chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received dose from a vial which was initially stored in the refrigerator 25-Apr-2022 and administered to patient on 25-Apr-22, after manufacturer date of expiry 24-Apr-2022; Expired vaccine administered to the patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to the patient) and PRODUCT STORAGE ERROR (Patient received dose from a vial which was initially stored in the refrigerator 25-Apr-2022 and administered to patient on 25-Apr-22, after manufacturer date of expiry 24-Apr-2022) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022J21A, 004M20A and 025J20A) for COVID-19 vaccination.     Patient has no acute illness at the time of vaccination and up to one month before. It was unknown that patient ever tested positive or diagnosed with COVID-19. It was also unknown that if patient had any chronic conditions. Patient had no known drug allergy.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 25-Apr-2022 at 1:50 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 25-Apr-2022 at 1:50 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to the patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received dose from a vial which was initially stored in the refrigerator 25-Apr-2022 and administered to patient on 25-Apr-22, after manufacturer date of expiry 24-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to the patient) and PRODUCT STORAGE ERROR (Patient received dose from a vial which was initially stored in the refrigerator 25-Apr-2022 and administered to patient on 25-Apr-22, after manufacturer date of expiry 24-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to the patient) and PRODUCT STORAGE ERROR (Patient received dose from a vial which was initially stored in the refrigerator 25-Apr-2022 and administered to patient on 25-Apr-22, after manufacturer date of expiry 24-Apr-2022) to be related.    The race of the patient was reported. Concomitant medication information was unknown. The vials were initially stored in refrigerator on 25-Apr-2022. The vials has not undergone temperature excursion. It was reported Moderna booster was given on 25-Apr-2022, thinking that expiration date was 27-Apr-2022. Later noticed that vaccine expiration date was 24-Apr-2022. No treatment medication information was given.
Vaccination given in the morning- exact time unknown- patient started with a rash and possibly fainted that night. The next day the rash has extended, experiencing sweating, sore arm, hard spot where vaccine was given and tingling in her thumb.
Patient Received a Pfizer Covid-19 Vaccine when they should of received a Moderna. Moderna vaccine was given first before the Pfizer.
The following day, developed hives. Typical appearance of urticaria on presentation to office 07/26/2002. No airway compromise
Sweating; Feeling warm; Arm soreness; Nausea; Vomiting; Headache; Muscle ache; Receiving a third Shingrix dose / received the two Shingrix doses last year.; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (FLUCELVAX) for prophylaxis.   Previously administered products included Shingrix (1st dose and 2nd dose received in last year).   On 26th September 2020, the patient received the 3rd dose of Shingrix (intramuscular) .5 ml and FLUCELVAX (intramuscular). On 26th September 2020, unknown after receiving Shingrix, the patient experienced extra dose administered. On 27th September 2020, the patient experienced pain in arm, nausea, vomiting, headache and muscle pain. On 28th September 2020, the patient experienced sweating and feeling of warmth. On 28th September 2020, the outcome of the pain in arm, nausea and vomiting were recovered/resolved. On an unknown date, the outcome of the headache, muscle pain, sweating and feeling of warmth were not recovered/not resolved and the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the pain in arm, nausea, vomiting, headache, muscle pain, sweating and feeling of warmth to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. A Patient reports received 3rd dose of Shingrix, along with her Flu shot (FLUCELVAX), at her pharmacy 2 days ago from the date of reporting.  The patient informed the Pharmacist after the vaccination was administered, The patient experienced arm soreness, nausea and vomiting beginning 1 day after vaccination and lasting 24 hours.  The patient reported Muscle ache, headache, and sweating (warm feeling) beginning 24-48 hours after vaccination and not recovered.  Limited information available.  The reporter consented to follow up.
3.2.21 super stiff and it hurts and a terrible headache  4.9.21 Shot #1 Feb NO SIDE EFFECTS Shot 2 -3 weeks after Next day neck was stiff and hard to move to either side x 3 days NOW CAN MOVE BUT STILL FEELS STIFF HA  Comes and goes since 2nd shot Different spots Lingers on right if she lays down Nagging, squeezing No neuro sx in hand No LOC/DIZZINESS/FALLS DIDN'T REPORT  5/4/21 New Back pain 1 week,  +2 mos h/o unprovoked neck and head pain Hurts to sleep, can't sleep sometimes Feels like she had a crick and has to pop it No more pains in legs  6/22/21 Pt called and stated she is still having neck stiffness, headache and back pain with arm tingling since she got the Covid vaccine in February.  7/14/21 Began having neck stiffness, HA, and tingling to left arm afterwards
Bell's palsy; This case was reported by a physician via sales rep and described the occurrence of bell's palsy in a adult patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was unknown.   It was unknown if the reporter considered the bell's palsy to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Bexsero and experienced Bell's palsy. The reporter consented for follow up.
77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; Product storage error; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and PRODUCT STORAGE ERROR (Product storage error).    This case contains information for the 56 out of 77 adult patients described by the reporter. No concomitant information was reported. It was reported that, Approximately 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion. The doses were administered before it was known if the vaccine was ok to use after the excursion. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:case
Patient received vaccinations on 10/25/2007 and developed a morbilliform rash over neck, legs and abdomen on 10/26/2007.  She also had fever to a maximum of 102F, that defervesced within 2 days, and upper respiratory symptoms.
On Tuesday, June 19th, at approx. 10 am, patient came into the office for a PPD, and Men B #2 for college forms. Pt seemed fine in the office before, and after administration. She received the PPD and Men B at approx. 10:10 am. Approx 10:30 am, the front desk staff received a phone call from patient's mother, stating that "she passed out, or had a seizure". I grabbed a wheelchair, and went outside. Patient was lying back in passenger seat of mom's car. Car was turned off. It was hot in the vehicle. On my assessment, patient was pale, and diaphoretic, lying with her eyes closed. Pulse and respirations normal. When I spoke to her, she was responsive to my questioning. I attempted to sit her up, to transfer her to the wheelchair. At that time, she told me "I am going to pass out". I laid her back down at this time. There was an initial period of approx. 5-10 seconds where her eyes rolled back, and her arms stiffened. At this time, I called 911. While I was on the phone with 911 at the car, the physician came out to the vehicle, and assessed the patient as well. We continued to monitor patient while awaiting EMS arrival. EMS arrived, and report was given to paramedic. Patient was responsive to sternal rub. She was able to get out of the car, with assistance, and ambulate to the gurney. Ambulance left to take her to Hospital for further evaluation and treatment. Mom followed behind in her vehicle.
Short-term manifestation of fever-like symptoms, chills, body aches, fatigue, dizziness occurred approximately 1 week after 2nd Pfizer dose. These symptoms faded within 24h of onset. However vertigo, dizziness, and light-headedness began immediately following the onset of other symptoms, and have persisted for 1 month. Lack of prior history of vertigo or light-headedness, lack of recent signs of illness prior to vaccine, and timing of the vertigo setting in immediately after the other symptoms and within a week of the vaccine lead me to believe the symptom is a result of the vaccine and/or its side effects. Have not yet scheduled medical visit since I was hoping it would go away, but am planning to do soon so since the vertigo sometimes impacts ability to function normally.
Pt. reported having itchiness on face and neck and reported hives @1259.  Offered cetirizine and pt. refused. Called EMT to site and vitals taken - 189/120- left arm, 106-HR, 100% RA , BS-202 @ 1303. Offered diphenhydramine and pt. accepted. Provided oral diphenhydramine. Pt. requested ambulance. Once ambulance service arrived, pt. refused. Pt. left vaccination site with family via car.
Took vaccine, still got shingles/suspected vaccination failure; shingles/Took vaccine, still got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 25-Jul-2022 Reporter's comment: The case was received from the consumer via interactive digital media. The reporter reported that she personally knew 4 other people who took vaccine and still got shingles. The reporter stated that the vaccine was expensive and did not work. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. The case is 1 of 5 linked cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR105917:Same reporter US-GLAXOSMITHKLINE-US2022AMR105921:Same reporter US-GSK-US2022AMR111696:Same reporter US-GSK-US2022AMR111698:Same reporter US-GSK-US2022AMR111699:Same reporter US-GSK-US2022AMR111700:Same reporter
No issues with injection, some minor discomfort at the injection site over the next 2 days, then noted loss of range of motion when scratching my back, which has continued for the past month.  I have continued try daily self directed PT, without any progress.
Had flu vaccine administered at pharmacy and have had trouble with my arm ever since. For the first week it was painful to sleep, my arm was extremely sore. As of date I can not fully extend my arm. Went back to the clinic today and was told to go to my primary doctor. He started me on anti-inflammatory medicine. The person given the shot could have administered it in a weird place in the arm. I noticed that it was given at a higher spot than normal. My arm when I move it certain ways almost feels like a pinched nerve. I went in before the shot fine and did nothing to cause pain in the arm. I also have gotten a flu shot every year with no adverse effects. This is day 13. Will see if the anti-inflammatory helps. This is most unusal for me and like I stated...I have never had anything like this happen after a seasonal flu shot. Thanks for your time.
No additional AE reported; an expired pediatric dose of RECOMBIVAX HB was administered to an adult patient; an expired pediatric dose of RECOMBIVAX HB was administered to an adult patient; Incorrect dosage administered; This spontaneous report was received from a nurse referring to an adult patient of unknown gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.    On 05-NOV-2021, the patient was vaccinated with an expired pediatric dose of hepatitis b vaccine (recombinant) thimerosal-free (RECOMBIVAX HB) (lot # S022583, expiration date 31-OCT-2021, 0.5 milliliter) for prophylaxis (product administered to patient of inappropriate age, incorrect dosage administered and expired product administered). No prior temperature excursions had occurred to the dose of Hepatitis B Vaccine (Recombinant)(RECOMBIVAX HB) that was administered. No additional AE reported.
Pt noticed right eyelid swollen.  No other symptoms.  Instructed by MD to monitor.
Swelling and sensation in left cheek; Swelling and sensation in my left cheek; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8734) via an unspecified route of administration in the left arm on 03Apr2021 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the 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 vaccine. Concomitant medications included mefenamic acid (MEFTAL) pain killer taken for unknown indication from an unknown date. On 03Apr2021, the patient experienced swelling and sensation in left cheek. The patient did not receive any treatment for the events. The clinical outcome of the event swelling and sensation in left cheek was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Vaccine failure. This patient received the vaccine on April 8, 2021, presented with severe COVID-19 on May4, and now is critically and gravely I?ll in the ICU.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 07-FEB-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # N020352, expiration date 10-APR-2020 (dose, route of administration and anatomical location were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion in the range between 47 Fahrenheit degrees (°F) to 77 °F (47°F) for 1 hour and 13 minutes, as recorded by a data logger. The vaccines had a previous temperature excursion in the range between 47 °F to 77 °F for 9 hours. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1802USA007812: US-009507513-1802USA007813.
Patient felt like he was going to pass out.  Reports this is normal and occurs when he gets shots or labs drawn.
I had my vaccination on 09/12/2022. I woke up 10/06/2022 with a sore throat and migraine. I had 2 COVID-19 negative tests on 10/06/2022. I tested COVID-19 positive on 10/07/2022. I contacted my doctor on 10/07/2022 and they prescribed PAXLOVID. I was also prescribed the antibodies infusion for 10/08/2022. 10/09/2022 I started the PAXLOVID till 10/14/2022 and taken off all my other prescriptions for 5 days until 10/14/2022. I resumed my regular medications 10/16/2022. On 10/18/2022 I started to feel worse again and restarted isolation.
fatigue, headache, muscle pain, joint pain, chills, nausea, and fever
Delayed injection site reaction in vaccine arm. Arm of patient was sore with minimal swelling after vaccination and resolved. 8 days after vaccination, vaccine arm started itching and is red, warm, and swollen (patient estimates the size of an orange). Patient also reports that there are whelps around the injection site. Patient called PCP and was advised to take Benadryl and watch;  if more systemic reactions develop, to seek emergency care.
This spontaneous case report was received from an office manager refers to an unspecified number of patients of unknown age and gender. No medical history, allergy and concurrent conditions were reported. On an unspecified date between 27-NOV-2015 and 15-DEC-2015, these patients were vaccinated with improperly stored PROQUAD (Merck) with lot number # L030587 (expiry date: 10-FEB-2017) or lot number # L032759 (expiry date: 24-FEB-2017). Concomitant medications of the patients were unknown. No adverse event reported. No product quality complaint was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not reported. On 09-AUG-2016, the patient inadvertently received a partial dose of ZOSTAVAX (strength was not reported, lot # L046295, expiration date on 17-FEB-2017) subcutaneously. No adverse effects were reported. Additional information has been requested.
Patient given vaccine Td adult on 3/19/04 instead of DTaP and received a long swelling on right deltoid area but no urticaria or difficulty breathing. Also given IPOL in same arm.
NO ADVERSE EVENT, only a medication error being reported. Patient being seen for a routine child health examination without abnormal findings. Influenza vaccine was ordered - was to be split in two doses, over 2 different appointments. MD order states "Influenza Quad 6-35 mo- 2.5ml", and patient was to report in a month for second dose of .25. Medication error occurred when the LPN gave .5 ml all at once.
40 y/o WM ADSM presents to FBVHC for follow-up of WAMC ED visit for limb pain (occurring in temporal relationship with receipt of vaccines) and release back to duty.  Symptoms:  Pain.
Feeling itch in palms, feet, lightheaded, nauseous, generalized flushing of skin.
NOT ADMINISTERED THROUGH OUR CLINIC VACCINATION DETAILS UNKNOWN.  GIVEN IN LEFT DELT.   -GENERALIZED PRURITIS -FINE PAPULAR FACIAL RASH -REPORTED HAND SWELLING -SENSE OF THROAT TIGHTNESS -NAUSEA/VOMITING/DIARRHEA -JOINT PAIN  NO FEVERS, CHILLS, HEADACHES, MYALGIAS, SYNCOPE, DYSPNEA/WHEEZING OR FACIAL SWELLING  BENADRYL ?DOSE YESTERDAY WAS HELPFUL -- >TODAY RECOMMENDING ZYRTEC 10MG QAM, BENADRYL 50MG QHS, PEPCID 20MG BID, MEDROL DOSE PACK
Felt light headed after she got the vaccine but she is not sure if she was light headed; Painful urination; Left groin going up to her stomach was painful when she urinate; Left side of her vagina was painful when she urinate; swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt light headed after she got the vaccine but she is not sure if she was light headed), DYSURIA (Painful urination), GROIN PAIN (Left groin going up to her stomach was painful when she urinate), VULVOVAGINAL PAIN (Left side of her vagina was painful when she urinate) and VACCINATION SITE SWELLING (swollen arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045AZ1A) for COVID-19 vaccination.     The patient's past medical history included UTI. Concurrent medical conditions included COPD.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced DIZZINESS (Felt light headed after she got the vaccine but she is not sure if she was light headed), DYSURIA (Painful urination), GROIN PAIN (Left groin going up to her stomach was painful when she urinate), VULVOVAGINAL PAIN (Left side of her vagina was painful when she urinate) and VACCINATION SITE SWELLING (swollen arm). At the time of the report, DIZZINESS (Felt light headed after she got the vaccine but she is not sure if she was light headed), DYSURIA (Painful urination), GROIN PAIN (Left groin going up to her stomach was painful when she urinate), VULVOVAGINAL PAIN (Left side of her vagina was painful when she urinate) and VACCINATION SITE SWELLING (swollen arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Was sore & swollen until last wk. Pt c/o tingling in hand & hurting to the bone at injection site. Went to Dr due to increased weakness, unsteady gait & feeling tired. Was walking 2 miles a day, now only 1/2 mile w/SOB.
Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. There was no medical history or drug reactions/allergies reported. On unknown dates the patients were vaccinated with doses of improperly stored ROTATEQ (lot # L013188 with expired date 02-NOV-2016, oral, dose was unknown). No concomitant therapy was provided. No adverse event was reported. Additional information has been requested.