10Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Recently physician ordered screening labs prior to a medication initiation and the platelet level was 101,000. The platelets were noticed to be clumped in the lab tube, this is being repeated. Her physician is performing follow-up testing in 2 weeks. The outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Menactra vaccine has been dispensed for the use on a 60 year old consumer, no AE; Initial information received on 16-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 60 years old patient who was dispensed vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number and Exp. Date not reported), on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a potential medication error case due to product dispensing error.  It was reported that the Menactra vaccine has been dispensed for the use on a 60 year old consumer.   It was unknown if the consumer has been administered this vaccine at the time of this report.  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.  Information on the batch number was requested.  List of documents held by sender: none.
Vaccinator states that she "likely used an empty injection device and that the patient most likely did not receive the vaccine. Vaccinator further states that patient came into the bay with 2 siblings. When she had completed the immunizations and they went to the observation area, she found her count still had one additional dose. She believes she used the empty syringe, previously given to the sister and that patient did not receive his vaccine. She immediately spoke with the medical coordinator for the POD and explained the situation. We spoke with the patients father as well as our on site pediatric medical consultant. The consultant felt that the dose should be re-administered at two to 4 weeks. The father was reluctant to commit to a second dose if there was any chance at all that his son had received the vaccine. Medical coordinator spoke with Pfizer rep who cited ACIP as recommending another dose ASAP. She also spoke to the patients mother who wanted 100 percent proof that he had not received the vaccine prior to giving him another dose. She was advised to follow up with patients pediatrician who could order quantitative antibody bloodwork as well as advise her moving forward as that office is now giving Pfizer vaccine as well.
Acute portal vein thrombosis; This literature-non-study case was reported in a literature article and describes the occurrence of PORTAL VEIN THROMBOSIS (Acute portal vein thrombosis) in a 34-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   No Medical History information was reported.  On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PORTAL VEIN THROMBOSIS (Acute portal vein thrombosis) (seriousness criterion medically significant). At the time of the report, PORTAL VEIN THROMBOSIS (Acute portal vein thrombosis) outcome was unknown.      For mRNA-1273 (Spikevax) (Unknown), the reporter considered PORTAL VEIN THROMBOSIS (Acute portal vein thrombosis) to be related.    No concomitant and treatment medications were reported.  Patient had no significant risk factors for pathologic clotting and was diagnosed with an acute portal vein thrombosis several days after receiving the Moderna COVID-19 vaccine.  Company comment: This literature-non-study case concerns a 34-year-old, female patient with no significant risk factors for pathologic clotting and no other medical history information provided, who experienced the unexpected serious (medically significant) AESI of portal vein thrombosis. The event occurred several days after the 2nd dose of mRNA-1273 and outcome of event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This literature-non-study case concerns a 34-year-old, female patient with no significant risk factors for pathologic clotting and no other medical history information provided, who experienced the unexpected serious (medically significant) AESI of portal vein thrombosis. The event occurred several days after the 2nd dose of mRNA-1273 and outcome of event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Allergic reaction; hives throughout his face, trunk, legs, and top of feet; Erythema throughout his face, trunk, legs, and top of feet; Initial information regarding an unsolicited valid non-serious case was received from a health care professional via a consumer/non-health care professional via Global Medical Information (Reference number- 00862288) and transmitted to Sanofi on 17-Nov-2021.  This case involves a 32 year old male patient who had allergic reaction (hypersensitivity) with associated symptoms hives throughout his face, trunk, legs, and top of feet (urticaria) and erythema throughout his face, trunk, legs, and top of feet (erythema) after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient had no concomitant vaccination.   On 02-Oct-2020, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7006NA and expiry: 30-Jun-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  On 02-Oct-2020 the patient developed a non-serious allergic reaction (hypersensitivity) with associated symptoms hives throughout his face, trunk, legs, and top of feet (urticaria) and erythema throughout his face, trunk, legs, and top of feet (erythema) on the same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported "Caller states that he had an allergic reaction to the FLUZONE QIV vaccine when he received it on 02-Oct-2020. The symptoms included hives and erythema throughout his face, trunk, legs, and top of feet. The symptoms persisted for 1 week. Caller wanted to know if there was any information available regarding changes made to the FLUZONE QIV vaccine from the 2020 season to the 2021 season so that he could possibly identify what he was allergic to. Caller asked for information on the product composition of FLUZONE QIV from 2019. Caller states that he does not have egg or protein allergies and asked what additional information was available regarding FLUZONE QIV and other types of allergies."  No laboratory data was reported.  The patient was treated with BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE] and METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL) for Hypersensitivity.  On an unknown date, the patient had recovered from the event.
Sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: Sick). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 13-JUL-2023 This case was reported by consumer via interactive digital media. The reporter reported that his/her friend got the shots it made her sick.  Follow up was not possible, as no contact details were available. This case was linked with case US2023AMR097176 with same reporter.; Sender's Comments:  US-GSK-US2023AMR097176:same reporter
Twinrix late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 69-year-old male patient who received HAB (Twinrix) (batch number 327E3, expiry date 14-MAY-2025) for prophylaxis.   Previously administered products included Twinrix (first dose was received on 12th October 2022).   On 27-MAR-2023, the patient received the 2nd dose of Twinrix. On 27-MAR-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Twinrix late second dose). The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 03-APR-2023 The reporter consented to follow up via fax. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Initial information received from a health care professional on 08 August 2008. A 28 year old female patient with no reported medical history received an injection of ADACEL (C2994BA) intramuscularly in the left deltoid on 05 August 2008. On 06 August 2008 she experienced diarrhea, chills, and a fever. She was seen on 07 August 2008 and she had 8x4 cm area of redness and demarcation. The patient was started on Bactrim DS. She was seen again by her doctor on 08 August 2008. Her symptoms persisted, although she was afebrile during this visit. The area of redness and demarcation was noted as 9x5 cm at the visit. The doctor's impression was that the area appeared to resemble Erysipelas. The patient was sent to the ER for further evaluation and labs. The patient had not recovered from the events at the time of the report. Follow-up information was received 13 October 2008 from a health care professional. The reporter completed the date field located in box eight of the VAERS form and entered a date of 08 August 2008 in that field. The patient had no illness at the time of vaccination and per the reporter, the patient recovered from the event on 11 August 2008. No additional information was provided at the time of the report. Follow-up information received on 01 December 2008 from a physician. Per the reporter, the patient was seen for evaluation in the physician office on 08 August 2008 and was subsequently evaluated in the emergency room that same day and again on 09 August 2008. The patient was diagnosed with cellulitis and received corrective treatment with intravenous Ceftriaxone. The patient recovered on 11 August 2008. Per the reporter, the case was reviewed and there is no further information to provide. Documents held by sender: None.
Rough night; Feeling terrible; Fever; Chills; Headache; Tinging in the arm of injection; loss of sensation in the arm of injection; This spontaneous case was reported by a pharmacist and describes the occurrence of INJECTION SITE PARAESTHESIA (Tinging in the arm of injection), INJECTION SITE HYPOAESTHESIA (loss of sensation in the arm of injection), SLEEP DISORDER (Rough night), MALAISE (Feeling terrible) and PYREXIA (Fever) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 08-Jan-2021, the patient experienced INJECTION SITE PARAESTHESIA (Tinging in the arm of injection) and INJECTION SITE HYPOAESTHESIA (loss of sensation in the arm of injection).   On an unknown date, the patient experienced SLEEP DISORDER (Rough night), MALAISE (Feeling terrible), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency.   At the time of the report, INJECTION SITE PARAESTHESIA (Tinging in the arm of injection) and INJECTION SITE HYPOAESTHESIA (loss of sensation in the arm of injection) had resolved and SLEEP DISORDER (Rough night), MALAISE (Feeling terrible), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.      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.   Concomitant product use was not provided by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 13-Jan-2021: Patient's information updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Child started with sneezing and then developed a generalized rash and urticaria. Treatment included Oxygen, 18.75 mg of Diphenhydramine HCl, and ORAPRED 15mg orally. Child observed in office for over 1 hour.
Chill, severe body ache, minor fever for two days minor body ache and Headache in day 3. Extreme fatigue in day 4
The first dose I was lethargic and was injected in my right arm. The second dose was injected into the left arm and I had an allergic reaction. The injection site was itchy, red, and produced a rash. After the itching went away, I was left with a faint black mark on my arm. Also, I noticed that the left side of my chest felt different. Some days I feel light pressure and it's relieved when I'm laying down. The pressure is on and off.
She was weak; Fever; Chills; She vomited; Rashes around injection site; Itchiness around injection site; Redness around injection site; So tired; She felt like vomiting; Elevated blood sugar at 365; Felt sick; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Elevated blood sugar at 365), ILLNESS (Felt sick), ASTHENIA (She was weak), VACCINATION SITE PRURITUS (Itchiness around injection site) and VOMITING (She felt like vomiting) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN and LISINOPRIL for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced BLOOD GLUCOSE INCREASED (Elevated blood sugar at 365), ILLNESS (Felt sick), VOMITING (She felt like vomiting) and FATIGUE (So tired). On 22-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness around injection site), VACCINATION SITE ERYTHEMA (Redness around injection site) and VACCINATION SITE RASH (Rashes around injection site). On 14-Mar-2021, the patient experienced ASTHENIA (She was weak), PYREXIA (Fever), CHILLS (Chills) and VOMITING (She vomited). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BLOOD GLUCOSE INCREASED (Elevated blood sugar at 365), ILLNESS (Felt sick), ASTHENIA (She was weak), VACCINATION SITE PRURITUS (Itchiness around injection site), VOMITING (She felt like vomiting), VACCINATION SITE ERYTHEMA (Redness around injection site), FATIGUE (So tired), PYREXIA (Fever), CHILLS (Chills), VOMITING (She vomited) and VACCINATION SITE RASH (Rashes around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
My oxygen saturation also fell to a low of 93 when it's usually 96-97; shortness of breath; chest pressure; my resting pulse surged to 98 to 114 over the next 3 hours. My resting pulse is usually 75; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received second dose of BNT162B2 (Pfizer COVID-19 vaccine, Solution for Injection, Lot number: EN6200), via an unspecified route in the left arm on 27Feb2021 at 15:30, as a single dose for covid-19 immunization. Patient medical history included polycythemia vera and known allergies to NSAIDS, citrus, caffeine. Patient concomitant medications included irbesartan, atorvastatin, omeprazole and acetylsalicylic acid (BABY ASPIRIN). Patient historical vaccine included first dose of BNT162B2 (Pfizer COVID-19 vaccine, Solution for Injection, Lot number: EL9261), in the left arm on 06Feb2021 at 15:30, as a single dose for covid-19 immunization. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 28Feb2021 at 12:15, approximately 20 hours after my 2nd Covid vaccine shot, patient experienced chest pressure, shortness of breath and resting pulse surged to 98 to 114 over the next 3 hours, his resting pulse is usually 75. Her oxygen saturation also fell to a low of 93 when it's usually 96-97. Patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included resting pulse surged to 98 to 114 his resting pulse is usually 75 and oxygen saturation also fell to a low of 93 when it's usually 96-97 on 28Feb2021. The clinical outcome of the events was recovering as by 42 hours after the shot, patient was pretty much back to normal although he had some lingering chest pressure and resting pulse was now in the low 80's.  No follow up attempts are possible. No further information is expected.
Pt received the Bivalent Moderna Vaccine - he has 3 Moderna previous to this vaccine Pt reports Bilateral tinnitus apprx 8 hrs after receiving vaccine.  Pt went to Audiologist on Thursday 10-20-22 2 days after vaccination).  Received high dose prednisone taper (10 days taper)
After my second dose of the Phizer vaccine I had a prostate infection. It took a few months to fully diagnosis. I first went to my general practitioner with testicular swelling. I was placed on an antibiotic. The swelling and tenderness did not fully go away. I then had a sonogram and a follow up appointment with a urologist.  It was determined with a prostate examine that I had a prostate infection that required a longer dose of antibiotics. This resolved the issue. I received my second dose in on 04-01-2021. The prostate infection was finally resolved in November of 2021. I received the booster vaccine 01-03-2022. Within 2 days of receiving the booster vaccine I am having the same side affects of a prostate infection as earlier in the year that were resolved with antibiotics. My urologist described a "burning or irritation" when urinating after ejaculation as a tell tale sign of a prostate infection. This is the same feeling I am having again after the booster vaccine.
A non-serious spontaneous report of administration of expired FLUMIST was received from a physician concerning a four-year-old patient. Neither relevant medical history nor concomitant medications have been reported for these patient. The product expired in 11-Dec-2011. The patient received the expired FLUMIST 20-Dec-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. There was no late occurring adverse event reported was added.
Initial information received from a consumer (the patient) on 09 December 2013. A 61-years-old patient had received a dose of 2.5 ml of FLUZONE (dose number, route, and site of administration unknown) on 09 December 2013. The patient had a lifetime (since childhood) history of egg allergy. At one paint, the patient used to keep in Epi-Pen handy and have been in the ER several times in lifetime due to inadvertent consumption of food with egg ingredients. Over the past 5 years or so, tolerance to eggs has improved such that the patient kept away from actual eggs but have been able to eat such things as bread crumbs that have eggs listed as an ingredient with no ill effect.  The patient also never had a problem with food that was "manufactured or equipment that processes eggs" etc. Prior to 2012, the patient had never received a fu shot. However, was motivated to look into getting a flu vaccine by a high local incidence of flu last year. After doing some online research the patient came across a study. It gave enough  personal confidence to get a FLUZONE vaccine from a local pharmacy by not admitting allergy to eggs. On an unspecified date, the patient experienced nausea. Laboratory tests and corrective treatment were not reported. At the time of this report, the outcome was unknown. Documents held by sender: none.
DEVELOPED HEAVY COUGH WITH PHLEGM WITHIN 24 HOURS OF VACCINE. DEVELOPED INTO AN INFECTION WITH A FEVER OF 102.
1 week after receiving Senior Flu Vaccine I had total body aches--particularly in fingers--diarrhea, headaches, fatigue. Dr took stool sample but no results yet (been waiting since Oct 8th). Gave me prescription for Immodium which helped and then constipated me. I took 400 mg of Ibuprophen every 6 hours which did not help at all. Ongoing now for 3 weeks.
Per pt " around 7 pm I felt like my throat was tighter, almost like I had a lump in my throat, then it felt scratchy. Around 8 pm I started itching really bad and broke out in hives"