chrisvoncsefalvay/vaers-outcomes huggingface dataset:
30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date).    This case contains information for the 25th of 30 adult patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  There was 13, 11, and 6 different doses given to patient. The 30 patients received Monovalent Moderna Vaccine past the manufacturer's expiration date.   The batch lot number was reported as 022D21A which was expired on 20 April 2022. The Lot number 033F21A which was expired on 08 April 2022. The Lot number 037C21A expired on 02 January 2022.  Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-703461 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-703461:case
Gave HPV in (R) arm, sat needle down put Bandaid on, her head went down, no response, layed her down, her body stiffened & arched back then was not breathing for 15 sec. Started to talk when Dr. was examining her. She urinated, pale, sweaty. Came around about 3min. was able to sit up, talk, wait 20min. Recheck BP, P & was alert oriented able to walk out door.
injection site was red and very itchy; injection site was red and very itchy; did not receive the second injection until January of 2022; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In January 2022, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. In January 2022, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced injection site erythema and injection site itching. On an unknown date, the outcome of the injection site erythema was recovered/resolved and the outcome of the injection site itching and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the injection site erythema and injection site itching to be related to Shingrix.     Additional Information: GSK Receipt Date: 13-APR-2022  Reporter's Comments: The reporter was the patient.   She refused to provide demographics or answer questions.   The patient received her first dose of Shingrix in 2019 and the injection site was red and very itchy and did not receive the second injection until January of 2022.   Spoke per content.  No other information was provided concerning this event. The reporter declined to provide health care professional (HCP) information. The reporter did not consent to follow-up. Additional Supportive Information: The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Area is raised, red, hot, sore and very tired ever since 6 x 4 cm. at injection site.
Redness and swelling, painful noted on 03-09-10 at 7:00 am (on LD). On next day redness diminished and reaction resolved on 03-15-10. No treatment given.
This is a spontaneous report from a RN referring to a 38 year old female who on 9/2/99, the pt received her first dose of Lymerix and within 2 hours, the pt experienced an allergic rash. She was treated with Benadryl and the rash resolved. The most recent information, received on 9/3/99, reports the condition of the pt is resolved.
Patient received Moderna monovalent as booster dose instead of Moderna Bivalent booster.
Died in the car on the way home after receiving the second dose of the Moderna COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Died in the car on the way home after receiving the second dose of the Moderna COVID-19) in a female patient of an unknown age 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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant medication information not provided. Treatment information not provided. Action taken with mRNA in response to the event/s was not applicable. A  patient called on 13MAY2021 to report adverse effects she experienced after receiving the Moderna COVID-19 vaccine. During the call, she reported a serious adverse effect for "another lady" who "died in the car on the way home" after receiving the second dose of the Moderna COVID-19 vaccine. The caller reported that the individual received the second dose of the vaccine.  No additional information was provided. The Serious Adverse Event Reporting form has been completed.  Based on the 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.   This case was linked to US-MODERNATX, INC.-MOD-2021-128107, MOD21-090166, US-MODERNATX, INC.-MOD-2021-128999 (E2B Linked Report).; Sender's Comments: Based on the 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. US-MODERNATX, INC.-MOD-2021-128107: MOD21-090166: US-MODERNATX, INC.-MOD-2021-128999:; Reported Cause(s) of Death: unknown cause of death
Shivering and upset stomach upon waking of the morning of 11/16/2023; symptoms persisted until mid afternoon (about 2:00 - 3:00 pm).  Both arms are still slightly sore as of this morning (11/17/2023), but pain has subsided considerably since the previous day
Information has been received from a registered pharmacist concerning an 8 year old male with asthma who on Oct 18 2005 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 650454/0751P). Concomitant therapy that day included influenza virus vaccine (unspecified), in the other arm. Other therapy included montelukast sodium (Singulair) and budesonide (Pulmicort). On Oct 19 2005 the patient had redness and swelling of his left arm. He was seen by the physician on Oct 20 2005 and as a result of this visit he was directed to admit 23 hours short stay on Oct 21 2005. He experienced redness and swelling at the site and he would not could not move his arm. He also had nausea and vomiting. He received one dose of ceftriaxone sodium (Rocephin) (IM) dose unknown in physicians office. After his admission to the short stay unit he was placed on IV clindamycin. He was discharged home, readmitted to impatient unit on Oct 23 2005 because the localized reaction kept getting larger instead of smaller and it continued to progress. He was placed on IV vancomycin. He was discharged on Oct 25 2005. According to his mother he was still not back to normal. The patient was considered to be recovering. Additional information has been requested.
Patient fainted couple minutes while seating on a chair after received the covid-19 shot.  His muscles got very stiff up and fell/ slide off the chair.  Rph was around the patient so, she was able to support his head down to the floor which prevent his head hitting the floor.  After a few minutes (less than 5 minutes), he gained consciousness and claimed he always have this symptom of fainting after immunization.  The EMT came and checked all his vital signs are all good.  He did not need to go the hospital.  He was fine after another 30 minutes of seating.
Pt vaccinated with Engerix-B developed HBSAB level 2.3 RU, hives, local soreness of the inject site, rash over her whole body, UTI, wheezing, tightness in chest.
The day after receiving the second dose, I experienced a very sore arm. I could hardly lift it for the day. About two weeks later, I started experiencing pain around my upper back/ shoulder blade. I had been playing badminton and I thought I may have been sore from that. The pain did not go away and continued for weeks. I went to the doctor and he did an x-ray. Everything came back okay with the x-ray. I still have the shoulder pain, at times, but I just live with it. We do not know the cause.
Pt received the Moderna bivalent booster only one month after her previous moderna booster (L# 011B22A). No signs or symptoms. Pt was called and reported no sickness or side affects after receiving the booster.
pt recv vax; febrile sz approx 18 hr p/ inject;nl hlth a/ vax & no illness focus noted p/ sz event occurrence 16may95;
Lethargy (unable to wake up for more than 10-15 minutes) for 48 hours
5JUN95 pt recv vax & had ear infect (otitis) given Amoxicillin; 9JUL95 devel lt eye ptosis, subsequently recv work up & dx & myasthenia gravis
Non-tender, erythematous swelling right arm 24 hours after DTAP and IPV given there.
cardiac arrest Narrative: Per medics, Patient was gardening when he stated he felt dizzy and collapsed. Wife started CPR until medics arrived. Patient arrived at the hospital after 20min of pulseless V tach and 10 min of PEA.
The patient received a 2nd dose of Moderna only 22 days after the 1st dose with the Pfizer vaccine instead of the recommended 28 days.
swollen & black & blue arm, could not move arm for 2 days, fever, headache, constant cough,chills, throwing up, could not sleep, felt better around January 3rd, but still don't feel fully recovered , took melatonin, methylprednisolone 4mg dospac 21 pills, benzonatate 100mg capsules
Pt received Pfizer vaccines on 04/19/21 and 05/10/21. Pt presented to the ED on 11/29/21 with complaints of cough and SOB. Pt was found to be COVID positive
Heart palpitations; This is a spontaneous report received from a contactable patient. A 41-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Ep7534,) via an unspecified route of administration on the left arm on 16Mar2021 at 11:15 AM (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination the patient was 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 4 weeks prior to the COVID vaccine. The patient's medical history included beta-thalassemia and chronic migraines. The patient had PCN, latex and shellfish allergy. The concomitant medications included wellbutrin Xl (MANUFACTURERE NKNOWN) 150 mg, zoloft (MANUFACTURER UNKNOWN) 25 mg and magnesium glycin (MANUFACTURER UNKNOWN) from unknown dates for unspecified indication. On 18Mar2021 at 11: 00 AM, the patient experienced event heart palpitations, which began 48 hours after injection and have continued since. The patient did not receive any treatment for the event. The clinical outcome Heart palpitations was not recovered.  No follow-up attempts are needed. No further information is expected.
Began feeling SOB with chest pressure into throat. No wheezing. Taken to ED for evaluation. Neb trmts & steroids given. Admitted to hospital. D'cd 24 h later
nosebleed; This spontaneous report was received from office manager via company representative refers to a male patient of unknown age. No information was provided regarding the patient's pertinent medical history, concomitant medication and drug reactions/allergies. On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, dose, frequency, route, lot number, expiry date unspecified). On an unknown date, the patient had nosebleed (epistaxis) after the administration of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). The patient never had nosebleed previously. It was unknown by reporter which dose of HPV series was received by the patient. No PQC involved. No further information provided. The outcome of epistaxis was unknown. Reporter's causality was not provided.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 14 years old adolescent and unknown gender. On 09-SEP-2014 the patient was vaccinated with an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported is unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
The patient experienced a "break through case of varicella" with less than 20 eruptions on his forearms and abdomen. As of 03/16/01, the patient had recovered from the "break through case of varicella" Additional information is not expected.
Rash at site area, low grade fever. muscle and joint pains, headache, fatigue, chills  set in aprox 24 hours after receiving vaccine.
Initially complained of dizziness, onset within minutes of receiving the vaccination.  Within 5 minutes complained of chest pain. Stated she had a history of angina at the initial assessment.  BP: 145/100.  P: 83.  O2 sat: 98%.   Anaphylaxis ruled out by medical director.   Pt was advised to have further evaluation for chest pain; chest pain was located in center of chest, described feeling as" a punch in the chest".    Pulse increased to 100, BP remained elevated.  EMS activated.  Pt then recanted statement; said it was her sister that had angina.  Pt continued to have dizziness and chest pain.   Ambulance arrived at 4:13.  Pt care transferred to EMS service for evaluation and possible transport to local emergency department.
varicella lesions noted approx 14days p/vax given to daughter 26JUN95; pt had varicella @ 3 had no skin lesions & was asymptomatic;
This non-serious medically confirmed report (initial receipt 17-OCT-2014) concerns a 43 year old female patient. The patient had received the flu shot before and had never had a problem up until now. The patient had no history of arm/shoulder injuries, no tobacco and was not pregnant. On the 23-SEP-2014, the patient received AFLURIA (batch number T57505) 0.5 ml annually via the intramuscular route. On the 23-SEP-2014, two hours after vaccination, the patient developed severe intense right deltoid and shoulder pain. The pain was constant, but worsened with movement. She had decreased range of motion. The pain appeared to be tendonitis -like. On the 06-OCT-2014, the patient returned to the doctor complaining of pain. The patient had no signs or symptoms of infection and no fever. There was no redness. The patient was prescribed oral prednisolone for six days. On the 15-OCT-2014, the patient returned to the office complaining of pain however stated that the prednisolone had helped. The patient was prescribed prednisolone again but for twelve days. The patient was instructed to call the doctor's office for an update and if was not better, would be referred to an "ortho" consult. Outcome was not yet recovered.
A report was received from a consumer on 1/21/02 concerning a 60 year old male patient who experienced a sore throat, cough, headache, and sinus pain after receiving Fluvirin vaccine on 11/1/01. The patient stated that he had experienced the same symptoms in the past several years despite receiving influenza vaccines of unknown manufacturers. On 11/1/01, the patient received a Fluvirin vaccine and on 12/24/01 the patient developed a sore throat which lasted for 3 days. Two days later the patient experienced low grade fever, chest congestion, and cough which lasted for 2.5 weeks. The patient visited his physician and he diagnosed influenza infection. One week later the patient developed headache, sinus pain, and slight body ache. These symptoms have currently subsided but are not resolved. The patient did not receive any treatment for his symptoms. The patient had not recovered at the time of reporting the event. The reporter's causality assessment is probable.
Soreness in arm extending beyond injection site; Soreness in arm extending beyond injection site; Fatigue; This is a spontaneous report from a contactable healthcare professional (patient). This 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK5730) via an unspecified route of administration on 28Dec2020 (at the age of 37-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included hepatitis C. The patient was not pregnant at the time of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included buprenorphine, naloxone (SUBOXONE); bupropion (WELLBUTRIN); meloxicam; and lamotrigine (LAMICTAL); all from unknown dates for unspecified indications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not have allergies to medications, food, or other products. On 28Dec2020 the patient experienced soreness in arm extending beyond the injection site and fatigue for 2 days. The events were reported as non-serious. The patient underwent lab tests and procedures which included COVID-19 tests on 28Dec2020, 30Dec2020, 04Jan2021, 08Jan2021, 11Jan2021, 14Jan2021, 19Jan2021, 25Jan2021 with results of negative. The patient did not receive treatment for the events. The events did not cause hospitalization. The outcome of soreness in arm extending beyond injection site was not recovered. The outcome of fatigue was recovered.   No follow-up attempts are needed. No further information is expected.
Temp - 99 degrees F. Irritability. Vomiting x 1.
patient reported on behalf of pharmacist Moderna booster shot on monday 5/23. 5/24 tuesday stiff arm swollen rash on wed 5/25 am continuing to front arm sensitive itchy traveling down to under arm pit to side of breast. same no change feels itchy no fever not warm to touch.
This case was reported by a nurse practitioner and described the occurrence of fatigue in a 32 yr old male subject who was vaccinated with hep A vaccine inactivated (Havrix) for prophylaxis. Concurrent medical conditions included codeine allergy. Concurrent medications included Bupropion hydrochloride (Wellbutrin) and Semisodium valproate (Depakote) for unspecified indications. On 15July05 the subject received 1st dose of Havrix (AHAVB021AA). Approx 3 hours after vaccination with Havrix on 15Jul05, the subject experienced fatigue, chills and nausea. The events resolved on 15Jul05. The nurse practitioner considered the events to possibly be related to vaccination with Havrix.
Man little red dots on ankles, top of foot, arm, etc. I advised patient to see md for bloodwork. She has appt next week.
severe arm swelling and pain down into the forearm (the arm doubled in size) 48 hours after the vaccine, severely swollen lymph nodes in neck, under arm pits, all lymph nodes on the left upper part of the body are still very swollen 62 hours later, vaccination site has small red bumps surrounding the injection site. This reaction to the  COVID-19 booster was much more severe that any of the two previous injections. Patient has had ongoing shoulder pain since the  second injection (vaccine burned in shoulder area during injection) Pfizer\BioNTech Lot EL1284 01/13/2021
pt devel t103.8 8JUL93 & sl rash around; mom was giving APAP; had raised, reddened rash; mom called MD who ordered DPH;
No adverse event; Pediatric dose was given to adults mistakenly; Moderna COVID-19 vaccine administered to patient post temperature excursion; Moderna COVID-19 vaccine administered to patient post temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion).    This case contains information for the 38th of 104 adult patients described by the reporter.  Concomitant product use was not provided by the reporter.  It was reported there was a temperature excursion between 26 May 2022 to 30 Sep 2022 and lot AR5186C was affected between 08 Sep 2022 to 27 Sep 2022. AR5186C was previously reported. Pediatric dose was given to adults mistakenly and were reported to CDPH, VAERS, CAIR and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. 051B22A was kept in the freezer upon receipt of shipment on 01-Aug-2022 and individual vials were put in the refrigerator on the day of use.  No treatment information was provided.