chrisvoncsefalvay/vaers-outcomes huggingface dataset:
12 Adult patients received Expired Monovalent dose of Moderna COVID-19 vaccine 19SEP2022 until 09NOV2022; Vaccine were stored in refrigerator after beyond use date; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (12 Adult patients received Expired Monovalent dose of Moderna COVID-19 vaccine 19SEP2022 until 09NOV2022), PRODUCT STORAGE ERROR (Vaccine were stored in refrigerator after beyond use date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 051B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (12 Adult patients received Expired Monovalent dose of Moderna COVID-19 vaccine 19SEP2022 until 09NOV2022), PRODUCT STORAGE ERROR (Vaccine were stored in refrigerator after beyond use date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (12 Adult patients received Expired Monovalent dose of Moderna COVID-19 vaccine 19SEP2022 until 09NOV2022), PRODUCT STORAGE ERROR (Vaccine were stored in refrigerator after beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (12 Adult patients received Expired Monovalent dose of Moderna COVID-19 vaccine 19SEP2022 until 09NOV2022) and PRODUCT STORAGE ERROR (Vaccine were stored in refrigerator after beyond use date).    Concomitant medication was not provided.   Monovalent vials of Moderna COVID-19 vaccine in the freezer moved to the refrigerator on 06-JUL-2022 and Beyond use date was 05-AUG-2022. 12 Adult patients received Expired Monovalent dose of Moderna COVID-19 vaccine 19-SEP-2022 until 09-NOV-2022. 9 Boosters 3rd dose and 3 second doses. No previous excursion. The vaccine was administered to 6 Patients on 19-SEP-2022, 2 Patients 04-OCT-2022, 1 Patients 06-OCT-2022, 1 Patient on 09-NOV-2022.  Treatment information was not provided.  This case contains information for the 6th patient out of 12 adult patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-720531 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720531:
Mastalgia, as severe/sharp/stabbing pain in the left breast, started ~36 hrs following administration of the 2nd dose of the vaccine, some lymphadenitis noted in the right armpit ~10 hrs following receiving the dose, no adverse reaction noted following the 1st dose (21 days ago).
C/o dizziness and tingling throughout body. Bp 144/88 at 1608. States this is above her normal trend. Then c/o of increased dizziness when turning head. Taken to er for eval at 1612
Approx. 15 min post vaccine, patient c/o rash on forearms, hands, feet, legs. C/O itching with rash. Pt. escorted to ED for eval.
Customer got shingles shot on 12/3/15. The site of injection was swollen and red 2 days after injection and by the 3rd day the swollen went down.
2 weeks after my vaccine I got a swollen lymph node under my left arm it was a little smaller than a ping pong ball. It lasted about 3 days. I had a telehealth appointment and they say just to monitor it.
Breakthrough COVID infection. Symptoms of fever, fatigue, cough. Unsure symptoms onset. Positive test collected 10/15/2022.
10 Days later I devolp  3/4 inch Red Race and itchiness  in the same area where vaccine was given  .
Had a fever all night; Aches all over; Head hurts; 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 PYREXIA (Had a fever all night), MYALGIA (Aches all over) and HEADACHE (Head hurts) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Had a fever all night), MYALGIA (Aches all over) and HEADACHE (Head hurts). At the time of the report, PYREXIA (Had a fever all night), MYALGIA (Aches all over) and HEADACHE (Head hurts) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.
Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN (Pain). At the time of the report, PAIN (Pain) outcome was unknown.            Patient mentioned that the pharmacist suggested not to use any pain relievers for 10-14 days. His concern is that they use over the counter pain medications for other medical conditions.  No concomitant medication information was provided. No treatment medication information was provided. Action taken with mRNA-1273 in response to the drug was not applicable.
she got the Moderna Covid vaccine for her 1st and 2nd dose but her booster was Pfizer Covid vaccine/tested positive for Covid 19 this past Sunday; she got the Moderna Covid vaccine for her 1st and 2nd dose but her booster was Pfizer Covid vaccine/tested positive for Covid 19 this past Sunday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 69-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Primary biliary cirrhosis" (unspecified if ongoing), notes: Primary biliary cirrhosis She takes medication for cirrhosis of the liver; "Emphysema" (unspecified if ongoing), notes: Emphysema diagnosed in the last 3 years and she takes a once a day inhaler. Concomitant medication(s) included: FLU taken for immunisation as dose number unknown, single. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Apr2022, outcome "unknown" and all described as "she got the Moderna Covid vaccine for her 1st and 2nd dose but her booster was Pfizer Covid vaccine/tested positive for Covid 19 this past Sunday". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Apr2022) positive, notes: tested positive for Covid 19 this past Sunday. Therapeutic measures were taken as a result of covid-19.  Clinical course: Additional Vaccines Administered on Same Date of the Pfizer Suspect: she thinks she got her flu shot that same day Adverse Event (AE) Details: Provide the time of onset of AE(s): started around 3 am this morning. Prior Vaccinations (within 4 weeks) was unknown. Caller states her mom has COVID 19 and last night started Paxlovid, the antiviral. Caller states that she was on the website looking and her mom has a massive headache. Caller is asking has that has been reported as a side effect. Caller states the massive headache started earlier this morning around 3 am and is persisting.  Suspect Product: Paxlovid. Caller states she does not have any information to provide as her mom has the medication. Caller does not have dose, NDC, lot or expiry to provide. Indication: States she got COVID 19 and is at high risk, she has emphysema and her age. Caller states she was boostered and everything and she got it. Caller states she got the Moderna COVID vaccine for her 1st and 2nd dose but her booster was Pfizer COVID vaccine. Caller does not have dates, NDC, lot or expiry to provide for any doses. States that her last dose was over 6 months ago, she has not gotten the most recent booster.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received flu immunization from pharmacy on October 4th, 2019. Patient was seen by outpatient clinic for warfarin management on 10/18/19 during which she complained of some blood in tissue after blowing nose and blood in sputum and some bruising. These symptoms continued through 10/26/2019 on which day patient was admitted to hospital for thrombocytopenia (i.e. platelet count of 1000/microliter). Patient received three transfusions and started on IVIG and methylprednisolone.
Patient developed lesion inner arm near elbow of (L) hand. Reports that his skin is painful when touched. Saw his PCP, being treated as Shingles.
Noticed my cervical lymph node felt swollen...about a day or two later it became hard...at this point pea sized. Making doctor appointment tomorrow.
started to break out in hives/ hives still come and go/ on my face, arms, back, the bra area and on my feet; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (started to break out in hives/ hives still come and go/ on my face, arms, back, the bra area and on my feet) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) for an unknown indication.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2021, the patient experienced URTICARIA (started to break out in hives/ hives still come and go/ on my face, arms, back, the bra area and on my feet). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (started to break out in hives/ hives still come and go/ on my face, arms, back, the bra area and on my feet) had not resolved.
All arthritic joints became very painful and swollen, had a fever for four days and a wart on my finger was gone after a couple of days. I had had it for 40 years, most concerning was I started a post menstrual bleed that lasted for 35 days while on  a HRT. A hyper scope of my uterus procedure is now needed and scheduled for next week.
approx 1wk p/vax pt began having sz 3-4times a day for 30-60sec followed by fear & crying;sz got less frequent & pretty much stopped p/a year passed;staring up & fixation began;dx PDD
Patient returned to flu clinic about 2 hours after injection of flu vaccine, complaining of discomfort and increased temperature. Per RN assessment, revealed mild redness around site.
Ongoing decline overall. Remained on Hospice with increased lethargy documented on 1/20/21 and progressively worsening thereafter.
@ 8:56AM Nauseated, but reported no breakfast  Prior to leave she said she was feeling ok to leave.
fatigue in the evening fevers, headache overnight mild nausea, achy, headache, fatigue in early morning fatigue, headache mid-morning until evening, but progressively better woke up in pool of sweat twice overnight 1/27/21 morning of 1/28/21 - just normal fatigue from poor sleep 1/26/21 felt great 1/29/21!
31 y/I female, h/I anxiety, depression, panic attacks, c/I lightheadedness, SOB. Pt stated ?I?m nervous, I usually have panic attacks when I get vaccinated.? Denies taking any prescription meds, NKA.  Upon assessment pt. breathing fast, Paramedics HR 108, BP 131/89, O2 Sat 98%. Pt. Instructed on deep breathing exercises and counseled on anxiety reducing techniques, verbalized understanding. Walked pt to her car, no s/s acute distress  noted upon d/c.
The day of receiving vax pt experienced redness at the injection site 2 cm in diameter. On an unspecified date the pt recovered. Another pt (WAES00092217) had a similar experience following exposure to MMRII. No further info is available.
mussle pain in upper chest and shortness of breath upon exertion which is unusual for me
I have been using Olmesartan (brand name Benicar) for controlling my hypertension since the mid-thirties. After generics became available, I switched to using them as my insurance did not cover the brand name medication. Over the years, I have tried different generic brands and have noticed that my hypertension has become less stable. Recently, I discovered that my blood pressure was consistently elevated while using the generic olmesartan made by Glennmark. I have also tried the generic version made by Alembic but it did not work well for me either. I found relief when I switched to the generic made by Accord, which I specifically request from my pharmacy. Another factor affecting my blood pressure control is that after receiving the COVID-19 vaccine (two initial shots and one booster, all made by Moderna), my blood pressure increased, requiring me to double my olmesartan dosage from 20mg to 40mg. I am now 55 years old and while my blood pressure is not fully controlled, it has improved and I have had readings under 120/80. I have noticed a difference in my blood pressure control when using different generic brands of olmesartan. The generic made by Accord works well for me, while others such as Glennmark and Alembic have not provided the same level of control. It is unclear why this difference exists, but I believe it may warrant further investigation.
Extreme diarrhea on second day, eating nothing and still having liquid feces; Extreme diarrhea on second day, eating nothing and still having liquid feces; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 29Apr2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to latex. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 30Apr2021 at 22:00, on second day of vaccination, the patient experienced extreme diarrhea, the patient was eating nothing and was still having liquid feces. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event's extreme diarrhea on second day, eating nothing and still having liquid feces was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
localized skin reaction-large reddened area around inject site (approx size of large orange) warm to touch; also reported feeling sl dizzy p/shot
pt recv vax 3PM & 310PM felt heat radiating down lt arm inj site red, red spots & streaks on lt forearm followed by lethargy, gen tingling  & spots before the eyes, BP 170/109;devel resp distress & used inhaler;
Shingles on right hip, lasted for approximately two weeks, started taking Valtrex on 4/13/2021 (three days after symptoms started)
Pt recvd Hep B vax approx 1990; following 1st & 3rd injections, pt devel sepsis & hepatorenal failure; since the time of vax sx have persisted; pt is currently hospitalized in intensive care unit; addtl info has been requested;
Mom came in with child for 4yr immunization. Did not tell nurse that child had just received H1N1 nasal mist on 12/10/09. 4 year Imm given. apprx 1 hour after immunization mom was called to come get child from school / elevated fever. Took child to ER fever 104.6 MD states could be from immunization or urinary tract infection.
3/22, admitted for NSTEMI 2 days after Covid vaccine. Patient was shoveling snow on the morning of March 22, 2021.  Shortly after doing that, he developed chest pain.  He did not immediately seek medical attention, however.  Rather, he had a preexisting appointment with his primary care provider, which he went to later that morning.  The PCP did an EKG and found him to be having an acute inferior ST elevation MI. The patient was subsequently transferred by EMS to the emergency room at the hospital and then was taken immediately for emergency cardiac catheterization.  The catheterization revealed 100% acute occlusions of both the proximal LAD and the distal RCA.  These were both opened and stented.  There was 1 drug-eluting stent placed in the proximal LAD, and 2 overlapping drug-eluting stents were placed extending from the distal RCA into the proximal PDA.  Postprocedure, the patient did well with resolution of his chest pain.  His peak troponin was 38.6.  An echocardiogram was done on March 22, 2021, and showed inferior akinesis and septal hypokinesis with an estimated ejection fraction of 45% to 50%.  The patient was started on the usual medications post MI and PCI.  On the morning of discharge, March 24, 2021, he is feeling well and is medically stable for discharge.
Patient had ED visit 9 days after COVID vaccine dose #2 and was admitted to hospital 10 days after COVID vaccine dose #2.
Client received vaccination in clinic, called about an hour later from the ER, reported that she started to develop hives, swollen tongue with throat pain about 20 minutes after the vaccine. She took two doses of BENADRYL and improved. She still went to be seen at the ER and she was given a prescription for a prednisone taper, but has elected not to take it. Reports that she is fully recovered today.
Developed profound leukocytosis with WBC 173,000 and elevated LDH following first dose. Increased hydrea (already on for CNL). Developed transfusion dependent thrombocytopenia
Information has been received from a certified medical assistant referring to multiple unspecified patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 08-JUN-2015, the patients were vaccinated with improperly stored doses of Liquid PEDVAXHIB (lot # was reported as J009051, expiration date was reported as 26-MAR-2016; lot # was reported as K026666, expiration date was reported as 22-OCT-2016, route and dose were not reported. Concomitant drug was not reported. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 11-OCT-2013, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 19-AUG-2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered.  Additional information has been requested.
orange-sized redness & swelling w/area hot to touch & itchy;tx w/prophylactic ATb;28MAy96 f/u rxn 2 days p/shot given;5cm erythema, center blister, swollen, hot & somewhat hard;pt recovered;
Had itchy rash, swollen; no fever; no lip or tongue tingling, or sob/wheezing, throat sx; no abdominal pain, n/v, diarrhea; no hiking or bug bites, partner in bed without this rash; no prior reaction to vaccination.
Bleeding a lot after the second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Bleeding a lot after the second vaccine) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (Bleeding a lot after the second vaccine). On 03-May-2021, VACCINATION SITE HAEMORRHAGE (Bleeding a lot after the second vaccine) outcome was unknown.            Concomitant and Treatment information not provided.
Circumscribed area on left deltoid at shot site location-center of area dark purple surrounded by red area, raised, warm to touch. Occurred within 3 hrs. No fever noted. Gradually subsided over 1 week period.
Got Hep A # 2 in R thigh, and developed warm red area radiating outward from the site. No fever.
Injected around noon on April 27 upon leaving hospital.  By 4:00 pm the site was slightly sore and had small bump around site - maybe 1/2 inch.  By 7:00 pm sore was even more sore and the site was now 1" in diameter.  I was chilling and had a slight fever of 99.6.  Got up about 8:00 a.m. April 28 and had a fever of 100.8 -- took 2 regular aspirin.  Arm was now very sore and site of redness was the size of my palm.  Temperature rose to 101.8 and continued asprin every 4 hours.  Generally felt fine but for fever.  By 11:00 p.m.  The site went out around the palm of my hand.  Temperature on going to bed was 101.9 - took 2 aspirin.  April 29 - up at 8:00 - no temperature.  Arm only at injection site is still very sore with a bump around the injection site the size of a 1/2 dollar in diameter, and the redness was spreading out around my arm, but lighter on the outer edges.    I called my doctor who referred me to hospital who gave me the shot who referred me back to doctor.   I called CDC and they said this is a reaction, so I didn't go to emergency room.
Pt noticed welps on the bilateral medial aspects of upper arms. Noted to be hives during office visit. No fevers or other reactions such as pain, dryness, eczematous inflammation, local warmth, weeping, exudate, red streaks, nasal stuffiness, wheezing, nor shortness of breath. Spoke with pt and she states no new symptoms except a couple of new welps.
5x5 area of erythema and warmth around left biceps. Child not ill and area does not hurt.