chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient complained of many complications her main concern was her pulse was dropping low to a 50. Her blood pressure was dropping at a high rate. She complain of fatigue and headaches and feeling really dizzy.
At approx. 11:00am, Pt was due for covid vaccine booster (3rd dose/orange cap bivalent) per providers orders. writer administered Pfizer grep cap bivalent instead of Pfizer orange cap bivalent. I realized this mistake after docuementing this in patients chart and also talking to another medical assisntant staff as I was documenting. After talking to them, I also spoke with CMA vaccine coordinator (who guided me what to do next and clinic;s procedure) and also Spoke do Dr. and PA-C  to provide medical advise or any side effects to look out for, to provide to patients parents. I looked up CDC administration errors and deviations and per CDC, pt will not need to repeat dose. I will continue with further protocol.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 01-FEB-2016 or 02-FEB-2016, the patient was vaccinated with a dose of PEDVAXHIB (lot # K02653 exp date 07-AUG-2017) (dose and route not reported) or a dose of GARDASIL (lot # K011562 exp date 08-APR-2017) (dose and route not reported) that were exposed to a minimum temperature of 32.8 degrees F and maximum of 84.3 degrees F for 8 hours. The current temperature was 48 degrees F in a time frame of 8 hours. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Patient's guardian was wrongly informed the date for second dose and received a second dose 10 days sooner than it should be. The first dose was given on 8/24/21 then second dose was given on 9/4/21 instead of 9/14/21. Patient's mother didn't report any adverse effect.
hot injection site; tight injection site; bright red 3 inches area on injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot injection site), VACCINATION SITE INDURATION (tight injection site) and VACCINATION SITE ERYTHEMA (bright red 3 inches area on injection site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced VACCINATION SITE WARMTH (hot injection site), VACCINATION SITE INDURATION (tight injection site) and VACCINATION SITE ERYTHEMA (bright red 3 inches area on injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Injection site reaction, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (hot injection site), VACCINATION SITE INDURATION (tight injection site) and VACCINATION SITE ERYTHEMA (bright red 3 inches area on injection site) outcome was unknown.            No relevant concomitant medications were reported. Patient treated reaction also by ice pack.   This case was linked to MOD-2021-089152 (Patient Link).
This spontaneous report was received from a 59 year old female consumer with anxiety, asthma, blood pressure, chronic obstructive pulmonary disease (COPD), sensitivity to many drugs, allergies, lung disorder and heart condition. On 15-SEP-2014, the patient was vaccinated with ZOSTAVAX (dose number, lot number, expiration date and route were not reported) in the left arm as vaccine. Patient reported she was on unspecified medications for many conditions. On 15-SEP-2014, same evening after vaccination the patient had a pink elongated 2 to 3 inches mark at injection site. The patient also experienced light dizziness, racing heartbeat and nausea right after the injection of ZOSTAVAX at the pharmacy. The patient has since maintained a light headache and nausea and the injection site was raised and itchy. The patient returned to the pharmacy and contacted a physician within the last couple of days for consultation. The patient was told she had allergic reaction and advised to use calamine lotion for the itchiness. Although the prescription was given by her physician the patient had the ZOSTAVAX administered at the pharmacy. Patient returned to the pharmacy that administered the ZOSTAVAX. The pharmacist there believed the 2 to 3 inch mark  at the injection site was now infected. At the time od the report the outcome was reported as not recovered. Patient sought medical attention at the pharmacy and consultation with her physician. Additional information has been requested.
Fever of 104.8 giving APAP; PC & visit to private MD, on 24SEP91 who found no evidence of other illness; Md advised mom to call clinic & report rxn & to obtain ped DT next time;
This non-serious initial spontaneous case, was received from nurse on 12-Oct-2017, concerning a 30-year-old adult female patient. The patient's medical history and concomitant medications were not reported. On 11-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported). The patient received frozen vaccine, which was considered as incorrect product storage and drug administration error. It was reported that, frozen vaccine was thawed before the administration. It was reported that, the patient had not experienced any adverse event. Follow up report received on 06-Dec-2017: The patient's age was added. It was reported that, the patient had not experienced any adverse event. The narrative was amended accordingly.
Episode of Shingles; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number 9HM59, expiry date 30-SEP-2023) for prophylaxis.   On 15-NOV-2022, the patient received the 1st dose of Shingrix. In DEC-2022, less than 2 months after receiving Shingrix, the patient experienced shingles (Verbatim: Episode of Shingles). The outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK receipt date: 26-APR-2023 The pharmacist reports patient experienced an episode of shingles after 1st Shingrix vaccine that was administered on 15th November 2022. The patient developed Shingles in December 2022. The patient was back today to receive 2nd Shingrix vaccine.  Unknown when shingles resolved.  Shingrix not administered at time of call. The reporter consented to follow up.
Patients received the Moderna Covid 19 vaccine after temperature excursion; Patients received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 28-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  The vials were stored at frozen storage at the time of the excursion. The Lot number which were expired are 065K21Aand 045L21A. The vials reached a maximum temperature of 30 Fahrenheit Degrees and minimum of -18.9 Fahrenheit Degrees. The vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute.  No treatment drug details was reported.
Information has been received from a physician concerning a female who in 2007 was vaccinated with Gardasil. It was reported that the patient had injection site pain after receiving the vaccination. The second dose was not given because of the continued pain. The patient sought unspecified medical attention. This is one of two reports received from the same source. Attempts are being made to obtain identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
He developed a low grade fever, chills, nausea, and fatigue the night after he got the vaccine.
Migraine; joint pain; chills; sweating; nausea; Dose number:3; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.   A 43-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 09Dec2021 at 11:45 (Lot number: FH8027) at the age of 43 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Colitis ulcerative" (unspecified if ongoing) and "Migraine" (unspecified if ongoing), notes: migraines. Concomitant medication(s) included: MESALAMINE; FLUTICASONE and MIRENA IUD. Past drug history included: Cecloretta, reaction(s): "Drug allergy", notes: known allergies: ceclore. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE; Lot number: EP6955; Anatomical location: Arm Right ; Vaccine Administration Time: 15:00), administration date: 06Apr2021, when the patient was 42 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 1, SINGLE; Lot number: EP6955; Anatomical location: Arm Right; Vaccine Administration Time: 13:00), administration date: 16Mar2021, when the patient was 42 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021 at 11:45, outcome "unknown", described as "dose number: 3"; MIGRAINE (non-serious) with onset 09Dec2021 at 21:00, outcome "recovered" (an unknown date in Dec2021), described as "migraine"; ARTHRALGIA (non-serious) with onset 09Dec2021 at 21:00, outcome "recovered" (an unknown date in Dec2021), described as "joint pain"; CHILLS (non-serious) with onset 09Dec2021 at 21:00, outcome "recovered" (an unknown date in Dec2021), described as "chills"; HYPERHIDROSIS (non-serious) with onset 09Dec2021 at 21:00, outcome "recovered" (an unknown date in Dec2021), described as "sweating"; NAUSEA (non-serious) with onset 09Dec2021 at 21:00, outcome "recovered" (an unknown date in Dec2021), described as "nausea". Therapeutic measures taken as a result of migraine, joint pain, chills, sweating, nausea was unknown.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Started with symptoms 12/04/2022 sore throat and nasal congestions; telehealth visit suggested over counter meds and quarantined.
2JUL92 recvd 1st dose of Engerix-B & 4 days post vax devel blurred vision; 30JUL92 blurred vison had resolved 95%:
Pain and swelling in left arm pit. Pain is 2-3, swelling is mild.
9 yo girl developed MIS-C with fairly classic symptoms following dose #1 of COVID vaccine.  Had had COVID but 10+ weeks prior to onset of symptoms.  Relationship to vaccine being considered.  She presented with prolonged fever, conjunctival injection, rash, shock with hypotension requiring pressors.  Patient was treated with IVIG, steroids, and Anakinra and eventually improved and was discharged.
G47.33 OBSTRUCTIVE SLEEP APNEA 5/2/2023 NORMAL DELIVERY
positive antigen (home) test after repeated negative antigen tests; positive antigen (home) test after repeated negative antigen tests; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 03Apr2021 as dose 1, single (Lot number: ER8733), on 24Apr2021 as dose 2, single (Lot number: EW0172) and on 06Dec2021 as dose 3 (booster), single (Lot number: FT1670) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN, start date: 10Jun2022. The following information was reported: COVID-19 (medically significant) with onset 16Jun2022, outcome "unknown", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "positive antigen (home) test after repeated negative antigen tests". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: positive antigen home test after repeated negative antigen tests; Negative, notes: positive antigen home test after repeated negative antigen tests. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
diminished vision; vaccine did not prevent shingles, but rather caused patient to contract a persistent strain of herpes zoster; numbness in his legs; herpes zoster/persistent painful rash; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to  a male patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused patient to contract a persistent strain of herpes zoster accompanied by pain. On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient developed a persistent painful rash, numbness in his legs and feet and diminished vision. On an unknown date, patient presented to a physician and remained under their care. As a result, patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. The reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).     Additional information has been requested.
Chest pain on the left side from around 8:30AM until around 6:30PM the same night.  The chest pain has continued intermittently since receiving the shot.  The chest pain is sharp and focused in the left pectoral area.
soreness at the point of administration of his left arm; Muscle soreness/muscle soreness at the point of injection spread to his whole body; it was like aches all over his body; Fatigue; Frequent urination; Cognitive fuzziness; This is a spontaneous report from a contactable consumer (patient) reported that a 42-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247, expiration date 31May2021), intramuscular on the left arm on 28Jan2021 16:15 at a single dose for Covid-19 immunization. Medical history included attention deficit hyperactivity disorder (ADHD), mentioned he was a patient facing drug addiction counselor in training, smoke cigarettes but he has cut down to a half a pack a day, at most. The patient previously received flu vaccine on an unspecified date for flu vaccination and experienced soreness at the point of administration of his left arm. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken from an unspecified date for ADHD. The patient received his first COVID-19 vaccine this past Thursday, 28Jan2021. The next morning (29Jan2021), he woke up with real soreness at the point of administration of his left arm, well beyond what he remembered for a flu vaccine. The second night (30Jan2021), the soreness progressed. It was hard to sleep on his left arm. It was like he had been punched. He had to sleep on his right side versus his left side. On 29Jan2021, the muscle soreness at the point of injection spread to his whole body, it was like aches all over his body. The soreness has gotten a little bit better day by day. He confirmed he got a rapid nasal molecular COVID swab test because he was just covering his bases and he tested negative for COVID-19 on 02Feb2021. He also experienced fatigue. The fatigue really started to set in on Friday evening (29Jan2021), it was like he got hit by a truck.  He was typically a high energy person and its very out of the ordinary for him to feel this way. He normally has class on Saturday from 9-noon but he had to cancel going with the amount of fatigue he was experiencing. He also had some cognitive fuzziness on Jan2021. His fatigue was still there, but it has gotten a little better. He was normally very high energy, but he missed two classes and skipped his internship today. He doesn't feel like himself. He also has had frequent urination which he noticed probably Friday night (29Jan2021), all the way up until now. However, he has been drinking a lot of water. The patient received a test/report showing he has no chromosomal issues and no likelihood of issues on an unspecified date. The outcome of soreness at the point of administration of his left arm and Frequent urination was not recovered; Muscle soreness/muscle soreness at the point of injection spread to his whole body and fatigue was recovering; it was like aches all over his body and cognitive fuzziness was unknown.
This spontaneous case, initially received from other non-health professional (consumer) on 19-Oct-2018, concerns a female patient of unspecified age (under 65 years as reported). On an unspecified date (couple of weeks ago as reported), the patient (under 65 years of age) was administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250798 and expiry date: 31-May-2018] (explicitly coded as inappropriate age at vaccine administration). At the time of this report, no adverse events were reported after the vaccine administration. The reporter assessed the case as non-serious. This case was linked to 201804741 due to same reporter. Significant follow-up received from the reporter on 20-Nov-2018: The batch number: 250798 and expiry date: 31-May-2018 were added. It was confirmed that, patient had not experienced any adverse events after the vaccination. The narrative was amended accordingly.
Sick with flu-like symptoms for 5 days following the injection. Within 12 weeks I developed debilitating migraines and was placed on short term disability on 5/17/2022. Diagnosed with Occipital Neuralgia and Chronic Mixed Migraine Disorder. Daily migraines continue.
6/9/03 am rash onset, mac/papular and fluid filled vesicles over entire body. Fever-no temp taken seen by pediatrician and dx varicella.
Sleeplessness/Insomnia; This is a spontaneous report from a contactable consumer or other non hcp (patient himself). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, and expiration date not reported), via an unspecified route of administration, administered on the left arm on 28Feb2021 15:45 (at the age of 50-years-old), as first dose, single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included probiotics (manufacturer unknown); unspecified daily multi-vitamin (manufacturer unknown); and curcuma longa (TURMERIC) all taken for an unspecified indication and all start and stop dates were not reported. Patient has no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sleeplessness/insomnia, so far two nights in a row, on 01Mar2021 00:00. The patient did not receive any treatment as a result of the events reported. Patient did not consult physician nor urgent care for the events reported. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt. taken to ER after seizure like activity. Mom reported to ER that pt. had seizure like activity that lasted approx 3-5 min at 20:30 on 11-16-17 (day after vaccines admin). Father observed approx 3 min of generalized shaking while the child stared into space and did not respond. Resolved spontaneously. *See reports provided.
EUPHORIA AND LAUGHING LIKE LITTLE GIRL; This spontaneous report received from a health care professional concerned a female of unspecified age. 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: unknown) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced euphoria and laughing like little girl. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from euphoria and laughing like little girl. This report was non-serious. This case, from the same reporter is linked to 20211115380.
pt recv vax & exp low grade fever & exp malaise & dizziness; lab eval revealed pos ANA; LDH 267; pt had 2 prev pos ANA unrelated to drugs or vax;
Swelling, redness, site was hard with pain hives on stomach and back fine red rash anterior (L) thigh radiates (L) knee.