chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No further AE details; PROQUAD was stored in the refrigerator instead of the freezer since 01DEC2020 and has since then been administered to patients; PROQUAD was also administered concomitantly with VARIVAX; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported.       It was reported that measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was stored in the refrigerator instead of the freezer since 01-DEC-2020. On 28-JAN-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength and route of administration were not reported, lot # T025221, expiration date 19-JAN-2022, therapy type: recombinant Human albumin (rHA)) at a dose of 0.5 milliliter for prophylaxis and varicella virus vaccine live (oka/merck) (VARIVAX) (strength, route of administration, lot # and expiration date were not reported) at a dose of 0.5 milliliter for prophylaxis (product storage error and inappropriate schedule of product administration).  It was reported that measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) vaccine was exposed to a temperature of 44 Fahrenheit (F) for a time frame of 1506 hours. There was no previous temperature excursion and the call was not due to a data logger. No further adverse event (AE) details were provided.  This is one of the several reports reported by the same reporter.; Sender's Comments:  US-009507513-2102USA000941: US-009507513-2102USA001248: US-009507513-2102USA001301: US-009507513-2102USA001487: US-009507513-2102USA001266:
12 days post injection of MMR and Tdap employee experienced bilateral swollen glands. No other symptoms.
Patient became distressed within 1 minute of injection.  Became sweaty and hot.  Pulse became elevated to 120 bpm.  After 20 minutes all symptoms returned to baseline.
paient got 3 rd  pfizer covid vaccine with doctor orders as patient did  not develope antibodies after 2 doses and patient is on transplant
Leakage during administration; This case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a 1-year-old female patient who received HAV (Havrix) (batch number F7X23, expiry date 5th May 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th December 2022, the patient received the 1st dose of Havrix and Havrix Pre-Filled Syringe Device. On 6th December 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-DEC-2022 Reporter's Comments: Registered nurse called in to report that the first dose of Havrix was administered but during the process, a leakage was witnessed, and the liquid fell on the table.  The incident took place on 6th December 2022  They inquired about how to proceed. The reporter consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter. Additional Supportive Information: The patient was administering with  1st dose of Havrix but during the process, a leakage was witnessed, and the liquid fell on the table, which led to incomplete dose administered. expiry date was captured as 5th May 2023 and due to lack of information administration error was not captured, as per conservative approach and clarification was raised for same.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2, Vaccine lot unknown reason: Not available/provided to reporter at the time of report completion), on 28Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 22Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 13Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 02May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Known allergies: No. Other medical history: None. There were no concomitant medications in 2weeks. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Anti Viral Details: Product: COVID 19 Treatment [Brand: Pfizer  Treatment start date: 28Sep2022, Treatment stop date: 02Oct2022, Lot number: 00069-1085-30, Indication: Treatment of COVID-19]. Rebound of Covid Symptoms 9 days after completing 5 days of Paxlovid and testing negative. Adverse event start date: 11Oct2022 07:00 PM. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; negative, notes: Rebound of Covid Symptoms 9 days after completing 5 days of Paxlovid and testing negative; Positive. Therapeutic measures were taken as a result of covid-19, vaccination failure.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
burning sensation from toes to knees bilaterally, onset 4 hours after her second shot. Persisting at time of MD eval 10/27/2021
Patient received the Bivalent vaccine for 2nd dose. Patient was in observation foe 15 min and did not have any adverse reactions.
lt breast side soreness, injection site soreness, swollen under arm, entire arm sore,...shoulder,
Dose 1- aprox 3-4 hrs after injection experienced rapid heart beat/palpitations lasting about a week Dose 2- aprox 3-4 hrs after injection experienced extreme rapid heart/palpitations and itching of extremities ongoing to current
Rash, Red patches, Hives from waist up, SEVERE itching that lasted 1 hour
Patient presented on Saturday 10/22/16 with a hematoma on left upper arm and complained of arm/shoulder soreness.
Pain in shoulder and arm. Swelling and redness of skin. Redness and pain spread to other parts of the upper arm. Went to urgent care on 03/22 and prescribed antibiotic for infection in the arm.
Red, warm L arm; BENADRYL 25 mg IM injection to R glut; TYLENOL 650 mg po advised to take BENADRYL 50 mg po bid & TYLENOL 650 mg.  f/u 4 days.
Information has been received from a medical assistant concerning a 16 year old female with no pertinent medical history who on 23-JUL-2007 was vaccinated with the first dose of GARDASIL vaccine (yeast). On 10-OCT-2007 the patient was vaccinated with the second dose of GARDASIL vaccine (yeast). On 18-FEB-2008 the patient was vaccinated with the third dose of GARDASIL vaccine (yeast). There was no concomitant medication. On 25-JUN-2008 the patient experienced alopecia. At the time of this report, the patient's alopecia persisted. The patient sought unspecified medical attention. Additional information has been requested.
Within 5 minutes of receiving the vaccine, I noticed my heart racing and fluttering. I asked one employee if this was normal and she replied that it could be anxiety. I waited another few minutes, as it got worse and asked another nurse. She got someone else to come over with a pulse oximeter and she took my blood pressure reading. My heart rate and blood pressure was high. My heart rate and blood pressure are always low normally. They brought me into another area for further onbaervation and kept me for another 45 minutes. By that time, I felt I was feeling well enough to leave with my husband picking me up. Now that I'm home, these effects seem to be coming and going. It is now 4:00 and I'm still having inadvertent fluttering of my heart.
This spontaneous report was received from a physician referring to a 3 years old patient of unknown gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On 18-AUG-2017, the patient was vaccinated with an improperly stored dose of VAQTA injection, lot # N008823, expiry date 26-MAY-2018 (dose, route of administration and site of the vaccination were not specified) for prophylaxis. The administered dose of VAQTA underwent a temperature excursion. The lowest temperature was 32 Fahrenheit degrees and the higher was 54 Fahrenheit degrees for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several cases received from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA007325: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1709USA012768.
The day I received the vaccine, I noticed that I feel thirsty later in the day. I didn't really take much into it and it seemed to be ok the next couple days. 5 days later, I woke up to extreme thirst and a very salty taste in my mouth. This continued until the day after two weeks after receiving the 2nd dose. It has now gone away so I think it was related. My doctor ran my AIC (fasting and not) the first week and several blood work on electrolytes, thyroid etc. Everything was normal and my blood sugar is controlled (as it was before the vaccine). I also had COVID in December (a mild case) and recovered fully. I also noted my urine was yellow (not scary, hospital) yellow but dark. No matter how much water I drank, it did not change. I also drank Gatorade etc. and that didn't change anything. After receiving the 2nd dose, two weeks later is when I noticed it start to be a little better and then two more days later, it went away.
About 3-4 hours after receiving the vaccine I had localized pain in my upper left chest area and in the exact same location on my back. It was definitely a muscular pain. Periodically I have a sharp pain in the underside of my left upper arm. I received the vaccine on my left arm. Additionally, the next day I woke up this morning with a red splotchy rash on my cheeks, chin and forehead that eventually faded away.
This previously healthy 1½-year-old male received a DTaP shot to his left thigh on 8/1 and, on 8/2, developed a rash on his left thigh. The rash worsened and he presented to the ED on 8/4 with an erythematous, somewhat blotchy macular rash encompassing approximately 70% of his thigh. The thigh was slightly swollen and warm to the touch. There was evidence of a puncture wound in the center of the rash that was consistent with a vaccination. The rash was consistent with cellulitis. He was started on clindamycin, admitted to the hospital, and discharged the same day.  10/6/08 Reviewed hospital medical records of 8/4/2008. FINAL DX: cellulitis left thigh/s/p vaccination; resolving acute left OM Records reveal patient experienced OM 8/1/08, tx w/oral antibiotics & given DTaP left thigh.  Developed macular blotchy rash left thigh next day.  Seen in outlying ER on 8/3, tx w/IM antibiotic, Rx for oral antibiotics & d/c to home.  Rash continued to worsen w/swelling & warmth of left thigh, fever 102.5 & admitted for IV antibiotics.  Improved & d/c home same day on continued oral antibiotics & PCP f/u.
staring spells began w/in 2wk of vax they occurred daily, 20 seconds in length, & as days went by more spells-up to a dozen-were witnessed w/in a 24hr period;dx petit mal sz by MD 15APR96 & 16APR96 neurologist dx complex partial sz;
Fractured his skull after 1st dose; Got into an accident after 1st dose; Dislocated his shoulder after 1st dose; Did not get 2nd dose within day 25-35 of the 1st dose; This spontaneous case was reported by a patient and describes the occurrence of SKULL FRACTURE (Fractured his skull after 1st dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKULL FRACTURE (Fractured his skull after 1st dose) (seriousness criterion medically significant), ACCIDENT (Got into an accident after 1st dose), JOINT DISLOCATION (Dislocated his shoulder after 1st dose) and INCOMPLETE COURSE OF VACCINATION (Did not get 2nd dose within day 25-35 of the 1st dose). At the time of the report, SKULL FRACTURE (Fractured his skull after 1st dose), ACCIDENT (Got into an accident after 1st dose), JOINT DISLOCATION (Dislocated his shoulder after 1st dose) and INCOMPLETE COURSE OF VACCINATION (Did not get 2nd dose within day 25-35 of the 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       As per report patient received his 1st dose in March and was scheduled for his 2nd dose in April. Patient was unable to received 2nd dose due to an accident. It has been 51 days since 1st dose.  No relevant concomitant medication information provided.  No relevant treatment medication information provided.  This is a case of incomplete course of vaccination. Based on the current available information and temporal association between the use of the product and the start date of the rest of the events, a causal relationship cannot be excluded.; Sender's Comments: This is a case of incomplete course of vaccination. Based on the current available information and temporal association between the use of the product and the start date of the rest of the events, a causal relationship cannot be excluded.
Generalized Aching; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Generalized Aching), CHILLS (chills) and PYREXIA (fever) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced PAIN (Generalized Aching), CHILLS (chills) and PYREXIA (fever). At the time of the report, PAIN (Generalized Aching), CHILLS (chills) and PYREXIA (fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment medications were provided
This spontaneous report has been received from a healthcare worker (also reported as clinical manager) refers to a patient of unknown age and gender who on 05-DEC-2014 was vaccinated with a dose of ZOSTAVAX (strength, dose and route not reported, lot # K003597, expiration date: 12-MAR-2015), that had been improperly stored. The temperature during the excursion was unknown, as it was not monitored. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a pharmacy intern reporting that there were an unspecified number of doses of MMR II (lot # not reported) that were improperly stored. The reporter did not know if any doses were administered to any patient. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Extreme headache,  very sore neck and back, rash at injection site and on my back, numb and tingling feet and my toes felt raw, nausea and diarrhea, and blurry vision. I took Benadryl orally, injected myself with my Epi-Pen, put Hydrocorticone on the rash, took Tylenol and 1of  my Methocarbamol 750mg.  I called the 24 hour pharmacy that was on the recording and they were "experiencing problems with their phones".  So, as a Certified EMT, I monitored myself and felt I was ok to stay home.  I am experiencing some of the side effects today, but of less intensity.  I did talk with my doctors office and she was off today, but they were to send her a message with all this info and if I get worse, I am to go to Urgent Care right away.
rash; developed symptoms of covid on 27Dec / on 30Dec2020 he tested positive for the virus / cough; developed symptoms of covid on 27Dec / on 30Dec2020 he tested positive for the virus / cough; This is a spontaneous report from a contactable consumer (patient).   A 63-year-old male patient received the 1st does of bnt162b2 (BNT162B2) at single dose left upper arm on 23Dec2020 for Covid-19 immunisation, administered at hospital.  Medical history included ongoing hypertension that began maybe 10 years before and still ongoing, controlled with medication. No family medical history relevant to the events. The concomitant medications included paracetamol (TYLENOL). History of all previous immunization with the Pfizer vaccine considered as suspect was none. No additional vaccines administered on same date of the suspect. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. He has not had reactions to any other vaccines. On 30Dec2020 he tested positive for Covid. His symptoms of covid started 27Dec2020 in the evening sometime probably around 7pm. He experienced cough in Dec2020. No visit to physician office was required. On the 06Jan2021 he went to the emergency room but that was because he was concerned about rash he developed. He thought it was due to the Tylenol he was taking. Relevant tests performed in Ja2021 included: blood work and chest X-ray did when he went in for the rash and they were was fine. He was treated with steroid injection for the rash. The rash cleared up in the next couple days. As of 12Jan2021 the only thing he has cough but he coughs anyway. He still had a cough but it was not atypical for him to have a cough. He was scheduled to receive his second dose on 13Jan2021. He no longer had any Covid symptoms and wanted to know if he could still get the second dose as scheduled. The outcome of event tested positive for the virus and not recovered was unknown, of coughs was not recovered. A Product Complaint was filed.  Information on lot/batch number has been requested.
Red, warm, itchy rash started as one hard lump the size of 1/2 a dime, is now 1 1/2 wide, 2 1/2 tall surrounding injection site. Quarter sized bruise about 2? below injection site. Acne on right arm and chin. Hard, painful lump in right underarm.
This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Moderna product on 02/10/2021, 03/10/2021, and 1/09/2021.  The individual tested positive for COVID-19 on 09/30/2022 at the residential facility at which they were a resident. They were seen in emergency department later in the day on 09/30/2022 with chief complaints of vomiting and fever. Symptom onset was thought to be 09/30/2022. They were given fluids , IV bebtelivomab, and acetaminophen . They were not hospitalized but were discharged back to residential facility. They were then seen in a clinic for 10/12/2022 for a "well adult exam." After that, their condition then deteriorated with increased seizure activity and fevers. They died on 10/17/2022.
metallic taste of tongue; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (metallic taste of tongue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-May-2021, the patient experienced DYSGEUSIA (metallic taste of tongue). At the time of the report, DYSGEUSIA (metallic taste of tongue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.   Treatment information was not provided.
Skin puffed up at injection site; at about 5 and 1/2 hours after shot, had chills and achiness that progressed to trembling; then fever; trembling made it hard to take medicine.
Did not seroconvert following booster MMR vaccine (Rubeola IgG level decreased after vaccine).
Skin rash - red bump at injection site.  Ice / ibuprofen to ease pain
2/15/06 - child slept through the night,8:00 am woke up with Blotchy, Red, Swollen, hive like areas on body with systemic rash. No respiratory distress. Decreased eating habits throughout entire time frame of reaction. Temp. ranging from 99.9-100.6 for several days. No complaints of pain. Mom states he was fussy, but not itching. 10AM on 2/16/06 seen local physician. Had been receiving amoxicillin (10 day dosage) for week prior to vaccination for ear inf. Only given Tylenol for reaction symptoms. No other tx. given. Mom states it did take until Friday for rash to begin disappearing. At this point, rash felt very sandpapery. Redness/blotch/swelling was down, but redness would continue if he got too hot or if he cried. Complete recovery with appetite returned to normal.
Can you advise.  Following 2nd Pfizer vaccine onFeb 20, 2021 (day 27 , delayed due to snow storm), I did well.  Milld left arm pain. About 4-5 weeks later I developed mod-severe left shoulder pain, subsequently dx'd as Frozen Shoulder, and now in PT, schedule'd for cortisone inj (interventional )tomorrow.  I am retired internist, know of SIRVA, and this pain clearly did not occur on days 1-3.  But I have never had Left shoulder prob, am aware that some feel this syndrome is auto-immune, so am concerned that vaccine started this cascade of symptoms. Xray was normal (No other imaging done). Also could the vaccine have been given improperly, so that I am not protected?  Has frozen shoulder been reported with COVID Vac
This is a spontaneous report received from a contactable reporter (consumer or other non HCP) from the Medical Information Team. The reporter is the patient.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 11Feb2021 (Lot number: EL9267) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "bad aortic valve" (ongoing), notes: the patient has a bad aortic valve and will have surgery for it. The patient's concomitant medications were not reported. The following information was reported: TOOTHACHE (non-serious) with onset 2021, outcome "unknown", described as "Dental pain". Additional information: The patient's second dose was scheduled on 04Mar2021.  No follow-up attempts are possible. No further information is expected.
Myalgia, Arthralgia, Diarrhea, NauseaVomiting, Low back pain and fatigue Narrative: