chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "hysterectomy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization completed but manufacturer unknown), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "tired".  Additional information: Patient stated I have had a complete hysterectomy I need to take the medication daily. Patient asked I am on 1.25 he's going to move me to 0.9mg this year. Does it matter if the prescription strength changes. Also patient stated how received covid vaccination and I had just minor reactions, tired that kind of stuff after the booster but it had been over 6 months after the original vaccination. So, I think that was part of the problem.  Follow-up attempts completed. No further information is expected.
muscle cramping in the right calf; This is a spontaneous report from a contactable consumer (Patient's husband).  A 78-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no: EL3246), on Left Arm via an unspecified route of administration on 30Jan2021 9:15 AM at single dose for covid-19 immunisation. The patient medical history was not reported. The patients concomitant medication included unspecified Vitamins since 50 year. It was reported that Patient experiencing muscle cramping in the right calf, began 30Jan2021 9:15am, cramping started that afternoon. 6 hours later or so. Patient questioned was this a normal side effect. Just feels different. The Fax sheet he received stating the indication was to administer the vaccine as 2 doses, 3 weeks apart. However, the card he received at vaccination center had both him and his wife scheduled 27Feb2021 which was 4 weeks. He also had to report a side effect for his wife. His wife got her vaccine on the left arm, but right leg calf muscle was constantly acting like a Charlie Horse, it's cramping, like the muscle was pulling in the right calf. His Wife's first dose was on 30Jan2021 at 9:15 AM, and in the afternoon on the same day was when right calf cramping started, since then it has been constant. The Right Calf Cramping was definitely the same. He did not know if it was worse or not but she was just complaining last night about it, it's continuing, it has caused her to wake up during the night. for both him and his wife the second dose may be schedule on 27Feb2021. He clarifies that he was not sure what his wife was told, but the young woman gave the same date on his card and said this was the earliest date that he can be scheduled. Outcome of the event was not recovered
Pt experienced warm, hot, erythematous, upper extremity at injection sight. Symptomatic treatment encouraged including Tylenol/ibuprophen for pain, Benadryl for itching at site, and hydrocortisone cream topically.
left ear sounds like going up a mountain under water and a drun rill; left ear sounds like going up a mountain under water and a drun rill; left ear sounds like going up a mountain under water and a drun rill; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 21Oct2021 13:00 (Batch/Lot number: unknown) at the age of 75 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "some clod blood vessels in brainls" (unspecified if ongoing); "known allergies:penicillan" (unspecified if ongoing); "known allergies:sulphur" (unspecified if ongoing); "Acid relflex" (unspecified if ongoing); "Ibs" (unspecified if ongoing). Concomitant medication(s) included: FLU taken for immunisation, administration date 11Oct2021; RABEPRAZOLE; HYOSCYAMINE; CARBAMAZEPINE. Vaccination history included: Bnt162b2 (Dose: 2, Location of injection: Arm Right), administration date: 25Mar2021, when the patient was 75 years old, for COVID-19 Immunization; Bnt162b2 (Dose: 1, Location of injection: Arm Right), administration date: 04Mar2021, when the patient was 75 years old, for COVID-19 Immunization. The following information was reported: EAR DISCOMFORT (non-serious), EAR DISORDER (non-serious), TINNITUS (non-serious) all with onset 2021, outcome "not recovered" and all described as "left ear sounds like going up a mountain under water and a drun rill". Therapeutic measures were not taken as a result of ear discomfort, ear disorder, tinnitus.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
COVID; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient states he is calling because he got COVID four days after his first vaccine. He says he just has a question. He does not provide his last name when queried. The caller declines to file a report. The caller asks is it ok for him to get his second dose after the 3 week period. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Initial information received on 15-Oct-2018 regarding an unsolicited valid non-serious case received from other health care professional. This case involves six patients (age and gender was not reported) who was vaccinated with a dose of FLUZONE QUADRIVALENT (lot UJ045AC; expiry date: 30-Jun-2019) on an unknown date. The patients' past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage. Caller reported that they received a shipment of FLUZONE QUADRIVALENT and started using them right away. They received an e-mail later that the product had been in transit too long, it was shipped on 10-Oct-2018. Six Patients were already vaccinated. It was not reported whether the patients experienced any adverse events. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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 party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Headache started 20 minutes after vaccine was administered Left arm feels very heavy, weak started 40 minutes after vaccine was administered
Two minutes post injection her arm went numb at site & then shot down to finger tips.  At times there is throbbing (like punch) just at the site.  Feels like her arm went to sleep.
This is in f/u to a report submitted on 8MAR94;it has been determined that WAES93100554 is a duplicate report of WAES92120298;therefore, WAES93100554 is being deleted from our files & the report consolidated into WAES921202298
Large round rash at injection sight, pain in arm and itching two days after shot.  I have not yet had treatment. I will take zytex and  and Ibuprofen. Sounds like "Covid Arm" from what I read.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via a company representative via media concerned multiple patients of unspecified sex, age, race and ethnic origin. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected clinical vaccination failure, and suspected covid-19 infection. The reporter reported that "I caught it from my vaccinated wife who caught it at a party where everyone was vaccinated. 8 of them caught it. My son and I both caught it and had mild symptoms. No loss of taste or smell or even a cough. No vaccines, and I have multiple issues that probably should have made me very ill at least. My vaccinated wife got very sick and lost taste and smell for 4 months. I see vaccinated people every day coming down with covid. Most tell me they were at least very ill. They are not telling you the whole truth. I was definitely less sick than most people tell me about their personal experience with vaccine side affects". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000217227. This case, from the same reporter is linked to 20220230277 and 20220230393.; Sender's Comments: V0: 20220230299-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Pt seen today with continued pain in left arm where got Men B and Flu shot- says hurt to lift arm above head- had pain since getting shot over 2.5 months ago and pain not going away.
The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 11-May-2022; patient administered expired moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient administered expired moderna vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 11-May-2022) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 035C21A, 014M20A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient administered expired moderna vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 11-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient administered expired moderna vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 11-May-2022) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. on 23-Nov-2021 the patient received fourth dose of Pfizer included for Product used for unknown indication. Date the vial was initially stored in the refrigerator was 11-Jan-2022. The vial did not undergo any temperature excursions. Patients not had reported any adverse reactions. No treatment medication were provided.
Pt was given immunization at 2:30 PM. Immediately pt had itching of the lips and nose. Started walking directly to the emergency room and pt slid to the floor. Pt never lost conciousness but states she was having trouble breathing. Pt was administered an Epipen x 2 and 50 mg of Benadryl.
This case was reported by a physician and described an adult patient who did not respond to immunization with hepatitis B recombinant vaccine (Engerix-B) immunization series. The physician state that "some" patients did not respond to immunization with Engerix-B; however no patient identifiers were available. Medical history included HIV. The patient's concurrent conditions and concurrent medications were not reported. On unspecified dates, the patient received three doses of Engerix-B (lot number not specified). Subsequently, on an unspecified date later, a hepatitis B surface antibody titer indicated that the patient was "non-immune."
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 11-JAN-2017, the patient was vaccinated with an improperly stored dose of VARIVAX, lot number M033906, expiration date 20-JUL-2018 (dose, route and anatomical location were not reported) for prophylaxis (incorrect product storage). The vaccine was exposed to temperature of -5 Fahrenheit (F) (-20 Celsius(C)) and to the lowest recorded temperature of -14 F (-25C) during 4 hours and 5 minutes. The storage type was reported as "data logger". There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1701USA012890: US-009507513-1701USA013083: US-009507513-1701USA013084: US-009507513-1701USA013085: US-009507513-1701USA013086: US-009507513-1701USA013087: US-009507513-1701USA013088: US-009507513-1701USA013089: US-009507513-1701USA013090: US-009507513-1701USA013091: US-009507513-1701USA013092: US-009507513-1701USA013093: US-009507513-1701USA013095: US-009507513-1701USA013096: US-009507513-1701USA013097: US-009507513-1701USA013098: US-009507513-1701USA013099: US-009507513-1701USA013100: US-009507513-1701USA013101: US-009507513-1701USA013102: US-009507513-1701USA013103: US-009507513-1701USA013104: US-009507513-1701USA013105: US-009507513-1701USA013106: US-009507513-1701USA013107: US-009507513-1701USA013108: US-009507513-1701USA013109: US-009507513-1701USA013110: US-009507513-1701USA013082:
pt recv vax & exp arm redness, swelling & itchiness;it was reported that arm felt like pox & 10 days later all glands were swollen;
Patient called March 7th stating she has soreness in arm and nausea, but also a 'feeling of a lump sitting in her throat'.  She had received the vaccine on March 6th. Patient advised to call doctor or go to emergency room. Pharmacist called patient back about 15 minutes later and patient reported the swelling seemed to have gone down some, but she feels fine.
Vertigo in various intensities has now lasted 28 days. I have had a 4-5 chiropractic adjustment and one acupuncture treatment. With more of each scheduled.
brain aneurysm/thunderclap headache on 3/1/21.  Intense pain in head for 3-4 minutes, body immobilized, followed by continued more general pain in head, dizziness, ringing in ears for several weeks afterwards.
Initial information received on 03-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves patient who experienced flublok quadrivalent to a pediatric patient, while he/she received vaccine FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via intramuscular route. It was a case of actual medication error due to Inappropriate age at vaccine administration. The patient outcome is reported as Not Applicable for flublok quadrivalent to a pediatric patient. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
Patient came in on 7/20/16, he reported that he experienced adverse reactions to ZOSTAVAX vaccine that was given to him on 7/10/16. He reported of skin redness, tender to touch, and also itchiness after one day of injection. Patient reported that the size of skin redness was about the size of his fist. It also raised/swollen about 1/4 inch. Patient did not seek medical help or reported to pharmacy during the duration of adverse event. All the symptoms have resolved on the day of reporting (7/20/16) AM, except, patient still experience itchiness. The site of injection is still slight pinkish. Pharmacist recommended patient to take BENADRYL as needed for itchiness according to label recommendation for OTC product. Also reported to patient's primary care physician.
Patient has swollen elbow does not radiate up arm or past elbow  not swollen or red at injection site    Dr thinks bursitis or cellulitis.
After the vaccine 2nd dose, I noticed the actual injection was painful (as compared to the 1st injection). An hour later, I started to feel really tired. In the evening, my whole body started to hurt. I had a headache and full body aches and pain from head to toe. I did not take any medications. The next several days, I was still fatigued, my body still in pain, nausea, numbness and tingling on the right side of body (right hand  and foot). I also felt feverish. On day 3, I noticed a rash which started in the center of both my palms going towards the wrists. The rash looked like hives and it was very itchy. I had itchiness on your hands, arms and legs. On 6/23/2021, I went to see my doctor. I was given Prednisone, Benadryl, triamcinolone ointment, Motrin 800mg and was diagnosed with an allergic reaction possibly to the vaccine. I am still feeling under the weather, but the rash has resolved.
No adverse reaction took place , on 04/06/2023 patient received an expired vaccine. We received lot #  FL2757 on 02/02/2023 , keep in fridge under recommended temperature up to 10 weeks , BUD was 04/13/2023. The manufacturer expiration is up to 18 months  which was 03/31/2023 , the vaccine expired before the BUD ( 04/13/2023). The box does not an expiration date on it , we add the BUD on box once received on 02/02/2023. from now on , I place both the Expiration  and BUD  date on box. child is fine.
Sudden Death 5-7 days after 2nd vaccne - I am unsure of vaccine or if family will report.
fever; tenderness at the injection site; weird taste in the mouth; headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), TENDERNESS (tenderness at the injection site), TASTE DISORDER (weird taste in the mouth) and HEADACHE (headache) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced PYREXIA (fever), TENDERNESS (tenderness at the injection site), TASTE DISORDER (weird taste in the mouth) and HEADACHE (headache). At the time of the report, PYREXIA (fever), TENDERNESS (tenderness at the injection site), TASTE DISORDER (weird taste in the mouth) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. Treatment included Tylenol and Aleve   This case was linked to US-MODERNATX, INC.-MOD-2021-085590 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-085590:Case for husband
lt arm from shoulder to elbow redness, swelling & tenderness 1 days p/vax;no lymphadenopathy;w/pruritus of arm & stiffness lasting 3 days;no fever;still swollen but improving 7DEC98;
Seven minutes post-vaccine patient stated she felt light-headed and dizzy. Vitals within normal limits, then BP and pulse slightly dropped the patient remained under further observation. The patient began to feel a headache and nausea 30 minutes post-vaccination. Benadryl 12.5 mg chewable was given. Due to increased headache and dizziness with no improvement, EMS was called, and the patient was taken for further observation.
fatigue starting 7 PM and continuing to present (1 PM following day) headache, fever and chills 8 PM to 8 AM muscle ache 2 hours after injection and continuing to present  treated with ice packs, tylenol, rest
Recipient presented to PCP office 12 days post injection with swelling and mild erythema with warm to touch area of injection.
Pt described burning, itchy, red puffy skin. Swollen about 3 in in diameter. Symptoms still present on 11-05-18.
Sore RT arm for over thirty hours could not move the arm up or down, like a frozen shoulder. After a few days, it seemed better but not back to normal use.  Around 8 - 10 days later both arms are now frozen with extreme pain as well as his hip flexors are bad. Both arms continue to freeze up where the pain and movement are extreme. Hips and legs also have heaviness feeling, cramps, and pain in LT hip flexors.
I tested positive for covid19; I tested positive for covid19, following sore throat and headache; I tested positive for covid19, following sore throat and headache; I tested positive for covid19, following sore throat and headache; This is a spontaneous report from a contactable pharmacist (Patient).  A 45-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Batch/Lot Number: EL3302), via an unspecified route of administration in Arm Left on 14Jan2021 16:00 as 2nd dose, single dose for covid-19 immunization.Medical history included drug allergies to sulfa. Concomitant medications included phendimetrazine (PHENDIMETRAZINE). Patient did not had COVID-19 prior to vaccination. Other vaccination, which was given within four weeks included, first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Batch/Lot Number: EL0140), via an unspecified route of administration in Arm Left on 24DEC2020 1st dose, single dose for covid-19 immunization. On 13Mar2021 at 08:30, the patient experienced vaccination failure, covid-19 following sore throat and headache. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 13Mar2021.The adverse event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures included treatment with azithromycin, ivermectin. The outcome for the events was resolving.    No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the onset of events and the administration of vaccine cannot be excluded.