chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administering an expired vaccine to a patient; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administering an expired vaccine to a patient) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administering an expired vaccine to a patient). On 13-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Administering an expired vaccine to a patient) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided. The vaccine vial was punctured and moved from the refrigerator to room temperature at 11:25 A.M in previous day, 12-Aug-2021, and this vial has been stored in room temperature since then.
Information has been received from a healthcare worker concerning an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. On an unknown date the patient was vaccinated with doses of improperly stored VAQTA (lot# L002717, expiration date 02-JUN-2017, strength, dose and route unknown). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Myalgia, Arthralgia & Fever Narrative: dose 1- day 1-2 - fever fatigue bodyache
pt exp an abscess (2cm induration) & fever 25SEP95 101;abscess was opened & drained twice;pt was treated w/augmentin
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 08-NOV-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September of 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days) VAQTA injection, 0.5 ml (lot # L018499, exp. date: 25-FEB-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
extreme rash; itching especially on palm of hands, knees, thighs, back; This is a spontaneous report received from a contactable Consumer, Pharmacist. A non-pregnant female patient of unspecified age, received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch number: Unknown) at an unspecified dose Via unspecified route of administration on left arm on 10Mar2021 at 09:45 AM (at an age of 59-year-old at vaccination) as second dose single for COVID-19 immunisation. The medical history and concomitant medication of the patient was not reported. The past drug history of the patient included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch number: unknown) at an unspecified dose Via unspecified route of administration on left arm on 11Feb2021 at 09:30 AM for COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient has not tested for COVID-19 since having the vaccination. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine or any other medications within 2 weeks of vaccination. On 16Mar2021, the patient experienced extreme rash and itching especially on palm of hands, knees, thighs, back. No therapeutic measures were taken for the events. The patient did not have any allergies to medications, food, or other products. The outcome for the events of extreme rash and itching especially on palm of hands, knees, thighs, back was reported as not recovered. Information about lot/batch number cannot be obtained. No further information is expected.
Injection site arm pain that lasted for 36 hours.; Joint pain and got worse in the next 24hours; As with first dose, skin allergic reactions that by now healed reappeared 1 day after the shot.; This is a spontaneous report from a contactable consumer, the patient.  A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732), via an unspecified route of administration in the left arm on 28Mar2021 at 10:30 (at the age of 29-years-old) as dose 2, single for COVID-19 immunisation. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199), via an unspecified route of administration in left arm on 07Mar2021 at 10:30 (at the age of 29-years-old) as dose 1, single for COVID-19 immunisation and experienced vaccination site pain and allergic skin reactions.Medical history included hashimotos thyroiditis and over active immune system. Concomitant medications included 50 mcg of levothyroxine (MANUFACTURER UNKNOWN) and 150mg of flucanazole (DIFLUCAN), both for an unknown indication, from unknown duration and unknown if ongoing. The patient was allergic to adhesive bandages, lemon grass and pea plant but not peas.  The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not been diagnosed with COVID-19 prior to the vaccination. The patient had not been tested for COVID-19 since the vaccination. On 28Mar2021, at 12:30, the patient had experienced vaccination site pain, which lasted for 36 hours and joint pain, which was felt few hours after the shot was given. Joint pain got worse in the next 24hours at which point pain medication was needed. The patient had also reported that as with first dose, skin allergic reactions that by then healed, reappeared one day after the shot. Therapeutic measures were taken as the result of adverse events, which included treatment with continued skin rash control for allergic skin rash and unknown point pain medication for joint pain. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events vaccination site pain, joint pain were recovered in Unknown date in Mar2021 and allergic skin rash was not recovered at the time of report.  No follow-up attempts are possible. No further information is expected.
Patient reported upper arm near site of injection was swollen and painful. Pt also states feeling a bit of nausea
Symptoms include breaking out in small red spots on shoulders and neck at first. Then eventually spread downward to elbow and bend of arms bilaterally . Now has continued on down clients body. Some are under the skin. A few errupt. They are very sore. If they do errupt they have a small white pustule in the center.  The rash has now spread completely down abdomen and covered legs also . There is periods that the itching stops with an antihistamine but it doesnt go away. This started on the 7th  and has continued..
patient came in one week after administration of vaccine. Her left arm (Shingrix) showed swelling, redness and patient said was warm to touch. Said no pain or itchiness. reported that it started almost a week after vaccine was administered. Told to put ice on to reduce swelling and also referred to physician for evaluation. Called to check in two days later and she said md gave her an antibiotic and that was getting a bit better
About a month after I was vaccinated - I woke up in the morning and every joint in my body hurt. Apt with Dr at clinic. Gave me prednisone. Cleared up (no pain).
This spontaneous report was received from a medical assistant and refers to a multiple unspecified patients of unknown age and gender. The patients' pertinent medical histories, concomitant medications and drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VAQTA injection (lot # M047658 with expiration date at 28-OCT-2017, lot # M033611 with expiration date at 02-MAR-2018, lot # M034893 with expiration date at 26-MAY-2017, lot # M039202 with expiration date at 11-MAR-2018; dose, route of administration and anatomical location were not reported), for prophylaxis. The administered doses of vaccine experienced multiple temperature excursions. From 16-MAR-2017 to 31-MAR-2017, the doses of VAQTA with lot numbers: M047658, M033611 and M039202 were exposed to a temperatures in the range between 47 degrees Fahrenheit (F) to 77 degrees Fahrenheit (F) for 1 hour and 52 minutes in total. On 21-MAR-2017, took place the longest (35 min) excursion with temperature of 49 degrees Fahrenheit (F). No details were reported regarding the temperature excursion with the doses of VAQTA with lot # M034893. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected since all scheduled correspondence was received.; Sender's Comments:  US-009507513-1705USA015599: US-009507513-1705USA000770: US-009507513-1705USA015601: US-009507513-1705USA015602: US-009507513-1705USA015597: US-009507513-1705USA015598:
Facial Swelling including top and lower lips , right and left cheeks. Tenderness in the inner cheeks.
A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was vaccinated with vial that might have had a temperature excursion.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 22 Dec 2020, the nurse reported a shipment was received. The vial arrived frozen and was placed in a freezer at recommended temperature.   On 02 Jan 2021, the freezer had failed, and the temperature alarm system did not alert anyone. It was noted that the freezer temperature at 5:50 AM was -5 degrees Celsius (C), at 7:50 AM the freezer was a 1.5 C. It remained between from 9.7 C at 12:51 PM then went to 8.3 C at 1:51 PM then down to -8.7 C at 2:51 PM.  On 03 Jan 2021 8:45 PM, the freezer returned to its normal temperature of -20.9 C, -1 C then went to 5.5 C at 11:56 PM.  On 04 Jan 2021, the temperature climbed to 19.4 C. On the same day, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A, 025L20A, or 027L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced vaccination with vial that might have had a temperature excursion  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, vaccinated with vial that might have had a temperature excursion, was considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use, product temperature excursion issue, and product storage error for mRNA-1273. There were no reported AEs associated with this case.
Rash on (L) arm and neck - cannot be sure rash was present prior to vaccination, gave BENADRYL IM 25 mg, ZYRTEC PO 10 mg. 30 minutes later gave BENADRYL 12.5 mg IM, DEPO-MEDROL 40 mg IM. Pt in no distress. Pulse ox 99% on room air.
Patient came in for 2nd dose of Moderna vaccine which should have been 0.5mL. Patient was only given 0.25mL. Dr notified ordered to administer additional 0.25mL of Moderna vaccine ass soon as possible same day for a total of 0.5mL to complete second dose requirement. No adverse reactions noted. Pt advised to return in 5 months for booster.
Information has been received from a physician concerning a 6 year old Caucasian male with gastrooesophageal reflux disease, chronic sinusitis, reactive airways disease and food allergies, who on 12-NOV-2007 was vaccinated intramuscularly with pneumococcal 23v polysaccharide vaccine into the right arm (lot# 656222/0381U). Concomitant therapy included FLUMIST and varicella virus vaccine live (unspecified) (manufacturer unknown), into the opposite arm. Other concomitant therapies included PREVACID and SINGULAIR. On 12-NOV-2007, the patient experienced a significant injection site reaction, edema and erythema almost immediately following the pneumococcal 23v polysaccharide vaccination. The injection site arm was affected from the shoulder area down the arm 2/3 of the way to the elbow. The area was warm, erythematous, and swollen. The patient was given steroids and diphenhydramine as treatment and the reaction resolved in a couple of days. Medical attention was sought, treated for the injection site reaction. Additional information has been requested.
Fever, Fatigue and Red Urine for a full week after shot.  This happened after both the 1st shot and the 2nd shot
burning pain in chest at the site of tumors; CAT scan from 2Mar2021 showed significant regression of tumors; This spontaneous case was reported by a health care professional and describes the occurrence of CHEST PAIN (burning pain in chest at the site of tumors) and COMPUTERISED TOMOGRAM (CAT scan from 2Mar2021 showed significant regression of tumors) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0262Z0A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (burning pain in chest at the site of tumors) and COMPUTERISED TOMOGRAM (CAT scan from 2Mar2021 showed significant regression of tumors). At the time of the report, CHEST PAIN (burning pain in chest at the site of tumors) and COMPUTERISED TOMOGRAM (CAT scan from 2Mar2021 showed significant regression of tumors) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Computerised tomogram: significant regression of tumors (Inconclusive) significant regression of tumors.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided. No relevant concomitant medications reported.
slight fever, not really high; felt bad/did not feel good for a day; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (felt bad/did not feel good for a day) and PYREXIA (slight fever, not really high) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020 and COVID-19 pneumonia (a mild case). Concurrent medical conditions included Adrenoleukodystrophy (rare disease called leukodystrophy adrenomyeloneuropathy (AMN), which defined as long fatty acids attacking myeloid sheath, damaging it similar to what happens in sclerosis. It is a long progression disease) and Walker user (walks around with a walker).    On 28-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (felt bad/did not feel good for a day) and PYREXIA (slight fever, not really high). At the time of the report, VACCINATION COMPLICATION (felt bad/did not feel good for a day) had resolved and PYREXIA (slight fever, not really high) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-370698, MOD-2021-370729 (Patient Link).
This non-serious spontaneous case, initially received on 19-Mar-2018, reported by other health professional, concerning a 13-year-old, adolescent patient of an unspecified gender. It was reported that, on an unspecified date, the temperature of the refrigerator in which vaccine was stored dropped to 32 F and was out of range for a total of 1 hour and continued for 2 weeks. On 15-Feb-2018, the patient was administered with FLUCELVAX QIV that was stored out of recommended temperature (route of administration: intramuscular, anatomical location: right deltoid, batch number: 195236, expiry date: 30-May-2018, dose: not reported). The patient had no adverse reactions from the suspect vaccine that underwent temperature excursion. Non-significant follow-up received on 07-May-2018: Upon internal review, it was realised that the expiry date was incorrect. Hence, the expiry date was changed from 31-May-2018 to 30-May-2018 in the product tab. The reporter confirmed that, the patient had no adverse reactions from the suspect vaccine that underwent temperature excursion. Narrative was amended accordingly.
Could not sleep; Left arm to wrist swollen; Left arm to wrist had incredibly bad itchy feeling; Left arm to wrist turned red; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Could not sleep), VACCINATION SITE SWELLING (Left arm to wrist swollen), VACCINATION SITE PRURITUS (Left arm to wrist had incredibly bad itchy feeling) and VACCINATION SITE ERYTHEMA (Left arm to wrist turned red) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K204(4 or A)) for COVID-19 vaccination.     The patient's past medical history included High cholesterol since an unknown date and Retinal tear (in both eyes.). Concurrent medical conditions included Seasonal allergy, Egg allergy and Herbal allergy. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2021, the patient experienced INSOMNIA (Could not sleep), VACCINATION SITE SWELLING (Left arm to wrist swollen), VACCINATION SITE PRURITUS (Left arm to wrist had incredibly bad itchy feeling) and VACCINATION SITE ERYTHEMA (Left arm to wrist turned red). At the time of the report, INSOMNIA (Could not sleep), VACCINATION SITE SWELLING (Left arm to wrist swollen), VACCINATION SITE PRURITUS (Left arm to wrist had incredibly bad itchy feeling) and VACCINATION SITE ERYTHEMA (Left arm to wrist turned red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded
This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 15-MAR-2018, the patient was vaccinated with  an expired dose of (wistar ra 27-3) M-M-R II  0.5 ml, once via intramuscular route, lot number M007277 with expiration date on 09-FEB-2018 (dose and anatomical location were not reported) for prophylaxis. It was stated that the sterile diluent used for reconstitution was not expired (lot number M006117 with expiration date on 24-AUG-2018) and that both products were stored appropriately. There was no adverse effect reported. No product quality complaint was involved.
Patient received Pfizer vaccine #2 today.    After the vaccine, the employee reported the following symptoms:  dizziness  burning sensation in the right side of her neck and r ear   Lot: EL 3247  Time of Administration: 1:10pm in LEFT arm  Time Symptoms Began: 1:40pm when she stood up.  Felt a rush and then got dizzy   She was given a pink card-dizziness and numbness in legs after last vaccine.  For the next few days, she had intermittent dizzyness, nausea, extremely tired  _____   Patient alerted observer who took the patient to the medical observation area.  I was alerted and responded.  She was sitting on the couch in the observation room.    Initial Assessment @ _1:42om_:  Patient is Patient is AAO.  The employee is sitting up on the sofa.  The employee is pink and does not appear to be in distress.  She is  talking and making conversation.   She was given a Ginger Ale.   We made convsersation for the next ~10 minutes.  She was in no distress at all.    Vitals @: 155pm  HR: 79  BP: --  O2: 98   Employee was discharged without treatment.  The RN was notified for follow up.     Patient wil call us if anything progresses.
Pounding headache - increased in intensity over several hours.  Fever and chills - started about 9 hours post vaccine. It was manageable. Nausea and vomiting - nausea was on and off starting about 10 hours post vaccine. My body attempted to throw up twice but there was nothing in my body to bring up. The nausea and vomiting could have been from the intensity of the headache but I am unsure.  About 10.5 hours post vaccine I took 1000 mg Tylenol and then an hour after taking Tylenol, I tool 220 mg naproxen sodium. I was unable to fall asleep because the headache was so bad.   I woke up about 5 hours later and knew my fever had broken and the headache was mild. The headache continued on and off (most noticeable in the morning and at night) for about a week post vaccine.
Employee reports within 15 minutes of leaving she had to pull over on side of the road with severe nausea, vomiting and dizziness. Symptoms continued for next two days with accompanied headache but is gradually subsiding.