chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received third dose 0.5 ml dose; This spontaneous case was reported by an other health care professional and describes the occurrence of OVERDOSE (Patient received third dose 0.5 ml dose) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A, 030L20A and 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (fluticasone), Drug allergy (bupropion), Drug allergy (citalopram), Drug allergy (codeine), Penicillin allergy (PNC), Drug allergy (primidone), Hypothyroidism since 12-Feb-2016, Memory loss since 12-Dec-2016, Peripheral neuropathy since 23-Aug-2021, Cystocele on 12-Dec-2016, Rectocele since 12-Dec-2016, Depression, Anxiety and Atrial fibrillation since 08-May-2022. Concomitant products included IPRATROPIUM BROMIDE (ATROVENT ADULTES) from 27-Apr-2022 to an unknown date for Allergy, BUSPIRONE HYDROCHLORIDE (BUSPAR) from 23-Aug-2021 to an unknown date for Anxiety, METOPROLOL from 04-May-2022 to an unknown date for Atrial fibrillation, TRAZODONE from 23-Aug-2021 to an unknown date for Depression, THIAMAZOLE (TAPAZOLE) from 09-May-2022 to an unknown date for Hypothyroidism.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 27-Oct-2021, the patient experienced OVERDOSE (Patient received third dose 0.5 ml dose). At the time of the report, OVERDOSE (Patient received third dose 0.5 ml dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details was not reported by the reporter.   This case was linked to MOD-2022-574080 (Patient Link).
The adverse  symptoms that I experienced and am still experiencing is an outbreak of tiny bumps on my face like a rash of some sort. I have never had any problems with my skin.
Passed out; Vasovagal reaction; Dizzy; Skin was sweaty; Pale; This is a spontaneous report from contactable Pharmacist. A 17-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Left on 06May2021 10:15 am (Lot Number: EW0171) at the age of 17-year-old as single dose for covid-19 immunisation. Medical history reported as none. No known allergies. The patient was not pregnant. The patient's concomitant medications were not reported. Vaccine was given, patient was sitting with her mother. Approximately 10 minutes after vaccine, she slumped to the side and passed out. When the reporter got to her she was just waking up. She still felt dizzy, skin was sweaty and pale. Paramedics arrived within 5-10 minutes to evaluate. They said they had seen this vasovagal reaction with the covid vaccine. Patient left on gurney with the paramedics. Adverse events start date was 06May2021. Events resulted in Emergency room/department or urgent care. The outcome of the events was unknown. The patient had no covid prior vaccination, no Covid tested post vaccination.; Sender's Comments: Based on a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event of Loss of consciousness. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
inflamed; Pain in the arm; Redness; Swelling; severe pain; my arm felt like a rock; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm), ERYTHEMA (Redness), SWELLING (Swelling), PAIN (severe pain) and INDURATION (my arm felt like a rock) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (sulfa drugs), Latex allergy, Drug allergy (formaldehyde), Hiatal hernia and Anxiety. Concomitant products included SERTRALINE for Anxiety, OMEPRAZOLE for Hiatal hernia, VITAMINS NOS for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in the arm), ERYTHEMA (Redness), SWELLING (Swelling), PAIN (severe pain) and INDURATION (my arm felt like a rock). On an unknown date, the patient experienced INFLAMMATION (inflamed). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in the arm) and PAIN (severe pain) had not resolved and ERYTHEMA (Redness), SWELLING (Swelling), INDURATION (my arm felt like a rock) and INFLAMMATION (inflamed) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had been to the physician's office. Treatment details included applying ice pad. Action taken with mRNA-1273 in response to events was not applicable.   This case was linked to MOD-2021-084745 (E2B Linked Report). This case was linked to MOD-2021-084638, MOD-2021-084638 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Follow-up information received and patient demographics updated, medical history, dosage information, reporter details and events updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. MOD-2021-084745:crosslinked, Husband
Lump on her arm that started right after her second dose of the vaccine; It is just a little red dot.; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE MASS (Lump on her arm that started right after her second dose of the vaccine) and VACCINATION SITE ERYTHEMA (It is just a little red dot.) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (INFLUENZA) for an unknown indication.    Previously administered products included for Product used for unknown indication: Pfizer (Dose 1), pfizer (Dose 3) and pfizer (Dose 2). Past adverse reactions to the above products included No adverse event with Pfizer, pfizer and pfizer.   On 22-Sep-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (INFLUENZA) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (Lump on her arm that started right after her second dose of the vaccine) and VACCINATION SITE ERYTHEMA (It is just a little red dot.). At the time of the report, VACCINATION SITE MASS (Lump on her arm that started right after her second dose of the vaccine) had not resolved and VACCINATION SITE ERYTHEMA (It is just a little red dot.) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Dose number 3 was Moderna which was taken on 16 Sep 2022 with lot number AS7145B. Bump was lower on her arm. It was not hard but squishy on her left arm. No treatment medication reported.
Patient C/O severe pain in Left deltoid that began in the am following receipt of Tdap. The pain has not improved since this time. The pain increase with movement. She rated the pain as 3-8/10. She is experiencing decreased ROM. She denies pain in any of her joints. She is using Ibuprofen PRN with Minimum relief. She saw her PMD on 3/21/06 and states that he told her to continue with comfort measures such as the application of heat or cold PRN, and use of Ibuprofen PRN. He also prescribed Vicodin PRN pain not relieved by Ibuprofen.
Arm was sore for 24 hours; This is a spontaneous report from a contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Jan2021 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced that her arm was sore for 24 hours on Jan2021 with outcome of recovered on Jan2021.  No follow-up attempts are possible; information on lot/batch number cannot be obtained.
Took 1 capsule 10PM 5/11/06 at 1 AM woke up with slight HA. Woke up again 4AM with HA still and slight stomach ache. At 6AM woke up with chills, HA, dizzy. Like this all day. Temp taken later in day was 10.3.7. Went to ER 9:30PM given IV fluids and 2 meds for stomach. Released 1 AM 5/13/06. Had diarrhea 5/14 and 15. No symp 5/16/06.
Initial report received from a Pharmacist on 15 JAN 2010: This patient, with an unknown medical history was vaccinated with 0.5 ml FLUVIRIN (Batch number 104045P1), intramuscularly, on an unspecified date. The FLUVIRIN vaccine was stored at a temperature which was as low as 34 degrees Fahrenheit and 35 degrees Fahrenheit. No adverse event was reported.
4/27/21 visit to clinic: 74yr old female who has had off balance and leaning way to right and stumbling. This lasted short time.  By time sister got to view she was sitting in a chair. Some of these symptoms began 2 days before this visit and have been completely resolved since that time.   Patient has tried No medications.  7/9/21 clinic 75yr old female presents for referral to ortho for fracture of elbow and possible wrist.  Had fallen 6 days ago.  Was seen in ER and pout in posterior cast and told to see ortho when back here.  recommends for her to be seen by Specialist.  She may need a total elbow replacement.    9/12/21 ED Closed displaced fracture of medial epicondyle of right humerus, unspecified fracture morphology, initial encounter Acute  9/17/21 admit to nursing home H/O: CVA (cerebrovascular accident)   Dementia without behavioral disturbance, unspecified dementia type (HCC)   Cognitive safety issue     Plan: She will be admitted to nursing home on Tuesday, 9/21/2021.  We have asked her that the physical therapy would evaluate her for the best cane possible   10/29/21 Patient presents to ED via EMS from nursing home for diaphoresis, altered mental status.  She was 'found like this' by nursing just prior to arrival to ED.  Patient has prior history of CVA, recovered.  Staff believed she may be having 'another stroke'.
-muscle pain    -no taste/smell-bitter tasting -chills/fever x3     -thought he was going to die-had the feeling of body shiftingdown -sinus drainage -weak not able to move -0 balance     -hot -couldnt eat x4 days    -tired     -diarrhea
Red warm sore arm after injection. TYLENOL ice OOW 2 days. Seen 6/29 no return calls of concern at this time.
Nausea, diarrhea, vomiting, fever, malaise, soreness at injection site
Discomfort; Hard; swollen; red, 3 to 4 inches, Slight redness; itching; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Hard), PERIPHERAL SWELLING (swollen), RASH ERYTHEMATOUS (red, 3 to 4 inches, Slight redness), PRURITUS (itching) and DISCOMFORT (Discomfort) in a 78-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 16-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Hard), PERIPHERAL SWELLING (swollen), RASH ERYTHEMATOUS (red, 3 to 4 inches, Slight redness) and PRURITUS (itching). On an unknown date, the patient experienced DISCOMFORT (Discomfort). At the time of the report, MUSCULOSKELETAL STIFFNESS (Hard), PERIPHERAL SWELLING (swollen), RASH ERYTHEMATOUS (red, 3 to 4 inches, Slight redness), PRURITUS (itching) and DISCOMFORT (Discomfort) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Benadryl and ice used as Treatment medication. No Concomitant medication was provided by Reporter.
Noted itching on cheeks at night. In AM reported "puffiness" of cheeks and an erythematous "blotchy" area on forehead. No raised lesions, mild excoriation from rubbing presumably. No other exposures or contact known. No shortness of breath, wheezing, throat swelling, urticaria, fever, chills, myalgia, cough or chest pain. Patient took Benadryl which helped the itching.
A few days after I received my Fall 2019 flu shot, I had awful side effects. I was going to class full-time and I all of a sudden had weak knees, I couldn't even make it back to my car after class. I was suddenly very lightheaded, I was crying uncontrollably for no reason, my hair was falling out, I couldn't even drive a mile down the road without feeling like I was going to pass out at any minute. These side effects lasted for about a month. To this day, I suffer every single day of lightheadedness/dizziness. It all came down after I received my flu shot. I've taken flu shots every single year and I have never had side effects. I take therapy for it and I have what they call "sensory mismatch." It is very common to have after a live virus enters your system. My life has been a living hell after last year's flu shot, unfortunately.
expired dose of Pentacel was administered to 4 month old patient, no adverse event; Initial information was received on 22-Jun-2020 regarding an unsolicited valid non-serious case from an other health professional  This case involves a 4 months old female patient who was administered an expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Expired product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE and ROTAVIRUS VACCINE for prophylactic vaccination.  On 18-Jun-2020, the patient received a 0.5 ml dose 1 of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (diluent: Lot: UJ066ABA, ActHib Lot: UJ100AA) (expiry date 13-Jun-2020) via intramuscular route in the left thigh for prophylactic vaccination  It was a case of an actual medication error due to expired vaccine used  At the time of report, 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 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.
Red rash, started small now is two inches. Warm to touch with knot. First two days arm hurt like a bee sting. Minimal pain now but rash still there.
My son had a reaction about 8 days after immunizations. Started with high fever for 2 days, irritability, at day 10, had full light body rash, at day 11 started with hives all over body that came and went, irritable, and a little in pain.
Vaccine Recipient received Pfizer Pediatric Dose 0.2mL instead of Pfizer 12+ 0.3mL dose for their 2nd dose.
approx 2yrs p/vax pt broke out in 8 pustule chickenpox lesions. seen in MD ofc w/less than 50 lesions & chickenpox confirmed.
Myalgia, Arthralgia & NauseaVomiting Narrative:  Nausea Body aches X 2 days
Hives presenting on the face that improves slightly with taking PO Benadryl. Hives still present after two days from initial presentation. Continued use of Benadryl is needed.
Patient got her booster shot on 3/17/22.  She stated that she didn't have any problems with the first two doses.  States that the next day at work her arm was red, swollen and had heat to it.  Her co-worker said that she had a similar reaction and advised her to go to the ER after work.  She did and the ER physician diagnosed her with a bacterial infection and gave her Augmentin.  Patient reported to the pharmacy a few days later to let us know so we could report the reaction.  Her arm was much improved, only slightly red around the injection site.  Patient denies any other symptoms (rash, fever, etc.)
Patient received his Pfizer booster dose (LOT#: FL3198) on 1/02/21 at 1448. Patient alerted RN and stated that he felt a slight headache and he felt his "heart racing" at 1457. RN's arrived on scene at 1458. RN took patients vital signs at 1458. BP: 200/113 HR: 120, O2: 98%. Patient stated that he still felt a slight headache and his heart racing. Patient stated that he was diagnosed with pre-hypertension in 2018. RN retook patient vital signs at 1503. BP: 170/100, HR: 110, O2: 99%. Patient stated symptoms were continuous and there was no change. RN retook patients vitals at 1508. BP: 172/92, HR: 115, O@: 98%. Patient stated symptoms have not changed. RN retook patients vitals at 1515. BP: 150/90, HR: 105, O2: 98%. Patient stated that symptoms are subsiding and he's "feeling better." RN retook patients vital signs at 1523. BP: 150/90, HR: 108, 98%. Patient stated he no longer feels like his heart is racing and his headache is subsiding. RN took patients final vital signs at 1529. BP: 154/ 96, HR: 108, O2: 98%. Patient stated that he was feeling better and that he no longer felt his heart racing or a headache. RN educated patient on adverse effects of COVID vaccine and educated client on hypertension and when to seek EMS, ED, or urgent care. RN gave patient paperwork and recommended that patient make appointment with PCP. Patient verbalized understanding. Patient completed 30 minutes of observation and left vaccination site with Dad unassisted and with a steady gait at 1535.
Pt recvd 2nd dose of vax on 24AUG90 & exp irritation @ inject site.
Inconsolable crying x 24 hrs. afebrile no resolution with TYLENOL.
Consecutively took first and second dose of Vivotif on 1st and 2nd day; A spontaneous report was received from nurse on 12AUG2022. It described a male patient of unknown age who "consecutively took first and second dose of Vivotif on 1st and 2nd day" (PT: Inappropriate schedule of product administration). The patient took the Vivotif (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation. It was reported that the patient did not follow the recommended schedule to take Vivotif and consecutively took the first and second dose on first and the second day respectively.  Action taken with Vivotif with respect to the reported event was not applicable.  The outcome of the reported event was unknown.  No additional information was reported.  Company comment: It was reported that a patient consecutively took first and second dose of Vivotif on 1st and 2nd day (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event.; Sender's Comments: It was reported that a patient consecutively took first and second dose of Vivotif on 1st and 2nd day (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event.
Narrative:  COVID infection following completion of COVID vaccine series: 02/12/2021 COVID vaccine dose #1 03/05/2021 COVID vaccine dose #2 06/23/2021 Pt presented to ED c/o 3-day hx of generalized weakness, unsteady gait, inability to eat. Pt denied experiencing CP, SOB, N/V, F/C. POCT glucose level >500 mg/dl. 06/23/2021 COVID negative (swab) 06/23/2021 Pt admitted to ICU at facility for tx of hyperglycemia. 06/24/2021 Pt status improved, transferred from ICU to med floor. 06/28/2021 Consult for transitioning pt to CLC with hospice at discharge from IP. 06/29/2021 COVID negative (swab) 06/30/2021 Pt discharged from IP service and admitted to hospice and palliative care service. 06/30/2021 COVID screen negative. No testing conducted. 07/01/2021 COVID screen negative. No testing conducted. 07/02/2021 COVID screen negative. No testing conducted. 07/03/2021 COVID screen negative. No testing conducted. 07/04/2021 COVID screen in morning negative. Another COVID screen in evening also negative. No testing conducted. 07/05/2021 COVID screen negative. Another COVID screen in evening also negative. 07/06/2021 COVID screen negative. CLC staff notified of COVID positive nasal swab test results. Pt transferred to IP COVID bed.
This is a spontaneous report from a contactable consumer (medical assistant) received via a Pfizer sales representative. This consumer reported similar events for four patients. This is the second of four reports. An infant patient of an unspecified gender received PREVNAR 13, (batch/lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced swelling and a little hardened area at the injection site. The reporter spoke to the doctor that said the swelling and a little hardened area at the injection site was okay and nothing serious. The outcome of the event was recovered within a few days on their own. The information on the batch/lot number and expiration date has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2018482503, Same reporter/drug/AE, different patient.
This spontaneous report has been received from a nurse prescriber, and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 24-JAN-2018, the patient may have received an improperly stored dose of VARIVAX lot # N023961, expiration date 01-SEP-2019 or PROQUAD lot # N024564, expiration date 06-Mar-2019 or lot # N020008, expiration date 13-JAN-2019 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). The temperature range was from -14 degrees Celsius (°C) to -10 °C for a time frame of 5 minutes, with a previous temperature excursion, in the recommended frozen range from -50 °C to -15 °C for 7 minutes. The temperature excursion was called because a data logger. There was not adverse effect or product quality complaint involved.
Patient stated that the day after receiving her 2nd dose of Pfizer Covid vaccine she developed cellulitis across her torso area. She has a history of recurrent cellulitis. The patient was prescribed oral Keflex on 6/11/21 and no further contact has been made.
Information has been received from a registered nurse concerning the mother of a patient, who as a child, was vaccinated with MMR. Subsequent to being vaccinated the patient developed a high pitched cry. It is unknown if medical attention was sought. No further information was provided. There was no product quality complaint. Additional information has been requested.
12 hrs of feeling fluish day after received booster vaccine.  72 hrs after booster dizziness.