chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feeling under weather and would like to reschedule.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) for a PFIZER sponsored program.  A female patient received first dose of bnt162b2 (BNT162B2, Batch/Lot number: Unknown) as DOSE 1, SINGLE for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SENSITIVITY TO WEATHER CHANGE (non-serious), outcome "unknown", described as "feeling under weather and would like to reschedule."  Additional Information: No patient identifiers were provided but the reporter had first hand knowledge of the patient and was reporting on a specific patient, the reporter called for mother. The patient was supposed to have second dose of COVID-19 vaccine today. Today was 21 days. The patient was feeling under weather and would like to reschedule. Wondering if there was a grace period or leeway or how that worked.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Buzzing in the ear; diarrhea; headache; nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Buzzing in the ear), DIARRHOEA (diarrhea), HEADACHE (headache), NAUSEA (nausea) and VOMITING (Vomiting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced TINNITUS (Buzzing in the ear), DIARRHOEA (diarrhea), HEADACHE (headache), NAUSEA (nausea) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, TINNITUS (Buzzing in the ear), DIARRHOEA (diarrhea), HEADACHE (headache), NAUSEA (nausea) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Second dose was reportedly added.
Extremely painful arm at location of shot. Could not move my arm for days, or touch the skin around it. Low grade fever and overall achy body.
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: Patient lost consciousness for ~1 minute, around 5 minutes after receiving first dose of Pfizer COVID-19 shot.  Patient was spotted by other patients in waiting area and nearby technician immediately.  Breathing never stopped, no epinephine/benadryl administered.  Patient was sweating and was provided water.  As soon as she regained consciousness, she was able to recite her name and DOB.  911 was called and paramedics arrived within 5 minutes.  Taken by EMS to ER.
This spontaneous report as received from a pharmacist (also reported as a non-health care professional) refers to a 58 year old male patient. The pharmacist did not know any additional information including patient's medical history, concomitant medications, and past drug history. On 13-SEP-2014 the patient was vaccinated with an expired dose of PNEUMOVAX23 lot # J009827 and expiration date 10-AUG-2014, dose: 0.5 ml, intramuscular. At the time of the report the outcome of the event was unknown. Additional information has been requested.
Pt is a 37y F with previous history of pericarditis diagnosed after an initial COVID infection SEP20 with a second occurrence NOV20. Pt subsequently received her first COVID Vaccine shot on 22JAN21 and reported to medical on 3FEB21 with mild chest pain and an EKG with changes demonstrating pericarditis and a US demonstrating trace effusion. Pt was minimally symptomatic but given her previous episodes was sent to the Role 3 for further evaluation. Her work up on 10FEB21 demonstrated resolution of EKG changes and effusion with normal cardiopulmonary work up. Given her history it has been recommended that she does not receive the second dose of the vaccination.
Systemic: Dizziness / Lightheadness-Mild, Systemic: gas and hiccups-Mild, Systemic: Hypertension-Mild, Systemic: Tachycardia-Mild, Additional Details: patient fully recovered from all symptoms before leaving. patient's son denied any further assistance. blood pressure was continuously checked and under recommended guidelines.
Really bad headache; Muscle pain; Joint pain; Fatigue; Swollen glands; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on 18Jan2021 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient said she received the first dose of Covid-19 vaccine yesterday 18th of January 2021. She stated she was experiencing a really bad headache, muscle pain, joint pain, extreme fatigue and swollen glands the night of 18Jan2021 after she took the first dose of Covid-19 vaccine. She was asking how long this effect lasts. Outcome of the event was unknown.  Information about lot/batch number has been requested.
Vaccine was given then weight was obtained by standing scale, pt then walked to waiting room (front of building) with other 2 sister who rec'd vaccinations as well. She fell backwards and hit her head on the floor. When front staff got to her, her eyes were closed. By the time RN's got up front she was awake, responsive, and pale. Cool wash cloth placed on head. BP checked 104/74, pulse was strong. Stayed on floor with knees up for approximately 5-10 mins. Able to walk out with family.
First I got a fever and started throwing up multiple times the night of receiving the booster. The vomitting lasted through the second day. On the third day, I broke out into hives on every part of my body and was hot to touch, my feet became swollen.  The rash continued and I am currently on day 5 after I had gotten the booster and still have hives. I did take a Covid test on 12/30 because I thought it was possibly covid and not from the booster. I went into urgent care on 01/01/21 because the hives would not go down with Benedryl and were getting worse, and I got prednisone 5mg and triamcinolone 0.1%. I have taken 3 doses of prednisone and the rash has still persisted.
hands and feet are itching constantly/[itching] kind of all over; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (hands and feet are itching constantly/[itching] kind of all over) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL DIHYDRATE (LISINOPRIL [LISINOPRIL DIHYDRATE]) and ATORVASTATIN for an unknown indication.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced PRURITUS (hands and feet are itching constantly/[itching] kind of all over). At the time of the report, PRURITUS (hands and feet are itching constantly/[itching] kind of all over) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Heavy period following injection. I was 2 weeks early for my cycle and I am experiencing extreme bleeding. More than normal.
2nd day after 2nd vaccine, my injection arm turned bright red, sore, hot and itchy. The area is about 5 inches in length and width. 4 days after the vaccine, the area is not getting better, symptoms are the same. With the 1st and 2nd vaccines I had bad back pain in my spine within 6-7 hours of injection lasting 1 day after 1st injection and 3 days after 2nd vaccine.
Headache (Migraine); This spontaneous case was reported by a nurse and describes the occurrence of MIGRAINE (Headache (Migraine)) in a 70-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-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced MIGRAINE (Headache (Migraine)). At the time of the report, MIGRAINE (Headache (Migraine)) had 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.   Concomitant medications were not provided. Treatment information was not reported.; Sender's Comments: MR-Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
product supply issue; Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 6th January 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In June 2019, less than 5 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced product supply issue. On an unknown date, the outcome of the shingles and product supply issue were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were received as follows: The pharmacist inquiring about the recommendations for a patient who went over the time frame for the 2nd dose.  The late dose was due to product shortage.  The reporter consented to follow up.
A non-serious spontaneous report of sleepy, fever, and lethargic has been received from a physician concerning a 25-month-old female subsequent to H1N1 2009 MONOVALENT Vaccine Live. The patient's medical history and concomitant medications were not provided. On 21-Oct-2009, the patient received the Intranasal H1N1 2009 MONOVALENT Vaccine Live with the Flu shot. Approximately two hours after receiving both vaccinations, the patient developed a fever of 102 degrees Fahrenheit, became sleepy and lethargic. The reporter indicated the patient was "otherwise ok" and didn't experience shortness of breath, cough and no signs of allergic reaction. The patient was treated with acetaminophen. The outcome of the events was not provided.
No adverse event- however, this was an administration error. Patient had previously received COVID-19 Johnson & Johnson vaccine on 03/19/2021, which was not known by pharmacy at time of administration.
ringing in one ear for 12-18 hours; states a week later the ringing began again; woke up drenched in sweat that night for an hour.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021376518 (Pfizer).  A 62 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "ringing in one ear for 12-18 hours"; DISEASE RECURRENCE (non-serious), outcome "unknown", described as "states a week later the ringing began again"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "woke up drenched in sweat that night for an hour.".  Additional information: Caller states he is calling about the Pfizer COVID19 vaccine and states he wanted guidance on the vaccine; states he had the 1st dose administered 2 weeks ago and then three days later he had ringing in one ear that lasted about 12 hours and then went away; states a week later the ringing began again for probably 4-5 hours and with the first occurrence of the ringing that night he started having ringing and woke up at 4:00am sweating and that went away in about an hour. States then the next morning the ringing was gone, and he was fine and then a week after that he had ringing for about 4-5 hours and then it went away. Caller states he is supposed to get his 2nd dose of the Pfizer COVID Vaccine this Friday and wants to know if he should go with it or not; caller aware that the company and Pfizer not able to offer treatment recommendations or medical advice.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a physician concerning a 15 year old female who was vaccinated, intramuscularly, into the deltoid, with a first dose of Gardasil. Subsequently the patient fainted. Subsequently, the patient recovered. Additional information has been requested.
Background: pharmacy received 49 vials of Pfizer COVID vaccine (Lot number EN6199) on 5 March 2021 and stored them in the pharmacy refrigerator.   The doses were labeled with an expiration date of 10 March 2021 at 0701.   Since starting the COVID-19 vaccine program, the MOB has always used the doses before they approached the expiration date.  This time, there were 16 vials of the Pfizer vaccine that had not been used and set to expire. The labeled expiration date and time were clearly present on the outside of the bag containing the doses.  On the morning of 10 March 2021, a pharmacist retrieved 1 vial at 0754 and 7 vials at 1138 from that allocation and provided them to nursing for the day?s administrations.  The pharmacy placed those doses in a new amber bag and did not label the bag with an expiration date and time.   The nursing team received the vials, diluted and drew up 20 doses that were administered to patients before 1230.    The charge nurse did not question the expiration date until after 20 patients had been vaccinated.  At that time she messaged the pharmacist to verify the expiration date.  The pharmacist indicated that the label did not state am or pm and misinterpreted the expiration time for the doses as 7:01 PM rather than 7:01 AM.  There was not a defined double check at the time of distribution from the pharmacy to nursing  The remaining 11 vials were quarantined.  The pharmacy manager contacted the manufacturer.  According to Pfizer it?s recommended to use the thawed vaccine within 120 hours, but can be used up to 144 hours.  The doses in question were administered before 125 hours after they were thawed.  The remaining expired vials will be wasted and appropriate notifications sent.  Assessment: Twenty patients received Pfizer COVID vaccine 5 hours passed the labeled expiration date and time.  While exceeding the manufacturer?s recommended beyond use dating, the doses were within the acceptable 144 hours post thaw period and still safe for patient administration.  There was misinterpretation of the labeled expiration time by the dispensing pharmacist, the container of COVID vaccine vials provided to nursing was not labeled with an expiration date or time, there was not a double check on hand off, the nursing team did not double check the expiration date/time before dilution or administration.  Recommendation:  When repackaging COVID Vaccine vials for distribution to vaccination centers, a label including the expiration date and time should be placed on the new container.    When COVID vaccine is transferred from one location or department to the next, a double check of the product, quantity, integrity and expiration date and time may prevent a recurrence of this situation.
Patient came to pharmacy on 3/14/2020 stating that she now has shingles even though she rec'd 2 shots of the shingrix.  On the 2nd shot of shingrix given on 2/15/2020, she felt body aches, soreness, and tingling of her lips (some swelling) the day after (2/16/2020). Patient is currently taking valcyclovir for shingles symptoms.
Blood in stool; Abdominal cramping; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (Not AVAILABLE). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4198471.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 18Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Intramuscular), administration date: 10Apr2021, for COVID-19 immunisation; BNT162b2 (DOSE 2, SINGLE, Intramuscular), administration date: 12May2021, for COVID-19 immunisation. The following information was reported: HAEMATOCHEZIA (medically significant), outcome "recovered", described as "Blood in stool"; ABDOMINAL PAIN (non-serious), outcome "recovered", described as "Abdominal cramping". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "blood in stool" and "abdominal cramping" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available, the causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded. 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.
AS SOON AS THE SHOT WAS ADMINISTERED PT RIGHT ARM BEGAN TO SWELL IMMEDIATLEY, FELT A TINGLING BURNING SENSATION AND SLIGHT PAIN. LASTED UNTIL PT LEFT THE STORE AFTER 15 MINUTES OF OBSERVATION.
chills; headache; body aches; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 61-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Oct2023 at 10:30 as dose 1, single (Lot number: HG4664) at the age of 61 years, in right arm for covid-19 immunisation; for covid-19 immunisation; influenza vaccine inact sag 3v (FLUCELVAX), on 21Oct2023 as dose 1 (Lot number: 375291), in left arm. The patient's relevant medical history included: "MCTD" (unspecified if ongoing); "hypercholesterolemia" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; PREDNISONE; PANTOPRAZOLE; CETIRIZIN. Past drug history included: Bactrim, reaction(s): "Drug allergy: Bactrim". Vaccination history included: Covid-19 vaccine (DOSE 1, manufacturer unknown), for COVID-19 IMMUNIZATION; Covid-19 vaccine (DOSE  2, manufacturer unknown), for COVID-19 IMMUNIZATION; Covid-19 vaccine (DOSE 3 (BOOSTER), manufacturer unknown), for COVID-19 IMMUNIZATION; Covid-19 vaccine (DOSE 4 (BOOSTER), manufacturer unknown), for COVID-19 IMMUNIZATION; Covid-19 vaccine (DOSE 5 (BOOSTER), manufacturer unknown), for COVID-19 IMMUNIZATION. The following information was reported: PAIN (non-serious) with onset 22Oct2023 at 06:30, outcome "recovering", described as "body aches"; CHILLS (non-serious) with onset 22Oct2023 at 06:30, outcome "recovering"; HEADACHE (non-serious) with onset 22Oct2023 at 06:30, outcome "recovering". Therapeutic measures were not taken as a result of chills, headache, pain. No follow-up attempts are possible. No further information is expected.
Pt left office after vaccination & returned 5 hours later with fever at home 103 given Tylenol -> fever 101 in our office.  Somnolent and vomited.
Large (shooter marble) swollen lymph nodes in groin that have not reduced in size even with antibiotics this week.
I had racing heart beat. My heart rate from 12:00 PM until I went to the emergency room and was discharged around 9:30 PM stayed between 135 and 192. I was dizzy, as well.
No Adverse Event; administered Moderna Covid 19 Bivalent after 30 day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid 19 Bivalent after 30 day use by date) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Dec-2022, 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 13-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid 19 Bivalent after 30 day use by date). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid 19 Bivalent after 30 day use by date) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid 19 Bivalent after 30 day use by date).    Concomitant product use was not provided by the reporter. Patients was accidentally administered Moderna Covid 19 Bivalent after 30 day use by date. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-687538, US-MODERNATX, INC.-MOD-2022-687454, US-MODERNATX, INC.-MOD-2022-687540, US-MODERNATX, INC.-MOD-2022-687541, US-MODERNATX, INC.-MOD-2022-687542 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-687541:Original Case : MOD-2022-687454 US-MODERNATX, INC.-MOD-2022-687540:Original Case : MOD-2022-687454 US-MODERNATX, INC.-MOD-2022-687454:Original Case : MOD-2022-687454 US-MODERNATX, INC.-MOD-2022-687542:Original Case : MOD-2022-687454 US-MODERNATX, INC.-MOD-2022-687538:Original Case : MOD-2022-687454
Fourth of fifth rabies vaccine given 5/7/05. On 5/8/05, developed headache and fever to 101 F.