chrisvoncsefalvay/vaers-outcomes huggingface dataset:
approx 19days p/vax pt exp a large vesicular lesion on the face. 5dec98 pt devel more lesions (40-50) on body & throat.
My daughter began complaining of left leg pain while playing outside on the swing set. We thought she hurt it possible from a fall, but as she was complaining and we began to look, her left thigh was extremely swollen compared to the right and the mid thigh (site of vaccination) was very red, raised, and warm to the touch.  We tried icing the area, but as time passed she complained of more pain and starting limping and wanting my husband and I to carry her so she did not have to bear weight on the left leg.  The next morning, 08/30/2015 she immediatley began complaining of pain and I noticed the redness had spread and the entire thigh and knee were swollen by at least 150%.  She continued to limp and I took her an after hours doctor at 8:00 PM to have it evaluated. We drew markings around the reddened area and I was advised to use warm compresses instead of ice. As of 9/01/2015, she began walking normally again and the redness and swelling had decreased some, but the site of injection was still red, feels hard, and warm to the touch.  As of today, 09/02/2015, the redness and swelling has decreased a little more, but the injection site is still hard, red and slightly warm to the touch. She is only complaining of pain directly at the injection site now instead of complaining of the whole leg. We are continuing to use a warm compress which does make the site feel softer temporarily.
Patient received her Pfizer COVID booster on 12/22/2021 and suffered a CVA the next day.
Child only received Dtap and IPV component of the pentacel; Client did not received HIB component; The nurse did not mix vaccine per the manufacture's guideline. Per communication with the immunization consultant, HIB portion of pentacel was wasted; child was given HIB single dose during child health visit on 12/6/2022;  Immunization records updated accordingly.
Patient called two days after vaccine admin and stated she had a rash near injection site and soreness at injection site.
No addtional AE; Expired MMR II was administered to a patient; This spontaneous report was received from a other(office manager) referring to a patient of unreported age and gender. The patient's pertinent medical history, and drug reactions or allergies were not provided. Concomitant therapies included sterile diluent (STERILE DILUENT).  On 26-JAN-2022, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (rHA) (M-M-R II) 0.5 milliliter, (expired product administered) (lot number T001212, expiration date 12-JAN-2022; vaccination scheme, route of administration, and anatomical location of vaccination were not reported) for prophylaxis. The vaccine did not have any prior temperature excursion.   No product quality complaint (PQC) and no additional adverse event (AEs) (no adverse event) was reported.
On 07/13/11 about 7:15 am pt got out of the shower and noticed "redness" & "pain in (L) outer upper arm. On 07/14/11 about 3:50 pm. Pt seen at clinic - erythema in (L) outer upper arm 3 in wide x 2 in long, slight swelling & c/o tenderness. Patient and her mother were advised to consult with medical provider if signs/symptoms increase or worsen. Pt's mother was advised by supervising PHN to administer over-the-counter BENADRYL, and to apply a cold pack over the site, but making sure to avoid direct contact with skin. On 07/15/11 follow-up phone conversation with pt's mother. Reported that pt. took BENADRYL at bedtime on 07/14/11, and "redness" seems now to be improving.
13 weeks pregnant, recently diagnosed low platelet count  Sudden fever, stomach ache, Dizziness, feeling faint, diarrhea, nausea (unrelated to pregnancy symptoms)
body aches starting 6 hours after injection lasting 4 hours; headache within 15 minutes of injection; Sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist). The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 28Feb2021 10:30 (Lot number: EN6201) at the age of 67 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Lung Sarcoidosis" (unspecified if ongoing); "HTN" (unspecified if ongoing); "Obesity" (unspecified if ongoing). Concomitant medication(s) included: HCTZ; FAMOTIDINE; VIT D [VITAMIN D NOS]. Past drug history included: Ibuprofen, reaction(s): "Allergy"; Atropine, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (administration time=10:30 AM, vaccine location=Left leg, dose number=1, event on 07Feb2021), administration date: 07Feb2021, when the patient was 67 years old, for covid-19 immunization, reaction(s): "headache within 15 min of injection", "body aches starting 6 hrs after injection lasting 8 hrs", "sore arm", "vaccine location Left leg". The following information was reported: HEADACHE (non-serious) with onset 28Feb2021 10:45, outcome "recovered" (2021), described as "headache within 15 minutes of injection"; PAIN (non-serious) with onset 28Feb2021 16:30, outcome "recovered" (28Feb2021), described as "body aches starting 6 hours after injection lasting 4 hours"; PAIN IN EXTREMITY (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "Sore arm". Therapeutic measures were not taken as a result of headache, pain, pain in extremity.  Additional information: Patient had no other vaccine within four weeks. Patient had no covid prior vaccination. Patient was not tested for covid post vaccination. Headache within 15 min of injection, body aches starting 6 hours after injection lasting 4 hours both doses: sore arm 24hour.  No follow-up attempts are possible. No further information is expected.
pt w/t106.6 @ 1210 dusky nails, irritable & one eye rolled back transported to hosp via ambulance & admitted;
redness around the injection site; swelling; arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt), VACCINATION SITE ERYTHEMA (redness around the injection site) and VACCINATION SITE SWELLING (swelling) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm hurt). On 25-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness around the injection site) and VACCINATION SITE SWELLING (swelling). At the time of the report, PAIN IN EXTREMITY (arm hurt), VACCINATION SITE ERYTHEMA (redness around the injection site) and VACCINATION SITE SWELLING (swelling) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
red rash at the injection site; itchy at the injection site; warm to the touch at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (red rash at the injection site), VACCINATION SITE PRURITUS (itchy at the injection site) and VACCINATION SITE WARMTH (warm to the touch at injection site) in an 80-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE RASH (red rash at the injection site), VACCINATION SITE PRURITUS (itchy at the injection site) and VACCINATION SITE WARMTH (warm to the touch at injection site). At the time of the report, VACCINATION SITE RASH (red rash at the injection site) and VACCINATION SITE WARMTH (warm to the touch at injection site) had not resolved and VACCINATION SITE PRURITUS (itchy at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.
This is a spontaneous report received from a contactable consumer or other non-HCP. An 8 year-old male patient received the 1st dose of BNT162B2 (Comirnaty, batch/lot# FK5618), at the age of 8, intramuscularly, in left arm, administration date Dec 10, 2021, at 14:00, single dose, for COVID-19 immunisation. Medical history included known allergies to egg (unspecified if ongoing). There were no concomitant medications. The patient reported chest pain/chest pains (medically significant), dyspnea/breathlessness (medically significant) and nasal congestion/blocked/stuffy nose (medically significant), all onset Dec 13, 2021, at 11:30, with outcome of recovered (Dec 2021). Chest pains, breathlessness and blocked/stuffy nose were evaluated at a physician office visit. Patient had no other medical history. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not tested for COVID-19. The patient complained of chest pains and breathlessness at school, but didn't appear to have any initiating event. No food was consumed prior to chest pains. Prior days (since vaccination), patient had blocked/stuffy nose but no coughing. No therapeutic measures taken as a result of chest pain, dyspnea and nasal congestion. Follow-up attempts completed. No further information expected.
Pt recvd vax on 22MAY92 & that evening the pt devel itching sx, flu-like synd, & some difficulty in breathing; next day hive-like rash devel; noted that menstrual period seemed heavier than nl; 26MAY92 recovered;
Vaccine was expired on 11-May-2023 and was stored in referigerator on 04-Jun-2023; No adverse event; Dose to patient on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose to patient on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired), PRODUCT STORAGE ERROR (Vaccine was expired on 11-May-2023 and was stored in referigerator on 04-Jun-2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose to patient on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 11-May-2023 and was stored in referigerator on 04-Jun-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose to patient on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired), PRODUCT STORAGE ERROR (Vaccine was expired on 11-May-2023 and was stored in referigerator on 04-Jun-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose to patient on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired) and PRODUCT STORAGE ERROR (Vaccine was expired on 11-May-2023 and was stored in referigerator on 04-Jun-2023).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. It was reported that no adverse reactions have been reported by any patients. The vial was initially stored in the refrigerator on 4-JUN-2023 and did not underwent any temperature excursions. No treatment medication was reported. This case is reported for patient 24 out of 50 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:master case
4 days after getting MMR and IPV, pt had fever for a day, then 9 days after MMR and IPV pt got fever again and acute redness of right cheek.  When I saw pt, I was concerned about facial cellulitis, given pt's fever, the redness of the cheek and how much hotter it was than the other side.  The redness was in the belly of the cheek and did not seem to be located over the parotid.  A CBC showed a normal WBC of 6.7 with 52% lymphs and 15% atypicals lymphs and 2% blasts.  I put the child on Augmentin.  The next day, I saw the patient and he had no swelling of the cheek at all, the warmth and redness were also gone.  A repeat CBC was WBC 7.3, 68% lymphs, no atypicals or blasts.  This made a bacterial cause very unlikely.
metallic taste in mouth, stomach cramps resolved after approx. 30 minutes, and chills
Immediately nausea followed by lightheadedness and blurred vision. Was able to speak and drink water. Susbsided after a minute. Could?ve been vagal response.
Information has been received concerning a 30 year old female nursing student gravidia 1 para 0, with blood group O, who about 2 weeks after her last normal menstrual period was vaccinated with a dose varicella virus vaccine live because she was varicella susceptible, and as a requirement for her nursing studies. It was noted the patient missed her next menstrual period and was subsequently determined to be pregnant. It was noted the family history for both partners was negative for medical and genetic problems. It was noted the patient was sent for genetic counseling and a targeted sonogram at approximately 15 weeks gestation. It was noted the sonogram showed the following: fetal biometric measurements compatible with gestational age, multiple echodensities in the liver and kidneys of the fetus which had the same echodensity as bone, mild subcutaneous edema of the abdomen but no ascites. It was noted the patient was offered amniocentesis for polymerase chain reaction (PRC) testing of the fluid for varicella, but she declined. It was noted that in view of the sonogram results which showed fetal tissue calcifications and the fetal hydrops, the patient elected to terminate the pregnancy. At the time of the termination, the patient declined to have an autopsy on the fetus and she declined enrollment in the varicella vaccine registry. The patient had the following lab and diagnostic testing done, with the following noted lab results: IgG and IgM for toxoplasmosis, cytomegalovirus, and parvovirus B19 were negative, herpes simplex virus (HSV) IgM was negative, venereal disease research lab test for syphlilis was negative, rubella immune, blood type was O positive and antibody screen was negative. The article noted that although there was no definitive diagnosis because the patient delcined amniocentesis for varicella PCR studies, and declined autopsy of the fetus and analysis of the fetal tissue for varicella virus it appears that the miliary fetal tissue calcifications were possibly due to the administration of varicella virus live during the cycle in which the patient became pregnant. It was noted the other potential causes for fetal tissue calcifications, which included acute infection with TORCH organism, syphilis, HSV, and genetic history were all negative in the patient. The reporter felt that miliary fetal tissue calcifications were possibly due to therapy with varicella virus vaccine live. The reporter also noted that the review of information from of the outcomes of completed pregnancies in the pregnancy registry for varicella virus vaccine from May 1995 to December 1998 indicate there is no report of fetal liver calcifications and hydrops, and to date there has been no reported cases of congenital varicella syndrome post immunization. Additional information has been requested.
1/26 vaccination 2/4 woke up,  I had extremely sore throat. I thought i had strep. Not uncommon to get strep. I went to urgent care to get tested. All tests came back negative for strep, rapid, Covid; negative. 7 days felt unwell. My OBGYN told me I could take Benadryl for congestion, nasal and chest congestion. Upper respiratory infection. Flonase.  2nd pregnancy, DOD 6/23/2021
reports lt arm aches w/needing 3-4 ASA day to alleviate; works into shoulder & into neck by evening; dizziness;
11-30-10 9:30 A.M. FLUZONE .5ml IM 12-1-10 3:00 PM Pt. had chills, headache, stomach cramps 12-2-10 10:00 A.M. Temp 101 degrees - but pt. feeling better pt. was told by RPh to take TYLENOL 500mg 2 q 6h prn fever.
IPOL that was not suitable for use post-excursion to a 4 month old patient, no AE; IPOL that was not suitable for use post-excursion to a 4 month old patient, no AE; Initial information received on 15-Dec-2021 regarding an unsolicited valid non-serious case from a other health professional via Agency (under reference number 00899982).  This case involves a 4 months old female patient who received IPV (VERO) [IPOL] that was not suitable for use post-excursion (product storage error) (poor quality product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included a dose of DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP VACCINE); HIB VACCINE; PNEUMOCOCCAL VACCINE and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for prophylactic vaccination.  The patient's visit on 07-Dec-2021 was a well-baby visit; and the patient has not had any other encounters per her chart.  On 07-Dec-2021, the patient received a 0.5 ml second dose of suspect IPV (VERO) (standard, once in total, lot T1D481M and expiry date:25-Jul-2022) via intramuscular route in the left vastus lateralis for prophylactic vaccination.  It was a case of an actual medication error due to incorrect product storage and poor quality vaccine administered (same day latency).  It was reported "Caller reports that they administered IPOL that was not suitable for use post-excursion to a 4 month old patient. Caller asks: Would the dose of IPOL be considered a valid dose? Should we re-vaccinate the patient? If we need to re-vaccinate the patient, how soon can it be done? Refunds/Credits will not be issued due to adverse events."  Reporter states that the patient did not require any treatment after receiving.  At time of reporting, no adverse event was reported.  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.
Patient sister called on behalf of brother stating that week after patient receiving vaccination patient had a stroke and was taken to Hospital. He has recovered from stroke, however as cold like symptoms and requires otc medications like nyquil.
? Maderna vaccine #1 on 3/16 at clinic ? Provider visit 3/22 dx bronchitis due to COVID-19, z pak and steroids ? ED 3/25 syncopy, full arrest and patient expired patient states she had COVID in February
Patient reported having extreme edema in shoulder and arm, extreme vertigo, sore arm, and extreme tiredness for 6-7 days after vaccination.
Thrombocytopenia: bruising and low platelet counts (5,000) beginning 10/16/2005, 12 days after vaccination. Dis Sum rec'd 10/26/2005, added terms-- petechae, bruising. Med Rec rec'd 10/26/2005 - complete Discharge summary states idiopathic thrombocytopenia. msv
Information has been received from a physician, for VARIVAX (Merck), a Pregnancy Registry product, concerning a female who was vaccinated with VARIVAX (Merck). It was reported that the patient was tested for chickenpox titers and there was no sign of them so the physician started VARIVAX (Merck) series. Then the patient became pregnant around the time she received the second dose of VARIVAX (Merck). No further adverse event information provided. Follow-up information was received from the physician who reported that the patient elected to terminate the pregnancy. No details were provided. Upon internal review, the elective abortion was considered to be other important medical event. Additional information has been requested.
Patient was given a dose of Pfizer vaccine that was not diluted.  Patients mother was notified and patient has had no adverse effects from vaccine.
morning p/date of vax parents found pt in crib weak, unable to stand or sit;took pt to ER;blood work done;pt cont to be weak
Patient developed acute hypoxic respiratory failure requiring more than 24 hours mechanical ventilation and associated with hypotension requiring pressor support.  Patient recovered almost entirely after 48 hours with no residual hypoxia or hypotension.
11 year old received Infanrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old female patient who received DTPa (Infanrix) (batch number 7EC55, expiry date 29th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd December 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 2nd December 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 details were provided as follows: The medical assistant reported that, the 11 year old pediatric patient inadvertently received Infanrix, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
C/o diffuse muscle spasms in mid-back since 10/29/09.
I am a breastfeeding mother. Both times after receiving my Pfizer vaccinations, my infant would projectile vomit my milk the next morning after the vaccine. This would persist for the next 2 days (him either having a heavy amount of spit up or projectile vomiting). Nothing new was taken for him to do this aside from me just receiving my vaccine. This side effect eventually stopped after 48 hours. Because of this, we did not get medically seen as it did not persist after the two days.
Severe chills. Fever, Nausea and Vomiting multiple times. Headache.  No pain at injection site. Began about 8.5 hours after injection. Lasted about 3.5 hours. I get the annual flu shot every year for about 20 years with no side effects, expect sometimes a slightly sore are.. This was VERY different. Shared an evening meal with friends and family - nobody was ill except me. I did a rapid Covid test when was experiencing strong vaccine side-effect - it was negative.