chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE; Caller reported that M-M-R II, ROTATEQ and VAQTA that underwent temperature excursions were administered. No further information was provided. No additional AE. No PQC.   ?    Names of vaccines involved (including lot/exp): M-M-R II LOT: T029550 EX; This spontaneous report was received from Pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 26-MAY-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1837116, expiration date: 24-MAR-2023, administered orally for prophylaxis (strength, dose, and anatomical location were not provided).  The vaccine was stored at the temperature that was reported as above 47 degrees of Fahrenheit (46.9 F) for 25 minutes. There was a previous temperature excursion reported: above 47 degrees of Fahrenheit (47.2 F) for 25 minutes.  No additional adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA005639: US-009507513-2206USA005640: US-009507513-2206USA006596: US-009507513-2206USA000873: US-009507513-2206USA006598: US-009507513-2206USA006599: US-009507513-2206USA006600:
Took first dose vaccine, by 10 days after that experienced Covid (SARS-CoV-2 infection); This is a spontaneous report received from a contactable consumer (patient) who reported for himself. A male patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: unknown, via unspecified route, on 17Apr2021 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications were not reported. On 26Apr2021 (10 days after the first dose vaccine, the patient tested positive with Covid-19. The patient's wife, she took the 1st dose on 17Apr2021. As per the caller, they both were tested positive with Covid-19, 10 days after taking the 1st dose. The 2nd dose was on (09May2021) which was more than 21 days. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt recvd 1st & 2nd dose Engerix-B on 15APR91 & 16MAY91 respectively; 1st vax uneventful; 3 hrs post 2nd vax had onset of chills (no fever) pain in arm, induration, SOB, next day still SOB, exp fatigue, inject site was bruised; tx ASA;
cerebrovascular accident; Information has been received regarding a case in litigation from a lawyer and the pt on 14-MAY-2020, referring to a 62 year old male pt. The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 15-OCT-2015, the pt was vaccinated by a medical provider with zoster vaccine live (ZOSTAVAX) (lot# and route unknown) for long-term prevention of shingles and zoster-related conditions. The pt suffered the following injuries as a result of the zoster vaccine live (ZOSTAVAX) vaccine: cerebrovascular accident diagnosed on 20-JAN-2016. The outcome of cerebrovascular accident was unknown. The causality assessment between cerebrovascular accident with zoster vaccine live (ZOSTAVAX) was reported as related. Upon internal review, cerebrovascular accident was determined to be a medically significant event.
This spontaneous report as received from a female healthcare student regarding herself as a patient of unknown age. Medical history and drug reactions/allergies were not reported. On an unknown date "as a child", the patient was vaccinated with M-M-R II series (lot, doses and route not reported). Concomitant medication was not reported. On an unknown date (reported as recently), the patient had titers draw for her school and the mumps titer was "too low". The outcome of mumps titer was "too low" was unknown. Additional information has been requested.
Moderna COVID-19 vaccine EUA I had a fever of 101.2 by 3/3:30pm and then it was 102.0 by 4:30pm and sustained at that level until around 1am.  The fever was accompanied by chills that felt like the neuropathy you can have with Shingles - meaning my skin felt sensitive to the touch.  It was not like normal flu muscle aches.  My whole body felt like it was made of lead or concrete and I was just lethargic.  It is curious that in hind sight the chills were not accompanied by any sweating.  The chills and fever stopped about the same time (1am), but the fatigue carried on for a couple days.   Additionally, my left arm where I had the injection was very painful and my range of motion was limited by the pain for probably 36 hours.  72 hours later the muscle is still sore, but the range of motion is fine.   Further, on April 4th I experienced nausea  with the beginning of my period which is not a normal menstrual symptom for me to have and the nausea has continued on to April 5th.
Itching Injection Site; Body Aches and pain; Sore Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching Injection Site), VACCINATION SITE PAIN (Sore Injection Site) and MYALGIA (Body Aches and pain) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore Injection Site). On 01-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Itching Injection Site) and MYALGIA (Body Aches and pain). At the time of the report, VACCINATION SITE PRURITUS (Itching Injection Site), VACCINATION SITE PAIN (Sore Injection Site) and MYALGIA (Body Aches and pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Information has been received from a healthcare worker, medical assistant who reported that 10 doses of improperly stored ROTATEQ suspension were administered to 10 patients on unspecified dates (2 doses from lot # K006457 expiration date 08-MAR-2015 and 8 doses from lot K023537 expiration date 22-JUN-2016, dose and route not reported. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Pt received shingrix on 03/24/22 and reports experiencing itchiness around the site of injection that night, and experienced itchiness and swelling next day as well. However, she noticed red raised itchy bumps which were not limited to the site of injection, on the morning of 03/26/22 and is concern she might be having a reaction to the vaccine. Pt also reports nausea and stomach upset. Per pt, she had not taking any medication to manage her symptoms.
Redness, soreness, & swelling on left arm at site of injection; headache, nausea, elevated temperature, shivering, exhaustion. Symptoms peaked in 18 hours, then gradually diminished and were gone by 72 hours.
Patient received her Pfizer booster (initially had J&J COVID19 vaccine) on 11/9/21. She after she left the clinic was driving home and vomited profusely. Patient reports "I thought I was going to die" and she also complained of stomach cramps and horrible diarrhea as well as feeling off with her equilibrium.  Patient states she took an Aspirin and called the triage line at the clinic where she was directed to go to the ER. In the ER patient had labs and imaging done. Initial ECG had some concerning ST and T wave changes but she did not have breathing concerns or chest pain, troponin negative so patient was discharged home. Patient called back to the clinic today (11/11/21) to report her symptoms and concerns.
Information has been received from a consumer concerning a child who was vaccinated with varicella virus vaccine live. Subsequently, the pt experienced chickenpox. It was noted that another child developed chickenpox after being exposed to this pt, (WAES01092956). No further information was provided. No further information is available.
No adverse event; 1 of our nurses administer a dose of Moderna Covid-19 Vaccine Monovalent that had expired.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 of our nurses administer a dose of Moderna Covid-19 Vaccine Monovalent that had expired.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 061B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Nov-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 of our nurses administer a dose of Moderna Covid-19 Vaccine Monovalent that had expired.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 of our nurses administer a dose of Moderna Covid-19 Vaccine Monovalent that had expired.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (1 of our nurses administer a dose of Moderna Covid-19 Vaccine Monovalent that had expired.).    No concomitant medications was provided. Vial size was  5.5 ml the vial was initially stored in the refrigerator on  09Nov2022 the vial did not undergo any temperature excursions.  No treatment medications was provided.
The patient was accidentally given the pediatric formulation (720 ELU) rather than the adult formulation (1420 ELU) of Havrix
Waxing, weaning fussiness Dx : intussusception.  6/21/07 Received vax rec which confirms RO lot & dose # & also includes multi additional vax received same date.  VAERS database updated w/same. 6/26/07 Received hospital med recs which reveal that on 5/30/07 patient experienced screaming & fussiness then excess sleepiness.  When awake, inconsolable, refusal to eat & drawing legs up.  Taken to PCP office & sent to ER.  Felt to have resolved IS spontaneously.  Held overnight for observation.  Tolerated oral intake well & was d/c to home 5/31/07. FINAL DX: none provided, no D/C summary done.
Swelling and Soreness of Left arm; Swelling and Soreness of Left arm; This is a spontaneous report from a contactable consumer. A 26-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 23Jan2021 (Batch/Lot Number: EL9263) as single dose for COVID-19 immunisation. The patient medical history was not reported. Allergies were unknown. There were no concomitant medications. The patient did not have any other vaccine in four weeks and any other medications in two weeks. The patient had no COVID prior vaccination. The patient had no COVID tested post vaccination. On 23Jan2021, the patient experienced swelling and soreness of left arm. The patient received no treatment for AE. Outcome of the events was recovered in 2021.  Follow-up attempts are completed. No further information is expected.
Developed vomiting and diarrhea, continue x 2 days, seen in ER and admitted for dehydration. Stool rotavirus positive.  Improved with IV fluids and oral rehydration.
Bells Palsy, onset 5/16/2021. Treatment started with prednisone, unknown outcome at this time.
NAUSEA, VOMITING AND DIARRHEA 48 HOURS AFTER VACCINE.
Time of vac:  0835 Time of reactx:  0837 symptoms: light headedness, dizzy, diaphoretic, nausea Interventx:  15 additional min monitoring, cool towel on forehead, small sips of water (pt refused to lay down)
Nausea, dizziness, arm pain & pins & needles.  Cannot lift arm.  Red, egg-shaped lump around injection site.
Lost all speech he had gained days after having MMR, regressed developmentally to 6 months.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 65 year old  female. 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: 204A21A, and expiry: 21-SEP-2021) dose was not reported, 1 total administered on 17-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 21-JAN-2022, the patient experienced suspected covid-19 infection, and suspected clinical vaccination failure. The patient had same symptoms (unspecified) like her son who had tested positive for covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20220214837. This report was associated with product quality complaint: 90000216385.; Sender's Comments: V0; 20220216238-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS
01/07/2021--Fever 102,  Fatigue, Muscle aches, Joint Pain 01/08/2021-Symptoms subside 01/11/2021-Moderate itching at injection site
This case was reported in a literature article and described the occurrence of autoimmune thyroiditis in a subject aged between 10 and 18 years of unspecified gender who was vaccinated with BOOSTRIX (GlaxoSmithKline). Medical records showed that symptoms and or clinical suspicion such a fatigue or abnormal laboratory results were present either on or before the day of vaccination, or family history of thyroid disease was present. On an unspecified date, the subject received unspecified dose of BOOSTRIX. Within 6 months of vaccination with BOOSTRIX, the subject experienced autoimmune thyroiditis. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. This case is one of the 11 cases (B0643778A, B0667819A, B0667865A, B0667866A, B0667868A, B0667867A, B0667870A, B0667867, B0667872A and B0667873A) described in the literature article and classified as 'new onset of chronic illness'. The case referred to 2 subjects who onset autoimmune thyroiditis. This literature article summarizes the results of an open, prospective, observational study that was carried out in a Health Maintenance Organization. The primary aim of this study was to estimate the incidence of specific categories of adverse events (medically attended neurologic and hematologic events, allergic reactions, and new onset of chronic illnesses) following administration of a single dose of BOOSTRIX (GlaxoSmithKline) to adolescents in a postlicensure setting. The study monitored safety outcomes among 13,427 10 to 18-year-old adolescents who received Tdap vaccination as part of their normal health care. The subjects were evaluated using self-control analysis comparing days 0 to 29 to days 30 to 59 post-vaccination for neurological events, hematologic events and allergic reactions. Furthermore the study evaluated new onset chronic illnesses within 6 months of Tdap vaccination by comparing with historical Td controls matched for age at vaccination, season, sex, and geographic area. The study also compared the incidence of events of interest between the Tdap and historical cohorts as exploratory analyses. The study showed no increased risk for medically attended neurological or allergic reactions following Tdap vaccination when comparing the first 30 postvaccination days to the second 30 postvaccination days. There was one hematologic event within 30 days of Tdap, compared with 0 events within days 30 to 59. When compared with matched historical Td recipients, no increase in new onset chronic illnesses was seen after Tdap. No deaths occurred in the Tdap cohort during the study. In conclusion, this study provided no evidence for an increased risk for neurological, hematological, allergic events, or new onset of chronic illnesses among adolescents vaccinated with Tdap.
This spontaneous report as received from a registered nurse refers to two patients of unknown age and gender. The patients were vaccinated with a dose of PNEUMOVAX23 (lot #, dose and route not reported) about two years ago, in approximately 2010. No other co-suspects were reported. No concomitant medications were reported. The nurse mentioned that another unspecified office in their practice had two cases of cellulitis following vaccination with PNEUMOVAX23, which occurred about two years ago (approximately in 2010). No treatment information was reported. It was unknown if the patients sought medical attention. The outcome of cellulitis was unknown. The relatedness for cellulitis was not provided for PNEUMOVAX23. The reporting nurse considered cellulitis to be life threatening. This is one of several reports received from the same source. Additional information has been requested.
temperature excursion for Varivax; no additional AE reported; This spontaneous report was received from a medical assistant and refers to a currently 18-year-old male patient. No information regarding his pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # S002395, expiry date: 23-JAN-2021, for prophylaxis (dose number, route of administration were not provided). No adverse events were reported.      Administered dose of vaccine experienced the temperature excursion of 6 degrees Fahrenheit for 1 hour. There were no previous excursions related. Data logger was involved.
Pt received first dose in primary series on 11/29/2022; however, the manufacturer's expiration date was 11/28/2022.  Physician and patient notified on 11/30/2022 as soon as staff was made aware of their error.  Pt states that he is not experiencing any adverse symptoms.
Left arm tender with swelling with bump, ice pack to area, IBU as directed. Follow up as needed.
Nausea; Had no appetite; Little bit tired; little red welt; Started developing little red welt or greyish circular spot on my neck and on the back of my calf on my right leg; it was very itchy and red and grey; it was very itchy and red and grey; This is a spontaneous report from a contactable consumer. A patient of an unspecified age and gender received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number was not reported), via an unspecified route of administration on 07May2021 as a single dose and covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced nausea, had no appetite, little bit tired, little red welt, started developing little red welt or greyish circular spot on patient neck and on the back of patient calf on patient right leg, it was very itchy and red and grey. Patient called to doctor and he said it was a local reaction. And so it was very itchy and red and grey. And so patient put Calamine (further clarification unknown) on it but nobody was telling what more to do, it feels weird 3 weeks later.   The outcome for all the events was unknown.  No further information available over the call as the consumer hung up the call abruptly. Hence limited information available over the call.  Additional information has been requested.
she has three shot of vaccine but still get COVID; she has three shot of vaccine but still get COVID; Fever; Coughing; Sick; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "cholesterol" (unspecified if ongoing), notes: She takes that for cholesterol. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she has three shot of vaccine but still get COVID"; PYREXIA (medically significant), outcome "unknown", described as "Fever"; COUGH (medically significant), outcome "unknown", described as "Coughing"; ILLNESS (medically significant), outcome "unknown", described as "Sick"; CHILLS (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: "caller's wife is prescribed because she got COVID-19, the Paxlovid drug. Under the it says she should not take and it says the simvastatin (Manufacture name was not clarified over the call). She takes that for cholesterol. That's it, that's the only drug that says that she should not take if you are on that medication that the doctor prescribed before. She takes this COVID (Incomplete Sentence), she has three shots of vaccine (Further not clarified) So, vaccinated but still get COVID because everybody can get back to it. Her brother died from it (Further not clarified). So, concerned about it. she is sick she got horrible chills, fever and coughing and that is why wanted to find out if she can take this treatment for 5 days being on regular medication that is simvastatin. For simvastatin, she took that for cholesterol; the only drug that said that she should not take if you are on that medication that the doctor prescribed before. (unknown if patient has started taking paxlovid with Simvastatin).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Several days after both doses I experienced an outbreak of mouth sores (~15) in my mouth- along my gums, tongue, roof of mouth, and under my tongue. After the first dose, the sores subsided after 4-5 days. It has been 6 days since the sores appeared after the second dose and they are still present. Some subside but others appear.
Pt received vaccine past the recommended refrigeration period of 30 days. Vaccine removed from ultracold temps on 1/13/22 and expired after 30 days in refrigerator 2/12/22.  Vaccine was administered on day on 2/15/22.
I began to have paresthesias in my lower extremities, which progressed to saddle anesthesia over about a week?s time. I then developed acute urinary retention. I could also not have a bowel movement at that time. In the ER, I was cathed and they also performed an enema, believing I was constipated but nothing came out, leading me to believe that it was a loss of nerve function. They also performed an emergency MRI which showed no nerve compression (ruling out cauda equina syndrome). I left because I believed I could urinate at home. I was not able to urinate until mid morning the next day. After this, I was seen by a neurologist who believed I may have multiple sclerosis. However, my work up came back negative. At the same time, the paresthesias continued to ascend into my hands and I could not sit due to overwhelming pain and saddle anesthesia/LE parenthesis. As this began to resolve, I woke up from sleep multiple times in a row for 3 nights gasping for air because I stopped breathing spontaneously (even with sitting up and changing positions). I recovered after this symptom resolved and have been completely fine since. I am a PA student and I truly believe that I had a Guillian Barre type reaction to the vaccine.