chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was administered after more than 12 hours post first vial puncture.), PRODUCT STORAGE ERROR (Initially stored on 20-Feb-2023, First punctured on 21-Feb-2023 and administered on 24-Feb-2023) and NO ADVERSE EVENT (No adverse reactions have been reported by any patients at this time.) in a 45-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 022H22A) for COVID-19 prophylaxis. No Medical History information was reported. On 24-Feb-2023, 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 24-Feb-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 was administered after more than 12 hours post first vial puncture.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Initially stored on 20-Feb-2023, First punctured on 21-Feb-2023 and administered on 24-Feb-2023) and NO ADVERSE EVENT (No adverse reactions have been reported by any patients at this time.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was administered after more than 12 hours post first vial puncture.), PRODUCT STORAGE ERROR (Initially stored on 20-Feb-2023, First punctured on 21-Feb-2023 and administered on 24-Feb-2023) and NO ADVERSE EVENT (No adverse reactions have been reported by any patients at this time.) 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 reactions have been reported by any patients at this time.) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose was administered after more than 12 hours post first vial puncture.) and PRODUCT STORAGE ERROR (Initially stored on 20-Feb-2023, First punctured on 21-Feb-2023 and administered on 24-Feb-2023). The concomitant medication was not reported. The date of last administration was 24-Feb-2023. The treatment medication was not reported. The dose was administered more than 12 hours post puncture. The information about individual vial used was unknown. The vial was initially stored in the refrigerator on 20-Feb-2023, first punctured on 21-Feb-2023 at 06:00 am.  Administered on 24-Feb-2023 at 07:45 am and 8.45 am respectively. Most recent FOLLOW-UP information incorporated above includes on 24-Feb-2023: Follow up received included non-significant information reporter's details were updated.
8/20/2023 - 8/29/2023 (9 days)  4/29/2021 Moderna 045B21A 4/1/2021 Moderna 021B21A  past medical is significant for CHF, COPD, hypertension
This was my first booster shot after having gotten my initial two shots. I had zero side effects after my first two shots aside from a very slight arm pain and I've never had any adverse side effects from any other vaccination. I went to a Pharmacy in the early afternoon to get it. I always get the flu shot every year so I figured I would do both at the same time - the person at the pharmacy said it was normal to do so. I got both shots in my left arm and went home. I felt fine all day - I'm a musician and was recording a song in my bedroom. I was working, but was sitting at a desk and it was rather non-strenuous. That night, I was lying in bed with my eyes closed trying to fall asleep when I felt an acute urge as if I needed to vomit. I quickly got up and rushed to the bathroom. All of the lights were off and I sat on the toilet with my head in my hands as I was not feeling very well. The next thing I remember, I was lying on the floor of the bathroom in the dark in a cold sweat in the fetal position with my ears ringing. I was very disoriented and got up to turn on the lights. I discovered in the mirror that my bottom lip was split open and bleeding. I was in complete shock considering I have never blacked out once in any context in my entire life. I woke up my brother to assist me in piecing together what had happened. I believe that while I was sitting on the toilet with my head in my heads, I blacked out and fell forward with my face landing on the bathroom tile. Luckily, because I was in the sitting position, the impact wasn't as bad as it could have been had I been standing up. I am also lucky that I didn't smash my face into the bathtub, for example. All things considered, it could have been much much worse. I called myself a ride and went to the nearest hospital to be evaluated and potentially have my lip stitched. They told me I didn't have any signs of a concussion (I didn't develop any later on either) and that the wound on my lip wasn't quite deep enough to warrant stitches. Aside from that taking about 2-3 weeks to heal, I did not experience any further symptoms or issues as a result of the incident. It was rather strange, but I am a strong proponent of vaccines in general and this event did not change that position even slightly. When I got my bivalent shot the following year (this past fall), I decided to get my flu shot separately. I got both shots without incident or a single side effect.
Vaccine date 17, migraine headache 18th, followed by a week of body aches, sweating, fatigue, headache. Loss of smell not sure when was the exact date but Christmas when I 100% noticed so smell. Tested 26 and results received today the 29th
Within a few minutes of vaccine administration, client stated she felt like she might faint; pallor noted.  Client's mother stated both her daughters had "become anxious about receiving these shots" and mother stated she felt her daughter was "experiencing a vasovagal response."  (Mother is a nurse.)  Client was laid down on clinic cot with feet elevated.  BP taken - 84/48.  Cool cloth placed on her forehead.  After 10 minutes, the client states she felt better; color had returned to pink.  Client walked out of the health department and was driven home by her mother.  In a follow-up phone conversation with client's mother, mother stated her daughter was fine after she left the HD, that she had taken her to get something to eat and that she exhibited no further problems.  Mother thanked me for the call.
Pt rcvd flu vaccine on 10/9/19. Pt reported this was her first ever flu vaccine. Pt noticed approximately one week after administration she noticed severe pain in left arm. She is unable to lift arm above her head. She said she is having difficulty dressing her upper body. She also reports that her pain is persistent, but not predictable. It has been approximately 4 months since the shot and her symptoms have not resolved. Pt said she saw a prescriber on January 31st. She said she saw another doctor prior to that in Oct or Nov. Pt said she saw a specialist on 2/11/2020 who prescribed her ibuprofen to help with the pain.
Patients mother called on 7-20-22 and stated that her daughter's arm became red, swollen and warm to touch, but resolved after 5 days
sleepinses devel the day p/vax; sleeping 20 hrs /day now; prev slept 9-10 hrs day + 2 hr nap; somnolence & difficulty arousing w/in 24 hrs of MMR:
SWELLING OF HALF OF THE RIGHT SIDE OF TOP LIP; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included allergy to fire ants. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 05-APR-2021 13:00 at left deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, treatment medications included: diphenhydramine hydrochloride. On 05-APR-2021, the subject experienced swelling of half of the right side of top lip. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling of half of the right side of top lip. This report was non-serious.
within 2 week time frame of getting my 2nd shot I began having sharp pain in my feet, back, hip, finger.  Ultimately it grew to severe pain in my jaw, neck, finger, hip and knee all on the left side of my body.  And, eventually in June my right index finger and right foot were swollen and painful as well. I've had multiple xrays and blood work ups in ER and then finally in my Dr. Office.  Final diagnosis from Dr. is Polymyalgia Rheumatica.  The only indicators that were abnormal were my very high C-reactive protein and SED rate.  *also note I had a respiratory virus not long after my second shot that lasted a few days and just involved a lot of nose blowing, nasal congestion  ** second and separate issue - I have barely had a period since my second shot
2" swelling and erythema at injection site. Self resolved over 72 hrs w/o treatment.
Nausea Vomiting, HYPERtension, Chest pain Narrative:
Site: Pain at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Heavy head and body and burning pain in back and very pale-Severe, Systemic: Headache-Severe
PT RECD 1ST DOSE PFIZER 4/18/21, HERE FOR SECOND DOSE. PT RECD 2ND DOSE AND VACCINATOR REALIZED IT WAS 6 DAYS EARLY. PT WAS ADVISED MY MED CONSULT TO STAY 30 MINS FOR OBSERVATION.
This is a spontaneous report from a contactable consumer (patient). A 88-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on an unspecified date in 2021 (age at vaccination: 88 years) as dose number unknown, single for COVID-19 immunization. The patient medical history included Myelodysplasia and immunocompromised from an unknown date. The patient Concomitant medications included PROCRIT taken for Myelodysplasia from an unknown date. On 09Aug2021, the patient tested positive for covid-19. On an unspecified date in 2021, the patient experienced fever of 100-101, congestion, fatigue. It was reported that Received vaccine Jan/Feb2021. Male Patient has myelodysplasia and is on Procrit twice/month. The Myelodysplasia, immunocompromised, injection bi-monthly to boost red blood cell count. The lab tests included Body temperature: 100-101 on an unknown date in 2021. SARS-CoV-2 test positive on 09Aug2021. The outcome of events was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
A few hours after the vaccine I suddenly started having pain and dry mouth on my tongue, lips and throat. I kept drinking water to alleviate the dry mouth. I also started feeling a burning and tingly sensation on my left eyelid. When I looked at my mouth the next morning all of the pink area in my mouth was white, under and all over my tongue, I tried to manage it at home by washing with peroxide hydrogen and felt better for a little while. After as few hours the same symptoms came and I felt like I had to go to the ER. However I again washed with Hydrogen Peroxide. I was seen by a physician and was diagnosed with an oral Yeast Infection in my mouth and throat. Also diagnosed with Shingles on my left eye. At this point I am only 25% recovered. Finished a course of medicine. for Shingles and it is slowly improving. Dr. prescribed a course of Diflucan.
Information has been received from a female registered nurse who was vaccinated with the second dose of varicella virus vaccine live. The pt subsequently developed a very sore throat. At the time of the report, the pt indicated that she had not yet consulted her physician, but unspecified medical attention was sought. Additional info has been requested.
Left arm pain, loss of muscle function, tingle in fingers, numbness from neck to fingers.
Vision in her right eye became blurry, "greyed out" and she saw "bolts of color."/Film over rt eye; Vision in her right eye became blurry, "greyed out" and she saw "bolts of color.\ Flashes of color/shapes; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Vision in her right eye became blurry, "greyed out" and she saw "bolts of color."/Film over rt eye) and VISUAL IMPAIRMENT (Vision in her right eye became blurry, "greyed out" and she saw "bolts of color.\ Flashes of color/shapes) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023m20A and 002B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Sulpha), GERD and Blood pressure high (Higher since vaccination). Concomitant products included METOPROLOL SUCCINATE (TOPROL) for Blood pressure high, SERTRALINE HYDROCHLORIDE (ZOLOFT) for Depression, PANTOPRAZOLE for GERD, AMLODIPINE and ALPRAZOLAM (ZOLAX [ALPRAZOLAM]) for an unknown indication.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced VISION BLURRED (Vision in her right eye became blurry, "greyed out" and she saw "bolts of color."/Film over rt eye) and VISUAL IMPAIRMENT (Vision in her right eye became blurry, "greyed out" and she saw "bolts of color.\ Flashes of color/shapes). The patient was treated with PREDNISONE at a dose of UNK dosage form. At the time of the report, VISION BLURRED (Vision in her right eye became blurry, "greyed out" and she saw "bolts of color."/Film over rt eye) and VISUAL IMPAIRMENT (Vision in her right eye became blurry, "greyed out" and she saw "bolts of color.\ Flashes of color/shapes) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient reported blood pressure fluctuation and noted high blood pressure since vaccination.   This case was linked to MOD-2021-152857 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Significant Follow up for AE Contact/Patient Details Update On 05-Jul-2021: Patient demography, medical history, concomitant medication and event outcome updated.
Tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced COVID-19 (Tested positive for COVID-19). At the time of the report, COVID-19 (Tested positive for COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included unspecified cold medicine.  No concomitant medications were reported.
Very sore pain from muscle of injection site as early as an hour post vaccination; Limited arm movement going into the next day; This is a spontaneous report from a non-contactable consumer. This consumer reported that, A 20-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot Number: EN6198) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization (age at vaccination 20-years-old). The patient medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient experienced very sore pain from muscle of injection site as early as an hour post vaccination, limited arm movement going into the next day on an unspecified date. Outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Information has been received from a pharmacist concerning an 84 year old female with hypertension and no known allergies who on 05-AUG-2010 was vaccinated subcutaneously with a 0.65 mL single dose of ZOSTAVAX (Merck) (LOT# not reported). Concomitant medication included unspecified blood pressure medication. On 24-AUG-2010, the patient called the pharmacy to report that she had 1.5 x 0.25 rash at the injection site. Pharmacist did not know when the rash started. The pharmacist didn't report the patient's outcome at this time. Additional information has been requested.
Pt came to clinic at 9:20am for T-dap vaccine he mentioned that on the left deltoid he has a red wheal and said it feels warm with touch and itchiness. No fever or shortness of breath or any other symptoms. Patient is alert and stable. He was given Prevnar20 on 1/26/2023. He believes is a reaction from the vaccine. I visualized the wheal, it feels warm and is red, but is under the injection site. I  sent him to see the RN  for further evaluation. RN said is tender and warm with touch, she mentioned  visualizes  a red wheal  4 inches under the vaccine site. No visual redness on the part where the vaccine was given.  Dr prescribed antibiotic and told the patient to put cold compresses.
28 hours after the second dose, I experienced chills and extreme fatigue that lasted about 10 hours.  12 hours after that, I experienced body aches and mild fatigue that lasted about 12 hours.
one week post vaccination I developed bacterial cellulitis at the injection site. After a couple days of pain, erythema, heat, swelling at injection site and feeling generally unwell, I contacted my Dr and included photos. She responded to my message Sunday 1/24 and based upon clinical signs and photos dx'd me with the skin infection and rx'd Cefadroxil 500mg BID x 7. I am currently on treatment. Affected area has grown but not rapidly. Awaiting full resolution.
fatigue, achy, chills sweats, diarrhea, back pain and severe headache that began 2 hours after receiving the vaccine
monthly headaches started after 3rd shot (1st booster) of COVID vaccine; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 2, Manufacture: Unknown, Primary Immunization series complete), for Covid-19 Immunization; Covid-19 vaccine (Dose: 1, Manufacture: Unknown, Primary Immunization series complete), for Covid-19 Immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "monthly headaches started after 3rd shot (1st booster) of COVID vaccine". Therapeutic measures were taken as a result of headache.  Additional Information: Reporter says monthly headaches started after 3rd shot (1st booster) of COVID vaccine.  Headaches somewhat respond to Advil or Tylenol and do seem to coincide with hormonal changes related to her period. Name of Product: 3rd shot COVID Vaccine for adult. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The injection site is still sore to the touch and tight feeling. I?ve never had any vaccine sore more than a day or two. It?s now been almost 2 months. Otherwise I feel fine. No other side effects.
Client received 1st dose of Moderna vaccine series on 3/10 and then received 1 dose of Janssen vaccine on 3/16.
Violaceous swelling at injection site starting 14 days after injection as well as diffuse varicella lesions.
No additonal adverse event or product quality concern reported/ No addittional adverse events were experienced by the patient; an expired dose of VAQTA was admnistered on 24-MAY-2021; This spontaneous report was received from a register nurse via a company representative and refers to a 69 year old female patient.  The patient's pertinent medical history and drug reactions or allergies were unknown. There was no concomitant therapies.  The nurse reported that on 24-MAY-2021, one of the medical assistants vaccinated the patient with of an expired dose of hepatitis a vaccine, inactivated (VAQTA) second dose, lot # T014590 expiration date 15-APR-2021 for prophylaxis (dosage, route of administration and anatomical location were not reported). No additional adverse event were experienced by the patient. No prescription drug treatment was required. The patient did not required emergency room (ER) doctor visit. The vaccine has not had a temperature excursion (TE). The vaccine was evaluated and found to be supported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T014590; expirationdate: 15-APR-2021; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Initial information received on 04-Dec-2018 regarding an unsolicited valid non-serious case received from a Healthcare Professional. This case involves a 12 year old male patient who received 0.5ml of  vaccine FLUBLOK QIV (batch number: QFAA1810, expiry date: 30-Jun-2019) (route and series of dose were not reported) in the right deltoid on 03-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. It was a case of actual medication error due to inappropriate age at vaccine administration. It was not reported if any adverse reaction was experienced or not. It was also reported that No treatment needed at this time. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
chills; cold; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 06Mar2021 (Batch/Lot number: unknown) at the age of 69 years as dose 1, single and administration date 27Mar2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 07Mar2021, outcome "unknown", described as "chills"; NASOPHARYNGITIS (non-serious) with onset 07Mar2021, outcome "unknown", described as "cold".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.