chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt overall crummy; muscle aches; headache; fatigue; cold; This is a spontaneous report from a non-contactable consumer.  A 32-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EJ1686, expiry date not reported), via an unspecified route of administration on 19Jan2021 at a single dose in the right arm for covid-19 immunization.  The patient's medical history was not reported. The patient was not pregnant at the time of the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included citalopram at 20 mg, daily; melatonin at 5 mg, as needed; and ibuprofen at 400 mg, as needed. The patient received the first dose of BNT162B2 (brand Pfizer, lot number EL1284, expiry date not reported, age at vaccination as 32 years old) on 28Dec2020 at the right arm. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The recent COVID-19 vaccine was administered in the hospital. Morning after vax, 20Jan2021, patient felt overall crummy, muscle aches, headache, fatigue, cold (cold is unusual for patient). The events improved throughout the day. Next morning, woke up with similar headache, but improved with daily activity and otherwise felt normal. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). No treatments received in response to the events reported. Since the vaccination, the patient has not been tested for COVID-19. The events felt overall crummy, muscle aches, headache, fatigue, and cold were recovered in Jan2021.
patient was administrated with a pediatric dose of Engerix-b; Adult patient received Engerix B pediatric; This case was reported by a nurse via call center representative and described the occurrence of underdose in a adult male patient who received HBV (Engerix B pediatric) (batch number lm992, expiry date 13th December 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd August 2022, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 23rd August 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-AUG-2022 Reporter's Comments: The registered nurse stated that an adult patient was administrated with a pediatric dose of Engerix-b with no adverse event was reported.  The nurse was asked about should she gave another pediatric dose and what was the recommendation. The patient's identifiers not provided The reporter consented to follow up.  Additional Supportive Information: The adult patient received Engerix B pediatric, which led to adult use of a child product and underdose.
Pt came to clinic for care and requested Pneumonia and flu vaccines. Vaccines where order by provider and this nurse administer the vaccines to pt.  Since the month on the expiration date for the pneumovax-23 vaccine was was abbreviated as Jan, it was mistaken for June. Vaccines where administer and this nurse went back to get the lot number and expiration date for documentation purpose. At the moment it was noticed that the actual expiration date for the pneumovax-23 vaccine was actually Jan 27,2022 not Jun 27,2022. The expiration date was verify with the ordering provider and at the time the pt. was notified of the administration of the expired vaccine. Pt was advise by the provider to return in a week to be revaccinated for the Pneumonia. Pt understood and agree to advise. Pt had stable vital signs and it look well over all.  Pt was talking and showing no signs of distress or discomfort, or signs of adverse effects or reaction at time of discharge.
Localized swelling, ecchymosis. Pain medial RUE/Detoid with swelling into (R) axillary and (R) anterior chest. Decreased ROM, neuropathic symptoms numbness extending down (R) arm.
first dose of Shingrix over 2 yeas ago; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received over 2 years ago from reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. At the time of reporting the patient was over 70 years age. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The VAERS details were reported for 1st dose of Shingrix. The reporter consented to follow up. The healthcare professional did not have any more information. This case had been linked to the case US2021226681, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021226681:Same reporter
that the first shot is still sitting in her arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 08Sep2021 (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: LIMB DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "that the first shot is still sitting in her arm".  Additional information: The course of the event was as follows: The patient who was having an issue with her first dose of the Pfizer Biontech COVID-19 vaccine which she received on 08Sep2021 and wanted to get the second dose but her medical technician, pharmacist, and primary HCP stated that her body was encapsulating the vaccine and was uncomfortable on giving the second dose. The patient stated that the first shot was still sitting in her arm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Shot Thursday, sluggish on Friday, vomited on Saturday, Monday weak, rundown, no fever.
Redness around the eyes and a couple of raised red bumps on the face.  The symptoms started 10 minutes after vaccines were administered. I checked her throat and mouth for swelling, but it looked normal. Advised mother to keep her in clinic for another 10 minutes. Client redness and bumps got better. But advised mother to taker her to the urgent care if symptoms got worse.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 26-JUN-2009, the patient was inoculated with ZOSTAVAX by a healthcare provider to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of patient's injuries. The patient was treated by a healthcare provider for shingles in 2016. The lawyer reported that as a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death- aggravation of preexisting conditions and activation- of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
Hospitalization within 6 weeks of COVID vaccine. Was also hospitalized 3/22/21.
As soon as he received Prevnar, he passed out immediately. He was white and his eyes went gray. Ten minutest after than he had a fever that went from normal to 102 degrees.
No arm just a little sore for 2 days; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 12-APR-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine and experienced no arm just a little soreness for 2 days. Additional supportive information: The follow-up would not possible, as no contact details were available.
Awoke with chills, fever and weakness lasting approximately 24 hours. Took Tylenol every 6 hours x4
Admit to hospital w/stroke on 2/1/2022. Positive COVID-19 test on 1/27/2022; s/p 3 doses of Pfizer (1/19/2021, 2/9/2021, 9/11/2021). Not currently being treated for COVID-19, but had sx (sore throat, cough, congestion, and nausea) prior to getting tested for COVID-19.
dizziness; fatigue; exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS ( dizziness ), FATIGUE (fatigue) and FATIGUE (exhaustion) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 015M20A) for COVID-19 vaccination.     Medical history not provided by the reporter.  Concomitant products included LEVOTHYROXINE and RALOXIFENE for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced DIZZINESS ( dizziness ) and FATIGUE (exhaustion). 05-Apr-2021, the patient experienced FATIGUE (fatigue). At the time of the report, DIZZINESS ( dizziness ), FATIGUE (fatigue) and FATIGUE (exhaustion) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: increased (High) INCREASED.         Treatment information was not provided.
I had a runny nose that showed up two days after the vaccine. I think I caught COVID either a day or so before I got the vaccine. I was in the hospital the day before I got my vaccine, and I was in there for a week or two prior; I was there for a sickle cell anemia crisis. Back to after the vaccine, I was having the runny nose and having problems breathing. I went to ER. I went to (city) ER - (city, state).
electrical system in my heart failed; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CONDUCTION DISORDER (electrical system in my heart failed) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CONDUCTION DISORDER (electrical system in my heart failed). At the time of the report, CONDUCTION DISORDER (electrical system in my heart failed) outcome was unknown.            No relevant concomitant medications were provided. No treatment information was provided.
Dizziness; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 19-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL1284) via an unspecified route of administration in the left arm on 20Jan2021 at a single dose as Covid vaccine. There were no medical history and no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). The patient experienced dizziness on an unspecified date. The outcome of the event was unknown.
PT REPORTS OF NASEA AND DIZZY WITH THE FIRST DOSE AT 2ND APPOINTMENT FOR PFIZER
I started having a scratchy throat, congestion in my nose, low-grade fever, cough. I used home COVID-19 test that came back positive, I sent my doctor a message through the portal letting her know my symptoms and that I had tested positive. She contacted me back letting me know she had sent a prescription for the Paxlovid to my pharmacy to be picked up. I was able to start the medication on March 6, 2023, the next day I started having loose stools that did not stop until I finish the Paxlovid. All my symptoms cleared up and I felt so much better. By the sixth day after finishing the Paxlovid I tested positive again for COVID-19. My doctor and I agreed that I would take over the counter medication to get through virus this time. The coughing seemed to linger for a while.
PT STATED SHE HAD SEVERE PAIN AT THE INJECTION AREA AND RIGHT SHOULDER. THERE WERE NO REDNESS, SWELLING, NOR WARMING AT THE PAIN AREAS. SHE TRIED MOTRIN 1 TAB THREE TIME A DAY.  THE PAIN AT THE INJECTION AREA WENT AWAY AFTER 10 DAYS. HOWEVER, THE PAIN ON HER RIGHT SHOULDER STILL BOTHERED HER. SHE SAW DR TODAY;9/25/20. SHE GOT DICLOFENAC GEL TO APPLY ON HER SHOULDER. SHE FELT A BIT BETTER AFTER 2 APPLICATIONS.
Pt had 2-3" red area with 2" blister-like area where vax was given. This was noticed on 12/20/99. 12/21, no blister-like area but 2-3" red area that burns, itches. Told him to see Dr. & he did & was told nml rxn to TD. Tx: Augmentin.
This was my second shot. My e-number from the first was e-number 285325  I experienced chills, fatigue , aches and constipation. I also had constipation after the first shot but forgot to list it. These lasted for a little over 24 hours.
persistant crying x 10 days p/DTP/OPV/HIB exam entirely nl;
Redness site of injection - baseball size. (B) axilla pea size lymph nodes 2-3. (L) axilla swelling - pain 9/10 lasted 3-4 days. Resolved now.
approx 15 individuals c/o painful injection w/different lot# of Engerix-B; No other info is available; This case is considered to be invalid;
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. On 30-Oct-2021, PYREXIA (Fever) had resolved.            No Concomitant medication was reported.  No treatment medications were reported.
Information has been received from a pharmacist concerning a 66 year old female who on 08-DEC-2006 was vaccinated subcutaneously with 0.5 mL of Pneumovax 23.  Subsequently, the patient developed cellulitis which had increased in diameter.  The pharmacist recommended the patient take TYLENOL and BENADRYL.  The physician recommended symptomatic care; cool compresses and anti-inflammatories and reported "immune response should resolve with time".  At the time of this report, the cellulitis was worsening.  Additional information has been requested.  07/30/2008 This is in follow-up to report(s) previously submitted on 7/30/2007. Additional information is not expected.
2 days post vax c/o pain rt chest radiates rt breast to shoulder is sharp-still occuring 10 days post vax; 14NOV994 still sporadic-has consulted MD who is evaluating pain;
Patient noted onset of edema, erythema and pruritis around injection site approximately 4 hours after administration. Exam revealed circular area of erythema, approximately 8cm in diameter, around injection site with mild edema.
Patient recieved an 3rd dose of Shingrx Vaacine. Patient stated that she had only had 1 shot of the series. No adverse reaction.
A few hours after vaccine administration the patient experienced swelling and itching at the injection site. Two days after the injection the patient was seen at a walk-in clinic and diagnosed with cellulitis.
One day onset of vesicular/papular rash on LEFT abdomen; came to doctor's office. non-tender. non-pruritic. suspicious for shingles
Information has been received from a registered nurse concerning a 82 year old female with allergies to NSAIDS ANAPROX, ZOMAX, and TOLECTIN. Concomitant medications include hydrochlorothiazide (manufacturer unknown), lisinopril (manufacturer unknown), LEVOXYL, omeprazole (manufacturer unknown) and simvastatin (manufacturer unknown). Pertinent medical history was reported as none. On 18-NOV-2014 the patient received a dose of PNEUMOVAX 23 (lot # K009874, expiration 21-JAN-2016) 0.5 mg intramuscularly in the left arm for prevention of pneumonia. The same night after receiving her dose of the vaccine, the patient developed swelling and warmth in her left shoulder. The swelling had spread to the patient's left upper breast and there was red "streaking" from the patient's left upper arm to her left upper breast. The patient sought medical attention on 20-NOV-2014 and the nurse reported that the patient was diagnosed with cellulitis by the nurse practitioner after the patient had been seen. The patient was treated with KEFLEX and the patient was instructed to apply warm compresses to the area. The outcome of cellulitis was not reported. Intervention to prevent serious criteria was no. The initial lot number was reported as K009105 expiring 21-JN-2015. However, lot was corrected to K009874 expires 21-JAN-2016 by registered nurse. Additional information is expected.
no adverse event; Improperly stored administered vaccines; This spontaneous report was received from a registered nurse and from vaccine coordinator and refers to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions and concomitant medications were not reported.   On 08-SEP-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T041687 expiration date 10-DEC-2022 (dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The suspect vaccine was stored in a temperature from -10 degree Celsius (C) to 8 C for 5 hours and 10 minutes. There was previous temperature excursion - the vaccine was stored in a temperature from -10 C to 8 C for 8 hours and 41 minutes and for 3 hours and 35 minutes. No additional adverse events were reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA005066: US-009507513-2109USA006582: US-009507513-2109USA006583: US-009507513-2109USA006584: US-009507513-2109USA006585: US-009507513-2109USA006586: US-009507513-2109USA006587: US-009507513-2109USA006588: US-009507513-2109USA006590: US-009507513-2109USA006591: US-009507513-2109USA006592: US-009507513-2109USA006593: US-009507513-2109USA006594: US-009507513-2109USA006595: US-009507513-2109USA006596: US-009507513-2109USA006597: US-009507513-2109USA006537:
Syncope; Diarrhoea; Dizziness; Fatigue; Gait inability; Pallor; Skin discolouration; Pyrexia; Vomiting; This case was received via Regulatory Authority on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of SYNCOPE (Syncope), DIARRHOEA (Diarrhoea), DIZZINESS (Dizziness), FATIGUE (Fatigue), GAIT INABILITY (Gait inability), PALLOR (Pallor), SKIN DISCOLOURATION (Skin discolouration), PYREXIA (Pyrexia) and VOMITING (Vomiting) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006c21a) for COVID-19 vaccination.     No medical history reported by the reporter.  Concomitant products included MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.   On 18-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, the patient experienced SYNCOPE (Syncope) (seriousness criteria medically significant and congenital anomaly), DIARRHOEA (Diarrhoea) (seriousness criterion congenital anomaly), DIZZINESS (Dizziness) (seriousness criterion congenital anomaly), FATIGUE (Fatigue) (seriousness criterion congenital anomaly), GAIT INABILITY (Gait inability) (seriousness criterion congenital anomaly), PALLOR (Pallor) (seriousness criterion congenital anomaly), SKIN DISCOLOURATION (Skin discolouration) (seriousness criterion congenital anomaly), PYREXIA (Pyrexia) (seriousness criterion congenital anomaly) and VOMITING (Vomiting) (seriousness criterion congenital anomaly). At the time of the report, SYNCOPE (Syncope), DIARRHOEA (Diarrhoea), DIZZINESS (Dizziness), FATIGUE (Fatigue), GAIT INABILITY (Gait inability), PALLOR (Pallor), SKIN DISCOLOURATION (Skin discolouration), PYREXIA (Pyrexia) and VOMITING (Vomiting) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.2 (High) 103.2.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment was reported.  Action taken with the mRNA-1273 in response to the event is not applicable.  Company Comment: 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.; 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.