chrisvoncsefalvay/vaers-outcomes huggingface dataset:
then I took the booster also then I realized that the COVID; Then I took the booster also then I realized that the COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2, NDC number, UPC number and Expiry Date are Unknown), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "then I took the booster also then I realized that the COVID"; SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "Then I took the booster also then I realized that the COVID".  Additional information: The report did not relate to a study or programme. When probed to spell name: The reporter stated, had the symptoms after having  first and second dose (clarified as COVID-19 Vaccine) and then took booster also was getting this situation and the side effects for tinnitus and they sent the patient form, it is 3 and more and month and a half, the patient had sent it back (Hence Report type captured as Follow-up Report). The patient never heard from anybody. The patient did not know who to talk to because now it is the second booster. The patient was  not sure what it is but the patient had this tinnitus situation right after the patient took the first and second and which the patient ignored and thought maybe it will go away then found out it is a tinnitus, then took the booster also then the patient realized that the COVID (not paraphrased and confirmed if the consumer experienced COVID, hence not captured as event) sometimes have that aspect and then the patient realized it happened after that (vaccination). Now, second booster has come back and so the patient was not sure what is the right thing. The reporter was informed to contact Pfizer Medical Information for the queries and was provided with the number of Pfizer Medical Information. Product details (LOT#, Expiration Date, NDC# and UPC#) and Pharmacy details could not be probed as consumer hung up the call abruptly.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I started feeling sick with nasal congestion, stuffiness in my head and had a sore throat. I took a COVID-19 Home Test which was expired, and it was negative. The next day it was the same symptoms but i was tired. I was a little better the next day but was completely better. Two days later I took another test and that was positive. I did reach out to my health care provider, and they did offer me Methyletrednisolone and I did take that. I now have lingering issues. I have developed watery eyes and I have seen my eye doctors about this. I have been told that I have blocked tear ducts but they water. I also have major congestion. I have had a CT Scan and they see that I have some mucus built up.
Information has been received from a pharmacist concerning a 51 year old female with hypertension and asthma who on 02/14/2001 was vaccinated with a first dose of hep b vaccine recombinant. On 03/23/2001 the pt was vaccinated with a second dose of hep b vaccine recombinant. Concomitant therapy included numerous other medications. It was reported that shortly before the second dose of hep b vaccine recombinant the pt sought unspecified medical attention and was found to have an increased erythrocyte sedimentation rate. Additional info has been requested.
Nausea and vomiting, dizziness, stomach upset, no appetite, headache
the patient was administered improperly stored VARlVAX; This spontaneous report has been received from a medical assistant referring to a 3 years old male patient. Information about pertinent medical history, concomitant medication or drug reactions/allergies was not provided.  On 27-AUG-2020, the patient was administered improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX); lot # S024364, expiration date 06-AUG-2021 (strength, dose and route were not reported) for prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT).  The administered dose of the vaccine experienced a temperature in the range -14 degree Celsius to -10 degree Celsius (-13.04 degree Celsius) for 45 minutes recorded by a data logger. There was no previous temperature excursion.
Got vaccine at 11am,  was ok all day.  About 11pm I felt nauseated.  Got up a 2am to go to bathroom and had teeth-chattering chills.  30 minutes later vomited several times.  Fever was 99.6  last night, 99.8 this morning, and 100.2 this afternoon.  Significant pain in joints, moderate in muscles.  Feel by far worse than when I had covid.  Though these side affects typically resolved in 24 hours? Mine are no better, other than I'm only nauseated, not throwing up.
Pt received Pfizer for his 1st two shots but was given moderna as his 3rd dose
inflammation around the heart; Hot then cold; Brain fog; chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (inflammation around the heart) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A TCP#4 and 008B212A TCP#4) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Positive. Nasal swabaf) on 05-Jan-2021, Vitamin D deficiency and Anxiety. Concurrent medical conditions included Drug allergy (allergy to trimpex), Drug allergy (allergy to macrodantin), Perfume sensitivity (allergy to stromg smells like perfume) and Seasonal allergy. Concomitant products included HYDROXYZINE for Anxiety, ASCORBIC ACID, COPPER GLUCONATE, TOCOPHERYL ACID SUCCINATE, XANTOFYL, ZEAXANTHIN, ZINC OXIDE (AREDS 2 VISUAL ADVANTAGE) for Eye disorder prophylaxis, CETIRIZINE HYDROCHLORIDE (ZYRTEK) for Seasonal allergy, VITAMIN D3 for Vitamin D decreased, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 23-Mar-2021 at 1:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021 at 12:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Hot then cold), FEELING ABNORMAL (Brain fog) and CHILLS (chills). On 09-May-2021, the patient experienced INFLAMMATION (inflammation around the heart) (seriousness criterion hospitalization). The patient was hospitalized on 10-May-2021 due to INFLAMMATION. At the time of the report, INFLAMMATION (inflammation around the heart), FEELING OF BODY TEMPERATURE CHANGE (Hot then cold), FEELING ABNORMAL (Brain fog) and CHILLS (chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2021, SARS-CoV-2 test positive: positive (Positive) nasal swab.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the patient spent a day and a half in the hospital, many tests were done and the patient is being treated for inflammation around the heart. More tests are coming up in two weeks.  Very limited information regarding this event has been provided at this time. Further information has been requested.   This case was linked to MOD-2021-057833 (Patient Link).; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
patient was administered the product post temperature excursion with no reported adverse event; lowest temperature it reached was 30.9F for a total duration out of range of 4 hours and 30 minutes with no reported adverse event; Initial and live follow-up information received on 15-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 12 years old male patient who was administered the Diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] post temperature excursion with no reported adverse event and lowest temperature it reached was 30.9f for a total duration out of range of 4 hours and 30 minutes with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 13-Feb-2023, the patient received suspect Diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection (strength were not reported) (lot C6003BA and expiry date- 01-Jun-2024) via intramuscular route in the left deltoid for Immunization post temperature excursion with no reported adverse event  (poor quality product administered).  On 13-Feb-2023 vaccine has lowest temperature it reached was 30.9f for a total duration out of range of 4 hours and 30 minutes with no reported adverse event (Product storage error ).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the 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 the 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.; Sender's Comments:  01493845: 01493759:
average increase in blood pressure and heart rate by 10-15%; swelling in lymph nodes; irregular heart beat; irregular blood pressure/blood pressure rising and dropping; pain in lymph node in left arm pit/stabbing feeling around lymph node in left arm; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE IRREGULAR (irregular heart beat), BLOOD PRESSURE ABNORMAL (irregular blood pressure/blood pressure rising and dropping), LYMPH NODE PAIN (pain in lymph node in left arm pit/stabbing feeling around lymph node in left arm), BLOOD PRESSURE INCREASED (average increase in blood pressure and heart rate by 10-15%) and LYMPHADENOPATHY (swelling in lymph nodes) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced HEART RATE IRREGULAR (irregular heart beat), BLOOD PRESSURE ABNORMAL (irregular blood pressure/blood pressure rising and dropping) and LYMPH NODE PAIN (pain in lymph node in left arm pit/stabbing feeling around lymph node in left arm). On 03-Apr-2021, the patient experienced BLOOD PRESSURE INCREASED (average increase in blood pressure and heart rate by 10-15%) and LYMPHADENOPATHY (swelling in lymph nodes). At the time of the report, HEART RATE IRREGULAR (irregular heart beat), BLOOD PRESSURE ABNORMAL (irregular blood pressure/blood pressure rising and dropping), LYMPH NODE PAIN (pain in lymph node in left arm pit/stabbing feeling around lymph node in left arm) and BLOOD PRESSURE INCREASED (average increase in blood pressure and heart rate by 10-15%) had not resolved and LYMPHADENOPATHY (swelling in lymph nodes) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was checked out by the clinic again on 12APR2021 and is still presenting with an irregular heart beat, blood pressure, and pain in the lymph gland of his left arm-pit.   No concomitant medications were reported.   Patient was suggested to see the infectious diseases department because doctors are not sure what is causing the symptoms, however, infectious diseases refused to see him as they believed that they were side effects from the COVID-19 vaccine.Patient sated that his blood pressure history has been around 134/79 and his highest heart rate was around 74 bpm. After receiving the vaccine, patient states that his average has increased 10-15% minimum. Patient reports that at the last clinic he went to the health care providers noticed swelling in the lymph nodes   No treatment information was reported.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Sep2021 at 02:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in right arm for covid-19 immunisation; COVID-19 Vaccine - Manufacturer Unknown, as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "anxiety disorder" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergy: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: BUSPIRONE; BYSTOLIC. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Left thigh - 1/2 cm diameter, firm nodule felt in subcutaneous tissue.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with GARDASIL (dose, route of administration, lot# and expiry date were not reported) that were improperly stored. No adverse symptom was reported. It was reported that the temperature excursion was unsupported with in-house stability data. This is one of several reports received from the same reporter. Additional information has been requested.
Arm developed a 3 inch diameter redness with hardened lump.  The area felt as if it were a severe burn.  Problem lasted for 10 days.
Received a dose of Shingrix by mistake, instead of the Varicella Vaccine; 12 year old patient received Shingrix; Shingrix vaccine was administered Subcutaneously rather than Intramuscularly; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old female patient who received Herpes zoster (Shingrix) (batch number Z3H93, expiry date 07-JUL-2024) for prophylaxis.   On 05-JUN-2023, the patient received the 1st dose of Shingrix (subcutaneous, left deltoid). On 05-JUN-2023, an unknown time after receiving Shingrix, the patient experienced wrong vaccine administered (Verbatim: Received a dose of Shingrix by mistake, instead of the Varicella Vaccine), inappropriate age at vaccine administration (Verbatim: 12 year old patient received Shingrix) and intramuscular formulation administered by other route (Verbatim: Shingrix vaccine was administered Subcutaneously rather than Intramuscularly). The outcome of the wrong vaccine administered, inappropriate age at vaccine administration and intramuscular formulation administered by other route were unknown.   Additional Information: GSK Receipt Date: 26-JUN-2023 The reporter was called on behalf of a patient that that received a dose of Shingrix by mistake in her left deltoid, instead of the Varicella Vaccine, which lead to wrong vaccine administered. The reporter also reported that the Shingrix vaccine was administered subcutaneously rather than intramuscularly, which lead to intramuscular formulation administered by other route. The reporter reported that the patient was doing fine. On call note reporter did not ask for consent to follow up with HCP. The reporter did consent to follow up. The reporter reported that 12 year old patient received Shingrix, which lead to inappropriate age at vaccine administration.
Patient received vaccine exposed to a temperature of 32°F degrees for 7 and a half hours; A spontaneous report was received from a nurse concerning patients of unknown ages and genders who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history and  concomitant medication use was not reported .  On 23-Jan-2021, the patients received their planned dose of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.  Late Friday evening, 22-Jan-2021, approximately one day prior to the onset of event, the vaccine administrator removed vials from the freezer and put them in a refrigerator for usage during the vaccination event that was set to occur on Saturday, 23-Jan-2021. In the refrigerator, the vaccines were stored for seven and a half hours at 32°F. It was reported that the vials were cold on Saturday and were used during the vaccination event. They had record of all the patients who received this vaccines, but reporter did not consider this a temperature excursion because their information stated that "vials can be stored refrigerated between 2° to 8°C (36° to 46°F)" and reach a temperature of 36°F.   Treatment is not applicable  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event is not applicable; Reporter's Comments: This report refers to a case of Product storage error for mRNA-1273, unknown lot number, with no associated AEs. Causality for the event is not applicable.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2012, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2013, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Rash at the injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE RASH (Rash at the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash at the injection site). At the time of the report, VACCINATION SITE RASH (Rash at the injection site) outcome was unknown.        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.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jan-2021: No specific follow-up information recorded.; Sender's Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded
Information has been received from a nurse practitioner concerning a 14-month-old patient who on 27-May-2003 at 10:30 AM was vaccinated in the right arm with a first 0.5 mL dose of varicella virus vaccine live (Lot #641155/0793M) at "age one-year". At the time of vaccination, the patient had a upper respiratory tract infection, eczema, and candida diaper rash. Subsequently, when the child was seen at 14-months, she had herpes zoster. No other information was provided. Unspecified medical attention was sought. There was no product quality complaint. Follow-up information received from a nurse practitioner indicated that on 06-Aug-2003 at 10:30 AM the patient developed zoster, described as less than or equal to 25 lesions on his right chest and right back for a two week duration. The rash did not occur at the site of injection or elsewhere within 42 days of the vaccination. There were no other systematic symptoms. The patient did recover. There was no history of chickenpox. It is unknown if there was a recent exposure to chickenpox or herpes zoster. There was no direct flourescent antibody done. There was no specimen collected for PCR. No photo was taken. No further information is expected.
Headache, Myalgia, Arthralgia, NauseaVomitin, fatigue Narrative:  Employee reported mild fever 01/25/2021, moderate headache 01/25/2021 until 01/29/2021, mild myalgia 01/25/2021 until 01/28/2021. Resulted in unable to work 01/25-26/2021. Did not seek medical attention for symptoms.
This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions or allergies were not provided. On 09-OCT-2018, there was an storage temperature excursion and on 01-NOV-2018, the patient was vaccinated with an improperly stored dose of M-M-R II lot # N035958 with expiration date on 18-DEC-2019 (strength, dose, anatomical location or route of administration were not provided), for prophylaxis; which was administered concomitantly with a sterile diluent (MERCK) that was not reported as improperly stored. The storage temperature of the vaccine was reported as 47 to 77 degrees Fahrenheit (°F) (58.5 °F) for a time frame of 13 hours and 20 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects were being reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1811USA012810.
12 hours after receiving 2nd dose of Pfizer Covid-19 vaccine, urinary tract infection symptoms showed up, in addition to general aches and pains in the legs and lower back. After a 5 day completed course of antibiotics (nitrofurantoin), symptoms of UTI returned
On 8th Day I developed a very large lump and rash on vaccine site. Hot to the touch and painful. ?Covid Arm?   Also was feeling dizzy, with body and joint pain, headache and slight fever.   I applied Hydrocortisone cream and took Advil for pain which gave relief