chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Wife delayed the second dose because of early pregnancy/decided not to take 2nd covid vaccine after 28days; later she got conceived; This spontaneous pregnancy case was reported by a non-health professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Wife delayed the second dose because of early pregnancy/decided not to take 2nd covid vaccine after 28days) and PREGNANCY (later she got conceived) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 17-Dec-2021. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Wife delayed the second dose because of early pregnancy/decided not to take 2nd covid vaccine after 28days) and PREGNANCY (later she got conceived). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Wife delayed the second dose because of early pregnancy/decided not to take 2nd covid vaccine after 28days) and PREGNANCY (later she got conceived) outcome was unknown.        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.   Patient took her 1st COVID moderna vaccine on may 16th 2021 and later she got conceived and decided not to take 2nd covid vaccine after 28days.. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: significant live follow up on 28-06-2021 was  added.Email added was added.The date of first dose was changed which Is given as 16-05-2021.Events are added.
No additional adverse effect reported; the patient received one improperly stored dose of VARIVAX on 03/18/2020; This spontaneous report as received from a nurse prescriber refers to a patient of unknown age and gender. No information regarding patient's medical history, concomitant medications and concurrent conditions was provided.     On 18-MAR-2020, the patient was vaccinated with one dose of an improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # S028920, expiration date 19-SEP-2021 (route of administration, dose and frequency not reported) for prophylaxis.   The vaccine was reconstituted with a properly stored sterile water diluent. Digital Data logger was involved. The vaccine was stored at the temperature reported as from 6 degrees of F to 14 degrees of F (5.81 degrees of F), the time frame as 28 minutes.  No adverse effect reported.
Pain at injection site was within an hour, seven hours later pain is radiating through out left arm, Left side neck stiffness, into left side upper back & down into hips to calf left side only. Off & on,ringing in left ear off & on, low grade fever through out 1st night. Have been taking Aleve & Tylenol....alternating. Fever under control, aches, pain, dizziness & ear ringing continues after 24 hours.
Sore arm; minor headache; minor fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 05Oct2021 13:30 (Lot number: FF2590) at the age of 59 years as dose 3 booster, single for covid-19 immunization. Relevant medical history included: "Asthma, diverticulitis, hay fever" (unspecified if ongoing); "Asthma, diverticulitis, hay fever" (unspecified if ongoing); "Asthma, diverticulitis, hay fever" (unspecified if ongoing). Concomitant medication(s) included: LORATADINE; IBUPROFEN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Right, Vaccine Administration Time: 10:45 AM, Route of Administration: Intramuscular), administration date: 15Mar2021, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 10:45 AM, Route of Administration: Intramuscular), administration date: 22Feb2021, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 05Oct2021 20:00, outcome "recovering", described as "Sore arm"; HEADACHE (non-serious) with onset 05Oct2021 20:00, outcome "recovering", described as "minor headache"; FATIGUE (non-serious) with onset 05Oct2021 20:00, outcome "recovering", described as "minor fatigue". Therapeutic measures were not taken as a result of pain in extremity, headache, fatigue.  Follow-up (22Oct2021): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
pt recvd vax;rash on neck,chest;n,ha,sore throat dec94;on 6jan95 vax, rash on face,neck,chest & arms;
Night sweats; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night sweats) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced NIGHT SWEATS (Night sweats). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, NIGHT SWEATS (Night sweats) outcome was unknown.            Patient stated that she was on no concomitant medication.   This case was linked to MOD-2021-417519 (Patient Link).
Other pharmacy called our pharmacy to report that the vaccine reporting system showed we had administered a 3rd covid shot to patient.  Per their pharmacy records patient received shots in march and april of 2021.  Patient received a vaccine at our location in may of 2021.  Patient reported it would be dose 2 of series whereas records after the fact show it was a third dose.  No adverse events reported to pharmacy.
Information has been received from a medical assistant concerning a 5 year old male who was inadvertently vaccinated with a dose of ZOSTAVAX (Merck) (SC, lot # 665520/1196Y) instead of PROQUAD (Merck) (human error not PQC). No adverse effects were reported. Follow up information received from a medical assistant concerning a 5 year old male who on 09-MAY-2010 at 1:30 pm was vaccinated with a first dose of ZOSTAVAX (Merck) (SC, lot # 66529Z/1224Y, previously reported as 665520/1196Y) in the right leg. No adverse effects were reported. No further information is available.
This is a spontaneous report from a contactable Health Care Professional. A 19-year-old male patient received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced back pain  (non-serious) and  bump in his forehead (non-serious) on an unspecified date. The outcome of both events was unknown. Customer wanted to know if skin reactions have been reported with TRUMENBA. The information on the batch number has been requested.
received a dose of Twinrix expired on September 22nd 2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 48-year-old female patient who received HAB (Twinrix) (batch number 2KE55, expiry date 22-SEP-2023) for prophylaxis.   On 14-OCT-2023, the patient received Twinrix. On 14-OCT-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: received a dose of Twinrix expired on September 22nd 2023). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-OCT-2023 The pharmacist reported on October 18th 2023 that female patient received a dose of Twinrix expired on September 22nd 2023 which led to expired vaccine used. The did not consent to follow up. The vaccine administration facility is the same as primary reporter.
Pain in injection site, woke up this morning feeling like I have a cold and I have a headache.
Sore arm day of and for another day or two, but then didn't notice again until I had shooting arm pain a few days ago. Yesterday, the soreness started again, and I'm still feeling it. I may also be more fatigued than usual, but I'm not sure.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On 26-NOV-2014 the patient was vaccinated with ZOSTAVAX (lot number and expiration date were not reported) 19400 plaque-forming unit (PFU), in the back of the arm by the triceps muscle. No concomitant medications were reported. The reporter stated that the patient did not receive a full dose of ZOSTAVAX when it was administered (on 26-NOV-2104). The reporter stated also the patient had thicker skin than usual and the needle did not go into the subcutaneous tissue during administration. The vaccine leaked out of the injection site during administration. The ZOSTAVAX was administered subcutaneously in the back of the arm by the triceps muscle and the patient had an area that looked like a mosquito bite at the injection site. The patient sought medical attention. There was no treatment given for adverse event. The outcome of the adverse events was reported as recovering. The relatedness between adverse events and ZOSAVAX was not reported. Additional information has been requested.
Became lethargic, leaning to right side. Confused. Low blood pressure. Slurring words. The thigh area had been reddened and weeping. Discussed with physician. Resident sent to hospital for eval and treat.
Patient received Varicella and TDAP in her left arm on 7/24/2015. Over the next 2-3 days she developed erythema, swelling and a rash. Patient was treated with Prednisone, Zyrtec, and Ibuprofen.
had lung issues and has had many strokes; had lung issues and has had many strokes; Interchange of vaccine products; Revaccination with different COVID-19 vaccine; This spontaneous case was reported by a patient and describes the occurrence of CEREBROVASCULAR ACCIDENT (had lung issues and has had many strokes) in a 70-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)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE JANSSEN (Primary dose) on 21-Mar-2021. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE JANSSEN.    On 08-Sep-2022, the patient received fourth 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 CEREBROVASCULAR ACCIDENT (had lung issues and has had many strokes) (seriousness criterion medically significant), LUNG DISORDER (had lung issues and has had many strokes), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). At the time of the report, CEREBROVASCULAR ACCIDENT (had lung issues and has had many strokes), LUNG DISORDER (had lung issues and has had many strokes), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that patient moderna booster on 4-Nov-2021 and another booster on 7-Apr-2022. No treatment medications were reported. Company comment-This spontaneous case concerns an elderly patient aged 70 years of unknown gender with no medical history reported, who experienced the unexpected serious (Medically significant) AESI event of Cerebrovascular accident and unexpected non-serious event of Lung disorder that occurred on unknown date in the context of a dose of mRNA-1273.222 bivalent vaccination in covid -19 vaccination series. Latency cannot be assessed since onset date of events was not disclosed. Patient had received primary dose with COVID-19 VACCINE JANSSEN followed by two doses of mRNA-1273 vaccines prior to current vaccination, so Interchange of vaccine products/ Covid-19 immunization was also noted. It was reported that patient had lung issues and has had many strokes. Chest x-ray done showed lung issues. No further information on risk factors, concurrent illness, detailed clinical course, investigations results, treatment and outcome of the events was available in the report. Advancing age of the patient remains a risk factor to the event Cerebrovascular accident. The benefit-risk relationship of mRNA-1273.222 bivalent vaccine is not affected by this report.
The vial was initially stored in the refrigerator was on 15-Jun-2022 and the vaccine was administered on 21-Jul-2022; The patient received COVID-19 vaccine past its Use by date of 16-Jul-2022 in her left arm on 21-Jul-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received COVID-19 vaccine past its Use by date of 16-Jul-2022 in her left arm on 21-Jul-2022) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator was on 15-Jun-2022 and the vaccine was administered on 21-Jul-2022) in a 75-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 014B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 21-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received COVID-19 vaccine past its Use by date of 16-Jul-2022 in her left arm on 21-Jul-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator was on 15-Jun-2022 and the vaccine was administered on 21-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received COVID-19 vaccine past its Use by date of 16-Jul-2022 in her left arm on 21-Jul-2022) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator was on 15-Jun-2022 and the vaccine was administered on 21-Jul-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The vial did not undergo any temperature excursions.  The reporter reported that the patient was administered with Moderna COVID-19 vaccine past the 30 day use by date.  No treatment information was provided by the reporter.
Inbound call from physician calling to report TE for ROTATEQ. Caller reports that vaccine was administered to patient following excursion.  Confirmed no symptoms or other adverse events were reported.  No other information at this time.  Permission t; Inbound call from physician calling to report TE for ROTATEQ. Caller reports that vaccine was administered to patient following excursion.  Confirmed no symptoms or other adverse events were reported.  No other information at this time.  Permission t; This spontaneous report was received from a physician referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug allergies/reactions, or concomitant medications was not provided.  On 04-OCT-2023, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), 2 milliliters (mL), once for prophylaxis (route of administration, and vaccination scheme frequency were not provided; valid lot number 1968393, with an expiration date of 24-MAY-2024). The administered dose of the vaccine experienced a temperature excursion of 0 degrees Celsius for 15 minutes, as recorded by a data logger. There were no previous temperature excursions. There was no adverse effect reported.
This case was reported by a nurse and described the occurrence of limb swelling in a 24 month old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. On 7/14/03, the patient received Infanrix. On 7/16/03, two days post immunization, the patient experienced limb swelling and an injection site reaction characterized by redness and warmth. The outcome of the events is unknown.
Chills for one hour and then severe nausea throughout the day, not able to eat.
Pt developed fever 103-104 the evening after immunization, no response to Tylenol.
This spontaneous report was received from a physician via company representative referring to an unspecified number of patients whom on an unknown dates, were vaccinated with a dose of PNEUMOVAX23 (lot # not reported), intramuscular. The reporter mentioned that a type of red and hot injection site reaction to PNEUMOVAX23 happened all the time to an unspecified number of anonymous patients on unknown dates. This is one of two reports from the same reporter source. Additional information has been requested.
she received vaccine at 8:30 am.  At approximately 11:00 am she developed sudden onset hives, scratchy throat, swelling sensation of the throat, hoarse voice, difficulty breathing.  Presented to the ED. Received IM Epi, IV Benadryl and Solumedrol.
Information has been received from a physician concerning a female patient in her early 60s with unspecified drug allergies and no pertinent medical history who a "couple of months ago" was vaccinated with a dose of ZOSTAVAX (Merck). Subsequently, the patient came down with shingles during the "middle of last week". The patient sought unspecified medical attention. It was unspecified if lab studies were performed. At the time of report, the patient had not recovered. Additional information has been requested.
Patient was administered Hep A vaccine as above and ceftriaxone 500 mg in lidocaine 1% IM. Known to have a documented past non-allergic reaction to penicillin. Both vaccine and antibiotic were administered within 1-2 minutes of each other. Patient sat in clinic lobby to be monitored for 15 minutes after receiving injections. 15 minutes following injection she experienced sense of feeling hot, nauseated, lightheaded, and diaphoretic. Pallor noted by staff. Out of concern for anaphylaxis epi pen was given and she was transferred to hospital for recovery. VS stable throughout incident with normal BP and oxygenation. No abnormal VS except tachycardia (HR 100).
pt recvd vax 23JAN95&15 days later 7FEB95 pt lost sight in both eyes & was hospitalized 11FEB95;tx steroids & discharged w/minimal vision returned to one eye;lost vision again 10MAR95 hospitalized & dx optic neuritis;22MAY95 noc blindness
Client with large localized reaction, upper deltoid area. Left arm edematous, tight, warm to touch, complained of itching, minimal erythema, increased 6"circumscribed area. Advised by Health Department physician to apply ice, cold compress, Benadryl every 4-6 hours when needed for itching. Follow up if worsens.
Fever, body aches, fatigue, large area of cellulitis at injection site, progressing to axillary area. Symptoms started within 24 hours, post vax.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The concurrent condition, medical history and concomitant medication was not reported. On 24-MAY-2016, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (lot # L030587, Expiry: 10-FEB-2017). The vaccine was stored at 42.8 F for 9 hours. There were no previous temperature excursions. There were no adverse effects. This is one of the three reports received from the same reporter. Additional information has been requested.
vial was exposed to room temperature for 24 hours and 10 minutes approximately; Booster dose administered after exposure to room temperature for 24 hours and 10 minutes; This case was received via an unknown source (no reference has been entered for a health authority or partner) on 06-Jul-2022 and was forwarded to Moderna on 06-Jul-2022.    This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster dose administered after exposure to room temperature for 24 hours and 10 minutes) and PRODUCT STORAGE ERROR (vial was exposed to room temperature for 24 hours and 10 minutes approximately) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jul-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster dose administered after exposure to room temperature for 24 hours and 10 minutes). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was exposed to room temperature for 24 hours and 10 minutes approximately). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Booster dose administered after exposure to room temperature for 24 hours and 10 minutes) and PRODUCT STORAGE ERROR (vial was exposed to room temperature for 24 hours and 10 minutes approximately) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. No Treatment medications were reported Date the vial was initially stored in the refrigerator was reported as 27-Jun-2022. Vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8 degree celcius to 25 degree celcius = 46 degree celcius to 77 degree F) was reported as 24 hours and 10 minutes.
Unlike first shot, these are  different: headaches, diarrhea, sore throat, tired and sleepy lethargic, not much energy.