chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vial was initially stored in the refrigerator on 31-May-2023 and administered to patient on 17-JUL-2023; No Adverse event; Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-May-2023 and administered to patient on 17-JUL-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. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jul-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 17-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-May-2023 and administered to patient on 17-JUL-2023) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-May-2023 and administered to patient on 17-JUL-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 (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-May-2023 and administered to patient on 17-JUL-2023).    It was unknown patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine No concomitant medication was reported.  Date the vial was initially stored in the refrigerator on 31-May-2023. The vial did not undergo any temperature excursions. No treatment information was reported.  This case contains information for patient 2 out of 19.   This case was linked to US-MODERNATX, INC.-MOD-2023-733761 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733761:Master case
Fever, vomiting, diarrhea, chronic migraine, body aches, and extreme back and leg pain that impaired the ability to walk.
This spontaneous report as received from a certified medical assistant refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX lot# L039092, expiry date 06-OCT-2017, lot # L043622, expiry date 03-NOV-2017, lot # M004326, expiry date 25-JAN-2018 (dose, route and site of administration were not reported). There were no known adverse effects. The vaccines experienced temperature excursion of -5.2 degrees Celsius for 50 hours 17 minutes. This is one of several reports received from the same source. Follow up information has been received from a certified medical assistant on 30-AUG-2016. The nurse reported that the specified lot numbers of improperly stored vaccines administered between 19-MAY-2016 to 01-JUL-2016 were not available. This report refers to a patient of unknown age and gender. On 13-JUN-2016, the patient was vaccinated with improperly stored doses of (Oka/Merck) VARIVAX lot # L039092, expiry date 06-OCT-2017 or lot # L043622, expiry date 03-NOV-2017 or lot # M004326, expiry date 25-JAN-2018, VAQTA (lot#M011116 or K008333) and (Wistar RA 27-3) M-M-R II (lot#L003855 or L026553) (doses, routes and sites of administration were not reported). Additional information has been requested.
This spontaneous report as received from a licensed practical nurse (L.P.N.) refers to an unspecified number of patients of unknown age and gender. Medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ vial (route of administration default to oral, lot# L000571, expiration date 26-JUL-2016, dose was not provided). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
16 week and 6 days pregnant. Due date is 8/8/2021.  I received my 1st dose of Moderna COVID vaccine around 5/45pm on Thursday 2/25 by a woman at the High School.  The shot felt fine at the time but I did notice she went a bit higher up on my shoulder.  However, the morning after, I was experiencing extreme shoulder pain with limited range of motion as the day progressed on 2/26. By night time of 2/26, I couldn?t remove my bra and had to ask my husband for assistance. I?m scared and terrified that I won?t be able to hold my newborn baby when he?s born. This is all I can think about. I don?t even care that I?m in severe pain. All I can think about is how this is going to ruin my experience caring for my child without full range in one of my arms. It?s 2:37am where I am and I can?t sleep because of the shoulder pain.
First shot i had severe flu like symptoms and extreme structural pain for 4 days.; First shot i had severe flu like symptoms and extreme structural pain for 4 days.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Mar2021 17:30 (Lot number: ER8127) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "All mammal meat (and products derived) including chicken, pork, turkey, beef and all land animals." (unspecified if ongoing), notes: All mammal meat (and products derived) including chicken, pork, turkey, beef and all land animals. There were no concomitant medications. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), PAIN (non-serious), outcome "recovered" (2021) and all described as "First shot i had severe flu like symptoms and extreme structural pain for 4 days.". Therapeutic measures were not taken as a result of influenza like illness, pain.  Additional information: Facility type vaccine was doctors office/urgent care. Patient not received other vaccine in four weeks. No other medications in two weeks. No treatment for ae. No covid prior vaccination. Covid was not tested post vaccination.   No follow-up attempts are possible. No further information is expected.
Patient was 17 at time of both first dose on 2/17/2021 and 2nd dose on 3/17/2021.
11/29 received booster with Moderna. 12/3 shot hives on neck, ears, elbows, knees. Treated with Benadryl. Then began getting hives intermittently sometimes a couple times a week and other times going 1-2 weeks between events. Always in the morning. Resolves with Allegra, Zyrtec, or Benadryl.
1 day after receiving flu vaccine, developed R - sided neck tenderness & swelling. Feeling fatigued, muscle aches
Headache two days after the second injection followed by a nosebleed on the fifth day.
Developed a red area around injection vaccine site 2 cm x 2 cm on (R) thigh after varicella.
Only got 1st vaccination / yet have shingles now; Only got 1st vaccination didn't get 2nd one; This case was reported by a consumer via  interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported for the 1st dose of Shingles vaccine. The age at vaccination was not applicable for the 2nd dose of Shingles vaccine. The age group was selected an an adult as per vaccine indication. The patient received the 1st dose of Shingles vaccine and experienced shingles now that was not good. Till the time of reporting patient had not receive the 2nd dose of Shingles vaccine, which led to incomplete course of vaccination. No further information reported.
Lower extremity swelling and purple discoloration with warmth (per mom). Happened about 24 hrs after injections. Legs seemed painful and patient was very fussy. Symptoms started at 6am and I saw baby at 10:30am. Legs were only very mildly swollen with no real erythema or discoloration.
DEATH; SUDDENLY STOPPED BREATHING; This spontaneous report received from a consumer concerned a 34 year old female of unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: Unknown) dose was not reported, 1 total, administered on unspecified date in AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified in AUG-2021, after one week of vaccination, the patient suddenly stopped breathing at home. The patient was trying to be brave and tough it out and she decided not to go to the emergency room (ER). On an unspecified date in 2021, the patient died from unknown cause of death at home. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on 2021, and the outcome of suddenly stopped breathing was not reported. This report was serious (Death, and Other Medically Important Condition). This case, from the same reporter is linked to 20210921562.; Sender's Comments: V0: 20210923692-covid-19 vaccine ad26.cov2.s -Death, Suddenly stopped breathing . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Received vaccine on Thursday and by evening, fatigue, achy, headaches and fever. Friday was worsening of those symptoms. Continued through Monday when I went to Emergency room with temp 103.9 and headaches.
Sudden onset of neck and back pain. Seen in ER- was hypertensive. Pain in neck seemed to be muscular (neck still a little sore one week later). Admitted for overnight observation w/suspected heart attack. all test negative. No local reaction in arms. No definitive dx at discharge from hospital.
received Pfizer vaccine on 07Jan2021 tested positive on 26Jan2021 for covid; received Pfizer vaccine on 07Jan2021 tested positive on 26Jan2021 for covid; This is a spontaneous report from a contactable other health care professional (reported as nurse and NP).  A female patient of an unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on 07Jan2021 for Covid-19 immunization. Medical history and concomitant drug were not provided. The reporter reported that patient received Pfizer vaccine on 07Jan2021 tested positive on 26Jan2021 for COVID.  The reporter inquired the recommendations to get their second shot. Outcome of the event was unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in this patient cannot be completely excluded.  However, no complete effect of the suspect vaccine could be reasonably achieved from the first dose to protect from the targeted infection.
Fever, headache, site of injection in deltoid sore, nausea, loss of appetite, weakness, lack of sleep, all within 24 hrs
03/14/2002 Vaccines given 03/15/2003 Child fussy, crying a lot 03/16/2003. Child OK 03/23/2003. Fever 4pm. 102.5 used Tylenol every 4-6 hours. Fever max was 104 degrees. 03/25/2003 at 6pm- Macules/papules/vesicles-head to toe. Saw MD at 10pm. No fever after 10am. Child eating at 03:30pm and appears to be recovering
Approximately five minutes after receiving the vaccine, pt's husband called out for assistance as the pt had complained of dizziness and then appeared to have a near-syncope as she leaned onto her husband while sitting in her chair. Montoring MD and RN support team responded and lowered pt to the floor, checking vitals and LOC. Pt remained conscious but drowsy, pallor and weak pulse at first check with pulse normalizing once supine. Pt denied trouble breathing or chest pressure. Pt and spouse endorsed pt has history of panic attacks as well as syncopal episodes. Pt admitted she had not eaten since the night before. Pt was given time to rest followed by water and juice, and ongoing assessments. Pallor resolved and pt stated she felt much better.
This is a spontaneous report from a Pfizer sponsored program, from a contactable pharmacist. A 65 year-old female patient of an unspecified race and ethnicity received a single dose of PREVNAR 13 via an unspecified route of administration on 24Oct2016 for immunization.  The patient medical history and concomitant medications were not reported.  After a couple of days, on 26Oct2016, not at the injection site but a couple of inches below the injection site, the patient got a big rash of about a 6 inches bigger. Outcome was unknown. The reporting pharmacist wanted to know if that was normal and if it was something related to the vaccine. She further added that she knew that there could be a skin reaction but that she thought that it would be at the same region (injection site) where the injection was given however this (big rash) was off the injection site a couple of inches.
itching; sore arm; bump at injection site; swelling and redness at injection site; swelling and redness at injection site; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (itching), VACCINATION SITE PAIN (sore arm), VACCINATION SITE MASS (bump at injection site), VACCINATION SITE SWELLING (swelling and redness at injection site) and VACCINATION SITE ERYTHEMA (swelling and redness at injection site) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20-A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 24-Dec-2020 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itching), VACCINATION SITE PAIN (sore arm), VACCINATION SITE MASS (bump at injection site), VACCINATION SITE SWELLING (swelling and redness at injection site) and VACCINATION SITE ERYTHEMA (swelling and redness at injection site). At the time of the report, VACCINATION SITE PRURITUS (itching), VACCINATION SITE PAIN (sore arm), VACCINATION SITE MASS (bump at injection site), VACCINATION SITE SWELLING (swelling and redness at injection site) and VACCINATION SITE ERYTHEMA (swelling and redness at injection site) was resolving.        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.   Company comment: 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.   Reporter did not allow further contact; 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.
after receiving the second dose of Shingrix experienced shingles; experienced Shingles; This case was reported by a physician via call center representative and described the occurrence of vaccination failure in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included psoriasis and immune system disorder. Concomitant products included adalimumab (Humira (Adalimumab)).   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and 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 and Shingrix.  Additional details were provided as follows: The patient was reporter's sister. The patient receiving the 2nd dose of Shingrix experienced shingles. The reporter consented to follow up. This case was considered as suspected vaccination failure as details regarding time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
About 2 days after receiving the vaccine, I started having a headache that comes and go and it is still happening even though it's been almost 2 weeks.
RECEIVED HALF DOSE FOR THEIR  BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 28 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (manufacturer not specified) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on unspecified date for prophylactic vaccination. (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number 211A21A expiry: unknown) dose was not reported, 1 total, administered on 27-NOV-2021 for prophylactic vaccination. (Dose number in series 2). No concomitant medications were reported.  On 27-NOV-2021, the patient experienced received half dose for their booster dose (vaccine underdose) and had off label use (dose series 2). HCP (from public health department) stated that there were 33 patients who received half doses (0.25ml) for their booster or 3rd dose. Most of them were patients from unknown. HCP stated that something was printed and disseminated that said to administer .25ml. HCP was not sure where that information came from. Stated it was over the holidays so people could have thought that info changed and staff was just not made aware. HCP stated that they figured it out after the event because they could not figure out how so many doses were given. They were looking for a discrepancy in the number of vials perhaps, but then realized that half doses were given.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received half dose for their booster dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211202250, 20211201046, 20211202193, 20211201228, 20211201168, 20211200752, 20211201351, 20211200994, 20211201450, 20211202199, 20211202469, 20211201362, 20211204104, 20211202379, 20211201179, 20211202515, 20211200675, 20211201179, 20211201304, 20211201392, 20211201963, 20211202161, 20211200717, 20211200723, 20211200769, 20211202207, 20211202246, 20211202371, 20211220152, 20211220146, 20211220262, 20211220250, 20211220145, 20211219871, 20211219926 and 20211220155.
Puffy arm/puffiness at the injection site; sore arm/pain in her left arm radiating to her neck; sore arm/pain in her left arm radiating to her neck; red arm/redness at the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 79-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 13-OCT-2023, the patient received Arexvy (left deltoid). On 13-OCT-2023, less than a day after receiving Arexvy, the patient experienced injection site erythema (Verbatim: red arm/redness at the injection site), pain in arm (Verbatim: sore arm/pain in her left arm radiating to her neck) and neck pain (Verbatim: sore arm/pain in her left arm radiating to her neck). On 14-OCT-2023, the patient experienced injection site swelling (Verbatim: Puffy arm/puffiness at the injection site). The outcome of the injection site erythema, injection site swelling, pain in arm and neck pain were not resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, pain in arm and neck pain to be related to Arexvy.     It was unknown if the company considered the injection site erythema, injection site swelling, pain in arm and neck pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 18-OCT-2023 The patient reported after receiving the Arexvy injection she was experiencing pain in her left arm radiating to her neck. The pain was still there but was milder. The patient was still experiencing puffiness and redness at the injection site. The contact to pharmacy was ok. The reporter did not consented to follow up with physician.
running eyes & nose, sinuses infect, tightness in chest, wheezing diarrhea, change in voice;
THROMBOCYTOPENIA (LOW BLOOD PLATELETS)-Primary; ECCHYMOSIS; PETECHIAE; treatment: prednisone (ORASONE) 20 mg Oral Tab (Taking) Take 4 tablets by mouth every morning with a meal as directed
suspected COVID-19 with symptoms; suspected COVID-19 with symptoms; This is a spontaneous report from a non contactable consumer (patient).   A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot numbers not reported), dose 1 via an unspecified route of administration on Mar2021 (at the age of 55-year-old) as single dose and dose 2 via an unspecified route of administration on Apr2021 as single dose for covid-19 immunisation.  Medical history included multiple sclerosis. Concomitant medication(s) included ocrelizumab (OCREVUS) taken for an unspecified indication.  The patient reported Covid-19 breakthrough infection in Jul2021 after receiving two doses of Pfizer covid-19 vaccine, one in Mar2021 and one in Apr2021. On 08Sep2021, the patient reported felt like she had COVID again because she had some of the same symptoms as when she had Covid in Jul2021 including weakness, fever, pounding headache, and  coughing.  The outcome was recovering.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Localized erythema, pain and swelling at site of injection without any fever and nausea as well.  Being treated with Benadryl and Tylenol.