chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccines administered beyound 30-day use by date; Vaccines administered after being in stored in fridge past 30 days; Patient that received first dose of primary series of Moderna Bivalent vaccine; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines administered beyound 30-day use by date), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine) and NO ADVERSE EVENT (no adverse event) in a 71-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)) (batch no. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first 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 EXPIRED PRODUCT ADMINISTERED (Vaccines administered beyound 30-day use by date), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines administered beyound 30-day use by date), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine) 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 (Vaccines administered beyound 30-day use by date), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days) and WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine).    No concomitant medication was reported.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-730541 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730541:Same reporter
Following first dose, patient became hypotensive, pale, and diaphoretic. Denies syncope. Patient went to nearby emergency department at Hospital. Was monitored for several hours and was discharged in stable condition.
PAIN CAN ONLY LEFT ARM HALF WAY, CAN NOT LAY ON MY LEFT SIDE.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021 at 3:41 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Nov-2021 at 3:41 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial moved from freezer to refrigerator, it was the day when the Moderna Covid-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer/refrigerator or maintained at room temperature.  The reporter stated that total 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No Previous temperature excursions was reported. Total 280 patients received Moderna Covid 19 stored at minus 82 degrees Fahrenheit.  No treatment medications were provided.   This case was linked to MOD-2021-402935 (Patient Link).
This spontaneous report was received from a consumer and refers to a "toddler" female patient. The patient's medical history and concurrent conditions were not reported. On an unknown date at the 4th and 6th vaccines, the patient was vaccinated with a dose of hepatitis b vaccine (manufacturer unknown), (dose, route, anatomical location, lot number and expiration date were not reported). Other suspect therapies included HIB (manufacturer unknown) and rotavirus vaccine, (manufacturer unknown) orally, (route, anatomical location, lot number and expiration date were not reported for the other suspect therapies). The patient's concomitant therapies included (unspecified), DTAP. On an unknown date, the patient "became more anxious, nervous and experienced personality changes", also the patient experienced "croup" and developed severe anxiety on an unspecified date which lasted an unspecified period of time. The reporter also stated that her daughter received an unspecified date a dose of DTAP and the patient "freaked out" and developed redness and swelling at the injection site. Her daughter was difficult to console for "3 days after she received the DTAP vaccine". At the time of the report, the outcome of became more anxious, nervous and experienced personality changes, also the patient experienced "croup" and developed severe anxiety was reported as recovery on an unspecified date described as her daughter was healthy. This is one of two reports from the same patient (case # 1511USA002338 and 1511USA004138). The relatedness between the events and therapy with hepatitis b vaccine (manufacturer unknown), HIB (manufacturer unknown) and rotavirus vaccine, oral (manufacturer unknown) was not reported.  Additional information is not expected because no contact details were available.
crying through noc following vax;t103 @ home through noc & am of 23APR97;suspected pertussis rxn, but did CBC, BC, & Rocephin inj;
This case was reported by a pharmacist via call center representative and described the occurrence of rash in a female patient who received Shingrix (batch number KB99G, expiry date 22nd February 2021) for prophylaxis. On 10th October 2018, the patient received the 2nd dose of Shingrix 1 dosage form(s). In October 2018, less than a week after receiving Shingrix, the patient experienced rash and generalized pruritus. On an unknown date, the outcome of the rash was recovered/resolved and the outcome of the generalized pruritus was not recovered/not resolved. It was unknown if the reporter considered the rash and generalized pruritus to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced a rash down her arm and itching all over.
CHEST PAIN, ELEVATED TROPONIN WITH EKG CHANGES, SUSPECTED MYOCARDITIS
the rash and the redness expanded, "like they connected"; rash around injection site; fever; felt sore at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (felt sore at injection site), VACCINATION SITE RASH (rash around injection site), PYREXIA (fever) and VACCINATION SITE ERYTHEMA (the rash and the redness expanded, "like they connected") in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE PAIN (felt sore at injection site). On 16-Mar-2021, the patient experienced VACCINATION SITE RASH (rash around injection site) and PYREXIA (fever). On 17-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (the rash and the redness expanded, "like they connected"). At the time of the report, VACCINATION SITE PAIN (felt sore at injection site), VACCINATION SITE RASH (rash around injection site), PYREXIA (fever) and VACCINATION SITE ERYTHEMA (the rash and the redness expanded, "like they connected") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient went to ER and her labs were normal. No concomitant information was reported. No treatment information was reported.    Reporter did not allow further contact
Heat; Redness at injection site; Tenderness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Heat), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Tenderness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L204) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Heat), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Tenderness). At the time of the report, VACCINATION SITE WARMTH (Heat), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Tenderness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant Medications were reported. No Treatment Information Provided.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-052035 (Patient Link).
I thought I had a sinus infection that is why I went to the doctor. My fever was 103.0 I was throwing up my muscles was hurting. I lost my taste and smell.
On 9/23 I was given the Flu Mist.  So much was squirted in my right nostril that it went down my throat into my stomach.  On 9/24 I had pain in my left chest.  I had the pain again on 9/25 but it was more severe.  Around 2 AM on 9/26 I was awoken by severe pain in my left chest and could not go back to sleep.  Around 1 AM on 9/27 I was again awoken by severe pain in my left chest.  I went to the emergency room.  After echocardiogram and having heart monitored for 12 hours they concluded it was not a heart issue.  Assumed it was Acid Reflux.  Up until then I had never had any odd stomach pains, but since then I have been dealing with stomach issues, including potentially becoming Lactose intolerant and having Acid Reflux.  I have an upper GI test this Friday and will continue to get tested until they identify the source of my stomach and chest pain.
Pt reports nausea, dizziness, decreased appetite, fatigue, HA, subjective fevers since 8-6-08 vaccination following laceration of hand.  She was treated with COMPAZINE for nausea.
Chills, aches and pains at site and hips. Took ibuprofen multiple times and slept.
poss sz; heart rate dropped to below 60's, lethargic, pale & hypotonic; hospitalized overnoc, 02 therapy or observation released in AM;
Pain at injection site, muscle tightening, increased muscle spasms, hard to move left arm and left leg, burning, tingling, and numbness in left extremities and neck and face and back. Onset progressive peaking five days after vaccine and waxing and waning since.
About a week after the vaccine my arm begin to itch super bad.  Which presisted to getting hot, red, hard and swollen which made my arm super sore and very painful.  Over the next few days it grew to about 6" in in length and a raised bump of about 1cm appeared.  I took benedryl and used hydrocortisone cream  and ice packs to help and after about 5 days it finally dimished.
Narrative:  74 year old male patient died due to cardiac arrest on 05/08/2021. He has his first dose COVID-19 Pfizer vaccine on 04/24/2021. Of note, there are no reasons for us to believe that patient passed away because of the vaccine based on hospital records. However, this event is being reported since patient died within 45 days of Pfizer vaccine administration per FDA requirement.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 26-JUN-2018 and 29-AUG-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength were unknown) (lot# N028258 and expiration date 30-MAY-2019; lot# N030175 and expiration date 16-JUN-2019) orally for prophylaxis, respectively. The MERCK STERILE DILUENT (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
After a week past the booster my left elbow joint started aching. Then my right pinky joint. A week later my right thumb joint aches.
This spontaneous report as received from a nurse prescriber and refers to a unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # M042599 with expiration date on 17-JUN-2018 for prophylaxis (dose, route and site of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 23 hours. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA006386: US-009507513-1707USA006387: US-009507513-1707USA006173.
Pain 8.5/10. c/o muscle aches, numbness to fingers and swelling to arm. Went to MD on 9-19-14; Dr. noted visual swelling from deltoid to elbow.
Increased pain in the same arm; Increased tightness in the same arm; Limited Range of Motion; Soreness in the arm of administration; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness in the arm of administration), PAIN (Increased pain in the same arm), VACCINATION SITE INDURATION (Increased tightness in the same arm) and HYPOKINESIA (Limited Range of Motion) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L2OA) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness in the arm of administration). On 04-Feb-2021, the patient experienced PAIN (Increased pain in the same arm), VACCINATION SITE INDURATION (Increased tightness in the same arm) and HYPOKINESIA (Limited Range of Motion). At the time of the report, VACCINATION SITE PAIN (Soreness in the arm of administration), PAIN (Increased pain in the same arm), VACCINATION SITE INDURATION (Increased tightness in the same arm) and HYPOKINESIA (Limited Range of Motion) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Initial and follow up information has been received from a physician and a registered nurse (RN), concerning a 77 year old (previously reported as "over age 65") male patient with no pertinent medical history and no known allergies, who on an 20-NOV-2007, at 12:45 pm, was vaccinated in the right deltoid with the first dose of Pneumovax 23 (lot # 657145/1226U). Concomitant vaccine therapy included a dose in the left deltoid of DTaP (manufacturer not specified; lot # C2826AA). There was no illness at the time of vaccination. The RN indicated at 2:45 pm, "patient returned to our office after receiving the [Pneumovax 23 vaccine) 2 hours prior." The patient was "in excruciating pain/screaming in pain." Treatment included 2 injections of DEMEROL. The patient continued to have pain and weakness at the injection site for 1 month. The event "cleared on its own" (date not specified) and the patient recovered. The nurse considered the events to be serious due to persistent disability/incapacity. Additional information is not expected.
Overwhelming fatigue, to the point of not being able to carry out daily activities other than eating and showering.  Disrupted sleep pattern. Recovered from the fatigue about 7 days later.
knot-like structure on her right hip/bump; rash on her buttocks/spread to groin area, les, and between her legs/the rash is only on the lower part of the body; Shingles; Rash is red; Rash is blistery; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles), RASH ERYTHEMATOUS (Rash is red), RASH VESICULAR (Rash is blistery), INDURATION (knot-like structure on her right hip/bump) and RASH (rash on her buttocks/spread to groin area, les, and between her legs/the rash is only on the lower part of the body) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011LZ0A and 01OMZOA) for COVID-19 vaccination.     The patient's past medical history included Kidney stone and Incontinence. Concurrent medical conditions included Thyroid disorder, Anxiety, Alzheimer's disease and Blood pressure management. Concomitant products included DONEPEZIL for Alzheimer's disease, HYDROXYZINE for Anxiety, LISINOPRIL for Blood pressure management, MIRABEGRON (MYRBETRIC) for Incontinence, LEVOTHYROXINE for Thyroid disorder, VITAMIN D3 for an unknown indication.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jan-2021, the patient experienced HERPES ZOSTER (Shingles), RASH ERYTHEMATOUS (Rash is red), RASH VESICULAR (Rash is blistery) and RASH (rash on her buttocks/spread to groin area, les, and between her legs/the rash is only on the lower part of the body). On 08-Jan-2021, the patient experienced INDURATION (knot-like structure on her right hip/bump). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) for Allergy, at an unspecified dose and frequency; LATANOPROST at a dose of .005 percent twice a day and TIMOLOL at a dose of .5 percent once a day. At the time of the report, HERPES ZOSTER (Shingles), RASH ERYTHEMATOUS (Rash is red), RASH VESICULAR (Rash is blistery), INDURATION (knot-like structure on her right hip/bump) and RASH (rash on her buttocks/spread to groin area, les, and between her legs/the rash is only on the lower part of the body) had not resolved.            Patient had a stroke on 01 Mar 2021   This case was linked to MOD-2021-255918.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow-up information received on 13 Jul 2021 contains medical history.
At 1539 pt stated, " I just walked to the office and felt like fainting." Patient Care Technician led her to a chair and sat the patient down. Pt was seated and given water for approx. 10 minutes. Pt's vitals at 1539 T: 97.5, BP: 153/83, P: 100. Pt's vitals at 1545 BP: 146/93 P:94. ATt 1545 pt stated, "I feel better." Pt denied c/o dizziness. Patient walked to her office and monitored for additional 15 minutes before leaving the building.
The case was considered as serious due to important medical event. Initial unsolicited report received from literature on 17-Sep-2015. Abstract: On February 4, 2010 the CDC's Advisory Committee on Immunization Practices voted for universal flu vaccination to expand protection against the flu. In addition to this administration expansion, six new influenza vaccines have been introduced into the market possibly introducing new allergenic potentials. We report two cases of delayed anaphylaxis to the flu vaccine. Drug Terms Acetylsalicylic acid, diphenhydramine, influenza vaccine, methylprednisolone, raloxifene. Disease Terms: anaphylaxis, angioneurotic edema, coughing, dyspnea, heart palpitation, influenza, thorax pain. Other terms: adult, aged, article, case report, drug marketing, drug megadose, female, flushing, human, influenza vaccination, skin test. This case involves 2 patients who had received a doses of Flu Vaccine (Manufacturer: unknown, batch number, route and site of administration were not reported) on unspecified dates. Medical history and concomitant medications were not reported. On unspecified dates, patients had experienced delayed anaphylaxis, angioneurotic edema, coughing, dyspnea, heart palpitation, influenza, thorax pain. Lab tests and corrective treatments were not  reported. Outcome of the events were not reported. Upon medical review, the case was considered as serious due to important medical event: anaphylaxis, angioneurotic edema, coughing, dyspnea, heart palpitation and flushing. Documents held by sender: none.
Information has been received from a registered nurse concerning 2 unspecified patients were administered improperly stored ZOSTAVAX (lot# L037790, expired date 30-DEC-2016, dose and route not reported) on multiple unspecified dates. These vaccines were stored under temperature -12 centigrade degree for 24 to 48 hours. The patients' concurrent condition, medical history and concomitant therapy was not reported. There was no previous temperature excursion. No adverse effects were reported. At the time of report, the patient's status was unknown. Additional information has been requested.
Janssen COVID-19 Vaccine EUA 2 1/2 days of severe flu symptoms. Nausea, Fever, Chills, weakness,no sleep.  The next days nausea and light headedness Day 7 (today 3/20/2021) nausea, weakness, and fainting spells. Fainting spells include vision impairment (everything looks fuzzy like a bad tv reception).
pt recv vax 10JUN96 & inc fever, t104 ax, irritable 17JUN96;saw MD 18JUN96 felt viral-put on Motrin, Augmentin, Amoxicillin