chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered Moderna Covid 19 Bivalent after 30 day use by date; No Adverse Event; administered Moderna Covid 19 Bivalent after 30 day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid 19 Bivalent after 30 day use by date), PRODUCT STORAGE ERROR (administered Moderna Covid 19 Bivalent after 30 day use by date) 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. 013H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 13-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid 19 Bivalent after 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (administered Moderna Covid 19 Bivalent after 30 day use by date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid 19 Bivalent after 30 day use by date), PRODUCT STORAGE ERROR (administered Moderna Covid 19 Bivalent after 30 day use by date) 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 (administered Moderna Covid 19 Bivalent after 30 day use by date) and PRODUCT STORAGE ERROR (administered Moderna Covid 19 Bivalent after 30 day use by date).    No concomitant medication information provided.  It was reported that HCP had called to inform that 4 or 5 adult patients were accidentally administered Moderna Covid 19 Bivalent after 30 day use by date.  No treatment information provided.   This case was linked to MOD-2022-687454, MOD-2022-687539, MOD-2022-687540, MOD-2022-687541, MOD-2022-687542 (Linked Report).; Sender's Comments:  MOD-2022-687541:Original Case : MOD-2022-687454 MOD-2022-687540:Original Case : MOD-2022-687454 MOD-2022-687539:Original Case : MOD-2022-687454 MOD-2022-687542:Original Case : MOD-2022-687454 MOD-2022-687454:Original Case : MOD-2022-687454
Patient received dose of 0.25ml on 9/14/22.  Came back on 9/16/22 and received 0.5ml, full dose.
Severe rash with blistering on left Arm and hands; This is a spontaneous report received from a contactable consumer (patient). A 58-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9262), via an unspecified route of administration on arm left on 25Jan2021 11:00 at single dose for COVID-19 immunization in hospital. The patient had no medical history and no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient developed Severe rash with blistering on left Arm and hands on 02Feb2021. The events result in doctor or other healthcare professional office/clinic visit. The patient received treatment with unspecified antibiotic medication, so far but still in Treatment. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient has not been tested for COVID-19 Since the vaccination. The outcome of the event was reported as unknown.
vaccine administration error regarding Pfizer lot # FL3197 EXP:12/31/22 administered on 7/5/22 with beyond use date of 3/18/22 with recommendation to get booster
Stomach pains, nausea, diarrhea, hives which were extremely bad and continued for 4 days.
At 10:05 dizzy, lightheaded, headache, "felt drunk." Noted: drowsy in appearance, eyes at half most "slurred speech" Doctor at site. At 11:20 patient reports feeling well improved. Only itching and headache remains. Its family bring Atarax for patient.
Minimum soreness around injection site; Some chills; muscle ache; This is a spontaneous report from a contactable consumer (Patient) self-reporting.  A 58-year-old female patient (who was not pregnant at the time of vaccination), received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: BNT162), via an unspecified route of administration, administered in Arm Right on 23Feb2021 as SINGLE DOSE for covid-19 immunisation. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. The patient medical history and concomitant medications were not reported. On 24Feb2021 the patient experienced minimum soreness around injection site, some chills and muscle ache. The outcome of the event was recovered.
Pt felt a pain inside his arm above the elbow at 1010am, he states he felt this pain a few times and then saw some swelling and redness to his arm.  PT was given a Motrin and a Zyrtec prescribed by provider and also a ice pack was applied to the area.
Pt was in to receive 2nd Pfizer vaccine. After the vaccine was administered, pt admitted that he had already received the Janssen vaccine and was considering getting the Moderna in the future.
5hr p/vax lt shoulder, redness, pain, & swelling 2 days later swelling moved to elbow;
severe brain fog; intense cramping; she got red really fast and almost a strange itching inside her body; felt she had Covid; Mild diarrhea; body aches; fever; Headaches; This is a spontaneous report received via medical information from a contactable consumer (patient).  A 61-years-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 30Mar2021 (Batch/Lot Number: ER8737) at the age of 61-year-old, as single dose for covid-19 immunisation.  Medical history included ongoing thyroid disorder has had for years, ongoing hypertension started about 8 years ago, ongoing immune system disorder ( Her spleen has been removed, and she is immune compromised). The patient was immune compromised and has no spleen and she had Covid and has Covid long haulers. The patient's concomitant medications were not reported.  The patient received the second dose of Covid vaccine received on 20Apr2021, at 09:00, right arm injection. After the 1st dose of Covid vaccine she felt she had Covid.  Mild Covid again, for about 4 days.  She experienced fever, body aches, and some mild diarrhea the same day of vaccination.   The patient did not confirm if she just felt like she had Covid again or tested positive for COVID-19 after first dose.  She had diarrhea until she received the second dose of the vaccine then got ulcers in her mouth, body swelling, and had headaches with both doses. The patient stated that fever started after the 1st shot, within 4 hours, It was fast.  She was sitting with a friend and she got red really fast and almost a strange itching inside her body.  She told her friend she needed to lie down.  Her friend told her she didn't look good.  It happened so quick.  It started on 30Mar2021 and she recovered completely.   Body aches started on 30Mar2021 but not until the evening and lasted until it ended with the fever.  She recovered completely.  She was a long hauler and this was a whole different ball of wax. Patientdidn't feel it when she had Covid.  Mild diarrhea started in the middle of the night on 30Mar2021 and she doesn't think it ever ended.  It spun around, It was now constant diarrhea and continues from the first dose.  It waswater and with intense cramping and is constant. She is on the BRAT diet. It won't hold so she is living on Gatorade and white rice. Headache started with the first dose. The headache came in after the first dose and was very mild.  It left just like the symptoms did. The headache started when the fever started and it started quickly and it hasn't left.  Patient also complained severe brain fog. The patient experienced felt she had covid (suspected covid-19) on 30Mar2021 with outcome of unknown, mild diarrhea on 30Mar2021 with outcome of unknown , body aches  on 30Mar2021 with outcome of recovered , fever (non-serious) on 30Mar2021 with outcome of unknown , headaches on an unspecified date with outcome of unknown, severe brain fog (feeling abnormal) on an unspecified date with outcome of not recovered , pruritus on 30Mar2021 with outcome of recovered , intense cramping  on an unspecified date with outcome of unknown.
Initial unsolicited report received from a non-healthcare professional on 02-Sep-2016. This case involves a 72-year-old female patient who was vaccinated with a dose of FLUZONE HD via intramuscular route (batch number: UI659AB, expiry date: 29-Mar-2017) (dose and dose in series not reported) in left deltoid on 29-Aug-2016. Patient's illness at time of vaccination was reported as no. It was also reported that pre-existing physician diagnosed allergies: eggs and birth defects, medical conditions are not reported. Concomitant medications were not reported. On 29-Aug-2016 by the evening, same day following the vaccination, the patient experienced had redness and warmth at the injection site, left deltoid. It was also reported that swelling was larger than the size of a softball. It was also reported that patient had Fluzone last year and had not experienced a reaction. Patient required ER/Doctor visit. Lab test and corrective treatment were not reported. Outcome of the events were reported as unknown. Documents held by sender: none.
Fever; Chills; Her body hurts; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Her body hurts) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Her body hurts). At the time of the report, PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Her body hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment information was not provided.
persistent inconsolable crying, lasting from 12noon until 6PM; no fever; reddness, sl swelling @ inject site; PMD consulted-no treatment; No problem during noc; fine according to mom 9AM 13JAN94;
PUFFINESS IN RIGHT ARM, SUPPOSED DIZZINESS THE DAY AFTER AND CONTINUING UNTIL 10/23 WHEN THE PT HAD A FALL AND WAS TRANSPORTED TO HOSPITAL WHERE SHE SUSTAINED A FRACTURED WRIST, FRACTURED RIBS, AND A PUNCTURED LUNG
Fever, chills, nausea, vomiting, blurred vision approx 7 hrs after vaccination.
This case was reported by a physician via call center representative and described the occurrence of eye swelling in a 75-year-old female patient who received SHINGRIX for prophylaxis. On 13th July 2018, the patient received the 1st dose of SHINGRIX. In July 2018, 3 days after receiving SHINGRIX, the patient experienced eye swelling and erythema. On an unknown date, the outcome of the eye swelling and erythema were not recovered/not resolved. It was unknown if the reporter considered the eye swelling and erythema to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The health care professional (HCP) stated that his patient received a dose of SHINGRIX 3 days ago from the date of reporting and experienced swelling under her eye and redness.
Within hours of getting the flu shot, the following occurred: Severe pain in upper arm where flu shot was given Loss of Motion - Cannot lift or move my arm without severe sharp stabbing pain Burning ? constantly on fire Feels like an axe is slicing deep into the bone from the front Feels like a jagged rock with pressure slicing from the outer side to inside of my arm  Cannot rotate hand/forearm unless I keep elbow at my side Cannot do normal activities Cannot pull, push, lift objects or twist arm  without pain Cannot remove clothes without severe pain Night time - Cannot sleep well due to arm burning, pressure, pain etc.
My second vaccine of Shingrix produced the same effect as my first vaccine that I received on 8/11/2020 at drs office which 2 days later sent me to the hospital thinking I was having a heart attack.  All tests that were run at the hospital and through a cardiologist did not find anything wrong with my heart. I had the 2nd Shingrix vaccine administered on 11/17/20 at same dr office. Besides the usual side effects of nausea, mild headache and chills/low grade fever that I experienced the first time, again I experienced waking up the night of 11/1920 at 1:30 am with some heaviness on my chest. I was able to fall back to sleep but awoke again at 4:20am with such a heaviness that I could only takes shallow breaths and could no longer lie down.  I had to sit up the remainder of the night. The feeling was quite scary  but knowing this time it was not heart related, I was remained sitting up until the feeling eventually subsided.
chills; Fatigue; body & head aches; body & head aches; This is a spontaneous report received from a contactable consumer (patient) reported that a 73-year-old male patient receive second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously took BNT162B2 as first dose and experienced headache. The caller reported he and her wife experienced some headaches, chills, fatigue and body and headaches after second dose of vaccine. Outcome of the events was unknown.  No follow-up attempts possible. No further information expected. Information about the lot/batch number has been requested.
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 22-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  The vaccine was stored in freezer, took out one to two vials and place in fridge each day as needed. Patient took booster shot.  Treatment medications was not provided.
right shoulder pain/ patient complaining of scapular pain; patchy weakness and pain in the upper body; patchy weakness and pain in the upper body; Initial information received on 02-Feb-2021 regarding an unsolicited valid non-serious case from a nurse practitioner via Agency (under reference number US-SANOFI-00457309).  This case involves a 32 years old male patient who experienced right shoulder pain/ complaining of scapular pain (arthralgia) and patchy weakness and pain in the upper body (pain) (asthenia), after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date in December 2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot U7045DA and expiration date not reported) via intramuscular route in the right deltoid for prophylactic vaccination.  On an unknown date, the patient reported at the neurology office having right shoulder pain/ complaining of scapular pain (arthralgia) and patchy weakness and pain in the upper body (pain) (asthenia), 2-3 weeks after administration.  Patient has had an MRI (Magnetic resonance imaging) on an unknown date which was unremarkable.  Treatment included OT and PT (Physical and Occupational Therapy).   At the time of reporting the patient did not recovered from any of the events.
2 nights of sleeplessness on top of the most common side effects. Fatigue also marked by inability to sleep.
This spontaneous report was received from a medical student refers to a 03 months old male patient. Patient's concurrent conditions, medical history, concomitant medications were not reported. On 23-JAN-2018 the patient was vaccinated with improperly stored RECOMBIVAX HB (dose and route unknown) lot # N002202 expiration date 04-NOV-2019 for prophylaxis (Product storage error). The temperature was 53.2 F, time frame was 5 hours and 57 minutes. It was reported that there was no previous temperature excursion. This case is linked to the case 1802USA001357 (same reporter link).
No adverse event; The patient was administered with improperly stored VAQTA; This spontaneous report was received from a certified medical assistant (CMA) referring a 15 year-old-female patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 19-NOV-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S007770, expiration date: 24-JUL-2020, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to the temperature above 47 degrees Fahrenheit/9 degree Celsius (9.3 Celsius) for 23 minutes. The previous temperature excursion were at the temperature above 47 degrees Fahrenheit/9 degree Celsius (10.7 Celsius) for 33 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.7 Celsius) for 36 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.9 Celsius) for 15 minutes and at the temperature above 47 degrees Fahrenheit/9 degree Celsius (9 Celsius) for 12 minutes. The call was because of a data logger. No adverse event was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; manufactureraddress: ; manufacturercity: ; manufacturerstate:  manufacturercountry: ; devicelotnumber: S007770; expirationdate: 24-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1910USA012749:
Wrong vaccine given.  Pt was given pediatric 6-35 mos instead of adult dose. No adverse symptoms occurred. Pt was given influenza vaccine FLUZONE QUADRIVALENT on the next day by nurse per instructions.
This spontaneous report was received from a registered nurse refers to an 11 year old female patient. On 16-DEC-2014 the patient was vaccinated with VAQTA (dosing regimen unspecified). No concomitant therapy was reported. On 16-DEC-2014 the patient inadvertently received adult doses of VAQTA, instead of pediatric doses. Nurse reports that the two patients are sisters. No adverse effect reported and there was no product quality complaint involved. The outcome of "inadvertently received adult doses of VAQTA" was unknown. This case is linked to: 1412USA010040 (same reporter). Additional information has been requested.
3 hours after administration, and after eating Korean food, pt reports had itchy skin. Perhaps some hives.  he day later he felt poorly. On 3d day he had swelling of face and extensive hives. Went to local hospital ER where he was found to have T 99.9F, HR 112, BP 128/78. They opted to admit him due to extensiveness of rash. Was kept in with IV Cortisone and antihistamine for 3 days. CBC showed WBC 11.32, Neuts 88%, Lymphs 10% and Eos 1%. Discharged day 3 on oral steroids. 11 days later, ate Korean food again and had a more rapid onset of facial swelling and hive development. Went back to ER, and has follow up with local physician today.
I did not have an adverse event after receiving the vaccine. In 05/21/2022, I was diagnosed with bronchitis. Since having bronchitis, it appears I am more prone to catch something. I have sinus infections and ear infection.
Matched the Lt# written on the clients service slip at that point I realized I had given a VZV (LUT) and MMRV (RUT). Printed 3231 form and gave to MGM. Then explained to MGM that child received a single dose chickenpox vaccine and another dose of chickenpox vaccine combined with MMR. Reinforced what to look for that's considered severe problems such as high fever (102 degrees and above), swelling of face and throat, difficulty breathing etc on V15 statement. Informed MGM should any of these problems occur to call 911 or take child to the nearest ER. MGM voiced understanding. Child remained in clinic 15-20 minutes after shots for observation, no s/s of any reaction. Again reinforced importance of watching for severe problems; if any call 911 or take child to nearest ER. Followed up with home phone provided in client's record at 11:45 AM. No answer, left voice message, again at 1:45 pm no answer left message; no response back. Phoned MGM again at 3:15 pm, spoke with MGM and she reported that child was fussier than usual but denied that child had fever, swelling pr difficulty breathing or any other reaction, Explained to MGM that child may be fussy due to ache or pain in the legs where shots were given. Acetaminophen can be given for pain or fever but read carefully before giving.  MGM voice understanding.
Tender, erythemic, swollen (L) deltoid/arm area measuring 10 long x  7 cm wide.
A physician reported that a male child (age unclear) rec'd his 5th dose of Prevnar on an unspecified date. Subsequently, an immunoglobulin G titer returned with a low level of Streptococcus pneumonia, serotype 19F. This child also developed a positive blood culture for Streptococcus pneumonia, serotype 19F following the second dose of Prevnar. See HQ8985729NOV2001. No further information was available at the date of this report.
Patient came to ED with chief complaint of cough, found to have COVID-19. She had received only one dose of COVID-19 vaccine on 8/6/21 and was admitted to the hospital on 8/21/21. During her 3 day stay, she did not require any oxygen support and physician noted she had no respiratory issues at time of discharge home.
side effects; 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 COMPLICATION (side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Reporter did not allow further contact