chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash all over the body; Swelling massively in injection site; itching; burning; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash all over the body), VACCINATION SITE SWELLING (Swelling massively in injection site), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE PAIN (burning) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rash all over the body), VACCINATION SITE SWELLING (Swelling massively in injection site), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE PAIN (burning). At the time of the report, RASH (rash all over the body), VACCINATION SITE SWELLING (Swelling massively in injection site), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE PAIN (burning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications were not provided. Treatment details Benadryl. Upon internal review on 04-Aug-21, the age was corrected 63 years.
This case was reported by a consumer via call center representative and described the occurrence of fall in a 84-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On 19th July 2018, less than a year after receiving SHINGRIX, the patient experienced fall, head injury, dizziness and denture failure. On an unknown date, the outcome of the fall, head injury, dizziness and denture failure were unknown. It was unknown if the reporter considered the fall, head injury, dizziness and denture failure to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter was the daughter of the patient. In 2018, at 4 PM, the patient received a dose of SHINGRIX. The patient stated that her mother said that she had fallen since she had the injection. The reporter said she received a call from her mother in morning of day of reporting, her mother said that she had just been able to get phone call from her daughter. The patient said that she had fallen 3 times, was dizzy, heat her head and had broken her denture. The reporter said that she did not know all the details since she had not gone to see her mother yet but was on her way.
Pt due for Varivax, MD ordered Varivax, Zostavax was administered.
Approx 3 hours after receiving injection began to feel tingling to left upper arm. By 8:00 pm - arm became severe painful. Upper arm - axillary and side of (L) breast involved - areas severe hot to touch, severe redden - maroon color to entire (L) upper arm - severe raised areas - with severe pain. Duration - Sunday 3/25/18 thru - following Saturday, having to go to urgent care for follow-up. Treatment - heating pad - elevation - and medications. Begin to feel some relief three weeks - past - after receiving injection. I also have pictures of the severe problem with my arm after injection.
From initial information received on 4/12/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 14 year old male patient received a post-exposure IMOVAX RABIES vaccination, lot number W0023, route and site of administration unknown, on 1/7/04. An unspecified time after receiving the vaccination, the patient complained of a stomach ache. On 1/14/04, the patient complained of tingling in the ears. On 1/30/04, he still complained of tingling in the ears and experienced a headache. On 4/8/04, the headache resolved, but the ear tingling still persisted. It is unknown whether the patient fully recovered. From additional information received on 5/27/04 from a physician, the physician stated that she was not the responsible physician at the time the vaccine was administered. No further information is anticipated, this case is considered closed.
Information has been received from an investigator concerning a 29 year old female patient enrolled in a study. The patient's current condition includes strawberry allergy, mitral valve prolapse and vasovagal syncope. The patient's medical history included bacterial vaginosis, cesarean and wisdom tooth extraction. On 01-MAY-2009, the patient was randomized into the base study and vaccinated with the first 0.5 ml intramuscular (IM) dose of blinded HPV V503. Subsequently, the patient was vaccinated with the second and third 0.5 ml IM doses of blinded V503 vaccine on 09-JUN-2009 and on 13-OCT-2009, respectively. The patient's status regarding the study was reported as completed. The patient continued into the next trial segment. No concomitant medications were reported. On 28-OCT-2014 (visit 14 month 60), the patient was vaccinated with the first dose of HPV vaccine 0.5 ml intramuscular in the left arm. On 29-OCT-2014, the patient experienced trigeminal neuropathy. That day, the patient complained of facial pain beginning at jaw bone radiating up to the face and behind the ear on the left side. The patient went to the emergency room (ER) on 01-NOV-2014. The patient reported a computerised tomogram (CT) scan and lab work in emergency room (results not reported). The site was waiting for medical records, which were expected by 12-OCT-2014. In the ER, the patient was prescribed TEGRETOL (04-NOV-2014 TO 19-NOV-2014) 200 mg BID PO and ROBAXIN (04-NOV-2014 to 19-NOV-2014) 500 mg PRN PO, both for left side face, jaw, eye pain. She was referred to a neurologist. Neurology visit was not expected until March 2015. The patient reported that as long as she took her medicine daily, the pain was controlled. On 19-NOV-2014, the patient recovered from trigeminal neuropathy. Follow up clinical course was pending at the time of this report. On 09-DEC-2014 (visit 15 month 62), the patient was vaccinated with the second dose of HPV vaccine 0.5 ml intramuscular in the left arm. The action taken regarding study therapy was reported as none. The reporting investigator considered trigeminal neuropathy to be related to study therapy, and not to any other suspect (concomitant) therapy. The reporting investigator considered trigeminal neuropathy to be a disabling event and to be medically significant. Additional information has been requested. Products, event and narrative sections were updated.
Received Hep A and Flu Mist on 12/11. Next day ( 12/12 noticed involuntary hand jerking a few times during day. Noticed again following day 12/13. Called on call nurse and she didn't think it was anything to be concerned about. Next day 12/14 started running fever. Gave Tylenol to son when fever continued to climb. An hour or so later he had a Grand Mal seizure lasting approximately 3-4 minutes. Called 911. Remained completely unresponsive to paramedics and parents. Went to hospital and patient was unresponsive for approximately 3 hours (no eye contact, staring at the light, didn't recognize or respond to anyone...a vegetative type state) After approximately 3-4 hours he snapped out of it and became responsive. Fever conitnued for approx. 2-3 more days. Unusual symptoms/behaviors following seizure (don't know if they were related) included eye twitching, complaint of periodic chest pain and complaints that face felt tingly/dry for months afterward. Chronic throat infections followed resulting in tonsilectomy in March 2009. Prior to the flu mist patient had never had the involuntary hand twitching ( fists ball up and both hands jerking inward). He had many fevers prior to this incident and never had a febrile seizure. I think that the flu mist was the cause of this. We do adore and respect our doctor - so I hope that this can be filed confidentially. We just feel that it is our responsibility to report the incident.
heart attack; stroke; This is a spontaneous report from a contactable consumer. A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 24Jan2021 13:00 (at the age of 67-years-old) (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  Medical history included hypothyroid, sleep apnea, known allergies: Shellfish, Sulfa, Possible Tree Nut allergy. Concomitant medications included levothyroxine sodium (SYNTHROID); ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]); clarithromycin (CLARITIN [CLARITHROMYCIN]). In Feb2021, Exactly 3 weeks after the first dose, the patient had a heart attack and stroke. The events were assessed as serious (hospitalized, life-threatening, disability). The event resulted in emergency room and physician visit.The patient was hospitalized for 10 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Patient is a 63 y.o. female who received the Janssen COVID Lot#: 1805020 on 3/12/2021. The patient experienced the following reaction(s) during the immediate 15 of observation: "tingling around lips and left arm" Patient was treated/managed as follows:   1120: BP: 162/80 HR:65 RR: 18 O2: 99%  1130: BP: 160/90 HR: 69 RR:18 O2: 98%  Pt reports tingling has completely stopped and feels fine.  Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. Pt escorted to door by RN.
This spontaneous report as received from a nurse refers to an unknown patients of unknown age and gender. No pertinent medical history, drug reactions/allergies and concomitant medications were reported. On an unknown date the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot# M018810 and expiry date 28-MAY-2018) (lot# M028323 and expiration date 26-SEP-2018) (lot# M032650 and expiration date 31-MAR-2019) (lot# L036301 and expiration date 20-DEC-2017) intramuscularly (also reported as depends on the vaccine). The vaccine was exposed to temperature excursion of 1.4C for 21 minutes. No previous temperature excursion was reported. No adverse events were reported. No product quality complaint was filed. This is one of several reports received from the same reporter. Additional information has been requested.
The first 24 hours I had numbness, tingling on lips, arms and feet but they went away without treatment. Four days after numbness on lips came back. Day five inflamation on the arm I had the injection and numbness on two hands. I went to the ER and started Ibuprofen for 10 days. Symptoms did not go away and got worse on seven days. Went back to the ER dimer altered but no curds. Follow-up with a primary doctor, prednisone treatment for a week. Appearance of red spots on the skin. Symptoms improving after 7 days but returned when treatment ended. Back with the doctor and second cycle of prednisone. Currently under treatment without numbness but with pain in the entire arm from the injection that prevents me from carrying out my normal life and the points on the skin.
No additional adverse event reported; a dose of expired PROQUAD was administered to an unspecified patient; Information has been received from an healthcare worker via field representative, referring to a 4 years old patient of unknown gender. The patient's pertinent medical history and drug reactions/allergies were not reported. Concomitant therapies included sterile diluent (STERILE DILUENT).  On 13-MAR-2020, the patient was vaccinated with a dose of expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, route and dose detail were not reported) (lot # R024020, expiration date 19-FEB-2020) for prophylaxis (expired product administered). It was unknown by the field representative if the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and sterile diluent (STERILE DILUENT) used to reconstitute measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) underwent any temperature excursion. No additional adverse event was reported.
Patient notified us today that he  just recently started having tingling in different parts of his body and requested we report this information to you.
needle and hub separate during administration; needle and hub separate during administration; This case was reported by a consumer via interactive digital media and described the occurrence of incorrect dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect dose administered and incomplete dose administered. On an unknown date, the outcome of the incorrect dose administered and incomplete dose administered were unknown.   Additional Information: GSK Receipt Date: 20-APR-2022 Reporter's Comments: This case was reported by patient via interactive digital media. The patient reported that during administration of Shingrix vaccine needle and hub were separated. The patient asked for guidance on revaccination. Additional Supportive Information: The patient reported that during administration of Shingrix vaccine needle and hub were separated, which led to incomplete dose administered. The follow-up would not possible as no contact details were available.
No adverse event; Patient took Bivalent vaccine on 17-Feb-2022 but Bivalent approval date was 31-Aug-2022; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took Bivalent vaccine on 17-Feb-2022 but Bivalent approval date was 31-Aug-2022) and NO ADVERSE EVENT (No adverse event) in an 85-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetes and Stroke (2 strokes).    On 17-Feb-2022, 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 17-Feb-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took Bivalent vaccine on 17-Feb-2022 but Bivalent approval date was 31-Aug-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took Bivalent vaccine on 17-Feb-2022 but Bivalent approval date was 31-Aug-2022) 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 assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took Bivalent vaccine on 17-Feb-2022 but Bivalent approval date was 31-Aug-2022).    Patient was on blood thinners. He received 6 of the Moderna vaccines and took only one bivalent booster dose on 17-FEB-2022. He was advised that he can't take paxlovid per doctor's recommendation. Treatment information was not reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2023: Follow up received and had no significant information.
Nausea; vomiting; diarrhea; severe vertigo; lethargy; brain fog; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 03May2021 at 14:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not received any concomitant medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04May2021 at 10:00 the patient experienced nausea, vomiting, diarrhea, severe vertigo, lethargy and brain fog. The clinical outcome of the events nausea, vomiting, diarrhea, severe vertigo, lethargy and brain fog was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE OBSTRUCTIVE SLEEP APNEA HYPOTENSION  12/15/2022 -- RECURRENCE OF SAME SYMPTOMS
Patient was out of country - came back from vaccination- noticed the bump today,  4 days later.  fluid like. at time of administration, the bump was not present- pharmacist felt area of injection and it was flat. patient said arm was sore days after injection, only found bump this morning
Systemic: Dizziness / Lightheadness-Mild, Systemic: Headache-Mild, Additional Details: Pt does not have PCP. Pt reported having symptoms of (dizziness and body code) within approximatley 1 minute of injection.  Pt confirmed taht she does not want to call 911 or ambulance. Couseled pt to wait at least 30 minutes to make sure she is safe.  Pt stated that she did not take her blood pressure medication in the morning and her elevated blood pressure is due to not taking it.  Pt reported not having symptoms after 38 minuts after injection.  Pt confirmed that she wants to go home-couseld
FEVER OF 98F; NAUSEA; GENERALLY TIRED; This spontaneous report received from a patient concerned a 55 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) .5 ml, administered on 10-MAR-2021 to Left Deltoid for prophylactic vaccination. the batch number and expiry date were not reported hence requested. No concomitant medications were reported. On 10-MAR-2021, the patient experienced fever of 98f. On 10-MAR-2021, the patient experienced nausea. On 10-MAR-2021, the patient experienced generally tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The batch number was not reported and has been requested.  The patient had not recovered from fever of 98f, nausea, and generally tired. This report was non-serious.
Vaccine was placed in refrigerator on 23-Mar-2022, Beyond use date on 17-Apr-2022 administration date on 19-Apr-2022; Past beyond use date Moderna Covid-19 vaccine given to 6 patients.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Past beyond use date Moderna Covid-19 vaccine given to 6 patients.) and PRODUCT STORAGE ERROR (Vaccine was placed in refrigerator on 23-Mar-2022, Beyond use date on 17-Apr-2022 administration date on 19-Apr-2022) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Past beyond use date Moderna Covid-19 vaccine given to 6 patients.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was placed in refrigerator on 23-Mar-2022, Beyond use date on 17-Apr-2022 administration date on 19-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Past beyond use date Moderna Covid-19 vaccine given to 6 patients.) and PRODUCT STORAGE ERROR (Vaccine was placed in refrigerator on 23-Mar-2022, Beyond use date on 17-Apr-2022 administration date on 19-Apr-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Date the vial was initially stored in the refrigerator on 23 Mar 2022. Beyond use date was on 17 Apr 2022. The vial did not undergo any temperature excursions.   The treatment information was unknown.   This case was linked to MOD-2022-546561, MOD-2022-546566, MOD-2022-546544, MOD-2022-546563, MOD-2022-546559 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2022: Follow-up received contains Significant information date of administration of vaccine was updated.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; SLEPT A LOT; This spontaneous report received from a patient via a company representative concerned a 47 year old white, not hispanic or latino male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported(dose number in series: 1), 1 total administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-DEC-2021, the patient experienced symptoms of slept a lot, headache, sore throat, congestion with runny nose, sneezing (dose number in series: 1) and performed rapid home test binax  Laboratory data included: COVID-19 antigen test (NR: not provided) negative. On 30-DEC-2021, the patient experienced confirmed covid-19 infection, and confirmed clinical vaccination failure. Laboratory data included: COVID-19 PCR( polymerase chain reaction) test (NR: not provided) positive, patient performed rapid home test binax , COVID-19 antigen test (NR: not provided) negative. On 31-DEC-2021, Laboratory data included: COVID-19 antigen test (NR: not provided) negative. On 01-JAN-2022, Laboratory data included: COVID-19 antigen test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection, slept a lot and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint:90000210285.; Sender's Comments: V0: 20220108126-COVID-19 VACCINE AD26.COV2.S-Confirmed clinical vaccination failure . This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Pneumothorax (Several seen during surgery) Surgery to correct pneumothorax Enlarged right atrium still under investigation