chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Product temperature excursion issue; Patients received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 25-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  Reporter informed about temperature excursions with freezer in the facility, where she works. It had been happening for weeks since April 2022. The storage condition at the time of the excursion was reported as frozen storage. The affected batch lot numbers were reported as 065K21A and 045L21A. The temperatures excursion range was reported as maximum 30 Fahrenheit degrees and minimum minus18.9 Fahrenheit degrees. The vaccines suffered 2 temperature excursions since April, both of which lasted less than 1 minute. The vials were stored frozen. Visual inspection did not noted any vaccine state change. No treatment medication were provided.
PT C/O AT APPROX 12PM THAT SHE FELT "FLUSHING" AND "TUNNEL VISION." STATES SHE FELT LIKE SHE WAS "GOING TO PASS OUT." 1203 :BP 180/98, P 120, R 14. BS CLEAR AND EQUAL. HAD PT LIE DOWN WITH FEET UP. 1210 : 159/116, P 104, R 14. 1215 : 144/111, P 104, R 16.  1215 : 144/111, 104. R 16.  1220 : 130/96, 83 , 14. 1225 : 133/90 P 83, R 14. PT FEELING MUCH BETTER. LEFT CLINIC W/O ASSISTANCE AND RETURNED TO WORK. SHE DID CONTACT CLINIC STAFF TO LET US KNOW SHE ARRIVED TO HER JOB WITHOUT PROBLEM AND FELT OK.
Information has been received from a physician concerning a 10 year old female who on 13-AUG-2007 was vaccinated SC (left) with a second dose of varicella virus vaccine live (Oka/Merck) (657944/0851U). On 15-AUG-2007, the patient developed injection site redness; injection site swelling 3 inches in diameter; injection site warmth to the touch; and a mildly painful injection site reaction. Additional information has been requested.
Patient became lethargic, increasingly suffered from delirium & hallucinations, leading to inability to walk.  ER visit resulted in no explanation.  Took him off meds, patient returned  to normal, added them back one at a time.  After adding Metformin, delirium began again so took him off medication again & he again returned to normal.  Doctors didn't prescribe new meds for diabetes, so Metformin was again re-added to control blood sugar, & again delirium and hallucinations began.  Patient had no issue with medication prior to 2nd dose of vaccine.  This occurred between 2/9/21 to currently.  He was recently in hospital after a car accident and was mistakenly given Metformin again, symptoms resumed and he's still recovering.
Tdap vaccine - not sure which specific one. 7 months pregnant with twins -delivered them 3 weeks later on 7/21/2018
No patients experienced symptoms; Improperly stored dose of PROQUAD was administered to the patient on 03-JUN-2020; This spontaneous report was received from a nurse referring to a patient of unknown age and gender.   The patient's concurrent conditions, medical history and concomitant medications were not reported.   On 03-JUN-2020, dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) subcutaneously, lot # S031705 and expiration date 06-APR-2021 (dose and frequency were not reported) as prophylaxis, which was improperly stored in a temperature of 17.2°F in a timeframe of 14 hours and 2 minutes and reconstituted with a properly stored sterile diluent (STERILE DILUENT MRK INJ HH) was administered to the patient.   It was reported that the call was made due to data logger and no previous temperature excursion occurred.  No adverse symptoms were reported for the patient.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA001624: US-009507513-2006USA001639: US-009507513-2006USA001645:
Patient reported feeling like she was going to "pass out". Patient reports syncope following her allergy shot once.
still can't see and her eyes have gotten terribly worse in the past year; states her eyesight feels like it is declining.; when she touches her eyelid hurts and feels like something is in her eye; swollen lymph node in her axillary region; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 07Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history included: "Lupus", start date: 1992 (ongoing), notes: she does have a mild case of Lupus but is not on any treatment for it. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose number: 02, Anatomical location: Arm), administration date: 15Mar2021, for Covid-19 immunization; BNT162b2 (Dose number: 01, Anatomical location: Arm), administration date: 22Feb2021, for Covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset Dec2021, outcome "not recovered", described as "swollen lymph node in her axillary region"; EYE DISORDER (non-serious), outcome "unknown", described as "still can't see and her eyes have gotten terribly worse in the past year"; VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "states her eyesight feels like it is declining."; EYELID PAIN (non-serious), outcome "not recovered", described as "when she touches her eyelid hurts and feels like something is in her eye". The event "swollen lymph node in her axillary region" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient expected some soreness when she got the vaccine and was not sick or fatigued like everybody else was talking about and the patient had no symptoms. About eyesight she recalls she just sent her doctor a message said she wants to see an ophthalmologist and she had glasses but did not see and her eyes have gotten terribly worse in the past year or year and a half and she did not say if it was before or after her Pfizer Covid vaccines or when it started; Said her right eye when she touches her eyelid hurts and feels like something is in her eye and this was going and coming and she reached out to her doctor and hopes it was not a cataract but does not know what it was; said the eyelid pain was ongoing and about the same as when it began; states her eyesight feels like it was declining. Patient did not receive any prior vaccinations (within 4 weeks). Husband had fatigue after his Moderna vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Okay, I was like really nauseous about 10 hours after, I had that for a couple of days, I vomited a couple times and I had the chills as well. It was not that different from my other two doses. Until I got the enlarged lymph nodes around 03/11/2022. I noticed it when I was taking a shower. The only other time I had an enlarged lymph node that lasted a few days within my 1st vaccine and it was very painful at the time. I could not even lift my arm really. The node after the 3rd dose took like 3-4 weeks to go down slowly. The doctor posterior cervically lymph adenopathy, he feels a reactive lymph node and feels it is not cancer. Repeat ultrasound is scheduled in about 2 weeks. I do not feel anything currently, I think it went away.
Generalized Tonic-Clonic afebrile seizure approx. 36 hrs after vaccination with DTaP #4, PCV #4, Hep B #3. 2 episodes as described with documentation. Temp elevation; no site reaction.
wheezing; congested; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 81-year-old male patient received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EL1283) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HHT (Hereditary Hemorrhagic Telangiectasia)", start date: 1963 (ongoing), notes: Numerous electrocautery sometimes under sedation ratio most recent was 28Nov2022; "Quad by pass for blocked arteries", start date: 2010 (unspecified if ongoing), notes: Quad by pass-2010 (Cannot take blood thinners due to HHT); "Chronic thromboembolic pulmonary hypertension", start date: Feb2021 (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Thyroid" (unspecified if ongoing); "Heart" (unspecified if ongoing); "Nose" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN taken for blood cholesterol abnormal (ongoing); LEVOTHYROXINE taken for thyroid disorder (ongoing); BETAPACE taken for cardiac disorder, start date: 2010 (ongoing); BACTROBAN CREAM nasal taken for nasal disorder (ongoing). The following information was reported: WHEEZING (non-serious), outcome "unknown"; NASAL CONGESTION (non-serious), outcome "unknown", described as "congested". Therapeutic measures were taken as a result of wheezing, nasal congestion.  Additional information: we received our 1st vaccine on 22Jan2021. I had no problem whatsoever. Her husband started wheezing and being congested, we did not suspect it could related to vaccine. We thought he had Bronchitis and the Dr. treated it as such, with antibiotics. He would get better and then it would start all over again. I think it was in May2021, He was diagnosed with Diabetes. The breathing problems continued. We saw a pulmonologist in May2022. He sent for CT with contrast of lungs. Showed blood clots. At that time, I made appts with the director of pulmonology at. He also happens to be the director of the (withheld) at (withheld). Her husband was put on Adempas and is now at full dose. Probably Feb2021, pertinent: We thought (withheld) had Bronchitis in Feb2021. Treated numerous times with antibiotics. In May2022 diagnosed with blood clots in lungs (which we were told actually shown up in Jul2021. We were not informed in '21'. In Jul2022 we went to (withheld) in (withheld). Diagnosed with CTEPH (Chronic thromboembolic pulmonary hypertension). The reason I contacted Pfizer was because I read an article about possible side issues from vaccine being blood clots. It is such a big coincidence I thought I should follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300020963 same patient/product, different event with dose;
Rapid heart rate, explosive cough that made me pee, chest pain, extreme fatigue, i felt like I had liquid in my lungs, fever, crusty eyes, shortness of breath
The same evening of the first vaccine dose I was dizzy, had brain fog, was extremely gassy, nauseous, and of course my arm was hurting at the vaccination site in my arm. The next morning, I felt very hot, dizzy and lethargic, I still couldn't think that well to where I was tripping over my words. I was sent home from work. I have no desire to eat anything but force myself to eat and drink to stay healthy. My stomach feels empty and light. I was tired all day. I've lost 6 pounds in three days. My arm pain has subsided greatly. I feel more energetic today but still no appetite. My knee joints hurt when walking or bending knees.
Myalgia & Diarrhea Narrative:  Employee called OHC to report side effects that occurred the night of vaccination and now getting better.
Tired, weakness, nausea/vomiting, severe chills, labored breathing, behavior change, muscle aches, restlessness, pale skin color, slight temperature. Recovery was 2 days.
Patient fainted (syncope) minutes after receiving vaccination. Patient was caught by a monitor and legal guardian and did not suffer any injuries. Legal guardian indicated that she has needle phobia and that her father faints when receiving vaccination. RN was onsite checked vitals of patient and were all stable. This occurred over the course of 8 minutes. Patient and guardian indicated she had previous incidents of syncope after receiving vaccination.
Be sure you get another shot if you were vaccinated before 2020 because that one was ineffective; I have shingles on my face and in my hair; This spontaneous report was received from a female patient of unknown age referring to herself via GlaxoSmithKline. The patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies were not reported.  On an unknown date (before 2020), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) subcutaneous injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).  On an unknown date in August 2022 (reported as "right now"), the patient experienced shingles on her face and in her hair. The patient's doctor gave her the information as the vaccine before 2020 was ineffective when she went to see what was wrong with her (Vaccination failure). The doctor also said that the vaccine had been taken off the market so she should be safe with the new shot. At the time of reporting, the outcome of both events was not reported.   The reporter considered vaccination failure to be related to zoster vaccine live (ZOSTAVAX). The causal relationship between shingles and zoster vaccine live (ZOSTAVAX) was not reported.
One week after receiving first dose, patient started to feel weak forearms. Client felt like he had pulled a muscle. Pain medications did not help patient. Patient went to PCP who conducted an EKG and blood work, all tests came back within normal range.
experiencing muscle pain in the injection arm; This case was reported by a pharmacist via call center representative and described the occurrence of injection site muscle pain in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site muscle pain. On an unknown date, the outcome of the injection site muscle pain was recovered/resolved.   It was unknown if the reporter considered the injection site muscle pain to be related to Shingrix.  Additional details were provided as follows: The age vaccination was not reported. The patient was vaccinated with 1st dose of Shingrix and experinced muscle pain in the injection arm. The reporter was patient. The reporter consent to follow up. This case was 1 of 4 cases reported by same patient. This case was linked with case US2020AMR202100 by patient link.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020201572:same reporter US-GLAXOSMITHKLINE-US2020201576:same reporter US-GLAXOSMITHKLINE-US2020201578:same reporter US-GLAXOSMITHKLINE-US2020AMR202100:same reporter
Starting 18 hours post-vaccination, patient began passing multiple bowel movements. Consistency was that of diarrhea and occurred 6 times in the following 24 hours. Patient also developed small rash around mouth that resembled the bumps of a heat rash. Since the vaccination, this has been almost constantly present on the patient's face. Additionally, patient now experiences sleep disturbances that seem to indicate digestive distress that was not previously present.
MENQUADFI administered to patient which underwent temperature excursion with low temperature of 0.5 degrees C with no reported adverse event; MENQUADFI administered to patient which underwent temperature excursion with low temperature of 0.5 degrees C with no reported adverse event; Initial information received on 18-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA157122(CLUSTER), 2023SA157726(CLUSTER), 2023SA157696(CLUSTER), 2023SA157752(CLUSTER), 2023SA157746(CLUSTER), 2023SA156938(CLUSTER), 2023SA157755(CLUSTER) and 2023SA157696(CLUSTER).  This case involves a 18 years old patient of unknown gender who was administered MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] which underwent temperature excursion with low temperature of 0.5 degrees C with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 08-May-2023, the patient received a dose of 0.5 ml (dose 2) of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE (Solution for injection) (lot: U7576AB; expiry date: 28-FEB-2025) via intramuscular route in the left arm for Immunization.  On 08-May-2023, the patient was administered menquadfi which underwent temperature excursion with low temperature of 0.5 degrees C with no reported adverse event (product storage error) (unknown latency) (poor quality product administered) (latency: same day).  It was reported, "Nurse says that the excursion was caused by additional gel packs being placed in the refrigerator. She asked for appropriate follow-up. The vaccines had been transported due to power outage and then cold packs were put into refrigerator and apparently made the refrigerator temperature drop."   Action taken was not applicable.  At time of reporting, the outcome was Unknown for both 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.
4 day after 2 month vaccines pt began high pitched screaming, had body stiffness and arm jerking.
Information has been received from a nurse practioner concerning a 25 year old female with a history of anemia (blood transfusion November, 2007) and drug reactions or allergies to penicillin and EFFEXOR (not specified) who on 09-APR-2008 was vaccinated with the first dose of GARDASIL intramuscularly in the arm. On 10-JUN-2008, the patient was vaccinated with the second dose of GARDASIL (lot#659655/1486U). On 10-OCT-2008, the patient was vaccinated with the third dose of GARDASIL (lot#661044/0548X). On 10-OCT-2008, the patient developed palpitations, tachycardia, nausea, and hot flashes within 30 minutes after the third dose of GARDASIL. On 10-OCT-2008 the patient was taken to the emergency room via ambulance and administered BENADRYL. The patient again experienced hot flashes, nausea, and tachycardia and went to the emergency room in the hospital where the patient works (date of treatment at the second emergency room is unknown). The patient underwent an electrocardiogram, chest X-ray, and unspecified lab work. The patient continues with symptoms of hot flashes, nausea and tachycardia that "comes and goes." The patient is out of work and has a follow up appointment with an unspecified primary care provider. The patient reported a similar reaction to EFFEXOR in the past (specified symptoms unspecified). No other symptoms or treatment reported. No other information available. Follow up AE information: The nurse practitioner called back to report that the patient has been diagnosed with thyroiditis. No further information was provided. Additional information has been requested.
Flushing; sweating; dizziness. BPs 147/94 (pulse 87), 136/78 (pulse 86).
After being given the shot pt was moved to a waiting area and was fine for a few minutes the fainted, and convulsing for about 20 to 30 seconds
The cases were received on 21 March 2014. Initial misuse report received from a healthcare professional on 23 September 2013. This case was linked to case # 2014SA041111 (same vaccine same reporter). A 68-year-old patient had received FLUZONE ID. It's an inappropriate age at vaccine administration. No adverse event was reported. List of documents held by sender: none.
Client reports approximately 1 hr after vaccination. Client had 5 min of dizziness and "eyesight diminished". Client did not pass out or lose consciousness.
Pt recvd MMR vax on 24APR91 & approx 13MAY91 devel rt ankle swelling & pain which was present intermittently for 2-3 wks;
dizzy; Felt odd; Couldn't sleep; blood pressure spiked to 151/85; Itchy arm; Tired; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of DIZZINESS (dizzy), FEELING ABNORMAL (Felt odd), INSOMNIA (Couldn't sleep), BLOOD PRESSURE MEASUREMENT (blood pressure spiked to 151/85) and PRURITUS (Itchy arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. #013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizzy), FEELING ABNORMAL (Felt odd), INSOMNIA (Couldn't sleep), BLOOD PRESSURE MEASUREMENT (blood pressure spiked to 151/85), PRURITUS (Itchy arm), FATIGUE (Tired) and HEADACHE (Headache). At the time of the report, DIZZINESS (dizzy), FEELING ABNORMAL (Felt odd), INSOMNIA (Couldn't sleep), BLOOD PRESSURE MEASUREMENT (blood pressure spiked to 151/85), PRURITUS (Itchy arm), FATIGUE (Tired) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Pt developed swelling, warmth, and redness at the injection site of left thigh. Treated with Benadryl and bacitracin ointment.
Oct 31 - First symptoms fever, chills, legs sore. Went home from work. Difficulty in moving Rt. arm. Dizziness, flush feeling. Arm sore for a couple of days.
Child had rash all over body, ran a temp. Mom stated rash had pustules, looked like chicken pox. Went to the doctor and was told it was a reaction to MMR.
cold frostbite like hands and feet; dizziness when warmed up too quickly; racing heart rate; trouble finding words; extreme fatigue; nausea; achiness at joints; swollen lymph nodes; This is a spontaneous report from a contactable nurse (patient herself). A 51-year-old female patient (not pregnant at time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL0140, expiry date unknown), via an unspecified route of administration (vaccine location: left arm), on 23Dec2020 17:00, at single dose, for covid-19 immunization. The patient had no medical history. There were no concomitant medications. The patient experienced cold frostbite like hands and feet, dizziness when warmed up too quickly, racing heart rate, trouble finding words, with extreme fatigue, nausea, achiness at joints, and swollen lymph nodes - all on 24Dec2020. These symptoms never left up until day 21 when the patient received her next shot. The patient had no other vaccine in four weeks, had no other medications in two weeks, had no Covid prior vaccination, and had not been Covid-tested post vaccination. It was unknown if treatment was received for the adverse events. The patient was recovering from the events.