chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 06-JUL-2022; No adverse event; Patient administered the vaccine after the 30 days by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 06-JUL-2022) and NO ADVERSE EVENT (No adverse event) in a 47-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 06-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 06-JUL-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 06-JUL-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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 06-JUL-2022).    Concomitant medications were not reported.  Patient received full dose. They administered the vaccine to 346 patients after the 30 days by used and total Number of vials was 35. The vial did not undergo any temperature excursions. Treatment medications were not reported.
Expired vaccine administered beyond 12 hours after first puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours after first puncture) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21B) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours after first puncture). On 04-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours after first puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment medications were not provided.
Patient came to the pharmacy with a discharge letter stating that she was diagnosed with Left sided Bell's Palsy. The doctor had not indicated whether or not this diagnosis was a direct outcome of the vaccination. She went to the emergency room with her face numb and drooping. No further information was provided to me aside from the discharge diagnosis. No labs were provided either.
itchiness on his back; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness on his back) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (itchiness on his back). At the time of the report, PRURITUS (itchiness on his back) outcome was unknown. Not Provided          No Relevant concomitant medications was reported.  Patient took an allergy medicine to treat symptoms.   This case was linked to US-MODERNATX, INC.-MOD-2021-098321, US-MODERNATX, INC.-MOD-2021-098353 (E2B Linked Report).; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested. US-MODERNATX, INC.-MOD-2021-098321:Cross-linked (reporter's dose 1) US-MODERNATX, INC.-MOD-2021-098353:Cross-linked (reporter's dose 2)
she developed rash on her breast after the first dose of the vaccine; itching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 33 year-old female patient received bnt162b2 (BNT162B2), administration date 16Aug2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious) with onset 17Aug2021, outcome "recovered" (Aug2021), described as "she developed rash on her breast after the first dose of the vaccine"; PRURITUS (non-serious) with onset 17Aug2021, outcome "recovered" (Aug2021), described as "itching".  Additional information: It was reported that caller got the Pfizer Covid vaccine back in 16Aug2021 and the next day she developed a rash on her breast and it was itching. Kind of think it was the vaccine. It died down kind of after 2-5 days. Yesterday she had a visit for the second dose and told the doctor about this and was told she should report this and see if she could go ahead with the second dose or wait.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pfizer-BioNTech COVID-19 Vaccine EUA: patient reports within four hours of vaccination development of rash on trunk, headache, and feeling "spacey" and fatigued. Also reports rash with first vaccine dose. Does not report and respiratory, neurologic, or respiratory symptoms. Symptoms resolved with diphenhydramine.
Information has been received from a certified medical assistant concerning a patient who on 25 Aug 2006 was vaccinated with a first dose of Gardasil, intramuscularly. Subsequently the patient developed a herpes virus infection. The patient's pediatrician had concluded that the infection was not due to Gardasil. It was also reported that the patient's second dose was delayed because some time after the first dose, because she developed the herpes virus infection. Additional information has been requested.
Significant Swelling and redness right deltoid area extending down to 4 cm above elbow. Painful, child crying. Had to be picked up from school.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2022 at 2:34 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Feb-2022 at 2:34 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of the patient was reported as 20.95.  Concomitant medication of the patient was not reported.  Batch number 014M20A underwent temperature excursion on 27-Feb-2021 with temperature of 33 degrees Fahrenheit at 09:00 AM, 35 degrees Fahrenheit at 11:00 AM, 12:00 PM, 01:00 PM and 02:00 PM, 34 degrees Fahrenheit at 03:00 PM and 04:00 PM and 35 degrees Fahrenheit at 05:00 PM. These vials were moved to fridge on 24-Feb-2021 and beyond use date for the vials was reported as 26-Mar-2021. The vaccines moved to clinic on 27-Feb-2021. Storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination. Vials were only punctured right before administration. Vaccines were not frozen at time of administration and prior to administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. The reporter reported that, no data logger reports were available and fisher brand traceable temperature monitor was used to record hourly temperatures.  No treatment information was provided by the reporter.
Information has been received from a non-Merck clinical site coordinator and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications were not reported. On 03-OCT-2018, the patient was vaccinated with improperly stored ROTATEQ, orally (exact dose was not provided), lot # N030364, expiration date: 06-MAR-2019, for prophylaxis. The vaccine was stored at 11 Celsius degrees (C) for 1 hour 20 minutes and 8.7 C for 7 minutes. There were no other previous temperature excursions noted. No adverse effects were reported. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1810USA012273: US-009507513-1810USA012274.
Joint pains, left leg aching, back of knee muscles hurt, pains lasted about 4 month and are still ongoing
Initial report was received on 25 August 2014 from a consumer who is also the patient's parent. A 25 month-old male patient had received on 12 December 2013, ACTHIB (lot number UH869AA) and an unidentifiable time later experienced asthma. According to the patient's parent, reports after receiving ACTHIB that pt developed asthma. "He had normal colds before and recovered since receiving the ACTHIB with each cold he got his symptoms worsened. He has a constant cough during the night, in the am and with activity. He has seen multiple Doctors both in the county and when we are traveling out of the country. In August he saw an allergist and he has now been diagnosed with asthma due to illness he is on VENTOLIN albuterol Queva arvestin and xudal." The patient's parent states "she is very upset as her child has had multiple issues after vaccines and she is very frustrated. She found a link to receiving ACTHIB and asthma she wants to know what we will do for her?" Made aware she can have her Pediatrician or other specialist speak with our Medical directors if needed for information on the vaccine he received." No further information received. Outcome was not recovered. This patient had additional events captured in cases 2013-05918, 2013-06117, 2013SA113995 and 2014SA104021. Documents held by sender: none.
Patient reports that overnight Monday into Tuesday he rolled over onto the arm he got his vaccination in and felt some pain with a lump that was hot to the touch. The lump has since gone away but the area is still hot to the touch. He also developed a bulls-eye rash where the lump was that has since gotten bigger. Patient reports that his vaccination was given in the tricep where the lump and rash have formed, however paperwork and the immunizer report the vaccination was given in the deltoid.  Patient was referred to their doctor for follow up.
Patient complained of feeling dizzy. He fainted and looked pale. Student laid down flat with both feet elevated. O2 given, vital signs taken. No respiratory distress noted. Patient arousable. Alert and oriented. Denied feeling dizzy and able to get up on his own. Patient recovered well. No injury noted. Student went home with his mother.
multiple pulmonary embolus diagnosed after pt came into the emergency room  4/5/2021
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 21-DEC-2018, the patient was vaccinated with a dose of improperly stored PROQUAD (exact dose, route and site of administration were not reported; lot number R020816, expiration date 16-JAN-2020) for prophylaxis. The administered dose was received as part of a late shipment. It was not possible to determine either the time frame or the temperature of the vaccine storage. No information regarding any previous temperature excursions was provided. Digital Data Logger was not used. No adverse effects were reported. The outcome of product distribution issue was unknown. The causality between the event and suspect vaccine was not reported.
pt recvd vax  & exp fatigue; lab eval on 15MAR93 revealed liver enzyme of 1000; repeat lab eval on 22MAR93 revealed liver enzymes of 783;
EVENING OF 1/6/21, DEVELOPED TREMORS AND DIZZINESS.  UNKNOWN DURATION, BUT IS RESOLVED NOW.
This spontaneous report was received from a Registered nurse regarding a 16 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-AUG-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. ; Sender's Comments: US-009507513-1804USA005153:
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Severe
Information has been received regarding a case in litigation, from a lawyer, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date in 2016, the patient was vaccinated with ZOSTAVAX, due to health care professional recommendation, for permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) (strength, anatomical location, dose, route of administration, lot # and expiration date were not provided). Later in 2016, the patient was treated by his/her healthcare providerfor shingles, as the patient was diagnosed with shingles or other related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient had and would continue suffer ongoing injuries, included but not limited to: mental and physical pain and suffering, extensive medical care and treatment for these injuries; significant medical an related expenses as a result of these injuries, included but not limited to medical losses and cost include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions. At the time of report, the patient was not recovered from emotional distress, injury and pain. The outcome of vaccination failure, quality of life decreased, herpes zoster and the pre-existing unspecified conditions aggravated was unknown. The reporter considered the events to be disabling, life-threatening and medically significant.
Not immunocompromised and received full third dose of 0.5ml; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Not immunocompromised and received full third dose of 0.5ml) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00F421A, 038K20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (Not immunocompromised and received full third dose of 0.5ml). On 19-Oct-2021, ACCIDENTAL OVERDOSE (Not immunocompromised and received full third dose of 0.5ml) had resolved.            Concomitant information was not provided. Treatment information was not provided.   This case was linked to MOD-2021-358928 (Patient Link).
Pt was A/O at start of vaccine administration. Stated she was very nervous and joked about not wanting to take vaccines. Pt was noted visibly anxious about receiving vaccines. This Nurse was explaining to Parent the need for a 15 minute observance period d/t Pt receiving HPV9 when Pt fell back on the exam table and her body began shaking. This Nurse and Parent lowered Pt to the floor and began calling out her name and trying to awaken her. Alcohol waived in Pt's nose to help with waking her up. Pt became alert and at first could not tell this Nurse where she was but was able to X3 within a few minutes. Vitals taken and all WNL. Mom then stated Pt has reacted the same way to vaccines administered in the past and also to labwork she has had done. Pt stated she had not eaten anything all day but just a small piece of cake and some chips. Offered Pt some water and taken with no further problems. Monitored for another 15-20 minutes. Pt stated she felt much better and requested to leave. Pt was A and O X3 at time of departure. Will f/u with Pt tomorrow.
7/31 - Immunizations given at 1447 8/1 - Fever - Tylenol given 8/2 - Left deltoid swollen, red and hot - 2230, contacted after hours Peds line - instructed to go to ER. Went to ER - given steroid injection, tylenol and benadryl, sent home with ATB- cephalexin 8/3 - Seen at PCP - only slight pink area noted on left deltoid, very slightly warm to touch, denies tenderness with palpation, itching or pain. No swelling or knots noted. Instructed to observe and monitor.
1st dose 4 years ago, no 2nd dose yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix 4 years ago ).   On an unknown date, the patient did not receive 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 Information: GSK Receipt Date: 04-NOV-2022 Reporter's Comment: The reporter was the patient's relative.  She stated that her relative never received his second dose of Shingrix. The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
pt vaxed 11NOV91 & w/in 48 hrs 13NOV exp chest congestion, spitting up blood & had a WBC of 14,000; pt had received an flu vax 2 wks prior; tx w/Floxin; pt has hx of congestive heart failure & bypass surgery; 15NOV doing better;
Information has been received from a physician concerning a 10 year old female patient who on approximately 23-OCT-2009 (also reported as 2 to 3 days ago) was vaccinated with an injection of GARDASIL. On approximately 23-OCT-2009 (also reported as 2 to 3 days ago), after receiving the vaccination the patient experienced tingling on her hands and feet. Unspecified medical attention was sought. At the time of the report, the patient's status was not reported. Additional information has been requested.
I received my second dose of the Moderna vaccine at approximately 11:00am. At approximately 7:00pm, I began experiencing flu-like symptoms including fever, weakness, fatigue, severe body aches, a swollen axillary lymph node (on the side of the injection). 48 hours after receiving the shot, I still maintain a fever of greater than 100 and body aches.
Information has been received from a physician concerning a patient who was vaccinated with the first, second and third doses of ROTATEQ and still developed rotavirus.  The outcome was unknown.  Additional information has been requested.
5 days post second pfizer covid vacine, ~4/25 developed pain over right maxillary teeth and right sided red facial rash consistent with herpes zoster opthalmicus V1. Also developed zoster keratitis. Admitted to hospital where he received IV acylcovir x 4 days before transition to PO valtrex.  Zoster rash resolved over time but then developed in mid May new diplopia and right pupilary dilation. Saw Opthomology who were concerned for CN3 defect. Represented and admitted to hospital where MRI was notable for right ocular motor nerve with questionable enhancement of right V1 nerve likely refelctive of post viral neuritis. Resumed IV acyclovir course x 10 days and started on PO prednisone taper.
Client received Menactra on 8/11/06, However c/o fever, body ache, joint pain, muscle pain, headache, loss of appetite and generalized weakness throughout weekend. Assessed client upon return on 8/14/06 client c/o hoarseness and low grade fever. Red blisters x2 noted to left arm with red streaks noted around left upper arm. Client did not seek medical care during 3/5.
pt says she noticed a rash in her armpits on 7/24/22 at 10pm, then at midnight she had rash waist on up, has slightly swollen eyes.
I had fatigue, running nose, and nausea.  These symptoms lasted for about 3 days.  I went to the urgent care.  They did two Covid-19 test, positive results on both.