chrisvoncsefalvay/vaers-outcomes huggingface dataset:
extreme dizzy spell; arm was hurting; mild headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "extreme dizzy spell"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm was hurting"; HEADACHE (non-serious), outcome "unknown", described as "mild headache".  Additional information: Patient was injected, she had an extreme dizzy spell and had to sit there for 45 minutes. Patient arm was hurting within 5 minutes and now she has a mild headache. Patient wants to know if the second shot going to be too dangerous for her to take.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The vial was initially stored in the refrigerator on 02-May-2022, expired on 25-Mar-2022 and administered on 13-May-2022; 5 doses administered to patients after Moderna vaccine expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 doses administered to patients after Moderna vaccine expired) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-May-2022, expired on 25-Mar-2022 and administered on 13-May-2022) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 doses administered to patients after Moderna vaccine expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-May-2022, expired on 25-Mar-2022 and administered on 13-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 doses administered to patients after Moderna vaccine expired) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-May-2022, expired on 25-Mar-2022 and administered on 13-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  It was reported that the vial was initially stored in the refrigerator on 02-May-2022. The vial did not undergo any temperature excursions.  The patient did not had any adverse reactions.  No treatment information was provided.
This spontaneous report was received from a nurse referring to a multiple unspecified patients of unknown ages and genders. The patients' concurrent conditions, medical histories and drug reactions/allergies were unknown. On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ (Lot # L0248854, expiration date 31-AUG-2017), doses and routes were not provided. There was no concomitant medication reported. The temperature/time frame was 33F for 60 hours. No data logger was involved and no previous excursions were reported. No adverse effects were reported. This is one of three cases received from the same source. Additional information has been requested.
Rash on the front and back of my trunk and then it started itching for 3-4 days; Chills; Temperature of 101.5 degrees Fahrenheit; Sore injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rash on the front and back of my trunk and then it started itching for 3-4 days), CHILLS (Chills), PYREXIA (Temperature of 101.5 degrees Fahrenheit) and VACCINATION SITE PAIN (Sore injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced CHILLS (Chills), PYREXIA (Temperature of 101.5 degrees Fahrenheit) and VACCINATION SITE PAIN (Sore injection site). On 07-Jan-2021, the patient experienced RASH PRURITIC (Rash on the front and back of my trunk and then it started itching for 3-4 days). On 11-Jan-2021, RASH PRURITIC (Rash on the front and back of my trunk and then it started itching for 3-4 days), CHILLS (Chills), PYREXIA (Temperature of 101.5 degrees Fahrenheit) and VACCINATION SITE PAIN (Sore injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, Body temperature: 101.5 (Inconclusive) 101.5 degrees Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
It has been 60 hours since the time of injection and I still have  a sizeable amount of pain at the injection site (feels like a bee has just stung my arm) . I also have redness, a swollen lump / bump - medium sized (about the size of a quarter)  and can feel the lump is raised up by touching it with my opposite hand. Also have a light burning sensation extending downward from the injection site. The burning sensation radiates out from the injection site and is also traveling 3-4 inches down from the injection site. I have not taken any kind of pain medication as I wanted to know when the pain stops on its own. I have not called my Dr etc but will continue to monitor the site for now.
pt recv vax OCT96 & pt exp pruritus;the nurse practitioner was not convinced the pt exp was d/t vax;
I had a positive pregnancy test on 28Sep after my second COVID vaccine. This pregnancy ended in miscarriage on 23Oct2021 at 6w5d pregnant.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 29-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 26Sep2021 (Batch/Lot Number: 30155BA) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration, administered in Arm Left on 05Sep2021 (Batch/Lot Number: Fc3183) as DOSE 1, SINGLE for covid-19 immunization (age at vaccination: 29-year-old). Medical history included allergies to Penicillin, Sulfa. Concomitant medication(s) included fluoxetine; valacyclovir [valaciclovir]; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); minerals nos, vitamins nos (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]). The patient had a positive pregnancy test on 28Sep2021 after the second covid vaccine. this pregnancy ended in miscarriage on 23Oct2021 at 6w5d pregnant. The event resulted in Doctor or other healthcare professional office/clinic visit. The outcome of events was recovering. No treatment received for the event. The patient underwent lab tests and procedures which included pregnancy test: positive on 28Sep2021. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19.  No follow up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101449286 similar report from same reporter
PATIENT COMPLAINT OF BLURRED VISION AFTER GIVING FLU VACCINE. SHE  ALSO COULD NOT HEAR AFTERTHAT. PATIENT 'S BREATHING WAS FINE.
Within several minutes of receiving her vaccination, she reported feeling left-sided chest discomfort. She was taken to a private section of the arena and monitored.
Patient called a few days later with extreme shoulder pain, he is unable to function at work properly. He was sent a Medrol Dose pack that provided very minimal relief. Advised to see Orthro.
before/during/after patient experienced tachycardia + "tingling". No rash, no resp. issues. Patient's baseline is PR=100. After 3rd set of vitals, well w/in her norms. MD advised patient as to what to expect (eg sore arm) 67 y/o female who presents with raised heart rate and body tingling. Pt thinks it could be anxiety. No vaccine allergies Exam - unremarkable except for tAchycArdiA PlAN - OBS with resolution of symptoms and tAchycARdiA. unlikely to be allergic RXN
Tdap given on 3-6-2007,On Friday 3-9-2007 started having pain in arm and left shoulder blade and neck area. Pain then extended down the arm.Applied cold and warm compresses without relief.Advised to seek MD care if not improvement today.
Area around injection site with redness, swelling and warmth noted day after injection that got larger throughout the day. Saw in office 1/30/19 and mom stated the redness and swelling was down. In office today 1/30, no warmth, mild erythema approximately 8 cm with induration directly around injection site. Patient was also noted to have clear runny nose and watery eyes the day after the injection.
Blood sugar started going over 250 at 2:00 am 4/16/21. Continued to raise well over 400 most of the day with correction doses every 2 hrs. Also a horrible headache. It did decline slightly to 325 overnight, but went right back up to 395 upon waking up on 4/17. Continue to do correction doses every 2 hrs with persistent headache.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The health care professional (HCP) reported that the patient experienced arm soreness. This report came from Inside sales. The Inside Sales representative did not have any patient or vaccine information. The representative only had limited information about the adverse event. This is one of the 7 cases reported by the same reporter.
given a dose of Tenivac in error due to the consumer not knowing she was to receive the Adacel; Initial information received on 24-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 22 years old female patient who DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] and reported that given a dose of Tenivac in error due to the consumer not knowing she was to receive the Adacel.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 19-Jun-2019, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot U6014AB and expiry date: 20-Jul-2020 via intramuscular route.  It was a case of actual medication error due to wrong vaccine administered.  It was unknown if the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Wrong Route of Administration; injection site Swelling; injection site Redness; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (subcutaneous). On an unknown date, less than a year after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, injection site erythema and intramuscular formulation administered by other route. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site erythema were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb and injection site erythema to be related to Shingrix.  Additional details were reported as follows: The reporter was the patient's husband.  The reporters wife received the second dose of Shingrix vaccine towards the end of 2018.  The patient was vaccinated subcutaneously on the back of the arm instead of intramuscularly.  The patient had red swelling area at injection site 4 inches round that lasted for 3 days. The reporter did not give consent to follow up. No further details were provided. The reporter referred to healthcare professional.
Patient received injection on 9/29/2009 and on 10/1/09. Mom called stating patient had redness and swelling and warm on injection site right thigh. Patient was seen that day and treated with Keflex x 10 days.
Fever, chills, muscle aches, bad headache, eyes hurt.  Took 975 mg Tylenol provided some relief.  Symptoms subsided within 24 hours
Onset started after injection. Started on (R) upper arm. Rash moved down to both sides of (R) arm to elbow up to chin across front of chest as well as back of chest.
Fever; Chills; Shaking; Muscle Pain; Fatigue; Itching on both arms and abdomen; Hives on both arms and abdomen; This case was reported by a consumer via call center representative and described the occurrence of fever in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number 53RF3, expiry date 17th October 2021) for prophylaxis.   On 17th July 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 18th July 2019, 1 days after receiving Shingrix, the patient experienced fever, chills, tremor, muscle pain, fatigue, pruritus and hives. The patient was treated with prednisone. On 19th July 2019, the outcome of the fever, chills, tremor, muscle pain and fatigue were recovered/resolved. On an unknown date, the outcome of the pruritus and hives were recovering/resolving.   It was unknown if the reporter considered the fever, chills, tremor, muscle pain, fatigue, pruritus and hives to be related to Shingrix.  Additional information received were as follows: The patient stated that next day post vaccination she woke up with fever, chills, shaking, muscle pain, and fatigue. The patient also experienced itching and hives on both arms and abdomen. On 19th July 2019, the patient went to urgent care and was prescribed prednisone ointment. The patient consented to follow up. No further details were provided.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021 at 3:29 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 9:14 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 13-Feb-2021 at 3:29 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 88.02 for dose administered on 13-Feb-2021 and 88.13 for dose administered on 27-Mar-2021.   No concomitant medications were reported.  Product moved to clinic on 13-Jan-2021. This vial was moved to fridge on 09-Feb-2021. Batch number 031L20A underwent temperature excursion on 13-Feb-2021 with temperature 32 degrees Fahrenheit at 09:00 AM. Beyond use date for the vial was reported as 10-Mar-2021. This vial was moved to fridge on 23-Mar-2021. Product moved to clinic on 27-Mar-2021. Batch number 019B21A underwent temperature excursion on 27-Mar-2021 with temperature 35 degrees Fahrenheit from 09:00 PM to 10:00 AM. Beyond use date for the vial was reported as 22-Apr-2021.   Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
The patient had requested Fluzone HD Quad and instead received the Fluzone Quad with no reported adverse event; Initial information received on 14-Oct-2021 regarding an unsolicited valid non-serious case received from other health professional, consumer/non health care professional and physician via media Information (under reference 00812641).  This case involves a 67 years old male patient who requested INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] and instead received the INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (wrong product administered).  The patient had no other vaccines.   The patient's medical history, medical treatment(s), concomitant medication(s) and family history were not provided.  14-Oct-2021, the patient received a 0.5 mL dose of suspect FLUZONE QUADRIVALENT (Solution for injection, Total, lot number: UT7317LA and expiration date: 30-Jun-2022) via intramuscular route in the right deltoid for prophylactic vaccination.  It was an actual medication error due to wrong vaccine administered (same day latency).  It was reported "Pharmacy intern is asking how to go about giving a patient the FLUZONE HD when they received the FLUZONE QUAD yesterday?"  At time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient described a bloodshot eye, or apparent broken blood vessel in her left eye, on the same side as the arm where she received her vaccine the day before. She did not have pain or other symptoms. She exchanged an email with her doctor who doubted it was related to the vaccine and advised her to keep an eye on it. No clinic visits or other medical care. Patient does not take a bloodthinner or have a bleeding disorder.
Moderna COVID-19 Vaccine EUA -  Pain at injection site together with significant muscle pain and stiffness in right arm (injection site) beginning a couple of hours after the injection and continuing at uncomfortable level for 24 hours,  Muscle stiffness completely gone in 48 hours; injection site still mildly sore at 48 hours.  Chills about 14 hours after injection, duration about 1 hour.  No treatment for any side-effect, not meds taken.
Improperly stored doses administered; no adverse event; This spontaneous report has been received from a Health Care Professional concerning to a 13-years-old male patient.  The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 24-SEP-2019, the patient received a improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (albumin status of recombinant human albumin (rHA) (M-M-R II) (dose number, dose and anatomical location were not reported) intramuscularly for prophylaxis (lot#: R028382, expiration date: 10-MAR-2020) (product storage error). The temperature excursion was due to a data logger. No adverse events were reported.
This case was considered medically important (OMIC). Information regarding Prevnar was received from a parent regarding her son who at approximately 29 months of age developed autism. The patient received the fourth dose on 5/6/03 at 12 months of age. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 3/6/03. Dose regimen was 1 dose (IM). Concomitant medications were not reported. A mother reported that her son developed delayed speech and autism in August 2005. No additional information was available at the time of this report. See related case: HQWYE343701NOV05 for reporter's nephew's SAE of autism (not genetically related).
Patients states that the next day the patient felt pain and had redness and bruising from the vaccine. The patient reported it about 5 days after the vaccination and he states that its much better and he's not experiencing any pain. The bruising is also gone.