chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nurse calling to report VARIVAX was administered to patient while it had a temperature excursion.; No additional AE.; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On an unknown date, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1 dose, lot #W032370, expiration date: 10-OCT-2024 (strength, route of administration, and indication were not provided). The vaccine had been improperly stored in the temperature of 24.4 Fahrenheit degrees (F) for 5 hours 51 minutes 0 seconds with no previous temperature excursion (product storage error). The patient was asymptomatic. No additional adverse event was reported. No product quality complaint (PQC) was involved.
Pt received 3rd dose of HPV in left deltoid at 4pm later that evening had left arm pain which persisted slept fine. Today pain persists with nausea T=100.5 at 5:30pm. Unable to raise arm above shoulder level. Sl. cough, legs feel weak.
she had a cut to the top of the roof of her mouth that had uncontrollable bleeding; she had a cut to the top of the roof of her mouth that had uncontrollable bleeding; right breast hurts; it radiates around to her back; Fatigue; and can't lift or pull anything and it really, really hurts; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunisation. Medical history included sinus disorder from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received a flu shot on an unspecified date. Consumer is calling about the Pfizer COVID-19 vaccine, and says she just spoke to a nurse who told her to call and find out if her experience for what she had after her first shot on Friday of the past week had been reported before. She says that on Saturday (23Jan2021), she woke up and her right breast hurt, there is something in there, it radiates around to her back, along with having fatigue. She says she was told to see if anyone else reported this, she expected normal stuff like, flu stuff, this is not that. She says she is on her way to urgent care to have that looked at. She asks if condition persists, she is supposed to get her second dose on 12Feb, does she get it? She got her first dose last Friday (22Jan2021) then woke up Saturday and can't lift or pull anything and it really, really hurts. She says to add to this, which she talked to two doctors (docs) who said it was unrelated, that night she had a cut to the top of the roof of her mouth that had uncontrollable bleeding, she went to the emergency room for that and got a shot to help her coagulate blood, and will be seeing an ENT so hopefully that will be under control. No further details provided about shot to help her coagulate blood. She got the flu shot but that was Thanksgiving, way back, not recent. She is going to get her sinuses checked out, they did a CAT scan yesterday, and is going to the doctor for that 1Feb. She is concerned that the breast pain started last Saturday and is still really painful, she doesn't know why all of a sudden that happened, so she is going to the urgent care to see if they can do something for it, and will be getting an appointment with her OBGYN. For her right breast hurting, she took Tylenol and Ibuprofen, that is all she has done. Tylenol, LOT: PPAO33, EXP: Sep2022. Ibuprofen, LOT: 113132. The patient underwent lab tests and procedures which included computerised tomogram: unknown results on 27Jan2021. Therapeutic measures were taken as a result of she had a cut to the top of the roof of her mouth that had uncontrollable bleeding she had a cut to the top of the roof of her mouth that had uncontrollable bleeding and right breast hurts. The outcome of the events was unknown.
Received 2 Pfizer doses, first on Dec 30, 2020. Have noticed myalgias in buttocks and thighs for the last week (actually several weeks, but more noticeable in the last few days). I'm not sure this is related to the vaccine, but thought I should report it, given the reports of myocarditis.
Narrative:  The patient was noted to have impaired speech and difficulty swallowing on the morning of 12/14/21. She was at baseline when she went to bed the evening prior. She was transported to Hospital. A CT scan showed a CVA. The patient was then transported to Medical Center for a higher level of care.
I received my third Covid vaccine/booster (Pfizer) on November 3, 2021.  In February of 2022 I began to experience several issues including muffled/loss of hearing, severe stomach aches, diarrhea, vomiting, soft runny stools, dizziness, brain fog, swollen feet, headaches etc.  I have been to numerous doctors, had numerous blood tests, MRI's, and other investigations.  Not once did a doctor determine the reason for my issues.  I came down with Covid-19 on March 14 with sore throat and cough.  I also had another episode of AFib which had to be converted by shock.
I have two lymph nodes on top of my left clavicle that are swollen and slightly painful since Tuesday, which is one day post my second injection and are still here today at Day 4 post administration
Pt developed breakthrough varicella with a temperature of 99.7F. The pt had 30-40 itching lesions.
TOTALLY PANIC STRICKEN; OTHER SYMPTOMS; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: active cancer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Non-company suspect vaccine included: bnt 162 (form of admin, route of admin, and batch number were not reported), dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced totally panic stricken, and other symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the totally panic stricken and other symptoms was not reported. This report was non-serious. This report was associated with product quality complaint.
Right arm became warm, tender to touch, red. Later that day, painful and swelled somewhat. Went to the ER that night.
The vial was initially stored in the refrigerator on 02-Mar-2023; No adverse event; Patient administered the vaccine after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-Mar-2023 ) and NO ADVERSE EVENT (No adverse event ) in an 80-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypertension.    On 10-May-2023, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 10-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-Mar-2023 ) and NO ADVERSE EVENT (No adverse event ). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-Mar-2023 ) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event ) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-Mar-2023 ).    No concomitant medications were reported.  It was unknown if the patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The vial was initially stored in the refrigerator on 02-Mar-2023.  The vial did not undergo any temperature excursions.   No AEs were reported.  No treatment medications were reported.  This case contains information for the 5th patient.
I was sick on August 10, 2021. We did an at home COVID 19 test and the first test was negative. I then tested positive with a home on August 13. On August 14 I tested positive at a facility with a PCR test. On the 19th I received a monoclonal antibody infusion. I felt nauseous, had a low grade fever, had body aches and was just very ill. I eventually after about a week, I was so sick I couldn't swallow my own saliva and then I went to a hospital. The hospital admitted me for 2 days, on the 3rd day I left for the infusion. My sodium and potassium were very low. After I left the hospital I had more blood tests done to make sure my sodium level did go back down. My symptoms lasted for more than one month. I lost my sense of smell and it is not back yet. I briefly lost my sense of taste. I had thrush and my blood pressure was high multiple times and I had Afib.
brain fog; lethargy; nausea; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (brain fog), LETHARGY (lethargy), NAUSEA (nausea), HEADACHE (headache) and PYREXIA (fever) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Pt was hospitalized for COVID in October of 2020.) in October 2020.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (brain fog), LETHARGY (lethargy), NAUSEA (nausea), HEADACHE (headache) and PYREXIA (fever). At the time of the report, FEELING ABNORMAL (brain fog), LETHARGY (lethargy), NAUSEA (nausea), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported  No treatment information was provided   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: TCR Was received on 21-JUL-2021 Does not contains any new information
Pt recv vax on 10/20/98; post vax pt exp red, swollen, warm, painful vax site area 3-4 in diameter
Patient experienced redness and swelling at the injection site that spread throughout the entire upper arm. Area was red, swollen and hot to the touch. Slight fever was noted 99.2 and patient experienced chills. Patient saw his PCP and they felt it was infected. Patient was prescribed an antibiotic and steroid to help with the reaction.
GENERAL SORENESS; HEADACHE; FATIGUE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry; unknown) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-APR-2021, the subject experienced general soreness. On 02-APR-2021, the subject experienced headache. On 02-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, fatigue, and general soreness. This report was non-serious.
When I got the vaccine, I got fever, nausea, headache, chills, body ache and I had that for 24 hours.
Flushed face; Feeling warmer than normal; Tingling at injection site; Numbness at injection site; Drug interaction; This case was reported by a physician via call center representative and described the occurrence of facial flushing in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included triamcinolone acetonide (Kenalog) for an unknown indication.   On 23rd July 2019, the patient received the 1st dose of Shingrix. On 12th August 2019, the patient started Kenalog at an unknown dose and frequency. On 23rd July 2019, 20 days after receiving Shingrix, the patient experienced drug interaction. On an unknown date, the patient experienced facial flushing, feeling of warmth, injection site tingling and injection site numbness. On an unknown date, the outcome of the facial flushing, feeling of warmth, injection site tingling, injection site numbness and drug interaction were unknown.   It was unknown if the reporter considered the facial flushing, feeling of warmth, injection site tingling and injection site numbness to be related to Shingrix.  Additional information received were as follows: The reporter asked for any information on drug interactions with Shingrix and Kenalog Shot. The reporter stated that, the patient received Shingrix 1st dose on 23rd July 2019 and Kenalog on 12th August 2019.  The reporter stated that the patient experienced experience flushed face, feeling warmer than normal, tingling and numbness at injection site when he received the kenalog shot, which led to a drug interaction. The reporter declined to provide patient details. The reporter consented to follow up.
Flu-like symptoms; off and on shooting headaches; swollen and very painful lymph node in left armpit where 2 shots were given (lasted 2 days, kept ice on it a lot); joint pain in knees, hands, hips, and feel brittle; tired but can't sleep; dark urine and blood in urine; injection sites extremely sore, still swollen, painful, and red after 3.5 days; kidney and neck pain. Used ALEVE and heating pad, along with ice under arm.
postherpetic neuralgia; vision issues; herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a approximately 71-year-old patient (pt) of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 03-AUG-2011, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not specified) at health center for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unspecified date, the pt was treated for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: herpes zoster, postherpetic neuralgia and vision issues. The outcome of herpes zoster, postherpetic neuralgia and vision issues was not reported. The reporter considered all the events to be related to zoster vaccine live (ZOSTAVAX).
Patient received 3rd Janssen vaccine when mRNA is currently recommended by the CDC.  Patient states she got a stuffy nose and cough for 4 days following shot.
Mixed-product series: patient had received a Moderna COVID-19 vaccination on 5/26/21. She returned on 7/9/21 for her second shot, however this was during our Pfizer clinic and the patient was inadvertently given a Pfizer shot instead of Moderna. We informed the patient of the mix-up, and let her know that she does not need to return for another Moderna shot (per CDC guidance, she would be considered fully vaccinated 2 weeks after this Pfizer shot). We followed up with her a few hours later to make sure she was still okay, and she said she was doing perfectly fine and she didn't have any further questions.
Received VARIVAX on 9/4/15. Seen in our office 9/14/15 with 3 day hx low grade fever and 2 day hx of multiple vesicles on body. Dx with varicella.
Vision in left eye a little blurry; Left eye less clear than right eye; Medical assistant at Medical Group was drawing TdVAX shot from the vial and it accidently squirted into her left eye. Patient did not experienced any pain or redness. However, she felt that her left eye was little blurry and less clear than her right eye. Patient did not immediately flush the affected eye with water but did so a few minutes later. She was advised to seek medical attention and contact Poison Control Center. When patient reached out Center they provided her with the Td Safety Data Sheet (SDS).  Personnel also reached out to patient directly to learn more about her AE. Upon being asked for lot number for the Td, Patient mentioned that she do not know the lot number and she would not able to find it out since she threw away the bottle. Patient indicated that she needs to end the conversation and insisted that she would give a call back next day which she did not.; Sender's Comments: The adverse event reported in this case was assessed as unexpected, non-serious, and not used as labeled.
Developed a rash that was very very bad; Skin disease; patient has not received the second dose of the vaccine and it is more than 36 days from the first dise; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Developed a rash that was very very bad), SKIN DISORDER (Skin disease) and PRODUCT DOSE OMISSION ISSUE (patient has not received the second dose of the vaccine and it is more than 36 days from the first dise) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Herpes eyelid (Had a history of herpes in her eyes.) and Anxiety attack. Concomitant products included VALACYCLOVIR [VALACICLOVIR] for Herpes eyelid, MULTIVITAMIN [VITAMINS NOS] and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (Developed a rash that was very very bad), SKIN DISORDER (Skin disease) and PRODUCT DOSE OMISSION ISSUE (patient has not received the second dose of the vaccine and it is more than 36 days from the first dise). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, RASH (Developed a rash that was very very bad), SKIN DISORDER (Skin disease) and PRODUCT DOSE OMISSION ISSUE (patient has not received the second dose of the vaccine and it is more than 36 days from the first dise) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products used included  pressure Vision.  Treatment medication included she took pills and applied topical cortisone.  She had reached out to her health care provider and dermatologist and they cannot seem to help her.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness), ERYTHEMA (redness), FEELING HOT (arm warm to touch) and PRURITUS (itchy) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (Soreness), ERYTHEMA (redness), FEELING HOT (arm warm to touch) and PRURITUS (itchy). At the time of the report, PAIN IN EXTREMITY (Soreness), ERYTHEMA (redness), FEELING HOT (arm warm to touch) and PRURITUS (itchy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment details were reported.
Within 5 minutes of receiving Pfizer vaccine, patient displayed symptoms of nausea and vomiting.  Patient looked pale and slightly disoriented.  She was provided a chair to sit, water to drink, and a waste basket with plastic bag to vomit, if needed.  She decided to remain seated on the floor and waited to improve.  After a short time, color in her face returned and it she or an employee called a paramedic for first aid assistance.  Paramedics arrived in about 15 minutes, took vitals, and determined it was be best to take her for further evaluation at hospital.
This spontaneous report was received from a registered nurse via employee refers to a male patient of an unknown age. The patient's pertinent medical history, concomitant medication and drug reactions or allergies were not reported. On 11-OCT-2018, the patient was vaccinated with a dose of PNEUMOVAX 23 for prophylaxis (lot#, expiry date, route and dosage details were not reported). On 12-OCT-2018, the patient sought medical attention, called the office and reported, "redness, swelling, and warmth at the insertion site. The patient was advised to take TYLENOL and to call back if the symptoms worsened. No product quality complaint (PQC) was involved. It was unknown if the patient's symptoms had resolved. The reporter did not provide any causality assessment.
Received Hepatitis B vaccination on 2/21/2011 at 11 AM. At 1900 on 2/21/2011 noticed sore throat - raw feeling coming on - hoarseness, back of throat reddened/swollen. Went home gargled with salt water; took NYQUIL and slept propped up. Soreness and hoarseness persists. Concerned over symptoms - unsure related.