chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient broke out into a sweat and became lightheaded and dizzy just a couple of minutes after receiving the vaccine.  We evaluated her pulse, blood pressure, and respirations which were all normal.  She laid down with her feet raised for about 10 minutes before the paramedics arrived and she left with them for further evaluation.
No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) in a 42-year-old male patient 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-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 17-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date).    Concomitant medications details were not reported by the reporter. Patient relevant medical history conditions, allergy, concomitant diseases and risk factor were not reported. Treatment details was not reported by the reporter.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium
Information has been received concerning a female who on 02-JUN-2009 was vaccinated with the first dose of GARDASIL (lot # 658271/0558X) while pregnant (WAES 0907USA00225). Subsequently she delivered a health normal baby. On an unspecified date the baby experienced irregular heart rate and was hospitalized for 3 weeks. At the time of the report the patient status was unknown. Additional information has been requested.
Resident was given the vaccine on 05/19/21 and has been doing well until 05/25/21 around 10:01 am, he was found very congested, lungs with crackles, O2 saturation went down to 60-70 %, placed on 100% non-rebreather masks. Resident suctioned as ordered. Resident was placed on Hospice care. Resident expired at 11:58am.
(100.6 degree F fever, headache, stomach ache)16 hours - 30 hours after inj. Petechia on lower legs 4 days.
has no energy; every 4 hours needs to sleep/cannot keep awake; he is in a daze; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (has no energy), SOMNOLENCE (every 4 hours needs to sleep/cannot keep awake), FEELING ABNORMAL (he is in a daze) and FATIGUE (fatigue) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced ASTHENIA (has no energy), SOMNOLENCE (every 4 hours needs to sleep/cannot keep awake), FEELING ABNORMAL (he is in a daze) and FATIGUE (fatigue). At the time of the report, ASTHENIA (has no energy), SOMNOLENCE (every 4 hours needs to sleep/cannot keep awake), FEELING ABNORMAL (he is in a daze) and FATIGUE (fatigue) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.
RN drew up Pfizer 0.1 mL Correct dose 0.3 mL Patient recieved less than correct dose of covid vaccine during am clinic. No adverse event noted.
Developed watery diarrhea; This is a spontaneous report from a contactable physician, the patient. An 81-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: EL1284), via an unspecified route of administration in the left arm on 31Dec2020 (at the age of 81-years-old) as a single dose for COVID-19 immunization. Medical history was none. The patient had no known allergies. Concomitant medications included allopurinol (ALLOPURINOL), losartan potassium (COZAAR), tadalafil (TADALAFIL), acetylsalicylic acid (ASPRIN) and simvastatin (ZOCOR); all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 on 19Jan2021 and result was negative. The patient developed watery diarrhea about 5 days after the administration of vaccine on 05Jan2021. Therapeutic measures were taken as a result of developed watery diarrhea with anti-diarrheals, budesinide. The event, diarrhea was resulted in doctor or other healthcare professional office/clinic visit. The outcome of event, diarrhea was recovering as it was improved somewhat.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021185835 second dose
Fever; Shivering; This case was reported by a consumer via call center representative and described the occurrence of fever in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUZONE (FLU SHOT)) for prophylaxis.  On 17th September 2021, the patient received the 2nd dose of Shingrix (intramuscular) 50 ug and the 2nd dose of FLUZONE (FLU SHOT) (intramuscular) 50 µg. On 17th September 2021, 9 hrs after receiving Shingrix, the patient experienced fever and shivering. On 18th September 2021, the outcome of the fever and shivering were recovered/resolved.   It was unknown if the reporter considered the fever and shivering to be related to Shingrix.  Additional details provided were as follows: The case was reported by patient herself. The patient received dose of Shingrix vaccine and Fluzone vaccine on the same day in left deltoid and after approximately 9 hours patient experienced shivering and fever.  The symptoms were resolved the next day. The patient was unsure whether the symptoms were due to Shingrix or Fluzone. The patient did not have expiry date for Shingrix vaccine. However, she provided NDC number (NDC: 58160-0823-11). The patient did not have expiry date or NDC number for Fluzone. The reporter did not a consent to follow-up with health care professional, as she did not have health care professional. Therefore, health care professional contact information was not collected. She did not provide her personal email address. It was unknown if the reporter considered the fever and shivering to be related to fluzone.
Severe lower back pain, nausea, emisis, weakness, decrease urine output. Present to ER for worseing syptoms was treated with IV fluids and mediation. CT scan to r/o kidney stones. Lab work showed elelvated WBC, and neutrophils.
Patient did not remember getting a COVID BIVALENT BOOSTER already , and received a 2nd  Bivalent booster 2 months after the first.
Swelling and itch at injection site one week after receiving dose. Went away after 48 hours. Blotchy rash on left arm 13 days after injection.
Got Moderna booster of 2.5 ml; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (Got Moderna booster of 2.5 ml) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Oct-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Got Moderna booster of 2.5 ml). On 23-Oct-2021, INCORRECT DOSE ADMINISTERED (Got Moderna booster of 2.5 ml) had resolved.            No concomitant and treatment medications are provided by the reporter.  Patient got her Moderna booster on Saturday and it was 2.5 ml. This is a case of inappropriate dose of vaccine administered for this female patient of unknown age with no relevant medical history. No adverse event was reported after administration of the third (booster) dose of the Moderna COVID-19 Vaccine. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This is a case of inappropriate dose of vaccine administered for this female patient of unknown age with no relevant medical history. No adverse event was reported after administration of the third (booster) dose of the Moderna COVID-19 Vaccine. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report.
Facial, ear, and neck  redness and swelling,  Throat tightened, tongue started to swell
Received MCV4 around 10-11 AM on 5/20/13 in (L) deltoid - that night child woke parent up - complaining his (L) upper arm hurt - felt a little hard (but admits was half asleep). Not day no complaints and didn't look at it. Last evening - after shower - Mom noted area -was very red, swollen and hot to touch - covered 2/3 of upper arm -called for appt. Today states it looks a lot better - less red, less swollen. Still feels hard and warm to touch - but again less than yesterday. Able to move arm. Mark for injection (IM) in correct place.
Insomnia first night, fever lasting a few hours beginning 12 hours after the shot. Body aches and exhausted muscles the next day. Night sweats lasting four days (ongoing), swollen lymph nodes in neck. Left lymph node is the size of an egg, right node the size of a grape. Nodes are getting so swollen it is affecting ability to eat, drink, swallow and talk. Feels as if it is restricting throat.  Taken single acetaminophen dose night of the vaccination (4/11/21), and one 4/15/21.
Fever, Chest Pain, Fatigue, Blurry vision. diarrhea, frequent urination, congestion, muscle aches, body aches, headache starting  the morning after the vaccine was received
She states that there were no witnessed adverse reactions; received a dose of VAQT A instead of the intended RECOMBIVAX HB; Patient was inadvertently administered VAQTA outside of the recommended age range.; This spontaneous report was received from a nurse and refers to a 2-month-old patient of an unknown gender. There was no information about the patient's concurrent condition, concomitant medication and medical history proviided.  On 09-MAR-2021, the patient accidently received a dose of hepatitis a vaccine, inactivated (VAQTA) 0.5 ml, lot number: S037576, expiration date: 10-APR-2021 for prophylaxis (route of administration was not provided) instead of the intended hepatitis b vaccine (recombinant)(RECOMBIVAX HB) outside of the recommended age range. There were no witnessed adverse reactions. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: S037576; expirationdate: 10-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
A day after injection, felt body malaise, headache and chills. Drank Panadol and felt okay after 2 days. Now, Injection site is very itchy, reddened and swollen.
Sinus infection; strep throat; Covid 19; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus infection), PHARYNGITIS STREPTOCOCCAL (strep throat) and COVID-19 (Covid 19) in a 64-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     Concomitant products included PROCAINE BENZYLPENICILLIN (PENICILLIN PROCAIN) for an unknown indication.  On 08-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 24-Jul-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced COVID-19 (Covid 19). On an unknown date, the patient experienced SINUSITIS (Sinus infection) and PHARYNGITIS STREPTOCOCCAL (strep throat). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. At the time of the report, SINUSITIS (Sinus infection) outcome was unknown and PHARYNGITIS STREPTOCOCCAL (strep throat) and COVID-19 (Covid 19) had not resolved.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   The patient received 4 doses of the Moderna COVID-19 vaccines and now has COVID-19.  The patient received first dose on 03-Mar-2021 (lot number 026A21A), second dose on 31-Mar-2021 (lot number 025B21A) and third dose on 25-Aug-2021 (lot number 028D21A).  On an unknown date, the symptoms started with mostly fatigue, and feeling overall crappy and tired. She went to the doctor yesterday who diagnosed her with COVID after a test. She also had a sinus infection and was taking penicillin.   The patient was so sick with COVID. HCP diagnosed her with COVID 4 days ago and prescribed her with Pfizer's Paxlovid and penicillin. Patient had throat and nasal swab 4 days ago and tested it and Doctor said she had COVID and strep throat. Taking Paxlovid and penicillin for 4 days. Feeling sicker than when she had chemo. This was patient's first time having COVID.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2023: Live follow-up information received included updated narrative.
24 hours after vaccine - erythema, swelling at injection site (2"x2"), gradual onset of headache, nausea, malaise 24-72 hours after vaccine. Erythema, swelling increased in size over next 4 days now measuring  7"x5 1/2"5 days after vaccine. Intermittent nausea, malaise still occurring.
This spontaneous report as received from a pharmacist refers to a patient of unknown age who was vaccinated with an expired 0.5 ml dose of PNEUMOVAX23 (Lot # 9874603, Exp 30-AUG-2012), IM on 10-SEP-2012. No adverse effects occurred. The patient was in the pharmacy when this happened and was discovered. Additional information has been requested.
Red, swollen, hot to the touch area localized around the injection site.  Spread over the next few days.  Swelling decreased, but darkened, red rash remains at one week post administration.
After vaccination pt described arm as becoming swollen from (R) shoulder to elbow, becoming very warm to touch w/ softball size nodule at injection site. As of 9/15/15, swelling was reduced, but still had softball size bruise at injection site.
then it's getting worse and worse and sharper and then it started hurt, so would not eat; hard to breath; pain in her right upper quadrant of her abdomen; This is a spontaneous report from a contactable consumer (patient). A 49-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0150), via an unspecified route of administration in left arm on 06Apr2021 at 16:00 (at the age of 49-year-old) as dose 1, single for COVID-19 immunisation. Medical history included polyps in gall bladder from an unknown date and unknown if ongoing (2 polyps in her gallbladder that she has monitored every few years), endometriosis from an unknown date and unknown if ongoing, mitral valve prolapse from an unknown date and unknown if ongoing, scoliosis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had a little bit of a reaction. She think it was through the Pfizer vaccine (first shot) and just wondering if should get the second dose which am supposed to get on next "Tuesday" the 27th or if she should not get it, so what happened was, She got the vaccine on 06Apr2021 and after about three hours after got it, she started to get pain in right side under her rib cage, so the upper right quadrant and at first she was thinking it was probably nothing, may be something she ate and then it was getting worse and worse and sharper and then it started hurt, so would not eat, it became very painful, hard to breath and she was thinking maybe it was because of gas, so she lay down for a while. She laid down and it was just strong and was not sure if she goes emergency room or not and then after about 4 hours, she was staying in one position and then she thought it was getting a little bit better. I was able to fall asleep and when I woke up it was completely gone. I have never had pain in that spot before or after that day, that night and I do not know it felt to me the gall bladder area again. She never had pain before, she does have two small Polyps in gall bladder that she has monitored every few years but she never and they never felt them before. It had never affected her, so anyway, I do not know if it has to do what she received or not (second dose). She was afraid if she should get second shot or not. She has not yet been seen by a doctor for her symptoms. Reporter seriousness for events was reported as unspecified. The outcome of pain in her right upper quadrant of her abdomen was reported as resolved on unknown date; then it was getting worse and worse and sharper and then it started hurt, so would not eat and hard to breath was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Resident vaccinated-1/7/21 Resident covid positive 1/11/21 Resident covid PNA-1/12/21 Resident hospitalized 1/16/21 Resident deceased 1/20/21
Client given Flu vaccine at 10:20. Client called at 10:30 c/o swelling at injection site. Client returned to clinic 10:35. Ice pk applied to site. 15 mins on and 15 mins off x 2. Swelling reduced.
Within 24 hours I experienced profuse sweating followed by aching in my neck, shoulders, arms and lower back. This was then followed with severe fatigue, cold chills and diarrhea. Symptoms subsided after approximately 24 hrs of onset.
Patient started to develop redness and warmth on the right arm around the site of the PNEUMOVAX injection approx. 7 hrs after injection. Condition eventually extended to just below the elbow, but did not go higher than injection site. Patient also reported swelling, itching and some bruising on the 2nd day. Cortisone cream was applied to affected areas the evening of the 2nd day. Pharmacy was notified on the afternoon of the 3rd day (11/21/18) at which time symptoms had already started improving.
Information has been received through the Merck pregnancy registry through a laboratory technician concerning a 19 year old female with a history of sulfonamide allergy (BACTRIM) who on 27-MAR-2007 was vaccinated with the first 0.5 ml dose of Gardasil (Lot # 657006/0188U). There was no concomitant medication. It was reported that on 25-MAY-2007 the patient got a positive pregnancy test through urine HCG test and had a miscarriage on 31-MAY-2007. The patient recovered around the end of May from the miscarriage. The patient did not report any adverse reaction. The patient completed the Gardasil series and received the second dose on 19-Jul-2007 and the third dose on 09-Nov-2007. Unknown medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Migraines started as soon as I received my final and 3rd vaccine. On the table of administration I had a migraine. After struggling with migraines and ocular migraines where I loose vision. 6 months of ocular migraines and 6 months after I had my 3rd shot, I started having grand Mal seizures. I am not fully diagnosed with epilepsy. Never had a seizure before the vaccines, and no family history of epilepsy.
Headache, Myalgia, Fever, NauseaVomiting, fatigue Narrative:  Other Relevant History:
4/27/21 started having scant/light vaginal bleeding dark in color that persisted through that day resolving. Spoke with her liver specialist who ordered CBC, PLT which was interpreted by MD Liver as normal. Follow up with gyn
Case number PHEH2013US003551 is an initial spontaneous report received from a nurse on 07 Feb 2013, with a follow up received on 05 Mar 2013. This report refers to a 25-months-old male patient. His medical history was not reported and his concomitant medication included MMR vaccine, PEDIARIX, PCV 13 and VCV and Hepatitis B vaccine. It was reported that he was administered a dose of MENVEO (batch number: A11051) intramuscularly to upper right vastus lateralis, but was supposed to receive a dose of HIB (manufacturer and batch number: not reported hence conservatively taken as VAXEMHIB INN) on 18 Jan 2013. No adverse reactions were reported. Follow up received on 05 Mar 2013: Updated the concomitant medications, time, site of application, height and weight of the patient.
A report has been received from a pharmacist concerning a 47 year old, female subject who had been receiving nasal FLUMIST.  The patients medical history included FLU vaccination. The patient experienced moderate numbness from nose down to chin, moderate fevers up to 37.5 degrees Celsius and severe headaches which started on 05-JAN-2014. The patient recovered from the event of numbness from nose down to chin, moderate shaking,  fevers up to 37.5 degrees Celsius and severe headaches on an unspecified date. The report was considered to be non-serious. The reporter considered casual relationship between all the reported events and suspect drug/FLUMIST.
Moderna vaccine administered to a 17 yo. 2nd dose to be administered 04/29 per CDC off label use recommendation.
Patient to vaccine area, seated. Reported feeling "like I'm about to faint". Patient became pale, was assisted to sitting position on floor. Patient began to vomit.  EMS activated. V/S - B/P 102/64, HR 95, O2 96%, Resp 16. Patient remained A&O x  4 ( person, place, time, situation). Patient monitored until EMS arrival, skin color returned to normal for ethnicity. Patient assessed by EMS, Report obtained by EMS - 89. Patient mother refused transportation to ED. Education provided on normal side affects, adverse reactions, and when to seek medial treatment, patient and guardian express understanding.
Reaction to IPV vaccine given on 10/11/23, injection on right thigh per record, both legs became red and swollen. Patient went with parents to ER and was given an Albuterol breathing treatment, Prednisolone PO, and Benadryl PO. The patient was also prescribed medications Prednisone and Benadryl, but meds were not given yet per parent. The swelling and redness went down in 1 hour. The patient had a mild fever of 100 F at the ER and the above previously mentioned medications were given. Petechiae rash on bilateral lower extremities worse on the left leg. No other petechiae anywhere else. Adverse event logged into the patient's chart. The patient was seen in office post event for an ER follow up on 10/13/2023 and is doing well with fading rash, will refer to investigate possible allergies.