chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Patient received Moderna Covid-19 monovalent vaccine on 22-JUN-2023 which was expired in 27-MAR-2022; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 monovalent vaccine on 22-JUN-2023 which was expired in 27-MAR-2022) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jun-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 monovalent vaccine on 22-JUN-2023 which was expired in 27-MAR-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 monovalent vaccine on 22-JUN-2023 which was expired in 27-MAR-2022) 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 (Patient received Moderna Covid-19 monovalent vaccine on 22-JUN-2023 which was expired in 27-MAR-2022).    No concomitant medication was reported.   It was reported that 4 doses of the Moderna Covid-19 vaccine were administered on 18-JUN-2022. 3 doses of Moderna Covid-19 vaccine were administered on 22-June-2023.  No treatment information was reported.  This case contains information for patient 6th out of 7.   This case was linked to US-MODERNATX, INC.-MOD-2023-731892 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-731892:Master case patient (1)
? x 24 hrs Amylase 1001. Pt seen for f/u post ED visit and facial swelling resolved.
No additional AE reported.; HCP reported PROQUAD was administered after a temperature excursion to a patient; This spontaneous report has been received from a registered nurse referring to a patient of unspecified age or gender. Information of concurrent condition, pertinent medical history, concomitant medications and drug reactions/allergies was not reported.  On 24-AUG-2022, the patient administered with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status recombinant human albumin (rHA)) (PROQUAD) subcutaneous injection (lot# U029323, expiration date 19-MAR-2023, once; dose, route of administration, anatomical location and strength were unknown) for prophylaxis. It was reported that the suspect vaccine was underwent temperature excursions at 8.42 degree Fahrenheit (F) for 1 hour and 2 minutes (product storage error). There was no previous temperature excursion. No additional adverse event (AE) was reported (no adverse event).
pt dx'd w/vitiligo prior to 12JUN93 but p/5AUG85;  10SEP93 vitiligo lesion now appeared; swelling, redness @ vax site 24 hrs later;
9 hours after taking the vaccine, I had chills, fever with high temperatures (101.4), severe headache, body pains and difficulty moving my left arm where I received the shot. I'm still experiencing all these symptoms until the following day.
Patient experienced redness, swelling, and itching at site of injection.  Symptoms started on 10-6-07 and began improving thereafter.  Patient visited physician assistant on 10-8-07 and was given Zyrtec 10mg and Cephalexin 500mg tid for 10 days.  The PA diagnosed the patient with cellulitis, however, after examination, it appears to be an injection site reaction because the symptoms had improved from the first day.
I have not received the 2nd shot in the series; Rash bothers her but is not painful; She had developed a rash on the tops of her hands; rash had extended up her right arm and around the right side of her trunk at the level of her abdomen and flank area; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of RASH PRURITIC (Rash bothers her but is not painful), RASH (She had developed a rash on the tops of her hands), RASH (rash had extended up her right arm and around the right side of her trunk at the level of her abdomen and flank area) and PRODUCT DOSE OMISSION ISSUE (I have not received the 2nd shot in the series) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced RASH PRURITIC (Rash bothers her but is not painful), RASH (She had developed a rash on the tops of her hands) and RASH (rash had extended up her right arm and around the right side of her trunk at the level of her abdomen and flank area). On 16-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (I have not received the 2nd shot in the series). On 16-Feb-2021, PRODUCT DOSE OMISSION ISSUE (I have not received the 2nd shot in the series) had resolved. At the time of the report, RASH PRURITIC (Rash bothers her but is not painful), RASH (She had developed a rash on the tops of her hands) and RASH (rash had extended up her right arm and around the right side of her trunk at the level of her abdomen and flank area) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the event includes Breast milk, Hydrocortisone cream   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2021: No specific follow-up information recorded. On 15-Apr-2021: No specific follow-up information recorded.
Left arm pain at injection site. shooting pain down the left arm. Persistent pain for 30 days since vaccine. No improvement with steroid or gabapentin.
approximately 5 minutes following the vaccination, patient began to experience lightheadedness, altered sensation in his arm, and shortness of breath.  He proceeded to lose consciousness.  He was placed supine on the floor, but continued to have increased tone in his extremities and did not regain consciousness for approximately 10-15 seconds.   When he regained consciousness he noted that he had lost bladder control.  He was diaphoretic, weak, pale, and nauseous for approx 30 minutes.  He was given water, offered food (he had complained of being hungry earlier)  but was too nauseous to eat.   He was given a glucose 4 gram tablet, which he vomited, and then offered a sports drink.    Patient left accompanied by wife and was instructed to seek an evaluation by a medical professional.
This spontaneous case, initially received from pharmacist on 15-Oct-2018, concerns a 43-year-old, adult, male patient. The patient's current condition included hypertension. The patient's concomitant medication included amlodipine for an unknown indication. On 15-Oct-2018, the patient (under age of 65 years) was administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250793, expiry date: 30-Apr-2019] (explicitly coded as inappropriate age at vaccine administration). At the time of this report, no adverse event was reported. The reporter assessed the case as non-serious. Non-significant follow up received from the pharmacist on 15-Nov-2018: The reporter confirmed that the patient did not experience any adverse event post-vaccination. No changes were made in narrative.
Pt developed a localized rash (about 10cm) around site of injection. Rash was red, warm with slight swelling. Two days later pt developed swelling around the upper arm that extends 2 cm above the injection down to 5 cm below elbow.
Got pregnant in December, miscarried at about 12 weeks. I?m sure no one will ever see that as causation and that it?s 1/4 chance to miscarry. But I do believe I should report it in case miscarriage rates are shown to be increasing in rates. I?m still dealing with retained pregnancy tissue.
Received vaccine DTap and Hibon left thigh on 7/9/01 on many of 7/10 developed signifant redness swelling > 10 cm and upper l thigh
received the first dose / in 2018 and has not received the second dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The health care professional declined to provide patient demographics, lot number and expiration date. The reporter did not consent to follow up.
Arthralgia, Fever, ErythemaMultiform, chills, sweats, arm soreness Narrative: Arthralgia, fever, chills, sweats, arm soreness; taking tylenol.
Information has been received from a pharmacist concerning a patient who on 11-MAY-2010 was vaccinated SC with a dose of VARIVAX (Merck) instead of ZOSTAVAX (Merck) (MSD). There was no adverse event reported. Additional information has been requested.
No adverse event reported.  Vaccine administered to patient 17 year and 2 months old.
Fever, runny nose and rash all over. First rash started on November 22, 2019 and ended on November 26, 2019. The rash came back on December 1, 2019 with a fever except the rash was worse and covered his entire face, cheeks and ears. It?s also on his body and the injection site on his left thigh is swollen with a mark.
This spontaneous case reported by a pharmacist, describes the occurrence of product preparation issue (patient received a re-frozen dose of the vaccine) in a 77-year-old patient, of an unknown gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 047C21A) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 0.25 milligram. On an unknown date, patient experienced product preparation issue (patient received a re-frozen dose of the vaccine). At the time of the report, product preparation issue (patient received a re-frozen dose of the vaccine) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Sender's comments: This case concerns a 77-year-old patient, unknown gender, with no known medical history, who experienced the event of product preparation issue. The event occurred on unknown date after the third dose of Moderna vaccine, whereupon patient received a re-frozen dose of the vaccine. The benefit-risk relationship of Moderna vaccine not affected by this report.
Initial report received from a health care professional on 11 May 2011. An 11-year-old female child received on 09 May 2011 an injection (route and site not reported) of MENACTRA, sanofi pasteur lot number U3840AA and an injection (route and site not reported) of GARDASIL, Merck lot number not reported. The patient had no known allergies, no history of any medical conditions, had no other vaccines within 4 weeks, had no adverse events following prior vaccinations and took no medications. The patient received MENACTRA and GARDASIL about 9:00 AM on 09 May 2011. The mother called to report at 9:00 PM on 09 May 2011 that the patient was experiencing swelling of the face, tenderness, burning sensation, and vaginal irritation. The patient was seen by a physician on 11 May 2011 for the swelling of the lower area of the face which was mostly on the cheeks, tenderness, burning sensation, vaginal irritation and hives on the inner forearms. The patient was treated with BENADRYL. The outcome was reported as not recovered. Documents held by sender: None.
Arm pain; This is a spontaneous report from a non-contactable physician, the patient. A 72-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0183) via an unspecified route of administration in the left arm on 01Jul2021 at 14:00 (at the age of 72-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient received other medicines (unspecified) within two weeks prior to the COVID-19 vaccine. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Jul2021 at 16:00 the patient experienced arm pain. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the event arm pain was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Discharge Provider:  MD Primary Care Provider at Discharge:  MD   Admission Date: 2/14/2023 Discharge Date: 2/15/2023   PRESENTING PROBLEM: Hypoxia [R09.02] COVID-19 [U07.1] Respiratory failure with hypoxia [J96.91]   HOSPITAL COURSE: The patient has a 61-year-old female presented with complaints of shortness of breath and cough.  On presentation the patient was noted to be hypoxic requiring supplementary oxygen.  Patient was felt to be suffering from acute respiratory failure secondary to asthma exacerbation from acute COVID infection.  On presentation the patient had a normal chest x-ray.  Patient was quickly weaned from oxygen.  Labs and vitals remained stable throughout her hospitalization.  Inflammatory markers were checked and noted to be negative.  On day of discharge the patient was maintaining appropriate saturations on room air.  She noted improvement of her respiratory status.  We discussed recommendations for continued rest at home along with continued oral prednisone.  Questions have been answered to patient's satisfaction she is being discharged home today in stable condition. Prior to becoming ill the patient reported using her albuterol inhaler on a daily basis.  Based on this her asthma is felt to be poorly controlled and therefore a maintenance inhaler of Symbicort is being added at discharge in hopes reducing patient's need for her rescue inhaler.
(R) shoulder pain, severe; tingling sensation along (R) arm; not able to rise (R) arm.
10:30am 2nd Shingrix dose 1:00 start feeling fatigued & vaguely unwell. Fatigue increases all afternoon. 7pm went to bed early 12 midnight awoke to fever of 103.3, all over body aches, queasiness. 9am took Covid test (negative) By 10 am fever & aches gone although fatigue remained. I slept several hours. Fatigue eased by the next day.
Found apneic and asystolic, tied up in blankets 24 hours after vax. Autopsy shows final cause of death as sudden infant death syndrome. A follow up report received 6/12/2000 clarifies that pt was found "tangled up in his blankets" rather than "tied up in blankets".
Approximately 1-1/2 weeks after vaccination broke out with fever blisters around mouth. Treated once with  Valacyclovir and a MethylPrednisolone decreasing dosage w/o any results. Am now being treated again with a 10 day run of Valacyclovir and  Decrasing Prednisone
Patient received his 3rd dose (booster) of Moderna vaccine on 12/16/21 and broke out in a rash on  his chest on 12/18/21. He reported to the pharmacist on 12/30/21 that he had a rash and that it has not gone away.
Swelling and warmth at site of injection, no treatment, approx 4 cm X 1 cm.
Pain and itching in arm as well as diffuse body itching, fatigue and shortness of breath
Moderna vaccine vials (Lot#:002C21A, expiration 10/14/21) were removed from freezer and delivered from larger healthcare facility within enterprise to our facility with a fridge expiration date of 6/24/21. The fridge expiration date was written on the bag that the vials came in, but not directly on the vials. On 7/7/21, pharmacist grabbed a vial from the pharmacy fridge without  looking at the expiration date on the bag and drew up 3 vials. The nurse then took the labeled 3 doses (labeled with manufacturer expiration and time of expiration from puncture of the vial time) and administered to 3 separate patients that day.  Pharmacy caught adverse event on 7/9/21 when reporting doses given. Notified Moderna safety team on 7/12/21 who recommended to report to report to VAERS but not to administer additional dose as no studies done on patients receiving more than 2 doses. No further follow-up recommended. No adverse reactions noted.
chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and PYREXIA (fever) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced CHILLS (chills) and PYREXIA (fever). At the time of the report, CHILLS (chills) and PYREXIA (fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Case previously recorded as MA2009-3021. We received the following information via our legal contractor on 15 OCT 2009: A female patient was vaccinated with influenza vaccine (manufacturer or batch no. unknown) on 03 SEP 2009. She stated that her left upper arm hurt since she received the shot. The outcome of the symptom is unknown. Addendum: Despite requests on 04 OCT 2009 and 21 OCT 2009 we did not receive any further information. No change in assessment.
Delayed injection site reaction to left arm nine days after vaccination, swelling, redness, tenderness, itching.  Self treated with tylenol, ice pack and antihistamine, symptoms reduced over half by next day.
1-2 hours after getting vaccines, mom states had whelps on hands. Mom came back for us to look at and it had already improved.
Extreme Hair loss over 3 months after 2nd dose (~70% of all hair volume); This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Apr2021 (Lot number: ER2613) at the age of 45 years as dose 2,single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Batch/Lot No: ER8731), administration date: Mar2021, when the patient was 45 years old, for COVID-19 immunization. The following information was reported: ALOPECIA (non-serious) with onset Apr2021, outcome "recovering", described as "Extreme Hair loss over 3 months after 2nd dose (~70% of all hair volume)". The event "extreme hair loss over 3 months after 2nd dose (~70% of all hair volume)" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
dizzy; hot & clammy; hot & clammy; nauseous; dry mouth; loss of appetite; bowel movement; This is a spontaneous report from a contactable consumer (patient). A 75-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: not reported), via an unspecified route of administration, administered in left arm on 06Feb2021 09:30, as dose 1, single for COVID-19 immunisation in hospital. Medical history included mitral valve prolapse. The patient had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 07Feb2021 01:00, the patient experienced dizzy, hot and clammy, nauseous, dry mouth, loss of appetite, bowel movement. Patient's B.P. was perfect, temp normal. This was about 30 hrs after dose. The patient underwent lab tests and procedures which included Blood Pressure: perfect on 07Feb2021, body temperature: normal on 07Feb2021. The patient did not receive treatment for the adverse events. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
no additional AE were reported; A dose of PROQUAD was administered to an adult instead of MMR II.  No additional AE's and no PQC's were reported.; This spontaneous report was received from a pharmacist and refers to an adult patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 02-SEP-2022, an adult patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD) subcutaneous injection, lot number W016357 was found to be valid, expiration date 16-NOV-2023 (strength, dose, route of administration and vaccination site were not reported) for prophylaxis (reported as "use as directed to prevent measles, mumps, rubella and varicella infection) instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection for the same indication (wrong product administered). No additional adverse events were reported.
Fever of 102.3 joint pain, body aches, fatigue, injection site pain x4 days, headache,, swollen arm
Vaccines administered after being in stored in fridge past 30 days; Vaccines administered after being in stored in fridge past 30 days; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days) and NO ADVERSE EVENT (no adverse event) in a 67-year-old 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. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days) and PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days).    Concomitant medication not reported.  Treatment medication not reported.