chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative:  69yr patient received J&J COVID vaccine 4/2021. Admitted to medical facility (9/1 to 9/10) secondary to COVID + PNA and acute hypoxic respiratory failure. Pertinent history: COPD, ESRD on HD, obesity, HTN, HFpEF, and DM2. Patient received dexamethasone 6mg daily along with ceftriaxone and azithryomycin.
Expired dose given; The patient was told that the vaccine has expired and the patient was given another dose; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose given) and EXTRA DOSE ADMINISTERED (The patient was told that the vaccine has expired and the patient was given another dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 07-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose given) and EXTRA DOSE ADMINISTERED (The patient was told that the vaccine has expired and the patient was given another dose). On 07-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose given) and EXTRA DOSE ADMINISTERED (The patient was told that the vaccine has expired and the patient was given another dose) had resolved.            No concomitant medications were reported. No treatment information was reported. The patient was not experiencing any side effect at the time of reporting.
Pt vaccinated w/DTP/OPV developed seizure & temp of 103.
Severe itchy Rash that looked like diaper rash on knees elbows hands buttocks and small of back. Patient had red face and neck.  Red face and neck relieved with Benadryl but would come back when Benadryl would wear off.  Patient had prednisone shot at MD.  2/2010 Rash lightened up pt given Zyretc and nerve pills (not filled).  Allergist stated may have flu shot again.
Large, local reaction of left leg at site of DPT vaccine; extends to posterior thigh.
expired dose administered; 65 year old received dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 67-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA87AZ, expiry date 30th January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd February 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 3rd February 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used and inappropriate age at vaccine administration. On an unknown date, the outcome of the expired vaccine used and inappropriate age at vaccine administration 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 details were provided as follows: The reporter stated that the 67 year old patient was administered an expired dose of Bexsero vaccine, which led to expired vaccine used and inappropriate age at vaccine administration. The reporter consented to follow up.
Patient is 15 years old and presented a signed consent for a Pfizer booster dose on December 8 at the High School COVID vaccination clinic.  Since he was over 12 years old, the provider who administered the vaccine was not aware that patient was under the age approved for a third (booster) dose of the Pfizer vaccine.  He received a full dose of 0.3 mL at 15:55 to the left deltoid.  The error was discovered by the Health Department when they reviewed the paperwork the next day.  I contacted patients mother at 10:58 on December 10, 2021 to inform her of the situation.  She was very understanding and reported that he never developed any symptoms after the vaccination. Per patient's mother, he currently remains symptom-free with no adverse events. Patient's second (previous) dose of Pfizer was over six months ago on June 4, 2021. Adverse event time/date entered due to requirement with this form in order to continue.  There have been no symptoms to this date.  VAERS report generated due to the under-aged booster (3rd dose) vaccination with a Pfizer vaccine.
felt a little tired; abdominal pain which started in the middle and went to the left; sore arm; low grade fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (abdominal pain which started in the middle and went to the left), PAIN IN EXTREMITY (sore arm), PYREXIA (low grade fever), CHILLS (chills) and FATIGUE (felt a little tired) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced ABDOMINAL PAIN (abdominal pain which started in the middle and went to the left), PAIN IN EXTREMITY (sore arm) and PYREXIA (low grade fever). 16-Feb-2021, the patient experienced CHILLS (chills). On 17-Feb-2021, the patient experienced FATIGUE (felt a little tired). On 16-Feb-2021, ABDOMINAL PAIN (abdominal pain which started in the middle and went to the left), PAIN IN EXTREMITY (sore arm), PYREXIA (low grade fever) and CHILLS (chills) had resolved. At the time of the report, FATIGUE (felt a little tired) outcome was unknown.            No Concomitant medications were provided by he reporter. No Treatment information was reported.
Sore arm near injection site, Achy joints, chills, head feeling hot, intense headache for 5 hours, blocked right ear
Red,  sore, itchy outbreak from lump that?s possibly injection site. Redness and soreness extending up to shoulder. Treated with nothing.
She was administered the vaccine on 10/16 approximately at 3:30 in the afternoon.  One Thursday, October 24th, I notice a large quantity of hair in her hoodie.  On Monday, October 28,   I helped her by brushing her hair in the morning and noticed large spots of hair missing on the top and sides of her head.   I brought her to the Doctor on October 29th to have it looked at.
Severe stomach cramps with diarrehea lasting four hours. Soreness in right arm/ site of shot.
quadriparesis; impaired driving ability; muscular weakness; tremor; headache; fatigue; moderna covid-19 vaccine and pfizer biontech covid-19 vaccine; PSP_DUPILUMAB_SAGLB.DUP.17.03.0229  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2020SA142197 (Moderna).  A female patient received BNT162b2 (BNT162B2), on 13May2022 as dose numner unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 24Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPILUMAB), in Dec2017 as first dose (Batch/Lot number: unknown) and on 09Mar2020 (Batch/Lot number: unknown) for dermatitis atopic, localised infection. The patient's relevant medical history included: "lung capacity abnormal" (unspecified if ongoing), notes: The patients past medical history included lung capacity abnormal; "laryngitis" (unspecified if ongoing), notes: had a little bit of laryngitis due to air very dry; "memory issues" (unspecified if ongoing), notes: memory issues (which was not elaborated further); "Rash" (unspecified if ongoing); "Eczema" (unspecified if ongoing). Concomitant medication(s) included: TRIAMCINOLONE taken for rash; PIMECROLIMUS taken for rash; KETOCONAZOLE taken for rash, eczema; LAMISIL [TERBINAFINE HYDROCHLORIDE] taken for eczema; TYLENOL. Vaccination history included: Influenza vaccine, for immunization. The following information was reported: QUADRIPARESIS (medically significant), outcome "recovering"; IMPAIRED DRIVING ABILITY (medically significant), outcome "recovering"; MUSCULAR WEAKNESS (non-serious), outcome "recovering"; TREMOR (non-serious), outcome "recovering"; HEADACHE (non-serious), outcome "recovering"; FATIGUE (non-serious), outcome "recovering"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "moderna covid-19 vaccine and pfizer biontech covid-19 vaccine". The patient underwent the following laboratory tests and procedures: Weight: Unknown results, notes: Relevant laboratory test results included: Weight-on the unknown date unknown pounds. The action taken for dupilumab was unknown.  The reporter's assessment of the causal relationship of "quadriparesis", "impaired driving ability", "muscular weakness", "tremor", "headache", "fatigue" and "moderna covid-19 vaccine and pfizer biontech covid-19 vaccine" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be excluded.
Healthcare worker proceeded to inject the individual, only half of the dose was administered when the needle  fell off of the syringe.
Higher-than-authorized dose administered (e.g., incorrect dose volume, incorrect product resulting in higher-than-authorized dose. Do not repeat dose per CDC. Patient did not have any reactions.
10pm patient started with fever, chills, vomiting, tachycardia, dizziness, sob,
Pneumonia; Crystal arthropathy; Osteoarthritis; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant), CRYSTAL ARTHROPATHY (Crystal arthropathy), OSTEOARTHRITIS (Osteoarthritis) and COVID-19 (COVID-19). At the time of the report, PNEUMONIA (Pneumonia) and COVID-19 (COVID-19) had resolved and CRYSTAL ARTHROPATHY (Crystal arthropathy) and OSTEOARTHRITIS (Osteoarthritis) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment medication information was not provided by the reporter. On unknown dates, the patient experienced arthritis conditions not improved with humira/osteoarthritis, rheumatoid arthritis and crystal arthritis, covid and pneumonia. on unknown dates, covid and pneumonia resolved. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This is a spontaneous case concerning an elderly female patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19 and the unexpected, serious (medically significant) event of Pneumonia, after receiving the first dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the events, clinical course, diagnostic tests and treatment details were not provided in the case. The events had resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning an elderly female patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19 and the unexpected, serious (medically significant) event of Pneumonia, after receiving the first dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the events, clinical course, diagnostic tests and treatment details were not provided in the case. The events had resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Immediate pain across left should across chest to other shoulder.  Then a pain in her upper left arm/shoulder.  Could not pick up any heavy object.  No fever, thought a muscle pain that would go away. Not sure if it was the needle itself that caused the pain (in administering the vaccine) or the vaccine.
This spontaneous report as received from a pharmacist via a company representative refers to a 51 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX lot # M014310 (dose, expiration date and route of administration were not reported). On an unknown date, the patient developed a 3 to 4 inch area of redness and itching. The patient received BENADRYL as a treatment of redness and itching and MORTIN if any pain would occur. The outcome of the events was reported as recovered on an unknown date. The relatedness between the events and ZOSTAVAX was not provided. Additional information has been requested.
Complete stop of menstrual cycle; Abnormal FSH Pab results indicating early onset menopause.
Tonic sz w/low grade fever & encephalopathy occurring Sunday following vax given Monday approx 7 days; sx's course & EEG findings not felt to be consistent w/MMR rxn;
ON THE MORNING OF 12-3-22, PATIENT AND I GOT UP, GOT READY, ATE BREAKFAST, AND WENT TO OUR GRANDDAUGHTER'S BASKETBALL GAME AT 12:00PM. WE ARRIVED EARLY, SO WE WAITED IN THE CAR FOR TEN MINUTES, THEN WE WENT INTO THE GYM. THE PREVIOUS GAME WAS STILL GOING ON, SO WE WATCHED THAT, THEN WE WENT TO OUR SEATS ON THE TOP ROW IN THE BLEACHERS. WE TALKED TO AN EX-NEIGHBOR FOR ABOUT FIVE MINUTES, THEN WE SAT DOWN. EVERYTHING WAS COMPLETELY AT THIS POINT. I WAS ON PATIENT'S LEFT SIDE, OUR DAUGHTER-IN-LAW WAS ON HER RIGHT SIDE, AND OUR SON WAS NEXT TO HER EVERYTHING WAS NORMAL TO THIS POINT. SHORTLY AFTER THE GAME STARTED PATEINT'S LEFT HAND GRABBED MY RIGHT LEG, AND I ASKED HER IF SHE NEEDED ANYTHING AND SHE SAID NO IN A SOFT VOICE. THEN OUR DAUGHTER-IN-LAW AND I BOTH SAW HER EYES STARTING TO CLOSE, AND WE BOTH SAID ARE YOU OK? SHE SAID YES. HER EYES THEN WENT COMPLETELY SHUT, AND WE AGAIN ASKED IF SHE WAS OK, BUT THERE WAS NO RESPONSE. TWO NURSES FROM THE SPECTATORS CAME OVER TO TEND TO PATIENT AND MY SON CALLED THE LIFE SQUAD AND OUR OTHER SON. I TOLD THE LIFE SQUAD SHE WAS A DIABETEC, AND THEY CHECKED HER BLOOD SUGAR, BUT IT WAS OK. AT ABOUT 12:30 PM, THE LIFE SQUAD RUSHED HER TO THE HOSPITAL. OUR OTHER SON ARRIVED, AND WE ALL WAITED IN THE WAITING ROOM FOR ABOUT AN HOUR. TWO DOCTORS THEN CAME DOWN AND SAID THE SITUATION WAS VERY BAD, AS A BLOOD CLOT WENT TO PATIENT'S BRAIN AND CAUSED A SEVERE STROKE. THEY TRIED TO DISSOLVE THE CLOT AND SUCK IT OUT BY RUNNING A WIRE UP TO PATIENT'S BRAIN, BUT THEY RAN INTO COMPLICATIONS. THE PASSAGE WAS TOO NARROW FOR THEM TO WORK IN, A BLOOD VESSEL BROKE, AND THERE WAS A CHOLESTEROL BUILD UP. THEY KEP HER OVERNIGHT AND RAN ANOTHER CT SCAN. THEY ALSO PUT A BREATHING TUBE IN HER. WHEN WE WENT IN THE NEXT MORNING 12/4/22, THEY SAID THE CT SCAN WAS WORSE, WITH TOO MUCH BRAIN DAMAGE, AND SHE WAS NOT COMING BACK. ONE DOCTOR SAID SHE WA COMOTOSE AT THE GYM WHEN SHE CLOSED HER EYES, THEY SAID WE COULD LET HER LIKE THAT OR TAKE THE BREATHING TUBE OUT AND LET HER PASS. WE OPTED TO TAKE THE BREATHING TUBE OUT, AND SHE PASSED WITHIN HOURS. OFFICIAL CAUSE OF DEATH-ACUTE ISCHEMIC STROKE NO SYMTOMS AT ALL - EVERYTHING WAS NORMAL. PATIENT'S FOUR EARLIER SHOTS MODERNA - THIS ONE WAS PFIZER
The injection site is rock hard, my arm is swollen and red. I have a fever, chills, it hurts to touch my skin, my neck feels like it?s in a vice, horrible headache, I feel lethargic, and I have a very upset stomach resulting in diarrhea. Symptoms started around 5:30 pm 1/16/2021, and have gotten worse as time progresses. The fevere comes and goes, but it always comes back.
Pt with abdominal pain 2 hours after vaccine and then developed apnea x 2. Pt taken by ambulance to hospital with oxygen saturation in 60's, pt given BENADRYL and monitored for several hours, then sent home.
Information was faxed in previously. I called multiple times, but was put on hold for long periods of time. So submitting again on the website but this information has been faxed. The vaccine was given and in March 2021, he began to have speech issues. Issues have progress and at this point and he is hardly able to be understood. He has had personality changes, cognitive changes. He has seen multiple doctors.
This spontaneous report as received from a pharmacy technician refers to a 1 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 12-FEB-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
I experienced pain in my right wrist, then my left wrist started hurting. My knees and ankles started hurting and I could not walk.
This spontaneous case was reported by a consumer and describes the occurrence of HYPERKERATOSIS (Feet soles were hardened) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 4782588) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.            No concomitant medication was reported. No treatment information was provided. It was unknown if patient was enrolled in COVID-19 vaccine trial.
Fever, chills, body aches, headache lasting 24 hours Same symptons and duration after second Moderna Covid vaccine (07-ZB21A) on 5/18/21
This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with improperly stored ROTATEQ lot # K009752, expiration date- 15-APR-2016, (incorrect product storage). No adverse event was reported. The outcome of event was unknown. Temperature was 10.5C, time frame- 2 hours and there was no temperature excursion earlier. Additional information has been requested.
Myalgia, Arthralgia, Pain at injection site, Vaginal spotting Narrative:
Several hours after vaccine was administered, Mother found child unresponsive, not breathing and without pulse. Child taken to medical center via EMT. Other circumstances, Child was sleeping and mother stated found child blue with a teddy bear.
Patient presented to the clinic for second COVID-19 vaccine. Vaccine was administered 9 days before due date. Patient was informed of the error on 12/1/22, and reports no side effects or adverse reactions.
Localized reaction at injection site R deltoid per pt. mom vaccine was given 4-10-08 & pt. seen by Dr. 4-24-08 with rxn.
Today patient came with her family to get her booster dose of Pfizer around 6 pm, the patient is qualified to get booster dose. So, I provided booster dose. Once provided booster dose, the patient caregiver mention that patient had past reaction of previous dose but with Benadryl patient feeling fine. After providing booster shot, patient experiencing redness on face and her caregiver insist to give her epi-pen injection. The patient was concisions at the time epinephrine shot. After epinephrine shot patient feeling well. I observe the patient next 30 minutes (after epinephrine shot). I also verified her condition by doing phone call to her at 9:30 pm.
Information has been received from a Registered Nurse referring to an 8 weeks old patient of unknown gender. Information about patient's concurrent conditions and medical history was not reported. On 19-JUN-2015 the patient was vaccinated with a dose of improperly stored PEDVAXHIB (route not reported, lot # K025002 with expiration date 20-JUL-2017, dose 0.5 (unit not reported). Concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
On Friday, 12/9/21, patient came to ECC Covid-19 Vaccination Site for her Pfizer Covid-19 booster vaccine and Flu shot. Client received her Pfizer Covid-19 booster dose (LOT #: FF8841) at 11:07 AM in her left deltoid and her Fluarix Quadravalent (LOT #: 7557A) in her right deltoid at 11:08 AM. During assessment questions, client stated her medical history included allergies to latex. Client was to be a 30 minute observation. At 11:33 AM, while waiting in Observation Area, client stated to EMT , she is feeling "10 out of 10 dizzy and hard for her to hear" while sitting in the observation chair. EMT had client sit in anti-gravity chair and vitals started. At 11:35 AM: BP: 138/88, O2 sat: 96%, HR: 80, RR: 16. Client was given a bottle of water that she drank and a granola bar. At 11:40 AM: BP: 132/80, O2 sat: 97%, HR: 70, RR: 16. Client stated to EMT she was feeling "5 out of 10 dizziness and was able to hear normally. Client denied any other symptoms including nausea, SOB, chest pain or stomach pain. Client stated in 2018 she experienced a similar sensation of dizziness and fainting after receiving a flu shot while pregnant and went to the emergency room. Client did eat breakfast this morning. At 11:55 AM: O2 sat: 97%, HR: 77, RR: 16. Client is drinking water and states she "feels better." At 12:05 PM: BP: 126/82, O2 sat: 97%, HR 65, RR 16 client stated her dizziness was a "1 out of 10" however when she tried to stand up she felt dizziness "8 out of 10" again. Client sat back down in anti-gravity chair and felt better immediately. At 12:10 PM, BP: 126/86, O2 sat: 98%, HR: 75, RR 16. EMT offered client Benedryl for moderate symptoms of allergic reaction and client denied. At 12:15 PM, BP: O2 sat: 97%, HR: 72, RR: 16. EMT offered to call 911 for client and client denied and stated her husband would drive her to hospital for further evaluation. Client stated she no longer felt any sensation of dizziness. No further interventions needed. Client was educated by EMTon signs and symptoms of adverse reactions and when to go to the ED/call MD. Client was also encouraged to sign-up on v-safe. At 12:20 PM, EMT used site's wheelchair to wheel client down to her husband's car. Client denied any dizziness upon standing up for the transfer.