chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vial was initially stored in the refrigerator on 06-Mar-2023 and was administered on 14-Apr-2023; No adverse event; Patient received vaccine that was stored in the refrigerator 7 days past 30-day storage mark; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that was stored in the refrigerator 7 days past 30-day storage mark), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-Mar-2023 and was administered on 14-Apr-2023) and NO ADVERSE EVENT (No adverse event) in an adult 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. AS7173B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Apr-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that was stored in the refrigerator 7 days past 30-day storage mark). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-Mar-2023 and was administered on 14-Apr-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that was stored in the refrigerator 7 days past 30-day storage mark), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-Mar-2023 and was administered on 14-Apr-2023) 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 (Patient received vaccine that was stored in the refrigerator 7 days past 30-day storage mark) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-Mar-2023 and was administered on 14-Apr-2023).    No concomitant medications were provided. Dosage text reported as unknown. The vial was initially stored in the refrigerator on 06-Mar-2023. The vial did not undergo any temperature excursions. No treatment medication was provided. This case contains information for the 10th of 10 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-728204 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728204:Master case Patient no-1
After administration of Hep B vaccination, patient was talking to mother and nurse. Then patient suddenly passed out, aroused with sternal rub and ammonia inhalant. Skin pale, diaphoretic. Cool cloth applied. Patient alert and oriented x 3 Patient slow to respond and to answering questions. Patient complains of nausea with dry heaves. Refused to lay back in chair or have legs elevated due to nausea and wanting to sit up. Patient states vision is blurry. Appears to stare off into ?space.? Pupils equal and reactive. Patient drank a few sips of juice without difficulty.  Patient complains of being tired. Stuttering words, which mother states is not normal.Mother states that patient has not had any reaction to vaccines in the past. 82/52-67-14. Spo2 96% room air. Emergency services called and arrived. Report given. No change in condition. Left via stretcher, alert, pale with mother following. Transferred to ER via squad.
Constipation following vaccine and up to date. Have been giving her fiber rich foods, prune juice, prune puree, unfiltered apple juice but no change. Will add probiotics. Swollen at injection site same day, bump still lightly raised on thigh to this date. Canker sore developed in mouth and noticed on December 5th.
Urinary tract infection, Pyrexia, Myalgia. This report describes the occurrence of a urinary tract infection in a 40-year-old female patient who received hepatitis A vaccine inactivated (Havrix) for prophylaxis. This report was received from the patient and has not been verified by a physician or other healthcare professional. On 27 July 2000 the patient received the 1st dose of Havrix, prior to traveling to Egypt. Approximately two weeks post-immunization, while in Egypt, she experienced "high" fever and muscle aches. She stated tat she was seen by a physician, who performed an ultrasound examination and unspecified laboratory tests. Based on the results, the physician made a diagnosis of urinary tract infection and prescribed trimethoprim/ sulfamethoxazole. The patient reported that the urinary tract infection, fever and muscle aches resolved after an unspecified period  of time. However, she reported that she has "had many other symptoms" that she attributes to Havrix; she would not state what the symptoms were. She stated that she did not believe that she had a urinary tract infection in August 2000, but rather "a severe adverse event due to the vaccine."
pt recv vax 7MAY96 & started getting dizzy, h/a, 8MAY96 h/a, fever recv advil;10MAY96 started having stomach pains, pt taken to ER, took blood, ua, states poss virus, red patches on both legs w/whelps;t105
I got my Moderna booster on Monday December 13th and now I broke out in hives and my hands hurt to the point where it hurts when trying to make a fist. I also get chills at night, and have a sore throat. I took two covid tests at home, one on Monday the 20th and one this morning. Both came back negative. Is this a typical reaction, a week after the vaccine?
can't even take a shower and put her arm behind her back; when she sleeps her arm is numb; She is still hurting/if she carries something heavy it hurts; her armpit hurts right now/she can't wear a bra.; This spontaneous case was reported by a patient and describes the occurrence of MOBILITY DECREASED (can't even take a shower and put her arm behind her back), HYPOAESTHESIA (when she sleeps her arm is numb), PAIN IN EXTREMITY (She is still hurting/if she carries something heavy it hurts) and AXILLARY PAIN (her armpit hurts right now/she can't wear a bra.) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A22B, 054B21A and 011B21A) for COVID-19 vaccination.     Patient had no allergies. Patient had no history related to mentioned adverse event. Patient had no acute or chronic illnesses at the time of vaccination. Patient never has had COVID 19 positive test or diagnosis. Patient did not receive other manufacturer vaccines one month prior to Moderna COVID 19 vaccine.    On 06-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-May-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MOBILITY DECREASED (can't even take a shower and put her arm behind her back), HYPOAESTHESIA (when she sleeps her arm is numb), PAIN IN EXTREMITY (She is still hurting/if she carries something heavy it hurts) and AXILLARY PAIN (her armpit hurts right now/she can't wear a bra.). At the time of the report, MOBILITY DECREASED (can't even take a shower and put her arm behind her back), HYPOAESTHESIA (when she sleeps her arm is numb), PAIN IN EXTREMITY (She is still hurting/if she carries something heavy it hurts) and AXILLARY PAIN (her armpit hurts right now/she can't wear a bra.) had not resolved.            No concomitant medications were reported. Patient received first booster dose. Patient did not seek medical care due to adverse event (urgent care, office visit, ER or hospitalization). No treatment medications were reported.   This case was linked to MOD-2022-601045 (Patient Link).
Itching, rashes, hives everywhere on my body except face & calves.  Comes and goes every few days since a week and a half after 1st shot.  Have been put on prednisone twice and it stopped for a while but eventually started in again and continues through today.
Per pt's report, she has exacerbation of Lupus which was confirmed by doctor that was result from flu shot.
1st dose of Shingrix on 23Ju2019 and is late for the 2nd dose; This case was reported by a pharmacist and described the occurrence of incomplete course of vaccination in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 23rd July 2019).   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 received 2nd dose of Shingrix, which led to incomplete course of vaccination. The HCP stated that, the patient received the 1st dose somewhere else, lot and expiration date was unknown. No symptoms were reported. The reporter consented to follow up.
Pt recvd vax 10APR92 @ approx 330PM & mom gave APAP q 4 hrs for next 2 days; On 12APR92 on awakening pt was trembling all over for approx 1 hr per mom report; no further problems; no MD eval referred to MD;
Suspected vaccination failure; Shingles; This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient developed shingles after having gotten vaccinated with Shingrix. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.    The reporter did not agree to follow up with GlaxoSmithKline. This case is one of 3 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR233841:Same reporter US-GLAXOSMITHKLINE-US2021AMR233832:Same reporter
Patient presented to the vaccine clinic to receive her first dose of COVID vaccine. Administration and post vital signs went smoothly and vitals were stable. After patient left the facility it was discovered that the patient was given an undiluted dose of COVID vaccine.
Fever for 1 day, swelling for 2-3 days, scar-like lesion remains 1/2/19.
On 1-23-21, left arm became sore area of injection site; hurt to lie on left side to sleep.  On 1-24-21, in am, upper arm very sore and red area, 3? X 1 1/2? at site. By evening it was more red and sore.  Morning of 1-25-21, red area was more diffuse. Same evening, redness started to fade in center, creating a ?figure 8? appearance, with faded area in centers of figure 8 circles. Morning of 1-26-21, redness nearly gone, much less soreness. Today, 1-27-21, no redness but arm slightly sore to touch. Note, arm was sore for only three days after vaccination given.
INJECTION SITE PAIN; SUSPECTED COVD-19 INFECTION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the subject experienced suspected covd-19 infection. On 08-APR-2021, the subject experienced injection site pain. On 11-APR-2021, Laboratory data included: COVID-19 rapid POC test (NR: not provided) Positive (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on 11-APR-2021, and the outcome of suspected covd-19 infection was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Vaccination site rash; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Vaccination site rash) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Vaccination site rash). At the time of the report, VACCINATION SITE RASH (Vaccination site rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient asked if it is normal to have rash at site of the shot. No concomitant medications were reported. No information regarding corrective treatment was reported by the patient.   Reporter did not allow further contact
Arm swelling, pain, and redness began shortly after injection. Does not appear to be infected as the entire arm is rapidly swollen to elbow
No additional AE details were provided and no additional AE's were reported; administered PROQUAD and VARIVAX on the same day; This spontaneous report has been received from a medical assistant referring to a 12-month-old patient of unknown gender. Information about the patient's current condition, historical condition and concomitant medication was unknown.      On 10-OCT-2022, the patient was vaccinated with dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, dose number, strength, lot/batch #, expiration date and route were unknown) and dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose, dose number, strength, lot/batch #, expiration date and route were unknown) for prophylaxis on the same day (overdose). No additional adverse events were reported. The outcome of the event was unknown.
Chills, weakness of the body, severe nausea and vomiting, headache, diarrhea , stomach & belly pain. Chills lasted just a few hours, all other symptoms lasted almost 5 days , i felt very weak & very sick . Had to stay in bed , took some Advil& Nausea medicine , but it didn?t help much. I could hardly eat anything.
Chills - nauseous - very dizzy - vomiting - light sensitive - ears ringing. Started 2-6-14 and worsened by 2-7-14. Was advised by Urgent Care to go to emergency at hospital.
Some kind of sinus pressure in my head; Tip of my nipples are kind of injured or kind of unwell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old patient received bnt162b2 (BNT162B2), administration date 06Apr2021 (Lot number: EW0150) 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: PARANASAL SINUS DISCOMFORT (non-serious), outcome "unknown", described as "Some kind of sinus pressure in my head"; NIPPLE DISORDER (non-serious), outcome "unknown", described as "Tip of my nipples are kind of injured or kind of unwell".  Additional Information: Consumer stated, I got the vaccine on Tuesday 06Apr2021, the first one since then I was having some kind of sinus pressure in my head. And my nipples, tip of my nipples are kind of injured or kind of unwell I am saying. I donot know if this something serious that I should stop getting the second one or I donot know. When probed for date of birth and age, consumer stated, Oh God all the information, yes, its 40 I was 40. Consumer stated, Yeah with the symptoms do I, my second dose was scheduled for 27, 27Apr2021.  No follow-up attempts are possible. No further information is expected.
COVID-19 after Moderna Dose 4; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 after Moderna Dose 4) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy.    On 02-Apr-2022 at 10:00 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19 after Moderna Dose 4). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 07-May-2022 to 11-May-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19 after Moderna Dose 4) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         No concomitant medication was provided by the reporter.  The patient did not took any other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received a COVID-19 Vaccine.  Device Date was reported as 29May2022.  Company Comment: This spontaneous case concerns a patient, of unknown age and unknown gender, with no relevant medical history reported, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred approximately 1 month after receiving the fourth dose of the mRNA-1273 vaccine. The patient took and completed a 5-day course of Paxlovid (nirmatrelvir, ritonavir) from 07May2022 to 11May2022. It was reported that the patient developed COVID-19 rebound 2 weeks after treatment with Paxlovid. The patient tested positive for SARS-CoV-2 unknown number of days after testing negative for SARS-CoV-2. The patient experienced bad cold symptoms and fever, and was still experiencing the symptoms at the time of the report. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient, of unknown age and unknown gender, with no relevant medical history reported, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred approximately 1 month after receiving the fourth dose of the mRNA-1273 vaccine. The patient took and completed a 5-day course of Paxlovid (nirmatrelvir, ritonavir) from 07May2022 to 11May2022. It was reported that the patient developed COVID-19 rebound 2 weeks after treatment with Paxlovid. The patient tested positive for SARS-CoV-2 unknown number of days after testing negative for SARS-CoV-2. The patient experienced bad cold symptoms and fever, and was still experiencing the symptoms at the time of the report. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
6 month diabetic follow up routine vaccination protocol. Severe local reaction, painful with exertion, aching at rest L arm. redness and swelling, initially at injection site, by 12 noon from L shoulder to mid forearm. Full circumference of upper arm to elbow. Anti-cubital area to mid forearm. Hot to touch continues x 30 hrs. Tx w/ antihistamines, anti-inflammatory, ice.
I woke up Saturday morning with pain on my arm where I had gotten my vaccine. There was a big red circle, the size of a baseball around my arm. It was firm, hot, and itchy. I was also feeling feverish and weak. Sunday and Monday, I was feeling better. The red circle on my arm was still hot and itchy but it was not that firm anymore. Today is Thursday and the red circle is going down.
On 05/01/2004, Dr. reported: some erythema, swelling, mild tenderness. Could be localizing infection from the immunization, though a high probability of simple immunization reaction to the immunization. Augmentin and Clarinex prescribed 5/6/04. Left deltoid slightly swollen. ? Lymph node left side. 5/14/04 spoke with dad-completely resolved.
Patient was found "acting abnormal" on 1/9/2021 at 1215. VS HR 20-30's. EMS activated. EMS arrived and patient was found pulseless in PEA/ asystole,  CPR and ACLS initiated and then transported to the MC. Unsuccessful resuscitation  and expired on 1/09/2021 at 1348. Clinical impression Cardiopulmonary arrest.
Ten minutes after vaccine administration in arms (MMR, Varicella, Dtap-IPV), child complained of (L) lateral muscle neck pain, torticollis. No midline cervical pain, normal neurological exam. Child given oral MOTRIN, BENADRYL, & warm pack. Observed and improved. The neck pain was muscular, suspected from moving abruptly when being given immunizations.
Arm it was administered on:  Feels sleepy Hurts to move Has itchy hives Feels weird On my other hand/left I have small hives.
A report has been received from a Pharmacist concerning a 17 year old, female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. Pharmacist inadvertently sprayed FLUMIST into the eye which started on 13-Oct-2014. The outcome of the event of inadvertent administration into eye is unknown. The report was considered to be non-serious.
Red + Rash at injection site,  patient describes warm to the  touch. Black + blue at injection site
improperly stored; no additioanl AE; This spontaneous report was received from a healthcare business professional referring to a 4 year old female patient.  The patient's pertinent medical history and drug reactions/ allergies were unknown. Patient was not being administered any concomitant medications at event time.  On 08-OCT-2021, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status of rHA (recombinant human albumin)) (PROQUAD) (lot # U010745, expiration date 03-OCT-2022; strength, dose and route were unknown) for prophylaxis (product storage error).         Previous temperature excursion was minus 10 degree Celsius to 8 degree Celsius (0.91 degree Celsius) for 6 hours on 04-OCT-2021 and minus 10 degree Celsius to 8 degree Celsius (1.45 degree Celsius) for 6 hours. Temperature excursion of this vaccine on 08-OCT-2021 was minus 14.6 degree Celsius for 6 hours. No additional adverse event was reported.  Additional Excursions had occurred after patient was administered the improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD): 13-OCT-2021 from minus 10 degrees Celsius to 8 degree Celsius (0.54 degree Celsius) for 13 hours.   This is one of several reports received from same reporter. ; Sender's Comments:  US-009507513-2111USA004036: US-009507513-2111USA003910: US-009507513-2111USA003731: US-009507513-2111USA004109: