chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the lower half of her right eye is bloodshot; It is just sort of red; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR HYPERAEMIA (the lower half of her right eye is bloodshot) and OCULAR HYPERAEMIA (It is just sort of red) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 immunisation.     Concomitant products included ALLOPURINOL (ELAVIL [ALLOPURINOL]), LISINOPRIL, AMITRIPTYLINE, LORAZEPAM and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced OCULAR HYPERAEMIA (the lower half of her right eye is bloodshot) and OCULAR HYPERAEMIA (It is just sort of red). At the time of the report, OCULAR HYPERAEMIA (the lower half of her right eye is bloodshot) and OCULAR HYPERAEMIA (It is just sort of red) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product includes blood pressure medication. No treatment was provided.
Almost 4 y/o with speech and dev. delays refused to walk after 4 y/o shots. Mother states she was weak, could not climb stairs or get in bed. After this legs were giving out. We rechecked at 48 and 72 hr. SX had resolved.
This spontaneous report was received from a healthcare professional refers to a unspecified number of unspecified patients of unknown age and gender. No medical history and concomitant medications were reported. On an unknown dates, the patients received improperly stored doses of M-M-R II (lot # J016235, expiry: 19-DEC-2015 and Lot# K010319, expiry: 22-JUL-2016). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt got vaccines DTaP/IPV/Comvax and Prevnar around 10:45am, cried with breath holding spells for long period till 3:30pm. Then calmed down.
had the first dose / has not had the second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in August 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follows:  The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix which led to incomplete course of vaccination. The reporter consented to follow up.
Pfizer vaccine was administered outside of source - reported by patient- ? NO LOT NUMBER WERE SUPPLIED --------------------------------------------------------------------------------------------------------------------------------------- J96.00 ACUTE RESPIRATORY FAILURE 12/5/2021 CANCER METASTATIC TO AXILLARY LN
This spontaneous report as received from a healthcare worker refers to a 67 years old male patient with high prostatic specific antigen (PSA), lactose intolerance, hypertension and no allergies. The patient was vaccinated subcutaneously in the left deltoid with lot # (672675/0068AE; expiration date 13-APR-2013), 0.65 ml of ZOSTAVAX on 16-JUL-2012. No other co-suspects were reported. There was no concomitant medications. On 17-JUL-2012, 30 hours post vaccination the patient had rash, looked like lesions, at the injection site of left deltoid. The patient went to the office to be seen on 19-JUL-2012. The reporter confirmed that the patient did not have shingles but the treatment for the injection site rash was ZOVIRARX topical ointment. No lab diagnostics tests were performed. The outcome of rash was reported as not recovered. The relatedness for rash was not provided for ZOSTAVAX. Additional information has been requested.
began having irregular heart beats (PVC's) lasting 6 weeks post vaccine.  Caused coughing, dizziness, tiredness too., Went to cardiologist.  She said give it time, it should go away after she did an ekg.  Started taking  a calcium blocker which did not help.
05/27/2003 states after received shots, face tingled, eyes burned, and felt dizzy. States when got home tongue swelled and throat felt like it was swelling. States took a nap and it resolved. BP 05/27/2003 received at health dept and waited 20 mm   BP 124/70 and stated was felling better when left  no complaints today 05/28/2003
was administered an expired daptacel with no adverse event reported; Initial information was received on 08-Mar-2023 regarding an unsolicited valid  non-serious case received from a consumer  This case involves a 1 years old female patient who was administered an expired diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis A vaccine for Prophylactic vaccination.  On 03-Mar-2023, the patient had received a suspect diphtheria-15/tetanus/5 AC pertussis vaccine suspension for injection at the dose of 0.5 ml once (1x) (batch number: C5829BA, expiry date: 01-Mar-2023) via intramuscular route in the left thigh for prophylactic vaccination.  On 03-MAR-2023 the patient was administered an expired Vaccine with no adverse event reported (expired product administered) (latency: same day) following the administration of diphtheria-15/tetanus/5 AC pertussis vaccine.  Action taken: not applicable.  Outcome: unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketig authorization holder's compliance with the requirements set out in the guidelines. 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 has been received from a health professional concerning a 7 day old patient who on 31-OCT-2007 inadvertently received a 0.5 ml intramuscular dose of was vaccinated with VAQTA instead of hepatitis B virus vaccine.  It was reported that the patient had not developed any known symptoms.  The reporter stated that the incident was due to human error and not product confusion.  A product quality complaint was not reported.  Additional information has been requested.
HSV/Zoster with SARS-CoV-2 mRNA Pfizer BioNTech vaccine; This is a spontaneous report from a contactable other hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported) via an unspecified route of administration as DOSE NUMBER UNKNOWN, SINGLE for COVD-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced hsv/zoster with sars-cov-2 mrna biontech vaccine. Outcome of the event was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Fever and fatigue  the day of injection, itching and rash all over his body 12 hrs after injection
Rash and swelling over large portion of mid arm and elbow area. Pt came back to pharmacy today (11/8/15) to show me her arm. She said it was getting better bit it was still red and swollen. She said it had also felt itchy.
This spontaneous report as received from a 73 year old female patient regarding herself. The patient's medical history included shingles in 2011. On an unknown date in 2012, the patient was vaccinated with ZOSTAVAX  (dose and route were not reported). Concomitant medications were not reported. On 07-OCT-2014, the patient has shingles again and painful at all like the first time. The outcome of now she has shingle again and painful was unknown. Causality assessment was not reported. Patient sought unspecified medical attention. Product quality complaint was not reported. Additional information has been requested.
booster shot on 10- 2, chest pain, short of breath to ER on 10-8
Vomiting; diarrhea for 2 days; Fever; cold symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 5 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 12Nov2021 11:00 (Lot number: Fk5127) at the age of 5 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CLARITIN [LORATADINE]; MMR, administration date 29Oct2021; DTAP, administration date 29Oct2021; POLIO, administration date 29Oct2021; VARICELLA VACC., administration date 29Oct2021. The following information was reported: VOMITING (non-serious) with onset 13Nov2021 20:00, outcome "recovered" (Nov2021), described as "Vomiting"; DIARRHOEA (non-serious) with onset 13Nov2021 20:00, outcome "recovered" (Nov2021), described as "diarrhea for 2 days"; PYREXIA (non-serious) with onset 13Nov2021 20:00, outcome "recovered" (Nov2021), described as "Fever"; NASOPHARYNGITIS (non-serious) with onset 13Nov2021 20:00, outcome "recovered" (Nov2021), described as "cold symptoms". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vomiting, diarrhoea, pyrexia, nasopharyngitis.  Additional information: vaccination facility: Public Health Clinic/Veterans Administration facility. It as unknown if patient had Known allergies.  No follow-up attempts are possible. No further information is expected.
11JUL91 pt passed out p/immun; Recovered immediately; Pulse & breathing were w/in normal limits; 12JUL91 mom brought pt to ER because passed out; MD saw slight rash & said was rxn to immun;
Hospitalized (9.21.21-present);  COVID-19 positive (9.21.21);  fully vaccinated  HISTORY OF PRESENT ILLNESS: Patient is a 85 y.o. male with PMHx of HTN, type 2 DM, HLD and BPH who presents today with altered mental status. Patient is hard of hearing so HPI obtained from him, his wife at bedside and ED report. Patient was previously admitted to the ED observation unit from 9/18 to 9/19 after an episode of syncope. He was placed on telemetry and an echocardiogram was obtained. LVEF was 42% but there were no significant valvular issues. He was given a Zio Patch for 7 days and discharged home.   Since his discharge the patient has reportedly declined. Wife states patient has at times been weak causing him to shuffle instead of walking with his walker. He is having difficulty performing ADLs. He was taken to his PCP office today and was directed to the ED for further evaluation   In the ED, he febrile with temp 39C but vital signs otherwise unremarkable. He was hypoglycemic with a glucose of 26. He was given juice and an ampule of D50 with improvement to 81. His glucose remained above 80 since then. UA was positive for leukocytes and chest x-ray showed possible bilateral perihilar infiltrates so he was empirically given ceftriaxone and doxycycline. He was also positive for COVID-19. CT head negative. Patient was admitted for further evaluation. Patient denies any recent fevers, chills, cough, SOB, nausea/vomiting, diarrhea, appetite changes, chest pain, myalgias. He received both doses of the Moderna COVID vaccine on 3/4/21 and 4/2/21. ASSESSMENT / PLAN: Altered mental status COVID-19 positive - patient with recent syncope episode and weakness since then - suspect metabolic vs infectious etiology - pt presented with hypoglycemia in setting of sulfonylurea - Also febrile with moderate leukocytes, negative nitrites on UA - COVID positive however was vaccinated with Moderna vaccine x 2 doses 3/4/21 and 4/2/21 - monitor POC glucose for further hypoglycemia - s/p ceftriaxone and doxycycline in the ED, will give levofloxacin 750 mg x 5 days due to history of enterococcus UTIs - follow up urine and blood cultures - supportive care for COVID infection, if becomes hypoxic would start dexamethasone - PT/OT Still admitted to hospital
rash on body; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2022US057269_NS.  A 70 year-old male patient received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) at the age of 70 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "rash on body".  Additional information: It was stated that, patient had no reaction at first then had a Covid shot in Nov2021- got a rash on body.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
fell; Being immunocompromised received 3rd dose on 01Nov2021 while 2nd dose on 08Mar2021; chills; exhaustion; flu like reactions; weakness; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like reactions), ASTHENIA (weakness), FALL (fell), CHILLS (chills) and FATIGUE (exhaustion) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunocompromised and RA.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Being immunocompromised received 3rd dose on 01Nov2021 while 2nd dose on 08Mar2021). In November 2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like reactions), ASTHENIA (weakness), CHILLS (chills) and FATIGUE (exhaustion). On an unknown date, the patient experienced FALL (fell). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] in November 2021 for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) in November 2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu like reactions), ASTHENIA (weakness), FALL (fell), CHILLS (chills), FATIGUE (exhaustion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Being immunocompromised received 3rd dose on 01Nov2021 while 2nd dose on 08Mar2021) outcome was unknown.            No concomitant medications were reported. Reporter stated that events usually started later the same day as or the next day after receiving the third dose.   This case was linked to MOD-2022-557659, MOD-2022-557548 (Patient Link).
Contracted covid 19 after the shot. Was exposed 1/23/2021 and tested positive on 1/29/2021
Site was red / Still bothers her / Symptoms are worse again; Site was swollen / Still bothers her / Symptoms are worse again; Arm at the injection site is still weak / muscle is weak / started after the shot / Still bothers her / Symptoms are worse again; Can't lift her arm higher than shoulder height / Still bothers her / Symptoms are worse again; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number JP427, expiry date unknown) for prophylaxis.   On 8th October 2020, the patient received Shingrix. On 8th October 2020, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, weakness of arms and mobility decreased. On 8th January 2021, the outcome of the injection site erythema and injection site swelling were recovered/resolved. On an unknown date, the outcome of the weakness of arms and mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, weakness of arms and mobility decreased to be related to Shingrix.  Additional details were provided as follows:  The reported batch number JPA27 for Shingrix did not exist and was updated to JP427 as per the sales database. After receiving dose of Shingrix, the patient experienced her arm at the injection site is still weak, the muscle was weak and can't lift her arm higher than shoulder height following. The HCP reports for the first 10 days the site was red and swollen, the weakness started after the shot. The Pharmacist reports that symptoms were bad at the beginning, got a little better during November and are worse again. The patient called her doctor about it, but he couldn't see her over the holidays. The patient wants to go see him though because it still bothers her. The reporter consent to follow up.
Patient received 2 doses of Moderna vaccine on 2/3/21, and 3/3/21.  Patient admitted to the hospital on 12/3/21 with respiratory failure due to COVID, and remains hospitalized on 12/7/21
SEVERE SHIVERING !!  Headache, body aches, muscle pain, fever.
This case was reported in a literature article and described the occurrence of facial palsy in a child subject of unspecified gender who was vaccinated with Oral polio vaccine (manufacturer unspecified), DTPw and hepatitis B vaccine. The present retrospective study of acute flaccid paralysis was conducting using computerized diagnosis data and medical record review of potential cases among children aged 1 month to less than 15 year and diagnosed from 1 January 1992 through 31 December 1998. The subjects were hospitalized or seen in the emergency room. None of the children were known to have a preexisting immunocompromising condition. The literature article included the description of 16 children with vaccine exposure prior to development of paralytic syndrome (B0642827A, B0642828A, B0642829A, B0642830A, B0642832A, B0642836A, B0642841A, B0642846A, B0642847A, B0642848A, B0642849A, B0642850A, B0642851A, B0642811A, B0642811A). On an unspecified date the subject received unspecified dose of Oral polio vaccine, unspecified dose of hepatitis B and unspecified dose of DTPw. Forty three days after vaccination with DTPw, Hepatitis B vaccine and Oral polio vaccine, the subject experienced facial palsy. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified. The author considered that internationally, there are advantages to using oral polio vaccine, but the stability of vaccine-derived oral polio vaccine viruses remained a concern and importation of such neurovirulent isolates to nonendemic areas remained an important risk.
Painful Arm, 4 days Fever 2 days Swollen lymph nodes in groin with tenderness, from day 7, currently ongoing.
mylagies, nausea, confusion, COVID -a-symptomatic, acute kidney injury
I have a large indent in my arm where shot was given and it is a dark color, it hurts, all over body aches and pains, fatigue.
Vaccine given 12/27/06. on 01/19/07 client felt "burning sensation" along waist, LT of center on abdomen, no marks on skin. On 01/24/07, client is experiencing hot, poking sensation over LT Hip.
Received HPV and MCV earlier and on his way out of the visit.   After vaccines, walking out when noted by a nurse to be imbalanced.  Looked pale and fell to the floor of a room, but  no loss of consciousness or head injury.  He was awake and alert. Knew where he was, first and last name and birthdate.  First time receiving these vaccines. Per mom, had heavy later breakfast.  Not sure if had sufficient fluid intake today.     98/59 HR of 63-72 O2 96% on RA. Pale and diaphoretic but at baseline speech. Laid down for about 5 min on exam table. Color returned.  BP of about 110/60 prior to discharge.  Able to walk back out without issues.  No further tremors to face and extremities during this episode. No nystagmus. Attempted hi-five without tremors noted. Facial movements without tremors. Tolerated a few sips of water.  Able to convey he felt better and back to normal. Able to walk out of office on own.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA injection (dose, route of administration, lot# and expiry date were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Information has been received on 25-APR-2017 from a medical assistant regarding an unspecified number of patients of unknown ages and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. From 13-APR-2017 through 25-APR-2017, an unspecified number of patients were vaccinated with doses of PROQUAD lot # M043306, expiration 24-APR-2018 and lot # M042502, expiration 17-APR-2018 subcutaneous for prophylaxis which were improperly stored. Other suspect therapy included sterile diluent lot # M034763 expiration 22-APR-2019. The vaccines were stored between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 4 hours and 14 minutes. There was no previous temperature excursion. The call was not made due to a data logger. The medical assistant confirmed that the sterile diluent used to reconstitute the PROQUAD was not improperly stored. No adverse effects were reported. No further information was reported. Follow up information was received from the medical assistant on 17-MAY-2017, referring to a 16 month old male patient. The patient administered the vaccine on 13-APR-2017. The medical assistant reported that they did not exactly know what caused the temperature excursion in April 2017, but they were thinking the door to the refrigerator might have been left slightly open. There had been no temperature excursions since that time. All telephone attempts to obtain follow-up information on 17-MAY-2017 had been unsuccessful. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA013406: US-009507513-1705USA014056: US-009507513-1705USA014057: US-009507513-1705USA014058: US-009507513-1705USA014059: US-009507513-1705USA014060: US-009507513-1705USA014061: US-009507513-1705USA014062: US-009507513-1705USA014063: US-009507513-1705USA014064: US-009507513-1705USA014065: US-009507513-1705USA014066: US-009507513-1705USA014067: US-009507513-1705USA014068.
Within 10 minutes I became nauseous. I left the vaccination center and drove home becoming increasing ill. When I got home I went to bed and slept for two days, nauseous, weak, body aches, a rash under the vaccinated arm and on my back left side,  headaches, fever, sleep interruption, vivid dreams.  The left arm which had been vaccinated was extremely sore and remained so, just recently lessening.  I believe I had Covid 19 in February of 2020 and while I got ill, did not experience the severity of illness that I experienced after vaccination. Now, 17 days later I continue to experience weakness, headaches and recently have had difficulty breathing after exercise. Although the rash has gone away, the left side is still itchy, but less so.     I have discussed this with my Doctor and he informed me that my response to second shot may be stronger, although he did not tell me to avoid the second dose.