chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3 weeks early and heavy period; 3 weeks early and heavy period; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA Vaccine; Lot number: EL3247), via an unspecified route of administration in left arm on 23Mar2021 at 11:45 (at age of 24 years old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Patient previously received the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA Vaccine; Lot number: EL3247), via an unspecified route of administration in left arm on 04Mar2021 at 09:00 (at age of 24 years old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 25Mar2020 at 12:00 after the vaccination, the patient reported she experienced 3 weeks early and heavy period. No therapeutic measures were taken for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event 3 weeks early and heavy period was recovered on an unknown date in Mar 2021.   No follow-up attempts are needed. No further information is expected.
Within 20 minutes of jab: Lightheadedness, pressure in the head  Within 60 minutes: Slight fatigue Within 90 minutes: Headache, foggy brain, slight  focus/concentration issue Within 2 hours: Extreme fatigue  After 6 hours: All issues better but still present. Fatigue especially better but still an issue.
This spontaneous non-valid report as received from a consumer refers to an unknown number of patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. The consumer reported about another parent's children who riddled with seizures after vaccination with GARDASIL (captured in MARRS# 1608USA012924). After that, the reporter did some research in the internet and found similar stories online. On an unknown date, the patients were vaccinated with GARDASIL (strength, dose, frequency, route of administration, lot # and expiration date were not reported). On an unknown date, the patients experienced seizure. The outcome of seizure was unknown. The relatedness between vaccination with GARDASIL and the event was not reported. Upon internal review the event of seizure was considered to be medically significant. This is one of 2 reports from the same reporter. Additional information is not expected.
This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 43-year-old, adult patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUCELVAX QIVc vaccine exposed to temperatures in the range of 47F to 50.9F. On 06-Sep-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported] which underwent temperature excursion. The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed the case as non-serious. This case 201804079 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Added Med info number (SEQ18-04086) in the additional information tab. No changes were made in the narrative.
At 1800 jaw pain started, felt tight and burning, face,lips and eyes swollen within 30 minutes, progressed to headache and swollen neck.  Took Ibuprofen and went to sleep at 2100.  By 2300 burning was resolved but swelling continued until noon the next day.  No coughing, hives or wheezing reported.
Patient received both the seasonal flu vaccine and his second dose of Shingrix. Patient was fine after both shots given. He left and said he had shopping in the store. He came back about 10 minutes later stating it felt like the muscle in his neck got tense and it happened pretty quickly. He also said he felt a "lump" in his throat but was having no issues of throat closure feeling or ability to carry on a conversation. I had him sit down in the immunization chair. He was nervous and I took his blood pressure. He stated it was higher than his normal. I sat and observed him for at least 30-45 minutes (talking and rechecking his blood pressure) As time went on he felt better and blood pressure decreased. Several times I offered to call 911 but kept stating no and that he was feeling better. He eventually left stating he felt fine. I did follow up with him the next morning and he stated everything was fine and normal. He receives a flu vaccine annually and he had no reaction to the first dose of shingrix.
Information has been received from a physician concerning a 9 year old female who on 04-OCT-2010 was vaccinated with one shot of PNEUMOVAX 23 (LOT# 663998/0623Y expiration 01-DEC-2010). Secondary suspected vaccination included a dose of seasonal influenza virus vaccine (unspecified) (manufacturer unknown). The patient's medical history included "not that she knows of". In October 2010 (unreported by physician), the patient experienced local reaction, severe cellulites at injection site, a fever of 103 degree and flu like symptoms. To treat these symptoms, the patient was put on DURICEF and BACTRIM. It had not had other lab diagnose study performed. At this time of reporting, the patient's local reaction and severe cellulites at injection site and a fever of 103 degree and flu like symptoms persisted. Additional information has been requested.
Patient received a dose of Boostrix on 7/14/2022 and then a dose of Adacel on 7/6/2023, less than a year later.    The provider ordered an HPV vaccine and the Tdap was given in error.  There were no adverse symptoms reported by patient or parent
L arm injection site itching, red & slight swelling 8 days following injection. Itching, red & swollen for 3 days.
Rash x 5in. Started on trunk.  Vesicular, pruritic.  Many lesions now scabbed, others vesicules.
Swollen armpit, pain in arm, armpit and hand, numbness in arm and hand. Diarrhea
3/2 - sore arm, chills, low grade fever 3/3 - woke up with heart palpitations.  Apple watch recorded range between 59 and 166.    3/4 - itchy rash near injection site ( have photo)
Nausea in the afternoon after receiving vaccine then ran a fever and vomited the next morning.
A non-serious spontaneous report of two doses of FLUMIST in the same day was received from a consumer concerning a 35-month-old female. Neither patient's medical history nor concomitant medications were reported. On 12-Sep-2011, the patient received two doses of FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
sleeping a lot after dose 1; sore arm after dose 1; nauseas after dose 1; headache after dose 1; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (sleeping a lot after dose 1), PAIN IN EXTREMITY (sore arm after dose 1), NAUSEA (nauseas after dose 1) and HEADACHE (headache after dose 1) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Blood pressure high.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSOMNIA (sleeping a lot after dose 1), PAIN IN EXTREMITY (sore arm after dose 1), NAUSEA (nauseas after dose 1) and HEADACHE (headache after dose 1). At the time of the report, HYPERSOMNIA (sleeping a lot after dose 1), PAIN IN EXTREMITY (sore arm after dose 1), NAUSEA (nauseas after dose 1) and HEADACHE (headache after dose 1) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications included are taken for high blood pressure and diabetes. No treatment drug details was reported.  This case concerns a 55-year-old, male patient with no medical history, who experienced non serious AESI events of   Hypersomnia, Pain in extremity, and expected events of Nausea and Headache. The event occurred on an unknown date after the first dose of mRNA-1273 vaccine. The re challenge was not applicable, since the patient did receive other two doses, but the outcome of the event hypersomnia was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-404786 (Patient Link).; Sender's Comments: This case concerns a 55-year-old, male patient with no medical history, who experienced Non serious AESI events of   Hypersomnia, Pain in extremity, and expected events of Nausea and Headache. The event occurred on an unknown date after the first dose of mRNA-1273 vaccine. The Re challenge was not applicable, since the patient did receive other two doses, but the outcome of the event hypersomnia was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Irritated; joint pain; nauseous overnight; had symptoms like colds, coughing,chills, hot and cold all night,sore on the arm and pain in her knee after the first dose; had symptoms like colds, coughing,chills, hot and cold all night,sore on the arm and pain in her knee after the first dose; had symptoms like colds, coughing,chills, hot and cold all night,sore on the arm and pain in her knee after the first dose; had symptoms like colds, coughing,chills, hot and cold all night,sore on the arm and pain in her knee after the first dose; had symptoms like colds, coughing,chills, hot and cold all night,sore on the arm and pain in her knee after the first dose; had symptoms like colds, coughing,chills, hot and cold all night,sore on the arm and pain in her knee after the first dose; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 13Apr2021 as dose 1, single for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. On an unspecified date, the patient experienced irritated, joint pain, nauseous overnight, had symptoms like colds, coughing,chills, hot and cold all night,sore on the arm and pain in her knee after the first dose. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a registered nurse concerning an 18 month old female patient with no known drug reactions, allergies and medical history who on 16-APR-2007, was vaccinated with the first dose of PROQUAD (Merck) (lot number, dose and site of administration not reported) and the second dose on 17-OCT-2007 of PROQUAD (Merck) (Lot number 657782/0612U, expiration date: 05-OCT-2008), subcutaneously (dose not reported). Secondary suspect vaccines also included Hepatitis A vaccine (manufacturer unknown) and influenza vaccine (manufacturer unknown) administered the same day of the second dose of PROQUAD (Merck). Concomitant vaccines included "DTaP", on the same date of the second dose of PROQUAD (Merck). On 21-MAR-2011, the patient developed chickenpox. The patient received unspecified medical attention. No treatment was given for the adverse event. No lab diagnostics were performed. At the time of the report, the patient was recovering. Additional information has been requested.
Presented to ED w/SOB; admitted for acute resp failure w/hypoxia & suspect COVID; COVID test +, tx w/ O2, abx & steroids; dc'd home w/ O2.
Bexsero ordered by provider. Patient recieved MenQuafi instead. Only headache reported 3 days after vaccination
Fever and chills for 3 days, injection site was swollen to the size of a baseball and was also bright red with heat emanating from the site for 5 days - still have a discolored area that looks like a bruise in the injection site, body aches and headache for 5 days - self treated with rest and tylenol and Benadryl
Redness that turned into rash and swelling that itched and covered most of underside of upper left arm. Black and blue mark that spread across entire region from injection site. Sore throat and nausea. Difficulty breathing. 6/9/16-6/17/16 still some black and blue discoloration.
left sided facial droop onset 24 hours prior, in addition patient had chest pain 48 hours prior nothing improved chest pain however it resolved on its own; nothing improved facial droop quality of chest pain was sharp, mild intensity, facial droop symptoms have been worsening since onset
Fever, body aches, headache, stomach pain. Started about 12 hours after injection and continued for 24 hours.
Client was given DTaP vaccine on this date. Based on clients age, the Tdap should have been administered instead.
Vaccine was stored in the refrigerator on 24 Jan 2022 and administered to the patient on 03 Mar 2022; Pharmacy gave Moderna Covid-19 vaccine past its beyond use date to 21 patients.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its beyond use date to 21 patients.) and PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator on 24 Jan 2022 and administered to the patient on 03 Mar 2022) in a 63-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 030H21B) for COVID-19 vaccination. No Medical History information was reported.    On 03-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its beyond use date to 21 patients.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator on 24 Jan 2022 and administered to the patient on 03 Mar 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its beyond use date to 21 patients.) and PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator on 24 Jan 2022 and administered to the patient on 03 Mar 2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the pharmacist had written an expiration date of 24-Mar-2022 on the Moderna COVID-19 vaccine instead of 24-Feb-2022. It was reported that the vaccine was transferred from the freezer to the refrigerator on 24-Jan-2022 and the vial did not undergo any temperature excursions. It was unknown on which arm the patient had received the vaccine. No other adverse events or side effects were reported.  No treatment medications were reported.
Short term: RHR of 150, shaking, feeling like collapsing  Longer term effects lasted three months:  severe tinnitus, hearing distortions
Pt recvd vax 530PM & several hrs later exp swollen throat, nervousness & jitters;
This spontaneous report was received from a pharmacist and refers to a female patient in her 60's who was enrolled in testing. No information regarding the patient's relevant medical history, concurrent conditions and concomitant medication was reported. On an unknown date in 2015, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously (dose, lot # and expiration date were not provided). On an unknown date in 2015, the patient experienced injection site reaction, rash and redness. On an unknown date in 2015, the patient recovered from the adverse events. The reporter considered the adverse events to be related to ZOSTAVAX. Additional information is not expected as the reporter refused to provide the contact information.
A mother reported that her 17 year old daughter received an injection of Tetanus Toxoid Adsorbed, on 05/30/00 and subsequently developed pain in the joints of her fingers, wrists, and knees. The patient's previous dose of Tetanus Toxoid was administered in 1998.
Swollen in my injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site swelling 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 injection site swelling. On an unknown date, the outcome of the injection site swelling was unknown.   It was unknown if the reporter considered the injection site swelling to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported this report. The age at vaccination was not reported. The patient received a dose of Shingles vaccine and only had swollen in his/her injection site. The follow-up could not possible as no contact details were available.
Date vials moved from freezer to refrigerator on 15 Jun 2022 and administered on 18 Jul 2022; Vaccine administered 30 days after beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered 30 days after beyond use date) and PRODUCT STORAGE ERROR (Date vials moved from freezer to refrigerator on 15 Jun 2022 and administered on 18 Jul 2022) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060A22A and 02602HA) for COVID-19 prophylaxis.     It was unknown if the patient had ever been diagnosed or tested positive for COVID-19. It was reported, acute illness at the time of vaccination and up to one month before and chronic or long-standing health conditions were unknown.    On 28-Oct-2021 at 12:57 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 18-Jul-2022 at 11:38 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 18-Jul-2022 at 11:38 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered 30 days after beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date vials moved from freezer to refrigerator on 15 Jun 2022 and administered on 18 Jul 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered 30 days after beyond use date) and PRODUCT STORAGE ERROR (Date vials moved from freezer to refrigerator on 15 Jun 2022 and administered on 18 Jul 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (Vaccine administered 30 days after beyond use date) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (Date vials moved from freezer to refrigerator on 15 Jun 2022 and administered on 18 Jul 2022).    Concomitant medications details were not reported by the reporter.  Patient reported no adverse events. The events did not cause the patient to seek medical care.  Treatment details were not reported by the reporter.   This case was linked to MODERNATX, INC.-MOD-2022-610650 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-610650:Master case
Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. Information about patients' concurrent conditions and medical history was not reported. On unspecified dates the patients were vaccinated with COMVAX (dose, route not reported, lot# reported as J002621 with expiration date 29-NOV-2015) that had been improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a physician concerning an 8 year old female who on 12/3/98 was vaccinated with the 1st dose of Hep-B. On 1/15/99, the pt developed symptoms of pyelonephritis and HSP (vasculitis). The pt was seen in the office on 1/16/99, 1/21/99 and 1/28/99. The pt was admitted to the hospital "in between this time". The physician noted that the pt was not seen until October (year not provided) for "enuresis exam". It was noted that the pt developed cellulitis in 1999, subsequent to vaccination with Hep-B. The pt was seen on 2/1/00 for a contusion of the eye which was considered unrelated (incidental finding). The pt was again seen in 3/01. The physician felt that the HSP was caused by Hep-B vaccine. No further details were provided. Additional information has been requested. F/U info from the phys indicatd that the pt developed a fever of 100.4F a red maculopapular rash on her legs and swelling of her feet and legs (R leg greater than left). On 1/13/99 or 1/14/99, five wks after the dose of hepatitis B vaccine. An antinuclear antibody titer was negative. She was treated with alex for probable cellulitis. She was also dx'd with pyelonephritis concurrently and was admitted to the hospital for IV fluids and IV alex from 1/16/99-1/19/99. The physician considered the events to be other medical events. Subsequently all of her symptoms resolved. No further info is available.
Employee was given a High Dose Fluzone by another RN.  High Dose Fluzone was not age-appropriate for the employee.
mom states shrill cry lasting from 10AM until 1PM & off & on crying for 2 days ( pt never has done this);
Right axillary tender lymphadenopathy.  Resolving with Tylenol and Ibuprofen.
Pt with pain in (L) arm with numbness and weakness. May have brachial plexopathy.
Diarrhea; Slight headache; Sorenessin the arm; A spontaneous report was received from a consumer concerning a 72-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced soreness in arm / pain in extremity, slight headache / headache and diarrhea.  No prior medical history and concomitant medications were reported.  On 04 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011L20A) in left arm for prophylaxis of COVID-19 infection. The dose quantity was reported as 0.5 ml. The expiry date of drug was reported as 31 Jul 2021.  On 04 Jan 2021, the patient experienced soreness in arm and headache. On 06 Jan 2021, the patient experienced diarrhea. Treatment information were not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, soreness in arm, headache and diarrhea, were not provided.; Reporter's Comments: This case concerns a 72-year-old female who experienced NS events of unexpected pain in extremity and diarrhea and expected headache. Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
COVID-19  07/29/2021  1 of 3  Full     COVID-19  08/19/2021  2 of 3  Full      Patient admitted for symptomatic COVID 8/22/22.