chrisvoncsefalvay/vaers-outcomes huggingface dataset:
been very itchy at the injection site; stomach cramps; diarrhea; a huge lump which is hard/lump was large as a silver dollar and now its the size of 50 cents; fever; arm hurt a lot; very tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (been very itchy at the injection site), ABDOMINAL PAIN UPPER (stomach cramps), DIARRHOEA (diarrhea), VACCINATION SITE MASS (a huge lump which is hard/lump was large as a silver dollar and now its the size of 50 cents) and PYREXIA (fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Aug-2021, the patient experienced VACCINATION SITE PRURITUS (been very itchy at the injection site), ABDOMINAL PAIN UPPER (stomach cramps), DIARRHOEA (diarrhea), VACCINATION SITE MASS (a huge lump which is hard/lump was large as a silver dollar and now its the size of 50 cents), PYREXIA (fever), PAIN IN EXTREMITY (arm hurt a lot) and FATIGUE (very tired). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM AD) at a dose of 1 dosage form and IBUPROFEN at a dose of 1 dosage form. On 01-Sep-2021, PYREXIA (fever) had resolved. On 04-Sep-2021, FATIGUE (very tired) had resolved. On 08-Sep-2021, ABDOMINAL PAIN UPPER (stomach cramps) and DIARRHOEA (diarrhea) had resolved. At the time of the report, VACCINATION SITE PRURITUS (been very itchy at the injection site), VACCINATION SITE MASS (a huge lump which is hard/lump was large as a silver dollar and now its the size of 50 cents) and PAIN IN EXTREMITY (arm hurt a lot) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reportedly, Patient was not allergic to anything.  Patient states that she possibly had been exposed to COVID-19 in Feb2020  Patient gave SO consent to follow up with vaccination site and HCP.  Concomitant product use was not provided.  Treatment product information was not provided.
Patient received dose of COVID19 (Pfizer-BioNTech) past the vial BUD (Beyond Use Date) of 32 days from transfer of deep freeze to refrigeration temperature. BUD date of dose was 1/7/22 at 0900, patient received vaccination on 1/14/22. When error discovered facility contacted CDC for course of action. At direction of the CDC, patient outreached regarding occurrence to offer re-vaccination of dose. No adverse side effects or event as result of dose.
Mixing error occurred, patient may have received only diluent. Pt wants to revaccinated when dose is available
localized cellulitis secondary TD vax accompanied w/n/v, fever;advised to take motrin, APAP, ice;area of cellulitis f/u PRN;
Upon follow-up information received on 20 January 2015, the unsolicited case became valid as patient was identified (initials provided). Initial case received from a healthcare professional on 13 January 2014. The physician reported that he has had several unidentified patients get confirmed with influenza after being immunized with FLUZONE vaccine this season. The patient's sex, age, date of birth, lot number, route, dates and site of administration were not reported. The patients' medical histories, relevant lab tests and concomitant medications were not reported. This case is invalid due to patient information details were not reported. No further details available at the time of this report. Patient outcomes are unknown. Follow-up information regarding unsolicited case received from a healthcare professional on 20 January 2015. The case became valid as patient's initials were provided. The suspect vaccine is FLUZONE. Documents held by sender: None.
Initial and follow up information has been received from a registered nurse concerning a healthy female infant who on 17-JUL-2008 was inadvertently vaccinated with PNEUMOVAX(lot number: 657626/1084U) (route not known) instead of PEDIARIX(lot number: AC21B138BA). The nurse reported that the boxes were right next to each other in the refrigerator. Both boxes are pink and white and both vials have maroon caps on them. Product confusion occurred. In follow up it was reported that patient recovered and had no treatments. Additional information is not expected.
Two weeks after 2 month shots (OPV, HIB, Hep B, DTaP, Pneumococcal), patient became ill, poor feeding, weight loss, and petechiae. Visited ER; referred to Hematology, had thrombocytopenia, platelets in 30's-40's for several weeks. No active bleeding. Platelet count recovering spontaneously. Currently 80,000.
This spontaneous report was received from a healthcare professional referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions and drug reactions/allergies was not reported. On 27-OCT-2015, the patient was vaccinated with PNEUMOVAX 23, (dose, lot # and expiration date were not provided). Concomitant medication was not reported. On 28-OCT-2015, reported as "within 24 hours", the patient experienced terrible pain in the arm after being vaccinated with PNEUMOVAX 23. The outcome of pain in extremity was reported as recovered on an unspecified date in November 2015, reported as "approximately one week after vaccination". The reporter did not assess the relatedness between pain in extremity and PNEUMOVAX 23. This is one of the several reports received from the same source. Additional information has been requested.
Started to have ear ache, had scheduled appointment with provider same day who reports severe otis media and ear drum looks like it was going to rupture.  Was given Antibiotic zithromax.  I got home and started violently vomiting at 12:30.  Did not take antibiotic until Saturday 8.21.21 do to vomiting. by 8.23.21 lost hearing in both ears and was worse.  PCP was unable to see me so went to walkin clinic.  There was tested for rapid Covid which came back negative.  Provider started sudafed 30-60 mg every 6 hours during day, benedryl 25-50mg at bedtime. Told to stop zithromycin and started Keflex twice daily.  PCP called and was told to start Levaquin.  Still having fever, chills, sore throat, fatigue, and was not able to hear.  8.26 called and went back to PCP.  Right ear was better and no signs of infection however now my left ear was inflammed.  PCP stated eustation tube was inflammed and started prednisone 20mg BID for 3 days and if hearing was not better to take another 3 days.  Hearing came back in right ear, but not the left ear.   I did take the other 3 days of prednisone.
got the Pfizer Booster shot; felt like I had Covid (infection); felt like I had Covid (infection); Bad Headache; Ears hurting and they kept constantly feeling like there was buzz; Ears hurting and they kept constantly feeling like there was buzz; Sore not at the site of the shot but everywhere just for 2 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administration date 17Nov2021 (Batch/Lot number: unknown) at the age of 64 years as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, administration date 16Nov2021; METOPROLOL. The following information was reported: IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "got the Pfizer Booster shot"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Nov2021, outcome "unknown" and all described as "felt like I had Covid (infection)"; HEADACHE (non-serious) with onset Nov2021, outcome "unknown", described as "Bad Headache"; EAR PAIN (non-serious), TINNITUS (non-serious) all with onset Nov2021, outcome "unknown" and all described as "Ears hurting and they kept constantly feeling like there was buzz"; PAIN (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "Sore not at the site of the shot but everywhere just for 2 days". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19, headache, ear pain, tinnitus, pain which included patient took some Tylenol that's all she could take and drank like a big bottle of water. She drank some tea and just thought that she was going to be dead, that's the worst thing ever. Clinical course: she started out with the really bad headache and her ears were hurting and they kept constantly feeling like there was buzz in into like that. She just got hearing she can't explain it and then there was a lot of pain, all she did she just go to bed. It just felt like she had Covid (infection), she had not have it but that's how she felt after getting the shot. She was in so much pain and it was not good, it was for 2 days. She got the vaccines (first and second dose) and after that she got the Booster shot (Covid Vaccine). Afterwards, she knew it can be sore or what not at the site of the shot but everywhere but it was just for 2 days, so all once all she had on Thursday but today she was feeling ok.  The lot number for bnt162b2 was not provided and will be requested during follow up.
In 05/2021, I went home for summer break and woke up sick with a really bad cough, bad sore throat, and sinus congestion. I went to urgent care and they said I had an upper respiratory infection. They gave me Benadryl as treatment. In 10/2021, I woke up sick with the same symptoms, but after a week I was fine. Then, about a week ago I woke up with the same symptoms again that I still have today 11/05/2021. I have been taking Nyquil and Coricdin.
At 18:00 on 2/10/01, pt had temperature and the fontanel was raised and firm. At 08:00 on 2/11/01, pt was brought to ER and about 11:00 on 2/11/01, pt underwent a CT Scan that showed hydrocephalus. An MRI was performed on pt on 2/12/01 at 13:00 and the report stated that pt had prominent hydrocephalus. Pt was seen by a neurosurgeon on 2/11/01 and started a treatment of acetazolamide. He took this for approx. 3 months. After 1 week of last dose, another MRI was done on 4/27/01 and still shows hydrocephalus. Follow up information received 09/18/02 states "(the child) is developing normally without any delays. His neurosurgeon has told me that she is no longer needs to see him,unless something happens that causes his hydroceohalus to begin progressing. I am intersted in trying to get another MRI done to see (the child) present condition.". The annual follow-up states "pt still has hydrocephalus, eventhough it is not progressing. Pt is developing normally without any delays. His neurosurgeon has tol dme that she no longer needs to see him, unless something happens that causes his hydrocephalus to begin progressing. I am interested in trying to get another MIR done to see pt's present condition." MRI done 04/21/2001 shows improvement from 02/12/2001 study, however prominent ? persuits despite Tx w/ acetazolamide.Pt was seen in ER on 06/03/2001 for a fever of 101.3. Some nasal congestion. Dx "virus", P O good, well hydrated, D/C'd to home.
This spontaneous report was received from a physician refers to a 15 years old female patient. On an unknown date (many years ago), the patient was vaccinated with a dose of VARIVAX (lot#, expiry, dose, route not reported). No concomitant medications were reported. On an unknown date in 2012 (currently), the patient developed shingles. The physician does not know how many doses of VARIVAX the patient had received. Physician did not know the name of the pediatrician who had administered the vaccine. Patient had sought medical attention(office visit). No treatment information was reported. The outcome of shingles was reported as not recovered. The relatedness for shingles was unknown for VARIVAX. Additional information is not expected.
Patient was administered a third dose of the Fluzone Quadrivalent no adverse reaction was reported or noted at the time of administration.
52 yo male received first dose of Pfizer vaccine on 3/20 at outside institution. The next morning, pt experienced uncontrollable tremors and twitching and presented to the ED. In the ED, patient had generalized tonic-clonic seizure that lasted for about 1-3 minutes. CT head scan was unremarkable. Neurology started pt on Keppra 500 mg BID and plan for MRI and routine EEG. The next morning, pt felt back to baseline and was alert and oriented.  Patient has a history of HIV and stroke with residual right-sided weakness. He has no history of seizure nor reactions to vaccines. Physician advised patient that he should not receive second dose of vaccine.
Patient fully vaccinated with Pfizer COVID vaccine at  on 12/30/20 and 1/20/21. Pt. reports COVID symptoms of Sinus Pressure, Cough, Headache, runny nose starting on 9/16/21 and tested COVID PCR positive via NP swab on 9/17/21.
Very large warm and red area in the arm; Very large warm and red area in the arm; Felt very bad; This spontaneous case from was received on 11-Oct-2021 from registered other health professional via the Regulatory Authority (reference number: SEQW21-03662) and concerned an 82-year-old female patient.   The patient's medical history and concomitant medications were not reported.   On an unspecified date in 2019, the patient was vaccinated with Flucelvax Quadrivalent (Influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid) for influenza prophylaxis. The batch number was 261200 and expiration date was 21-Jun-2020.  On an unspecified date in 2019, an unspecified amount of time after receiving Flucelvax Quadrivalent, the patient felt very bad. She experienced very large warm and red area in the arm.  At the time of this initially reporting, the outcome of the events 'felt very bad' and 'very large warm and red area in the arm' (redness and skin warm) was not reported.  This case was assessed as non-serious.  Case updated on 26-Nov-2021: Correction made to information received on 11-Oct-2021: Company causality assessment was amended from 'related' to 'unassessable'. No changes made in narrative.  Company comment: An 82-year-old female patient was vaccinated with the suspect product Flucelvax Quadrivalent. An unknown amount of time after vaccination the patient was feeling abnormal and experienced warm skin and erythema of arm. Due to limited information provided, causality is unassessable.; Sender's Comments: An 82-year-old female patient was vaccinated with the suspect product Flucelvax Quadrivalent. An unknown amount of time after vaccination the patient was feeling abnormal and experienced warm skin and erythema of arm. Due to limited information provided, causality is unassessable.
patient received  1.0 ml  of Fluzone Quadrivalenton, no AE; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA297927, 2019SA317307, 2019SA317358, 2019SA317359, 2019SA317360, 2019SA317361, 2019SA317362, 2019SA317363, 2019SA317364, 2019SA317365, 2019SA317366, 2019SA317367, 2019SA317369, 2019SA317370, 2019SA317371, 2019SA317372, 2019SA317373, 2019SA317374, 2019SA317375, 2019SA317376 (same reporter).  This case involves a 59 years old patient (gender not reported) who received a 1.0 ml of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [Fluzone Quadrivalent] (lot UJ223AB, expiry date not reported) via unknown route in unknown administration site (side reported as left) on 22-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of overdose.   At the time of reporting, no adverse event was reported.   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.
Erectile dysfunction.  Inability to gain a full erection; This is a spontaneous report from a contactable consumer (patient). A 19-year-old male patient reported that he received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration, administered in right arm on 01Jun2021 at 15:45 (at the age of 19 years) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Facility type vaccine was pharmacy or drug store. No other vaccine in four weeks. No COVID prior vaccination and no COVID tested post vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration, administered in right arm on 11May2021 at 15:45 (at the age of 19 years) as dose 1, single for covid-19 immunisation. The patient experienced erectile dysfunction and inability to gain a full erection on 03Jun2021. AE resulted in doctor or other healthcare professional office/clinic visit. No treatment received. The outcome of event was not recovered.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101103163 similar report from same reporter
fluzone quadrivalent given during pregnancy with no reported adverse event; Initial information received on 14-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 38 years old female patient who was exposed to vaccine influenza quadrival A-B vaccine [Fluzone Quadrivalent] in context of fluzone quadrivalent given during pregnancy with no reported adverse event.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.   The reported fluzone quadrivalent given during pregnancy with no reported adverse event occurred at 19 weeks of pregnancy.  The date of last menstrual period was reported as 14-May-2023.  The estimated due date is 17-Feb-2024.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 14-Sep-2023, the patient received a DOSE 1 dose of suspect Influenza Quadrival A-B Vaccine Suspension for injection dose, strength, expiry date, lot number not reported via intramuscular route in unknown administration site for prophylactic vaccination (immunization).  On 14-SEP-2023 fluzone quadrivalent given during pregnancy with no reported adverse event (exposure during pregnancy) on the same day.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event fluzone quadrivalent given during pregnancy with no reported adverse event.  Additionally, at time of reporting, the pregnancy is still ongoing.
Patient received the vaccine and after 3 to 5 minutes, reported a feeling of dizziness and felt like he was going to pass out. The patient shortly reported sharp spiking, pulsating pain in his spine area and lower back. He rated the pain as 8/10. The pharmacist stayed with the patient and asked question to determine if there are any signs of severe allergic reaction but did not find any. The pharmacist kept talking to the patient for and after a couple of minutes, the patient reported that the feeling of passing out was no longer felt. The pain in the spine and the lower back improved and the patient indicated that he was able to drive home. The patient called back to the pharmacy to tell that he feels fine and he was no longer in pain. The pharmacist followed up with the patient on 05/20/2020 at 7:15pm and the patient indicated that he is fine and is not having any adverse symptoms.
Patient's mother called in and stated that the area around the injection site is hot, red, itchy, and the size (circumference) of a baseball.
Patient with Apprehension noted prior to 1st dose, pt received 3 dose, HPV (2nd) Followed by IPV, pt with complaint of  "not feeling good", passed out immediately after, had tonic-clonic movement and posturing noted, Lasted 30 seconds, responsive after 3rd Ammonia inhalant, alert x3, with c/o "eyes; see Back; Feeling Funny ", patient with urinary incontinence  during event. Placed supine on Floor with legs Elevated, Released to Father 30 min Later. Patient Ambulatory. Follow-up with parent 3 Hrs Later, pt home Resting with complaint of nausea, No other events reported.
This spontaneous report as received from a medical assistant refers to two unspecified patients of unknown age and gender. There was no information about the patients' pertinent medical histories, concomitant medications and drug reactions or allergies reported. On an unknown dates, two patients were vaccinated with an improperly stored doses of ROTATEQ (lot# L010844, expiration date 16-NOV-2016, dose was not reported; orally). No adverse effects were reported. Temperature 34.9 Fahrenheit with time frame 3 hours, data logger was involved and there was no previous temperature excursion reported. This is one of several reports received from the same reporter. Additional information has been requested.
Two weeks later he was diagnosed with Covid.; he was diagnosed with Covid. he was asymptomatic, but not feeling 100%; This is a spontaneous report received from a contactable pharmacist. A 50-year old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration as single dose on an unspecified date for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received his first dose of BNT162B2 vaccine. Two weeks later he was diagnosed with COVID. He was asymptomatic, but not feeling 100%. The pharmacist asked if patient should receive the second dose of vaccine. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
I experienced stage 3 reactions during the night,tachycardia,  nausea, vomiting, diarrhea, vasovagal reaction when I got up with bradycardia of 40/min, syncope,  and my face swelling.  It continued to swell including my lips, inside of my cheeks.  I took 12.5 mg of Benedryl to prevent my throat from swelling too.  This am March 19 my mouth isn't as swollen but my face still is.
Patient developed fever on day of covid vaccine (got flu same day) and continued into the next day, Tmax 102. Went away for a week and then started having a fever again up to 101 Also had chills, sweating, and headache
Swollen and tender in the armpit area under my left arm where the shot was administered. I assume it is my lymph node that is swollen.